Merck Sharp & Dohme Corp.

Manufacturer Details

There are currently no manufacturer details available.

Merck Sharp & Dohme Corp. Drugs

Revalor-ih

Revalor-ih

DOSAGE

One implant containing 80 mg trenbolone acetate and 8 mg estradiol is administered to each animal. The 4 pellets which make up the dosage of Revalor®-IH are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge. The cartridge is designed to be used with a special implant gun.
Revalor-200

Revalor-200

DOSAGE

One implant containing 200 mg trenbolone acetate and 20 mg estradiol is administered to each animal. The 10 pellets which make up the dosage of Revalor®-200 are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge. The cartridge is designed to be used with a special implant gun.
Revalor-h

Revalor-h

DOSAGE

One implant containing 140 mg trenbolone acetate and 14 mg estradiol is administered to each animal. The 7 small pellets which make up the dosage of Revalor®-H are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge.

The cartridge is designed to be used with a special implant gun.
Revalor-xs

Revalor-xs

One implant containing 200 mg trenbolone acetate and 40 mg estradiol is administered to each animal. The 10 pellets which make up the dosage of Revalor®-XS are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge. The cartridge is designed to be used with a special implant gun.
Safe-guard

Safe-guard

Directions: The daily dose for Safe-Guard® Canine is 50 mg/kg (22.7 mg/lb) of body weight. You should weigh your dog to make sure you are using the right dose; i.e. correct gram amount and appropriate number of pouches.

Your dog must be treated with the following dose for 3 days in a row.
Dog Weight(lbs) Pouch Size(Daily Dose) * Combine pouches to obtain recommended daily dosage. 10 1 gram 11 to 20 2 gram 21 to 30* 1 gram + 2 gram 31 to 40 4 gram 41 to 50* 1 gram + 4 gram 51 to 60* 2 gram + 4 gram 61 to 80* Two 4 gram Over 80* Mix daily dose with a small amount of the usual food. Make sure your dog eats all the medicated food. You may need to moisten dry dog food to aid mixing.Repeat the dose for 3 days in a row.
Safe-guard

Safe-guard

Directions: The daily dose for Safe-Guard® Canine is 50 mg/kg (22.7 mg/lb) of body weight. You should weigh your dog to make sure you are using the right dose; i.e. correct gram amount and appropriate number of pouches.

Your dog must be treated with the following dose for 3 days in a row.
Dog Weight (lbs) Pouch Size (Daily Dose) * Combine pouches to obtain recommended daily dosage. 10 1 gram 11 to 20 2 gram 21 to 30* 1 gram + 2 gram 31 to 40 4 gram 41 to 50* 1 gram + 4 gram 51 to 60* 2 gram + 4 gram 61 to 80* Two 4 gram Over 80* Mix daily dose with a small amount of the usual food. Make sure your dog eats all the medicated food. You may need to moisten dry dog food to aid mixing. Repeat the dose for 3 days in a row.
Safe-guard

Safe-guard

Directions: The daily dose for Safe-Guard® Canine is 50 mg/kg (22.7 mg/lb) of body weight. You should weigh your dog to make sure you are using the right dose; i.e. correct gram amount and appropriate number of pouches.

Your dog must be treated with the following dose for 3 days in a row.
Dog Weight(lbs) Pouch Size(Daily Dose) * Combine pouches to obtain recommended daily dosage. 10 1 gram 11 to 20 2 gram 21 to 30* 1 gram + 2 gram 31 to 40 4 gram 41 to 50* 1 gram + 4 gram 51 to 60* 2 gram + 4 gram 61 to 80* Two 4 gram Over 80* Mix daily dose with a small amount of the usual food. Make sure your dog eats all the medicated food. You may need to moisten dry dog food to aid mixing.

Repeat the dose for 3 days in a row.
Panacur C Canine

Panacur C Canine

Directions:

The daily dose for Panacur® C is 50 mg/kg (22.7 mg/lb) of body weight. Please refer to the following dosing table for help in finding the right dose for your dog.
Dosing Table Dog Weight Packet Size* * Packet size is the daily dose. The dog must be treated with this dose for 3 days in a row. 10 pounds 1 gram 20 pounds 2 gram 30 pounds 1 gram + 2 gram 40 pounds 4 gram 50 pounds 1 gram + 4 gram 60 pounds 2 gram + 4 gram 80 pounds Two 4 gram Over 80 pounds Use combinations to obtain recommended daily dose. You should weigh your dog to make sure you are using the right size and number of packets. If your dog's weight is in-between the suggested dosing sizes, it is safe to use the next higher size. For example, a 15-pound dog should be treated with the 2-gram packet. Give Panacur® C to your dog by mixing the daily dose with a small amount of the usual food. Make sure your dog eats all of the medicated food. You may need to moisten dry dog food to aid mixing. Repeat the daily dose for three days in a row.
Recommended Deworming Schedule:

Deworming schedules may vary depending on the climate where you live and the activity of your dog. The following schedule should be used as general guidance. Newly weaned pups (6 to 8 weeks of age) should be dewormed at 6, 8, 10, and 12 weeks of age. Treat the dam at the same time as the puppies. Dogs over six months of age should be dewormed at least twice each year. Each deworming requires 3 daily treatments. (See Directions)
Garasol

Garasol

DOSAGE AND ADMINISTRATION

Chickens: Each day-old chicken should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 0.2 mg gentamicin in a 0.2-mL dose. This concentration can be provided by diluting GARASOL Injection as follows:
GARASOL mL Sterile Saline mL # Doses Dose/Chicken mL 1 99 500 0.2 2 198 1000 0.2 4 396 2000 0.2 10 990 5000 0.2 100 (1 bottle) 9900 50000 0.2
Turkeys: Each 1- to 3-day-old turkey should be aseptically injected subcutaneously in the neck with GARASOL Injection diluted with sterile, physiologic saline solution to provide 1 mg gentamicin in a 0.2-mL dose. The dose should be injected under the loose skin on top of the neck, halfway between the head and base of the neck. This concentration can be provided by diluting GARASOL Injection as follows:
GARASOL mL Sterile Saline mL # Doses Dose/Turkey mL 1 19 100 0.2 2 38 200 0.2 4 76 400 0.2 10 190 1000 0.2 100 (1 bottle) 1900 10000 0.2
Clean and sterilize needles and syringes by boiling in water for 15 minutes prior to use.

Disinfect the injection site and top of the bottle with a suitable disinfectant, such as 70% isopropyl alcohol. Use all precautions to prevent contamination of vial contents.
Panacur C Canine

Panacur C Canine

Directions:

The daily dose for Panacur® C is 50 mg/kg (22.7 mg/lb) of body weight. Please refer to the following dosing table for help in finding the right dose for your dog.
Dosing Table Dog Weight Packet Size* * Packet size is the daily dose. The dog must be treated with this dose for 3 days in a row. 10 pounds 1 gram 20 pounds 2 gram 30 pounds 1 gram + 2 gram 40 pounds 4 gram 50 pounds 1 gram + 4 gram 60 pounds 2 gram + 4 gram 80 pounds Two 4 gram Over 80 pounds Use combinations to obtain recommended daily dose. You should weigh your dog to make sure you are using the right size and number of packets. If your dog's weight is in-between the suggested dosing sizes, it is safe to use the next higher size. For example, a 15-pound dog should be treated with the 2-gram packet. Give Panacur® C to your dog by mixing the daily dose with a small amount of the usual food. Make sure your dog eats all of the medicated food. You may need to moisten dry dog food to aid mixing. Repeat the daily dose for three days in a row.
Regumate

Regumate

DOSAGE AND ADMINISTRATION:

While wearing protective gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Remove cover from bottle dispensing tip and connect luer lock syringe (without needle). Draw out appropriate volume of Regu-Mate® solution. (Note: Do not remove syringe while bottle is inverted as spillage may result.) Detach syringe and administer solution orally at the rate of 1 mL per 110 pounds body weight (0.044 mg/kg) once daily for 15 consecutive days. Administer solution directly on the base of the mare's tongue or on the mare's usual grain ration. Replace cover on bottle dispensing tip to prevent leakage. Excessive use of a syringe may cause the syringe to stick; therefore, replace syringe as necessary.
DOSAGE CHART: Approximate Weight In Pounds Dose in mL 770 7 880 8 990 9 1100 10 1210 11 1320 12
WHICH MARES WILL RESPON D TO REGU-MATE® (altrenogest) SOLUTION 0.22%: Extensive clinical trials have demonstrated that estrus will be suppressed in approximately 95% of the mares within three days; however, the post-treatment response depended on the level of ovarian activity when treatment was initiated. Estrus in mares exhibiting regular estrus cycles during the breeding season will be suppressed during treatment; these mares return to estrus four to five days following treatment and continue to cycle normally. Mares in winter anestrus with small follicles continued in anestrus and failed to exhibit normal estrus following withdrawal.

Response in mares in the transition phase between winter anestrus and the summer breeding season depended on the degree of follicular activity. Mares with inactive ovaries and small follicles failed to respond with normal cycles post-treatment, whereas a higher proportion of mares with ovarian follicles 20 mm or greater in diameter exhibited normal estrus cycles post-treatment. Regu-Mate® (altrenogest) Solution 0.22% was very effective for suppressing the prolonged estrus behavior frequently observed in mares during the transition period (February, March and April). In addition, a high proportion of these mares responded with regular estrus cycles post-treatment.

SPECIFIC USES FOR REGU-MATE® (altrenogest) SOLUTION 0.22%:

SUPPRESSION OF ESTRUS TO:
Facilitate attainment of regular cycles during the transition period from winter anestrus to the physiological breeding season. To facilitate attainment of regular cycles during the transition phase, mares should be examined to determine the degree of ovarian activity. Estrus in mares with inactive ovaries (no follicles greater than 20 mm in diameter) will be suppressed but these mares may not begin regular cycles following treatment. However, mares with active ovaries (follicles greater than 20 mm in diameter) frequently respond with regular post-treatment estrus cycles. Facilitate management of the mare exhibiting prolonged estrus during the transition period. Estrus will be suppressed in mares exhibiting prolonged behavioral estrus either early or late during the transition period. Again, the posttreatment response depends on the level of ovarian activity. The mares with greater ovarian activity initiate regular cycles and conceive sooner than the inactive mares. Regu-Mate® (altrenogest) Solution 0.22% may be administered early in the transition period to suppress estrus in mares with inactive ovaries to aid in the management of these mares or to mares later in the transition period with active ovaries to prepare and schedule the mare for breeding. Permit scheduled breeding of mares during the physiological breeding season. To permit scheduled breeding, mares which are regularly cycling or which have active ovarian function should be given Regu-Mate® (altrenogest) Solution 0.22% daily for 15 consecutive days beginning 20 days before the date of the planned estrus. Ovulation will occur 5 to 7 days following the onset of estrus as expected for non-treated mares. Breeding should follow usual procedures for mares in estrus. Mares may be regulated and scheduled either individually or in groups.
Panacur C Canine

Panacur C Canine

Directions:

The daily dose for Panacur® C is 50 mg/kg (22.7 mg/lb) of body weight. Please refer to the following dosing table for help in finding the right dose for your dog.
Dosing Table Dog Weight Packet Size* * Packet size is the daily dose. The dog must be treated with this dose for 3 days in a row. 10 pounds 1 gram 20 pounds 2 gram 30 pounds 1 gram + 2 gram 40 pounds 4 gram 50 pounds 1 gram + 4 gram 60 pounds 2 gram + 4 gram 80 pounds Two 4 gram Over 80 pounds Use combinations to obtain recommended daily dose. You should weigh your dog to make sure you are using the right size and number of packets. If your dog's weight is in-between the suggested dosing sizes, it is safe to use the next higher size. For example, a 15-pound dog should be treated with the 2-gram packet. Give Panacur® C to your dog by mixing the daily dose with a small amount of the usual food. Make sure your dog eats all of the medicated food. You may need to moisten dry dog food to aid mixing. Repeat the daily dose for three days in a row.
Matrix

Matrix

Dosage and Directions: While wearing protective gloves, remove shipping cap and seal; replace with enclosed plastic dispensing cap. Connect the Matrix® Dosing Device to the solution bottle according to the dosing device instructions provided as an attachment to the Matrix® Dosing Device package.

Administer 6.8 mL (15 mg altrenogest) per gilt once daily for 14 consecutive days. Treat gilts on an individual animal basis by top-dressing MATRIX® on a portion of each gilt's daily feed allowance. To produce the desired synchronization of estrus in a group of gilts, treat all of the gilts daily for the same 14-day period.
Revalor-s

Revalor-s

DOSAGE

One implant containing 120 mg trenbolone acetate and 24 mg estradiol is administered to each animal. The 6 pellets which make up the dosage of Revalor®-S are contained in one division of the multiple dose cartridge. Ten doses are in each cartridge. The cartridge is designed to be used with a special implant gun.

ROUTE OF ADMINISTRATION

The implant is placed under the skin on the posterior aspect of the ear by means of a special implanter available from Intervet Inc.

With the animal suitably restrained, the skin on the outer surface of the ear should be cleaned. The implant is then administered by the method shown in the diagram below.
Revalor-is

Revalor-is

There is currently no dosage information available for this product. We apologize for any inconvenience.
Panacur

Panacur

The dose for Felidae and Ursidae is 10 mg/kg BW daily for 3 consecutive days. Please see INDICATIONS for details as to claims for animal and parasite.

Directions: The daily dose of 10 mg/kg (4.54 mg/lb) can be achieved as follows:

Using a gram scale, weigh out 1 gram of Panacur® Granules 22.2% for each 22 kg or 50 lbs body weight.

50 mg/kg (22.7 mg/lb) daily for 3 consecutive days for the removal of ascarids (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala), whipworms (Trichuris vulpis), and tapeworms (Taenia pisiformis).

The daily dosage of 50 mg/kg (22.7 mg/lb) can be achieved as follows:

Using a gram scale, weigh out 1 gram of Panacur® (fenbendazole) Granules 22.2% for each 4.44 kg or 10 lbs body weight.

Daily dosages must be repeated for 3 consecutive days. Mix the appropriate amount of drug with a small amount of the usual food: dry dog food may require slight moistening to facilitate mixing with the drug.
Beuthanasia-d Special

Beuthanasia-d Special

Dosage: Dogs, 1 mL for each 10 pounds of body weight.

Administration: Intravenous injection is preferred. Intracardiac injection may be made when intravenous injection is impractical, as in a very small dog or in a comatose dog with impaired vascular functions. Good injection skill is necessary for intracardiac injection.

The calculated dose should be given in a single bolus injection.

For intravenous injection, a needle of sufficient gauge to ensure intravenous placement of the entire dose should be used. The use of a Luer-Lok® syringe is recommended to prevent accidental exposure due to needle/syringe separation.
Amoxi-mast

Amoxi-mast

DOSAGE AND ADMINISTRATION: Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy antiseptic. Dry thoroughly. Clean and disinfect the teat with alcohol swabs provided in the carton. Remove the syringe tip cover and insert the tip of the syringe into the teat orifice. Express the suspension into the quarter with gentle and continuous pressure. Withdraw the syringe and grasp the end of the teat firmly. Massage the medication up into the milk cistern.

For optimum response, the drug should be administered by intramammary infusion in each infected quarter as described above. Treatment should be repeated at 12-hour intervals for a total of 3 doses. At the next routine milking after the last dose, the treated quarter should be milked out and the milk discarded.

Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.
Nuflor

Nuflor

DOSAGE AND ADMINISTRATION For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot): NUFLOR Injectable Solution should be administered by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, NUFLOR Injectable Solution can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

For control of respiratory disease in cattle at high-risk of developing BRD: Nuflor Injectable Solution should be administered by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.
NUFLOR Injectable Solution DOSAGE GUIDE ANIMAL WEIGHT(lbs) IM NUFLOR DOSAGE 3.0 mL/100 lb Body Weight(mL) SC NUFLOR DOSAGE 6.0 mL/100 lb Body Weight (mL) Recommended Injection Location 100 3.0 6.0 200 6.0 12.0 300 9.0 18.0 400 12.0 24.0 500 15.0 30.0 600 18.0 36.0 Do not inject more than 10 mL per injection site. 700 21.0 42.0 800 24.0 48.0 900 27.0 54.0 1000 30.0 60.0
Clinical improvement should be evident in most treated subjects within 24 hours of initiation of treatment. If a positive response is not noted within 72 hours of initiation of treatment, the diagnosis should be re-evaluated.
Dariclox

Dariclox

DOSAGE AND ADMINISTRATION: Milk out udder completely. Wash udder and teats thoroughly with warm water containing a suitable dairy antiseptic. Dry thoroughly. Clean and disinfect the teat with alcohol swabs provided in the carton. Remove the syringe tip cover and insert the tip of the syringe into the teat orifice. Express the suspension into the quarter with gentle and continuous pressure. Withdraw the syringe and grasp the end of the teat firmly. Massage the medication up into the milk cistern.

For optimum response the drug should be administered by intramammary infusion in each infected quarter as described above. Treatment should be repeated at 12-hour intervals for a total of 3 doses. The treated quarter should be milked out at the next routine milking.

Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.
Orbenin-dc

Orbenin-dc

DOSAGE AND ADMINISTRATION: At the last milking of lactation, milk the cow out normally. Clean and disinfect the teats with alcohol swabs provided in the carton, and infuse 1 syringe of Orbenin-DC, which has been warmed to room temperature, into each quarter. Do not milk out. The cow may be milked as usual when she calves.

The extent of subclinical and latent mastitis in a herd is frequently greater than suspected. In untreated herds a significant buildup of subclinical mastitis may occur during the dry period, which results in clinical severity after a few lactations. The adverse influence of subclinical mastitis on milk yield, the risk of cross-infection, and the chance of clinical mastitis flare-up make it necessary to treat the matter as a herd problem. Clinical studies have proven the value of treating all the cows in heavily infected herds as they are dried off. When the herd infection has been reduced, it may be desirable to be more selective in treating infected quarters.

Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.
Otomax

Otomax

The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area. After verifying that the eardrum is intact, instill 4 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (2 drops from the 215 g bottle) of OTOMAX ointment twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more. Massage external ear canal carefully after instillation to ensure appropriate distribution of medication. Therapy should continue for 7 consecutive days.
Mometamax

Mometamax

The external ear canal should be thoroughly cleaned and dried before treatment. Verify that the eardrum is intact. For dogs weighing less than 30 lbs, instill 4 drops from the 7.5 g, 15 g, and 30 g bottles (2 drops from the 215 g bottle) of MOMETAMAX Otic Suspension once daily into the ear canal. For dogs weighing 30 lbs or more, instill 8 drops from the 7.5 g, 15 g, and 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.
Primaxin Iv

Primaxin Iv

There is currently no dosage information available for this product. We apologize for any inconvenience.
Primaxin Iv

Primaxin Iv

There is currently no dosage information available for this product. We apologize for any inconvenience.
Cancidas

Cancidas

There is currently no dosage information available for this product. We apologize for any inconvenience.
Integrilin

Integrilin

Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.

The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.

2.1 Dosage in Acute Coronary Syndrome (ACS)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy Aspirin, 160 to 325 mg, should be given daily
INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:
During Medical Management: Target aPTT 50 to 70 seconds If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h. If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h. During PCI: Target ACT 200 to 300 seconds If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds. Heparin infusion after the PCI is discouraged.
2.2 Dosage in Percutaneous Coronary Intervention (PCI)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended. In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery. Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI. Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.
Patients requiring thrombolytic therapy should discontinue INTEGRILIN.

2.3 Important Administration Instructions
Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top. Discard any unused portion left in the vial.
Administer INTEGRILIN by volume according to patient weight (see Table 1).
Table 1: INTEGRILIN Dosing Charts by Weight Patient Weight 180-mcg/kgBolus Volume 2-mcg/kg/minInfusion Volume(CrCl greater than or equal to 50 mL/min) 1-mcg/kg/minInfusion Volume(CrCl less than 50 mL/min) (kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) 37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h 42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h 47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h 54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h 60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h 66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h 72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h 79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h 85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h 91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h 97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h 104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h 110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h 116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h >121 >267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h
Gentocin Durafilm

Gentocin Durafilm

DOSAGE AND ADMINISTRATION The topical application of GENTOCIN DURAFILM Ophthalmic Solution should, in each instance, be administered to meet the specific needs of the individual case. One or two drops of the solution may be instilled into the conjunctival sac three or four times a day. Thereafter, the frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.
Chorulon

Chorulon

DOSAGE AND ADMINISTRATION

To reconstitute, transfer the contents of one vial of sterile diluent into one vial of freeze-dried powder. The resulting 10 mL of CHORULON® contains 10,000 I.U. chorionic gonadotropin.

COWS: The contents of one vial (10 mL) of reconstituted CHORULON® should be administered as a single deep intramuscular injection. Dosage may be repeated in 14 days if the animal's behavior or rectal examination of the ovaries indicates the necessity for retreatment.

FINFISH: CHORULON® should be administered via intramuscular injection just ventral to the dorsal fin for one (1) to three (3) injections. Any single injection should be administered, depending on the fish species, at a dose of 50 to 510 I.U./lb body weight (bw) for males and 67 to 1816 I.U./lb bw for females. Depending on body weight and dose administered, it may be necessary to divide the dose among two or more injection sites to avoid injecting a large volume at a single site.

Summaries of doses tested in representative fish species are contained within the following tables. The dose of CHORULON® to be used in other species of finfish may differ from those species listed in the tables, but should fall within the suggested range of 50 to 510 I.U./lb bw for males and 67 to 1816 I.U./lb bw for females.
Table 1: Tested Fish Species/Dose Combinations Found to be Effective Nomenclature Common Name, Genus & Species, Family Tested Dose(s)(I.U./lb bw/injection) Number of Injections Injection Interval (h) Males Females Footnotes: 1, nt = not tested yellow perch, Perca flavescens, Percidae nt1 67-300 1 - striped bass, Morone saxitilis, Percichthyidae 50-500 75-252 1 - white bass, Morone chrysops, Percichthyidae 65-510 91-750 1 - razorback sucker, Xyrauchen texanus, Catostomidae nt 100 3 24 walleye, Stizostedion vitreum, Percidae 75-400 145-830 1-3 72 red snapper, Lutjanus campechanus, Lutjanidae 250 500 1 - sauger, Stizostedion canadense, Percidae 500 500-1000 1 - Chinese catfish, Clarius fuscus, Clariidae nt 1816 1 - Table 2: Tested Fish Species/Dose Combinations Found to be Safe Nomenclature Common Name, Genus & Species, Family Tested Dose(s)(I.U./lb bw/injection) Number of Injections Injection Interval (h) Males Females white bass, Morone chrysops, Percichthyidae 750 1500 1 - walleye, Stizostedion vitreum, Percidae 750 1500 1 - grass carp, Ctenopharyngodon idella, Cyprinidae 2500 5000 1 - channel catfish, Ictalurus punctatus, Ictaluridae 2500 5000 1 -
Nitro-dur

Nitro-dur

The suggested starting dose is between 0.2 mg/hr1 and 0.4 mg/hr1. Doses between 0.4 mg/hr1 and 0.8 mg/hr1 have shown continued effectiveness for 10 to 12 hours daily for at least 1 month (the longest period studied) of intermittent administration. Although the minimum nitrate-free interval has not been defined, data show that a nitrate-free interval of 10 to 12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12 to 14 hours and a daily patch-off period of 10 to 12 hours.

Although some well-controlled clinical trials using exercise tolerance testing have shown maintenance of effectiveness when patches are worn continuously, the large majority of such controlled trials have shown the development of tolerance (ie, complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustment, even to levels much higher than generally used, did not restore efficacy.
1 Release rates were formerly described in terms of drug delivered per 24 hours. In these terms, the supplied NITRO-DUR systems would be rated at 2.5 mg/24 hours (0.1 mg/hour), 5 mg/24 hours (0.2 mg/hour), 7.5 mg/24 hours (0.3 mg/hour), 10 mg/24 hours (0.4 mg/hour), and 15 mg/24 hours (0.6 mg/hour).
Diprolene Af

Diprolene Af

Apply a thin film of DIPROLENE AF Cream to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved. DIPROLENE AF Cream is a high-potency corticosteroid. Treatment with DIPROLENE AF Cream should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

DIPROLENE AF Cream should not be used with occlusive dressings unless directed by a physician.

DIPROLENE AF Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Diprolene

Diprolene

Apply a few drops of DIPROLENE Lotion to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Lotion is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Lotion should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

DIPROLENE Lotion should not be used with occlusive dressings unless directed by a physician.

DIPROLENE Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Stromectol

Stromectol

Strongyloidiasis

The recommended dosage of STROMECTOL for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table 1 for dosage guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.) In general, additional doses are not necessary. However, follow-up stool examinations should be performed to verify eradication of infection. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Table 1: Dosage Guidelines for STROMECTOL for Strongyloidiasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-24 1 tablet 25-35 2 tablets 36-50 3 tablets 51-65 4 tablets 66-79 5 tablets ≥80 200 mcg/kg
Onchocerciasis

The recommended dosage of STROMECTOL for the treatment of onchocerciasis is a single oral dose designed to provide approximately 150 mcg of ivermectin per kg of body weight. See Table 2 for dosage guidelines. Patients should take tablets on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.) In mass distribution campaigns in international treatment programs, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as 3 months.
Table 2: Dosage Guidelines for STROMECTOL for Onchocerciasis Body Weight (kg) Single Oral Dose Number of 3-mg Tablets 15-25 1 tablet 26-44 2 tablets 45-64 3 tablets 65-84 4 tablets ≥85 150 mcg/kg
Aminohippurate Sodium P...

Aminohippurate Sodium Pah

For intravenous use only

Clearance measurements using single injection techniques are generally inaccurate, particularly in the measurement of ERPF. For this reason, intravenous infusions at fixed rates are used to sustain the plasma PAH concentration at the desired level.

To measure ERPF, the concentration of PAH in the plasma should be maintained at 2 mg per 100 mL, which can be achieved with a priming dose of 6 to 10 mg/kg and an infusion dose of 10 to 24 mg/min.

As a research procedure for the measurement of TmPAH, the plasma level of PAH must be sufficient to saturate the capacity of the tubular secretory cells. Concentrations from 40 to 60 mg per 100 mL are usually necessary.

Technical details of these tests may be found in Smith {1}; Wesson {2}; Bauer {3}; Pitts{4}; and Schnurr {5}.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. NOTE: The normal color range for this product is a colorless to yellow/brown solution. The efficacy is not affected by color changes within this range.

Calculations

Effective Renal Plasma Flow (ERPF)

The clearance of PAH, which is extracted almost completely from the plasma during its passage through the renal circulation, constitutes a measure of ERPF. Hence:

ERPF = UPAHV/PPAH

Where UPAH = concentration of PAH (mg/mL) in the urine

V = rate of urine excretion (mL/min), and

PPAH = plasma concentration of PAH (mg/mL).

Example:

UPAH = 8.0 mg/mL

V = 1.5 mL/min

PPAH = 0.02 mg/mL

ERPF = 8.0 x 1.5/0.02 = 600 mL/min

Based on PAH clearance studies, the normal values for ERPF are:

men 675 ± 150 mL/min

women 595 ± 125 mL/min

Maximum Tubular Secretory (TmPAH ) Mechanism

The quantity of PAH secreted by the tubules (TmPAH) is given by the difference between the total rate of excretion (UPAHV) and the quantity filtered by the glomeruli (GFR x PPAH). Hence:

TmPAH = UPAHV – (GFR x PPAH x 0.83)

The factor, 0.83, corrects for that portion of PAH which is bound to plasma protein and hence is unfilterable.

Example:

UPAH = 9.55 mg/mL

V = 16.68 mL/min

GFR = 120 mL/min

PPAH = 0.60 mg/mL

Then TmPAH = 9.55 x 16.68 – (120 x 0.60 x 0.83) = 100 mg/min.

Average normal values of TmPAH are 80-90 mg/min.

The value of the expression UPAHV, used in calculations of ERPF and TmPAH, may be found by determining the amount of PAH in a measured volume of urine excreted within a specific period of time.

These calculations are based on a body surface area of 1.73 m2. Corrections for variations in surface area are made by multiplying the values obtained for ERPF and TmPAH by 1.73/A, where A is the subject surface area.
Mefenamic Acid

Mefenamic Acid

For sublingual use only.

2.1 Dose

One GRASTEK tablet daily.

2.2 Administration

Administer the first dose of GRASTEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of GRASTEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.
Administer GRASTEK to children under adult supervision. Take the tablet from the blister unit after carefully removing the foil with dry hands. Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute. Wash hands after handling the tablet. Do not take the tablet with food or beverage. Food or beverage should not be taken for the following 5 minutes after taking the tablet.
Initiate treatment at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. For sustained effectiveness for one grass pollen season after cessation of treatment, GRASTEK may be taken daily for three consecutive years (including the intervals between the grass pollen seasons). The safety and efficacy of initiating treatment in season have not been established.

Data regarding the safety of restarting treatment after missing a dose of GRASTEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.

Prescribe auto-injectable epinephrine to patients prescribed GRASTEK and instruct them in the proper use of emergency self-injection of epinephrine [See Warnings and Precautions (5.2)].
Primaxin Iv

Primaxin Iv

Adults

The dosage recommendations for PRIMAXIN I.V. represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.

The total daily dosage for PRIMAXIN I.V. should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.

Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥70 kg

Doses cited in Table 3 are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of ≥71 mL/min/1.73 m2 and a body weight of ≥70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (See Tables 4 and 5.)

Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.
TABLE 3: INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥70 kg Type or Severity of Infection AFully susceptible organisms including gram-positive and gram-negative aerobes and anaerobes BModerately susceptible organisms, primarily some strains of P. aeruginosa Mild 250 mg q6h(TOTAL DAILY DOSE = 1.0g) 500 mg q6h(TOTAL DAILY DOSE = 2.0g) Moderate 500 mg q8h(TOTAL DAILY DOSE = 1.5g)or500 mg q6h(TOTAL DAILY DOSE = 2.0g) 500 mg q6h(TOTAL DAILY DOSE = 2.0g)or1 g q8h(TOTAL DAILY DOSE = 3.0g) Severe, life  threatening only 500 mg q6h(TOTAL DAILY DOSE = 2.0g) 1 g q8h(TOTAL DAILY DOSE = 3.0g)or1 g q6h(TOTAL DAILY DOSE = 4.0g) Uncomplicated  urinary tract infection 250 mg q6h(TOTAL DAILY DOSE = 1.0g) 250 mg q6h(TOTAL DAILY DOSE = 1.0g) Complicated  urinary tract infection 500 mg q6h(TOTAL DAILY DOSE = 2.0g) 500 mg q6h(TOTAL DAILY DOSE = 2.0g)
Due to the high antimicrobial activity of PRIMAXIN I.V., it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4.0 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with PRIMAXIN I.V. at doses up to 90 mg/kg/day in divided doses, not exceeding 4.0 g/day.

Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg

Patients with creatinine clearance of ≤70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of PRIMAXIN I.V. as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:

Tcc (Males)            =              (wt. in kg) (140 - age)                                            (72) (creatinine in mg/dL)

Tcc (Females)        =             0.85 x above value

To determine the dose for adults with impaired renal function and/or reduced body weight:
Choose a total daily dose from Table 3 based on infection characteristics. a) If the total daily dose is 1.0 g, 1.5 g, or 2.0 g, use the appropriate subsection of Table 4 and continue with step 3.b) If the total daily dose is 3.0 g or 4.0 g, use the appropriate subsection of Table 5 and continue with step 3. From Table 4 or 5:a) Select the body weight on the far left which is closest to the patient's body weight (kg).b) Select the patient's creatinine clearance category.c) Where the row and column intersect is the reduced dosage regimen. TABLE 4: REDUCED INTRAVENOUS DOSAGE OF PRIMAXIN I.V. IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg If TOTAL DAILY DOSE from TABLE 3 is: 1.0 g/day 1.5 g/day 2.0 g/day And Body Weight (kg) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: ≥70 250q6h 250q8h 250q12h 250q12h 500q8h 250q6h 250q8h 250q12h 500q6h 500q8h 250q6h 250q12h 60 250q8h 125q6h 250q12h 125q12h 250q6h 250q8h 250q8h 250q12h 500q8h 250q6h 250q8h 250q12h 50 125q6h 125q6h 125q8h 125q12h 250q6h 250q8h 250q12h 250q12h 250q6h 250q6h 250q8h 250q12h 40 125q6h 125q8h 125q12h 125q12h 250q8h 125q6h 125q8h 125q12h 250q6h 250q8h 250q12h 250q12h 30 125q8h 125q8h 125q12h 125q12h 125q6h 125q8h 125q8h 125q12h 250q8h 125q6h 125q8h 125q12h TABLE 5: REDUCED INTRAVENOUS DOSAGE OF PRIMAXIN I.V. IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT <70 kg If TOTAL DAILY DOSE from TABLE 3 is: 3.0 g/day 4.0 g/day And Body Weight (kg) is: and creatinine clearance (mL/min/1.73 m2) is: and creatinine clearance (mL/min/1.73 m2) is: ≥71 41-70 21-40 6-20 ≥71 41-70 21-40 6-20 then the reduced dosage regimen (mg) is: then the reduced dosage regimen (mg) is: ≥70 1000q8h 500q6h 500q8h 500q12h 1000q6h 750q8h 500q6h 500q12h 60 750q8h 500q8h 500q8h 500q12h 1000q8h 750q8h 500q8h 500q12h 50 500q6h 500q8h 250q6h 250q12h 750q8h 500q6h 500q8h 500q12h 40 500q8h 250q6h 250q8h 250q12h 500q6h 500q8h 250q6h 250q12h 30 250q6h 250q8h 250q8h 250q12h 500q8h 250q6h 250q8h 250q12h
Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with PRIMAXIN I.V. 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.

Patients with creatinine clearance ≤5 mL/min/1.73 m2 should not receive PRIMAXIN I.V. unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of PRIMAXIN I.V. for patients undergoing peritoneal dialysis.

Hemodialysis

When treating patients with creatinine clearances of ≤5 mL/min/1.73 m2 who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6-20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight <70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive PRIMAXIN I.V. after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, PRIMAXIN I.V. is recommended only when the benefit outweighs the potential risk of seizures. (See PRECAUTIONS.)

Pediatric Patients

See PRECAUTIONS, Pediatric Patients.

For pediatric patients ≥3 months of age, the recommended dose for non-CNS infections is 15-25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2.0 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4.0 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.

For pediatric patients ≤3 months of age (weighing ≥1,500 g), the following dosage schedule is recommended for non-CNS infections:

<1 wk of age: 25 mg/kg every 12 hrs

1-4 wks of age: 25 mg/kg every 8 hrs

4 wks-3 mos. of age: 25 mg/kg every 6 hrs.

Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.

PRIMAXIN I.V. is not recommended in pediatric patients with CNS infections because of the risk of seizures.

PRIMAXIN I.V. is not recommended in pediatric patients <30 kg with impaired renal function, as no data are available.
Cosopt Pf

Cosopt Pf

The dose is one drop of COSOPT PF in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart [see Drug Interactions (7.3)].

The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Glytone Suncare Block S...

Glytone Suncare Block Sunscreen

2.1 Recommended Dosage

The recommended dosage regimen is ZERBAXA 1.5 gram (g) (ceftolozane 1 g and tazobactam 0.5 g) for injection administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and with normal renal function or mild renal impairment. The duration of therapy should be guided by the severity and site of infection and the patient's clinical and bacteriological progress (Table 1).
Table 1: Dosage of ZERBAXA 1.5 g (ceftolozane 1 g and tazobactam 0.5 g) by Infection in Patients with Creatinine Clearance (CrCl) Greater than 50 mL/min Infection Dose Frequency Infusion Time (hours) Duration of Treatment * Used in conjunction with metronidazole 500 mg intravenously every 8 hours Complicated Intra-abdominal Infections* 1.5 g Every 8 Hours 1 4-14 days Complicated Urinary Tract Infections, including Pyelonephritis 1.5 g Every 8 Hours 1 7 days
2.2 Patients with Renal Impairment

Dose adjustment is required for patients whose creatinine clearance is 50 mL/min or less. Renal dose adjustments are listed in Table 2. For patients with changing renal function, monitor CrCl at least daily and adjust the dosage of ZERBAXA accordingly [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Table 2: Dosage of ZERBAXA in Patients with Renal Impairment Estimated CrCl (mL/min)* Recommended Dosage Regimen for ZERBAXA 1.5 g (ceftolozane 1 g and tazobactam 0.5 g)† * CrCl estimated using Cockcroft-Gault formula † All doses of ZERBAXA are administered over 1 hour. 30 to 50 750 mg (500 mg and 250 mg) intravenously every 8 hours 15 to 29 375 mg (250 mg and 125 mg) intravenously every 8 hours End-stage renal disease (ESRD) on hemodialysis (HD) A single loading dose of 750 mg (500 mg and 250 mg) followed by a 150 mg (100 mg and 50 mg) maintenance dose administered every 8 hours for the remainder of the treatment period (on hemodialysis days, administer the dose at the earliest possible time following completion of dialysis)
2.3 Preparation of Solutions

ZERBAXA does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparing the infusion solution.

Preparation of doses:

Constitute the vial with 10 mL of sterile water for injection or 0.9% Sodium Chloride for Injection, USP and gently shake to dissolve. The final volume is approximately 11.4 mL. Caution: The constituted solution is not for direct injection.

To prepare the required dose, withdraw the appropriate volume determined from Table 3 from the reconstituted vial. Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% Sodium Chloride for Injection, USP or 5% Dextrose Injection, USP.
Table 3: Preparation of Doses ZERBAXA (ceftolozane and tazobactam) Dose Volume to Withdraw from Reconstituted Vial 1.5 g (1 g and 0.5 g) 11.4 mL (entire contents) 750 mg (500 mg and 250 mg) 5.7 mL 375 mg (250 mg and 125 mg) 2.9 mL 150 mg (100 mg and 50 mg) 1.2 mL
Inspect drug products visually for particulate matter and discoloration prior to use. ZERBAXA infusions range from clear, colorless solutions to solutions that are clear and slightly yellow. Variations in color within this range do not affect the potency of the product.

2.4 Compatibility

Compatibility of ZERBAXA with other drugs has not been established. ZERBAXA should not be mixed with other drugs or physically added to solutions containing other drugs.

2.5 Storage of Constituted Solutions

Upon constitution with sterile water for injection or 0.9% sodium chloride injection, reconstituted ZERBAXA solution may be held for 1 hour prior to transfer and dilution in a suitable infusion bag.

Following dilution of the solution with 0.9% sodium chloride or 5% dextrose, ZERBAXA is stable for 24 hours when stored at room temperature or 7 days when stored under refrigeration at 2 to 8°C (36 to 46°F).

Constituted ZERBAXA solution or diluted ZERBAXA infusion should not be frozen.
Dolorex

Dolorex

The recommended dosage in the horse is 0.1 mg butorphanol per kilogram of body weight (0.05 mg/lb) by intravenous injection. This is equivalent to 5 mL DOLOREX for each 1000 lb body weight. The dose may be repeated within 3 to 4 hours but treatment should not exceed 48 hours. Preclinical model studies and clinical field trials in horses demonstrate that the analgesic effects of butorphanol are seen within 15 minutes following injection and persist for about 4 hours.
Guanidine Hydrochloride...

Guanidine Hydrochloride

Initial dosage is usually between 10 and 15 mg/kg (5 to 7 mg/pound) of body weight per day in 3 or 4 divided doses. This dosage may be gradually increased to a total daily dosage of 35 mg/kg (16 mg/pound) of body weight per day or up to the development of side effects. As individual tolerance is highly variable, the dosage must be carefully titrated. Once a tolerable dose has been established, it should be continued. Occasionally removal of the primary neoplastic lesion may result in improvement of symptoms, permitting the discontinuance of guanidine.
Allerfed Cold And Aller...

Allerfed Cold And Allergy

Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.

The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.

2.1 Dosage in Acute Coronary Syndrome (ACS)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy Aspirin, 160 to 325 mg, should be given daily
INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:
During Medical Management: Target aPTT 50 to 70 seconds If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h. If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h. During PCI: Target ACT 200 to 300 seconds If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds. Heparin infusion after the PCI is discouraged.
2.2 Dosage in Percutaneous Coronary Intervention (PCI)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended. In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery. Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI. Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.
Patients requiring thrombolytic therapy should discontinue INTEGRILIN.

2.3 Important Administration Instructions
Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top. Discard any unused portion left in the vial.
Administer INTEGRILIN by volume according to patient weight (see Table 1).
Table 1: INTEGRILIN Dosing Charts by Weight Patient Weight 180-mcg/kgBolus Volume 2-mcg/kg/minInfusion Volume(CrCl greater than or equal to 50 mL/min) 1-mcg/kg/minInfusion Volume(CrCl less than 50 mL/min) (kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) 37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h 42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h 47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h 54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h 60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h 66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h 72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h 79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h 85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h 91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h 97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h 104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h 110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h 116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h >121 >267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h
Lovastatin

Lovastatin

2.1 General Dosing Information

Take one tablet of ZONTIVITY 2.08 mg orally once daily, with or without food.

2.2 Coadministration with Other Antiplatelet Drugs

There is no experience with use of ZONTIVITY alone as the only administered antiplatelet agent. ZONTIVITY has been studied only as an addition to aspirin and/or clopidogrel. Use ZONTIVITY with aspirin and/or clopidogrel according to their indications or standard of care [see Clinical Studies (14)]. There is limited clinical experience with other antiplatelet drugs.
Cosopt

Cosopt

The dose is one drop of COSOPT in the affected eye(s) two times daily.

If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart (see also PRECAUTIONS, Drug Interactions).
Foradil

Foradil

FORADIL capsules should be administered only by the oral inhalation route and only using the AEROLIZER Inhaler (see the accompanying Medication Guide). FORADIL capsules should not be swallowed. FORADIL capsules should always be stored in the blister, and only removed IMMEDIATELY BEFORE USE.

2.1     Asthma

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, the active ingredient in FORADIL AEROLIZER, increase the risk of asthma-related death [see Warnings and Precautions (5.1)]. Because of this risk, use of FORADIL AEROLIZER for the treatment of asthma without concomitant use of a long-term asthma control medication, such as an inhaled corticosteroid, is contraindicated. Use FORADIL AEROLIZER only as additional therapy for patients with asthma who are currently taking but are inadequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue FORADIL AEROLIZER) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use FORADIL AEROLIZER for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Pediatric and Adolescent Patients

For adults and children 5 years of age and older, the usual dosage is the inhalation of the contents of one 12-mcg FORADIL capsule every 12 hours using the AEROLIZER Inhaler. The patient must not exhale into the device. The total daily dose of FORADIL should not exceed one capsule twice daily (24 mcg total daily dose). More frequent administration or administration of a larger number of inhalations is not recommended. If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma less than 18 years of age who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g., inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.

2.2     Exercise-Induced Bronchospasm (EIB)

Use of FORADIL AEROLIZER as a single agent for the prevention of exercise induced bronchospasm may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of FORADIL AEROLIZER for the prevention of exercise induced bronchospasm may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid. For adults and children 5 years of age or older, the usual dosage is the inhalation of the contents of one 12-mcg FORADIL capsule at least 15 minutes before exercise administered on an occasional as needed basis. When used intermittently as needed for prevention, protection may last up to 12 hours.

Additional doses of FORADIL AEROLIZER should not be used for 12 hours after the administration of this drug. Regular, twice-daily dosing has not been studied in preventing EIB. Patients who are receiving FORADIL AEROLIZER twice daily for treatment of their asthma should not use additional doses for prevention of EIB and may require a short-acting bronchodilator.

2.3     Chronic Obstructive Pulmonary Disease (COPD)

For maintenance treatment of bronchoconstriction in patients with COPD (including chronic bronchitis and emphysema) the usual dosage is the inhalation of the contents of one 12 mcg FORADIL capsule every 12 hours using the AEROLIZER inhaler.

A total daily dose of greater than 24 mcg is not recommended.
Prinivil

Prinivil

2.1 Hypertension

Initial therapy in adults: The recommended initial dose is 10 mg once a day. Adjust dosage according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered in a single daily dose. Doses up to 80 mg have been used but do not appear to give a greater effect.

Use with Diuretics in Adults

If blood pressure is not controlled with PRINIVIL alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide 12.5 mg).

The recommended starting dose in adult patients with hypertension taking diuretics is 5 mg once per day [see Drug Interactions (7.1)].

Pediatric Patients 6 Years of Age and Older with Hypertension

For pediatric patients with glomerular filtration rate >30 mL/min/1.73 m2, the recommended starting dose is 0.07 mg/kg once daily (up to 5 mg total). Dosage should be adjusted according to blood pressure response up to a maximum of 0.61 mg/kg (up to 40 mg) once daily. Doses above 0.61 mg/kg (or in excess of 40 mg) have not been studied in pediatric patients [see Clinical Pharmacology (12.3)].

PRINIVIL is not recommended in pediatric patients <6 years or in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2 [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].

2.2 Heart Failure

The recommended starting dose for PRINIVIL, when used with diuretics and (usually) digitalis as adjunctive therapy is 5 mg once daily. The recommended starting dose in these patients with hyponatremia (serum sodium <130 mEq/L) is 2.5 mg once daily. Increase as tolerated to a maximum of 40 mg once daily.

Diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension [see Warnings and Precautions (5.4), and Drug Interactions (7.1)]. The appearance of hypotension after the initial dose of PRINIVIL does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension.

2.3 Acute Myocardial Infarction

In hemodynamically stable patients within 24 hours of the onset of symptoms of acute myocardial infarction, give PRINIVIL 5 mg orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily. Dosing should continue for at least 6 weeks.

Initiate therapy with 2.5 mg in patients with a low systolic blood pressure (100-120 mmHg) during the first 3 days after the infarct [see Warnings and Precautions (5.4)]. If hypotension occurs (systolic blood pressure ≤100 mmHg) consider doses of 2.5 or 5 mg. If prolonged hypotension occurs (systolic blood pressure <90 mmHg for more than 1 hour) discontinue PRINIVIL.

2.4 Dose in Patients with Renal Impairment

No dose adjustment of PRINIVIL is required in patients with creatinine clearance >30 mL/min. In patients with creatinine clearance 10-30 mL/min, reduce the initial dose of PRINIVIL to half of the usual recommended dose (i.e., hypertension, 5 mg; heart failure or acute MI, 2.5 mg). For patients on hemodialysis or creatinine clearance <10 mL/min, the recommended initial dose is 2.5 mg once daily [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Elocon

Elocon

Apply a thin film of ELOCON Ointment to the affected skin areas once daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Safety and efficacy of ELOCON Ointment in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

ELOCON Ointment should not be used with occlusive dressings unless directed by a physician. ELOCON Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

ELOCON Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.
Elocon

Elocon

Apply a few drops of ELOCON Lotion to the affected skin areas once daily and massage lightly until it disappears.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

ELOCON Lotion should not be used with occlusive dressings unless directed by a physician. ELOCON Lotion should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

ELOCON Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.
Elocon

Elocon

Apply a thin film of ELOCON Cream to the affected skin areas once daily. ELOCON Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream in pediatric patients for more than 3 weeks of use have not been established.

ELOCON Cream should not be used with occlusive dressings unless directed by a physician. ELOCON Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.
Rotateq

Rotateq

FOR ORAL USE ONLY. NOT FOR INJECTION.

The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age [see Clinical Studies (14)].

There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.

Do not mix the RotaTeq vaccine with any other vaccines or solutions. Do not reconstitute or dilute [see Dosage and Administration (2.2)].

For storage instructions [see How Supplied/Storage and Handling (16.1)].

Each dose is supplied in a container consisting of a squeezable plastic dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch [see Dosage and Administration (2.2)].

2.1 Use with Other Vaccines

In clinical trials, RotaTeq was administered concomitantly with other licensed pediatric vaccines [see Adverse Reactions (6.1), Drug Interactions (7.1), and Clinical Studies (14)].

2.2 Instructions for Use
To administer the vaccine: Tear open the pouch and remove the dosing tube. Clear the fluid from the dispensing tip by holding tube vertically and tapping cap. Open the dosing tube in 2 easy motions: 1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight. 2. Remove cap by turning it counterclockwise. Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.) If for any reason an incomplete dose is administered (e.g., infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series. Discard the empty tube and cap in approved biological waste containers according to local regulations.
Amnesteem

Amnesteem

Apply a thin film of DIPROLENE Ointment to the affected skin areas once or twice daily.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. DIPROLENE Ointment is a super-high-potency topical corticosteroid. Treatment with DIPROLENE Ointment should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

DIPROLENE Ointment should not be used with occlusive dressings unless directed by a physician.

DIPROLENE Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Zioptan

Zioptan

The recommended dose is one drop of ZIOPTAN in the conjunctival sac of the affected eye(s) once daily in the evening.

The dose should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect.

Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours.

ZIOPTAN may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
Cancidas

Cancidas

2.1 Instructions for Use in All Patients

CANCIDAS should be administered by slow intravenous (IV) infusion over approximately 1 hour. CANCIDAS should not be administered by IV bolus administration.

Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.

2.2 Recommended Dosing in Adult Patients [≥18 years of age]

The usual dose is 50 mg once daily (following a 70-mg loading dose for most indications). The safety and efficacy of a dose of 150 mg daily (range: 1 to 51 days; median: 14 days) have been studied in 100 adult patients with candidemia and other Candida infections. The efficacy of CANCIDAS at this higher dose was not significantly better than the efficacy of the 50-mg daily dose of CANCIDAS. The efficacy of doses higher than 50 mg daily in the other adult patients for whom CANCIDAS is indicated is not known [see Clinical Studies (14.2)].

Empirical Therapy

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based on the patient's clinical response. Empirical therapy should be continued until resolution of neutropenia. Patients found to have a fungal infection should be treated for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved. If the 50-mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg.

Candidemia and Other Candida Infections [see Clinical Studies (14.2)]

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be dictated by the patient's clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia.

Esophageal Candidiasis

The dose is 50 mg once daily for 7 to 14 days after symptom resolution. A 70-mg loading dose has not been studied for this indication. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered [see Clinical Studies (14.3)].

Invasive Aspergillosis

A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.

2.3 Recommended Dosing in Pediatric Patients [3 months to 17 years of age]

For all indications, a single 70-mg/m2 loading dose should be administered on Day 1, followed by 50 mg/m2 once daily thereafter. The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosing in pediatric patients (3 months to 17 years of age) should be based on the patient's body surface area (BSA) as calculated by the Mosteller Formula [see References (15)]:

Following calculation of the patient's BSA, the loading dose in milligrams should be calculated as BSA (m2) X 70 mg/m2. The maintenance dose in milligrams should be calculated as BSA (m2) X 50 mg/m2.

Duration of treatment should be individualized to the indication, as described for each indication in adults [see Dosage and Administration (2.2)]. If the 50-mg/m2 daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m2 daily (not to exceed 70 mg).

2.4 Patients with Hepatic Impairment

Adult patients with mild hepatic impairment (Child-Pugh score 5 to 6) do not need a dosage adjustment. For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), CANCIDAS 35 mg once daily is recommended based upon pharmacokinetic data [see Clinical Pharmacology (12.3)]. However, where recommended, a 70-mg loading dose should still be administered on Day 1. There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score >9) and in pediatric patients with any degree of hepatic impairment.

2.5 Patients Receiving Concomitant Inducers of Drug Clearance

Adult patients on rifampin should receive 70 mg of CANCIDAS once daily. Adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS once daily [see Drug Interactions (7)].

When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70 mg/m2 once daily (not to exceed 70 mg) should be considered [see Drug Interactions (7)].

2.6 Preparation and Reconstitution for Administration

Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose.

Preparation of CANCIDAS for Infusion
Equilibrate the refrigerated vial of CANCIDAS to room temperature. Aseptically add 10.8 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the vial.
Each vial of CANCIDAS contains an intentional overfill of CANCIDAS. Thus, the drug concentration of the resulting solution is listed in Table 1 below.
Table 1: Information for Preparation of CANCIDAS CANCIDAS vial Total Drug Content (including overfill) Reconstitution Volume to be added Resulting Concentration following Reconstitution 50 mg 54.6 mg 10.8 mL 5 mg/mL 70 mg 75.6 mg 10.8 mL 7 mg/mL
The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

The reconstituted solution may be stored for up to one hour at ≤25°C (≤77°F).

CANCIDAS vials are for single use only; the remaining solution should be discarded.
C. Aseptically transfer the appropriate volume (mL) of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection. Alternatively, the volume (mL) of reconstituted CANCIDAS can be added to a reduced volume of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/mL.
This infusion solution must be used within 24 hours if stored at ≤25°C (≤77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F).

Special Considerations for Pediatric Patients >3 Months of Age

Follow the reconstitution procedures described above using either the 70-mg or 50-mg vial to create the reconstituted solution [see Dosage and Administration (2.3)]. From the reconstituted solution in the vial, remove the volume of drug equal to the calculated loading dose or calculated maintenance dose based on a concentration of 7 mg/mL (if reconstituted from the 70-mg vial) or a concentration of 5 mg/mL (if reconstituted from the 50-mg vial).

The choice of vial should be based on total milligram dose of drug to be administered to the pediatric patient. To help ensure accurate dosing, it is recommended for pediatric doses less than 50 mg that 50-mg vials (with a concentration of 5 mg/mL) be used if available. The 70-mg vial should be reserved for pediatric patients requiring doses greater than 50 mg.

The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose.
Noroxin

Noroxin

Tablets NOROXIN should be taken at least one hour before or at least two hours after a meal or ingestion of milk and/or other dairy products. Multivitamins, other products containing iron or zinc, antacids containing magnesium and aluminum, sucralfate, or Videx® (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours of administration of norfloxacin. Tablets NOROXIN should be taken with a glass of water. Patients receiving NOROXIN should be well hydrated (see PRECAUTIONS).

Normal Renal Function

The recommended daily dose of NOROXIN is as described in the following chart:

Infection

Description

Unit Dose

Frequency

Duration

Daily Dose

Urinary Tract

Uncomplicated UTI's (cystitis) due to E. coli, K. pneumoniae, or P. mirabilis

400 mg

q12h

3 days

800 mg

Uncomplicated UTI's due to other indicated organisms

400 mg

q12h

7-10days

800 mg

Complicated UTI's

400 mg

q12h

10-21days

800 mg

Sexually Transmitted Diseases

Uncomplicated Gonorrhea

800 mg

singledose

1 day

800 mg

Prostatitis

Acute or Chronic

400 mg

q12h

28 days

800 mg

Renal Impairment

NOROXIN may be used for the treatment of urinary tract infections in patients with renal insufficiency. In patients with a creatinine clearance rate of 30 mL/min/1.73 m2 or less, the recommended dosage is one 400-mg tablet once daily for the duration given above. At this dosage, the urinary concentration exceeds the MICs for most urinary pathogens susceptible to norfloxacin, even when the creatinine clearance is less than 10 mL/min/1.73 m2.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males: (weight in kg) × (140 − age) (72) × serum creatinine (mg/100 mL)

Females: (0.85) × (above value)

Elderly

Elderly patients being treated for urinary tract infections who have a creatinine clearance of greater than 30 mL/min/1.73 m2 should receive the dosages recommended under Normal Renal Function.

Elderly patients being treated for urinary tract infections who have a creatinine clearance of 30 mL/min/1.73 m2 or less should receive 400 mg once daily as recommended under Renal Impairment.
Zetia

Zetia

2.1 General Dosing Information

The recommended dose of ZETIA is 10 mg once daily.

ZETIA can be administered with or without food.

2.2 Concomitant Lipid-Lowering Therapy

ZETIA may be administered with a statin (in patients with primary hyperlipidemia) or with fenofibrate (in patients with mixed hyperlipidemia) for incremental effect. For convenience, the daily dose of ZETIA may be taken at the same time as the statin or fenofibrate, according to the dosing recommendations for the respective medications.

2.3 Coadministration with Bile Acid Sequestrants

Dosing of ZETIA should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.4)].

2.4 Patients with Hepatic Impairment

No dosage adjustment is necessary in patients with mild hepatic impairment [see Warnings and Precautions (5.4)].

2.5 Patients with Renal Impairment

No dosage adjustment is necessary in patients with renal impairment [see Clinical Pharmacology (12.3)]. When given with simvastatin in patients with moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2), doses of simvastatin exceeding 20 mg should be used with caution and close monitoring [see Use in Specific Populations (8.6)].

2.6 Geriatric Patients

No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].
Liptruzet

Liptruzet

2.1 Recommended Dosing

The dosage range of LIPTRUZET is 10/10 mg/day to 10/80 mg/day. The recommended starting dose of LIPTRUZET is 10/10 mg/day or 10/20 mg/day. LIPTRUZET can be administered as a single dose at any time of the day, with or without food. The recommended starting dose for patients who require a larger reduction in LDL-C (greater than 55%) is 10/40 mg/day. After initiation and/or upon titration of LIPTRUZET, lipid levels should be analyzed within 2 or more weeks and dosage adjusted accordingly.

Patients should swallow LIPTRUZET tablets whole. Tablets should not be crushed, dissolved, or chewed.

2.2 Patients with Homozygous Familial Hypercholesterolemia

The dosage of LIPTRUZET in patients with homozygous familial hypercholesterolemia is 10/40 mg/day or 10/80 mg/day. LIPTRUZET should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

2.3 Coadministration with Other Drugs

Bile Acid Sequestrants

Dosing of LIPTRUZET should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.11)].

Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors

In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with LIPTRUZET should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing LIPTRUZET and the lowest dose necessary employed. In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with LIPTRUZET should be limited to 10/20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with LIPTRUZET should be limited to 10/40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of LIPTRUZET is employed. [See Warnings and Precautions (5.1) and Drug Interactions (7).]

Other Concomitant Lipid-Lowering Therapy

The combination of LIPTRUZET and gemfibrozil is not recommended [see Warnings and Precautions (5.1) and Drug Interactions (7.4)].
Proscar

Proscar

PROSCAR may be administered with or without meals.

2.1 Monotherapy

The recommended dose of PROSCAR is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].

2.2 Combination with Alpha-Blocker

The recommended dose of PROSCAR is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].
Propecia

Propecia

PROPECIA may be administered with or without meals.

The recommended dose of PROPECIA is one tablet (1 mg) taken once daily.

In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.
Health Mart Nicotine

Health Mart Nicotine

2.1 Patient Selection

Select patients for second line or greater treatment of metastatic NSCLC with KEYTRUDA based on the presence of positive PD-L1 expression [see Clinical Studies (14.2)]. Information on FDA-approved tests for the detection of PD-L1 expression in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

2.2 Recommended Dosing

The recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

2.3 Dose Modifications

Withhold KEYTRUDA for any of the following:
Grade 2 pneumonitis [see Warnings and Precautions (5.1)] Grade 2 or 3 colitis [see Warnings and Precautions (5.2)] Grade 3 or 4 endocrinopathies [see Warnings and Precautions (5.4)] Grade 2 nephritis [see Warnings and Precautions (5.5)] Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin greater than 1.5 and up to 3 times ULN Any other severe or Grade 3 treatment-related adverse reaction [see Warnings and Precautions (5.6)]
Resume KEYTRUDA in patients whose adverse reactions recover to Grade 0-1.

Permanently discontinue KEYTRUDA for any of the following:
Any life-threatening adverse reaction (excluding endocrinopathies controlled with hormone replacement therapy) Grade 3 or 4 pneumonitis or recurrent pneumonitis of Grade 2 severity [see Warnings and Precautions (5.1)] Grade 3 or 4 nephritis [see Warnings and Precautions (5.5)] AST or ALT greater than 5 times ULN or total bilirubin greater than 3 times ULN For patients with liver metastasis who begin treatment with Grade 2 AST or ALT, if AST or ALT increases by greater than or equal to 50% relative to baseline and lasts for at least 1 week Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.7)] Inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks Persistent Grade 2 or 3 adverse reactions (excluding endocrinopathies controlled with hormone replacement therapy) that do not recover to Grade 0-1 within 12 weeks after last dose of KEYTRUDA Any severe or Grade 3 treatment-related adverse reaction that recurs [see Warnings and Precautions (5.6)]
2.4 Preparation and Administration

Reconstitution of KEYTRUDA for Injection (Lyophilized Powder)
Add 2.3 mL of Sterile Water for Injection, USP by injecting the water along the walls of the vial and not directly on the lyophilized powder (resulting concentration 25 mg/mL). Slowly swirl the vial. Allow up to 5 minutes for the bubbles to clear. Do not shake the vial.
Preparation for Intravenous Infusion
Visually inspect the solution for particulate matter and discoloration prior to administration. The solution is clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed. Dilute KEYTRUDA injection (solution) or reconstituted lyophilized powder prior to intravenous administration. Withdraw the required volume from the vial(s) of KEYTRUDA and transfer into an intravenous (IV) bag containing 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL to 10 mg/mL. Discard any unused portion left in the vial.
Storage of Reconstituted and Diluted Solutions

The product does not contain a preservative.

Store the reconstituted and diluted solution from the KEYTRUDA 50 mg vial either:
At room temperature for no more than 6 hours from the time of reconstitution. This includes room temperature storage of reconstituted vials, storage of the infusion solution in the IV bag, and the duration of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of reconstitution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
Store the diluted solution from the KEYTRUDA 100 mg/4 mL vial either:
At room temperature for no more than 6 hours from the time of dilution. This includes room temperature storage of the infusion solution in the IV bag, and the duration of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of dilution. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
Do not freeze.

Administration
Administer infusion solution intravenously over 30 minutes through an intravenous line containing a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Do not co-administer other drugs through the same infusion line.
Proventil Hfa

Proventil Hfa

For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours. More frequent administration or a larger number of inhalations is not recommended. In some patients, one inhalation every 4 hours may be sufficient. Each actuation of PROVENTIL® HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.

Exercise Induced Bronchospasm Prevention: The usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise.

To maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week. The inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see PRECAUTIONS, Information for Patients section). Keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. The inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly. If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage.

If a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Benefix

Benefix

2.1 Recommended Dosing

The usual dosage range is 5 to 40 mg/day. In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet. The recommended usual starting dose is 10 or 20 mg once a day in the evening. For patients at high risk for a CHD event due to existing CHD, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter.

2.2 Restricted Dosing for 80 mg

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 80-mg dose of ZOCOR should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5.1)].

Patients who are currently tolerating the 80-mg dose of ZOCOR who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of ZOCOR, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of ZOCOR should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.

2.3 Coadministration with Other Drugs

Patients taking Verapamil, Diltiazem, or Dronedarone
The dose of ZOCOR should not exceed 10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of ZOCOR should not exceed 20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
2.4 Patients with Homozygous Familial Hypercholesterolemia

The recommended dosage is 40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 80 mg (2.2)]. ZOCOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of ZOCOR should be reduced by 50% if initiating lomitapide. ZOCOR dosage should not exceed 20 mg/day (or 40 mg/day for patients who have previously taken ZOCOR 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

2.5 Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines1 and Clinical Studies (14.2)]. Adjustments should be made at intervals of 4 weeks or more.
1
National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.

2.6 Patients with Renal Impairment

Because ZOCOR does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when ZOCOR is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with simvastatin doses exceeding 20 mg/day coadministered with lipid-modifying doses of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive simvastatin 80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.1).]
Flurbiprofen

Flurbiprofen

2.1 Recommended Dose and Schedule

FOR SUBCUTANEOUS ADMINISTRATION ONLY

Each 0.5-mL dose of ProQuad is administered subcutaneously.

The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R® II (measles, mumps, and rubella virus vaccine live) and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

2.2 Preparation for Administration

CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents, and other anti-viral substances for reconstitution and injection of ProQuad.

Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives or other anti-viral substances.

Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.

Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

2.3 Method of Administration

Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

Use With Other Vaccines

Use different injection sites to administer each vaccine if other vaccines are administered concomitantly. [See Drug Interactions (7.5).]
Zolinza

Zolinza

2.1 Dosing Information

The recommended dose is 400 mg orally once daily with food.

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

ZOLINZA capsules should not be opened or crushed [see How Supplied/Storage and Handling (16)].

2.2 Dose Modifications

If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary.

Hepatic Impairment

Reduce the starting dose to 300 mg orally once daily with food in patients with mild to moderate hepatic impairment (bilirubin 1 to 3 × ULN or AST > ULN). There is insufficient evidence to recommend a starting dose for patients with severe hepatic impairment (bilirubin > 3 × ULN). [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Janumet

Janumet

2.1 Recommended Dosing

The dosage of JANUMET should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the health care provider.

JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. JANUMET must not be split or divided before swallowing.

The starting dose of JANUMET should be based on the patient's current regimen. JANUMET should be given twice daily with meals. The following doses are available:

50 mg sitagliptin/500 mg metformin hydrochloride

50 mg sitagliptin/1000 mg metformin hydrochloride.

The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.

The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of JANUMET is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.

Patients treated with an insulin secretagogue or insulin

Coadministration of JANUMET with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.9)].

No studies have been performed specifically examining the safety and efficacy of JANUMET in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Trusopt

Trusopt

The dose is one drop of TRUSOPT Ophthalmic Solution in the affected eye(s) three times daily.

TRUSOPT may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
Janumet Xr

Janumet Xr

2.1 Recommended Dosing

The dose of JANUMET XR should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the healthcare provider.
In patients not currently treated with metformin, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride (HCl) extended-release. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose. In patients already treated with metformin, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and the previously prescribed dose of metformin. For patients taking metformin immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets taken together once daily. Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose.
JANUMET XR should be administered with food to reduce the gastrointestinal side effects associated with the metformin component. JANUMET XR should be given once daily with a meal preferably in the evening. JANUMET XR should be swallowed whole. The tablets must not be split, crushed, or chewed before swallowing. There have been reports of incompletely dissolved JANUMET XR tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control [see Patient Counseling Information (17.1)].

The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using two JANUMET XR tablets (such as two 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablets or two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets) should take the two tablets together once daily.

Patients treated with an insulin secretagogue or insulin

Coadministration of JANUMET XR with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.9)].

No studies have been performed specifically examining the safety and efficacy of JANUMET XR in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Aquaflor Type A Medicat...

Aquaflor Type A Medicated Article

There is currently no dosage information available for this product. We apologize for any inconvenience.
Crixivan

Crixivan

The recommended dosage of CRIXIVAN is 800 mg (usually two 400-mg capsules) orally every 8 hours.

CRIXIVAN must be taken at intervals of 8 hours. For optimal absorption, CRIXIVAN should be administered without food but with water 1 hour before or 2 hours after a meal. Alternatively, CRIXIVAN may be administered with other liquids such as skim milk, juice, coffee, or tea, or with a light meal, e.g., dry toast with jelly, juice, and coffee with skim milk and sugar; or corn flakes, skim milk and sugar. (See CLINICAL PHARMACOLOGY, Effect of Food on Oral Absorption.)

To ensure adequate hydration, it is recommended that adults drink at least 1.5 liters (approximately 48 ounces) of liquids during the course of 24 hours.

Concomitant Therapy

(See CLINICAL PHARMACOLOGY, Drug Interactions, and/or PRECAUTIONS, Drug Interactions.)

Delavirdine

Dose reduction of CRIXIVAN to 600 mg every 8 hours should be considered when administering delavirdine 400 mg three times a day.

Didanosine

If indinavir and didanosine are administered concomitantly, they should be administered at least one hour apart on an empty stomach (consult the manufacturer's product circular for didanosine).

Itraconazole

Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended when administering itraconazole 200 mg twice daily concurrently.

Ketoconazole

Dose reduction of CRIXIVAN to 600 mg every 8 hours is recommended when administering ketoconazole concurrently.

Rifabutin

Dose reduction of rifabutin to half the standard dose (consult the manufacturer's product circular for rifabutin) and a dose increase of CRIXIVAN to 1000 mg every 8 hours are recommended when rifabutin and CRIXIVAN are coadministered.

Hepatic Insufficiency

The dosage of CRIXIVAN should be reduced to 600 mg every 8 hours in patients with mild-to-moderate hepatic insufficiency due to cirrhosis.

Nephrolithiasis/Urolithiasis

In addition to adequate hydration, medical management in patients who experience nephrolithiasis/urolithiasis may include temporary interruption (e.g., 1 to 3 days) or discontinuation of therapy.
Berinert

Berinert

2.1 Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

Adults and Pediatric Patients 12 Years of Age and Older and Patients Less Than 12 Years of Age who Weigh at least 30 kg

The recommended oral dosage of EMEND capsules, dexamethasone, and a 5-HT3 antagonist in adults and pediatric patients 12 years of age and older and patients less than 12 years of age who weigh at least 30 kg, who can swallow oral capsules, for the prevention of nausea and vomiting associated with administration of HEC or MEC is shown in Table 1 or Table 2, respectively.

In adults only, EMEND for injection (115 mg), a prodrug of aprepitant, may be substituted for EMEND capsules (125 mg), 30 minutes prior to chemotherapy, on Day 1 of the CINV regimen as an intravenous infusion administered over 15 minutes, followed by oral EMEND (80 mg) on Days 2 and 3. See the prescribing information for EMEND for injection.
Table 1: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with HEC Population Day 1 Day 2 Day 3 Day 4 * Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning on Days 2 and 3. † Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone reflects a 50% dosage reduction to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3)]. EMEND capsules* Adults, Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg 125 mg orally 80 mg orally 80 mg orally none Dexamethasone† Adults 12 mg orally 8 mg orally 8 mg orally 8 mg orally Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)]. 5-HT3 antagonist Adults, Pediatric Patients 12 Years and Older, and Pediatric Patients less than 12 Years Who Weigh at least 30 kg See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none Table 2: Recommended Dosing for the Prevention of Nausea and Vomiting Associated with MEC Population Day 1 Day 2 Day 3 * Administer EMEND capsules 1 hour prior to chemotherapy treatment on Days 1, 2, and 3. If no chemotherapy is given on Days 2 and 3, administer EMEND capsules in the morning on Days 2 and 3. † Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone reflects a 50% dosage reduction to account for a drug interaction with EMEND [see Clinical Pharmacology (12.3)]. EMEND capsules* Adults,Pediatric Patients 12 Years and Older, andPediatric Patients less than 12 Years Who Weigh at least 30 kg 125 mg orally 80 mg orally 80 mg orally Dexamethasone† Adults 12 mg orally none none Pediatric Patients 12 Years and Older, andPediatric Patients less than 12 Years Who Weigh at least 30 kg If a corticosteroid, such as dexamethasone, is co-administered, administer 50% of the recommended corticosteroid dose on Days 1 through 4 [see Clinical Studies (14.3)]. 5-HT3 antagonist Adults,Pediatric Patients 12 Years and Older, andPediatric Patients less than 12 Years Who Weigh at least 30 kg See the selected 5-HT3 antagonist prescribing information for recommended dosage none none
2.2 Prevention of Postoperative Nausea and Vomiting (PONV)

The recommended oral dosage of EMEND capsules in adults is 40 mg within 3 hours prior to induction of anesthesia.

2.3 Administration Instructions
Take with or without food. Swallow capsules whole.
Juvisync

Juvisync

2.1 Recommended Dosing

The dosages for therapy with JUVISYNC are 100 mg/10 mg, 100 mg/20 mg, 100 mg/40 mg, 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg (sitagliptin/simvastatin) once daily. JUVISYNC should be taken as a single daily dose in the evening. JUVISYNC must not be split or divided before swallowing.

The recommended starting dose is 100 mg/40 mg per day. For patients already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 100 mg daily, JUVISYNC may be initiated at the dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

After initiation or titration of JUVISYNC, lipid levels may be analyzed after 4 or more weeks and dosage adjusted, if needed.

2.2 Patients with Renal Impairment

JUVISYNC is not recommended in patients with severe renal impairment or ESRD. JUVISYNC can be used in patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), without adjustment of the sitagliptin dose. Because simvastatin does not undergo significant renal excretion, modification of the dose of the simvastatin component should not be necessary in patients with mild renal impairment.

For patients with moderate renal impairment (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the recommended starting dose of JUVISYNC is 50 mg/40 mg once daily. For patients with moderate renal impairment who are already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 50 mg daily, JUVISYNC may be initiated at the dose of 50 mg sitagliptin and the dose of simvastatin already being taken.

Assessment of renal function is recommended prior to initiation of JUVISYNC and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See Warnings and Precautions (5.4); Clinical Pharmacology (12.3).] There have been postmarketing reports of worsening renal function in patients with renal impairment treated with sitagliptin, some of whom were prescribed inappropriate doses of sitagliptin.

2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

When JUVISYNC is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.5).]

2.4 Coadministration with Other Drugs

Patients taking Verapamil, Diltiazem, or Dronedarone
The dose of simvastatin should not exceed 10 mg per day (100 mg/10 mg or 50 mg/10 mg per day of JUVISYNC) [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)].
Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of simvastatin should not exceed 20 mg per day (100 mg/20 mg or 50 mg/20 mg per day of JUVISYNC) [see Warnings and Precautions (5.2); Drug Interactions (7.3); Clinical Pharmacology (12.3)].
2.5 Patients with Homozygous Familial Hypercholesterolemia

The recommended dosage is 100 mg/40 mg (for patients with normal or mildly impaired renal function) or 50 mg/40 mg (for patients with moderately impaired renal function) per day in the evening. JUVISYNC should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of simvastatin should be reduced by 50% if initiating lomitapide. For patients with normal or mildly impaired renal function, JUVISYNC dosage should not exceed 100 mg/20 mg daily (or 100 mg/40 mg daily for patients who have previously taken simvastatin 80 mg daily chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide. For patients with moderately impaired renal function, JUVISYNC dosage should not exceed 50 mg/20 mg daily (or 50 mg/40 mg daily for patients who have previously taken simvastatin 80 mg daily chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

2.6 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with JUVISYNC 100 mg/40 mg or 50 mg/40 mg per day coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of JUVISYNC with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.2).]
Mevacor

Mevacor

The patient should be placed on a standard cholesterol-lowering diet before receiving MEVACOR and should continue on this diet during treatment with MEVACOR (see NCEP Treatment Guidelines for details on dietary therapy). MEVACOR should be given with meals.

Adult Patients

The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10-80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Guidelines and CLINICAL PHARMACOLOGY). Patients requiring reductions in LDL‑C of 20% or more to achieve their goal (see INDICATIONS AND USAGE) should be started on 20 mg/day of MEVACOR. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. The 10 mg dosage is provided for information purposes only. Although lovastatin tablets 10 mg are available in the marketplace, MEVACOR is no longer marketed in the 10 mg strength.

Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of MEVACOR if cholesterol levels fall significantly below the targeted range.

Dosage in Patients taking Danazol, Diltiazem, Dronedarone or Verapamil

In patients taking danazol, diltiazem, dronedarone or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day (see CLINICAL PHARMACOLOGY, Pharmacokinetics, WARNINGS, Myopathy/Rhabdomyolysis, PRECAUTIONS, Drug Interactions, Other Drug Interactions).

Dosage in Patients taking Amiodarone

In patients taking amiodarone concomitantly with MEVACOR, the dose should not exceed 40 mg/day (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions, Other Drug Interactions).

Adolescent Patients (10-17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended dosing range of lovastatin is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines4, CLINICAL PHARMACOLOGY, and INDICATIONS AND USAGE). Patients requiring reductions in LDL‑C of 20% or more to achieve their goal should be started on 20 mg/day of MEVACOR. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more.
4
National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.

Concomitant Lipid-Lowering Therapy

MEVACOR is effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS, Myopathy/Rhabdomyolysis and PRECAUTIONS, Drug Interactions).

Dosage in Patients with Renal Insufficiency

In patients with severe renal insufficiency (creatinine clearance <30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS, Myopathy/Rhabdomyolysis).
Zocor

Zocor

2.1 Recommended Dosing

The usual dosage range is 10/10 mg/day to 10/40 mg/day. The recommended usual starting dose is 10/10 mg/day or 10/20 mg/day. VYTORIN should be taken as a single daily dose in the evening, with or without food. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m2). After initiation or titration of VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.

2.2 Restricted Dosing for 10/80 mg

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of treatment, use of the 10/80-mg dose of VYTORIN should be restricted to patients who have been taking VYTORIN 10/80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity [see Warnings and Precautions (5.1)].

Patients who are currently tolerating the 10/80-mg dose of VYTORIN who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10/80-mg dose of VYTORIN, patients unable to achieve their LDL-C goal utilizing the 10/40-mg dose of VYTORIN should not be titrated to the 10/80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering.

2.3 Coadministration with Other Drugs

Patients taking Verapamil, Diltiazem, or Dronedarone
The dose of VYTORIN should not exceed 10/10 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
Patients taking Amiodarone, Amlodipine or Ranolazine
The dose of VYTORIN should not exceed 10/20 mg/day [see Warnings and Precautions (5.1), Drug Interactions (7.3), and Clinical Pharmacology (12.3)].
Patients taking Bile Acid Sequestrants
Dosing of VYTORIN should occur either greater than or equal to 2 hours before or greater than or equal to 4 hours after administration of a bile acid sequestrant [see Drug Interactions (7.5)].
2.4 Patients with Homozygous Familial Hypercholesterolemia

The recommended dosage for patients with homozygous familial hypercholesterolemia is VYTORIN 10/40 mg/day in the evening [see Dosage and Administration, Restricted Dosing for 10/80 mg (2.2)]. VYTORIN should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Simvastatin exposure is approximately doubled with concomitant use of lomitapide; therefore, the dose of VYTORIN should be reduced by 50% if initiating lomitapide. VYTORIN dosage should not exceed 10/20 mg/day (or 10/40 mg/day for patients who have previously taken simvastatin 80 mg/day chronically, e.g., for 12 months or more, without evidence of muscle toxicity) while taking lomitapide.

2.5 Patients with Renal Impairment/Chronic Kidney Disease

In patients with mild renal impairment (estimated GFR greater than or equal to 60 mL/min/1.73 m2), no dosage adjustment is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate less than 60 mL/min/1.73 m2, the dose of VYTORIN is 10/20 mg/day in the evening. In such patients, higher doses should be used with caution and close monitoring [see Warnings and Precautions (5.1); Clinical Pharmacology (12.3)].

2.6 Geriatric Patients

No dosage adjustment is necessary in geriatric patients [see Clinical Pharmacology (12.3)].

2.7 Chinese Patients Taking Lipid-Modifying Doses (greater than or equal to 1 g/day Niacin) of Niacin-Containing Products

Because of an increased risk for myopathy in Chinese patients taking simvastatin 40 mg coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products, caution should be used when treating Chinese patients with VYTORIN doses exceeding 10/20 mg/day coadministered with lipid-modifying doses (greater than or equal to 1 g/day niacin) of niacin-containing products. Because the risk for myopathy is dose-related, Chinese patients should not receive VYTORIN 10/80 mg coadministered with lipid-modifying doses of niacin-containing products. The cause of the increased risk of myopathy is not known. It is also unknown if the risk for myopathy with coadministration of simvastatin with lipid-modifying doses of niacin-containing products observed in Chinese patients applies to other Asian patients. [See Warnings and Precautions (5.1).]
Clarinex-d 12 Hour

Clarinex-d 12 Hour

Administer CLARINEX-D 12 HOUR Extended Release Tablet by the oral route only. Do not break, chew, or crush the tablet. Swallow the tablet whole.

2.1 Adults and Adolescents 12 years of Age and Over

The recommended dose of CLARINEX-D 12 HOUR Extended Release Tablets is 1 tablet twice a day, administered approximately 12 hours apart and with or without a meal. Higher doses or increased dosing frequency of CLARINEX-D 12 HOUR Extended Release Tablets have not demonstrated increased effectiveness. Do not exceed the recommended dose as desloratadine and pseudoephedrine, the active components of CLARINEX-D 12 HOUR Extended Release Tablets have been associated with adverse effects at higher doses [see Overdosage (10.1) and (10.2)].
Estrumate

Estrumate

Two mL of Estrumate (500 mcg of cloprostenol) should be administered by INTRAMUSCULAR INJECTION for all indications in both beef and dairy cattle.

Do not puncture stopper more than 12 times.
Pedvaxhib

Pedvaxhib

Liquid PedvaxHIB

FOR INTRAMUSCULAR ADMINISTRATION

DO NOT INJECT INTRAVENOUSLY

If there is an interruption or delay between doses in the primary series, there is no need to repeat the series, but dosing should be continued at the next clinic visit. (See CONTRAINDICATIONS and PRECAUTIONS.)

2 to 14 Months of Age

Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine ideally beginning at 2 months of age followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary two-dose regimen is completed before 12 months of age, a booster dose is required (see below and TABLE 6). Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.{46}

15 Months of Age and Older

Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.

Booster Dose

In infants completing the primary two-dose regimen before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months of age, but not earlier than 2 months after the second dose.

Vaccination regimens for Liquid PedvaxHIB by age group are outlined in TABLE 6.
TABLE 6: Vaccination Regimens for Liquid PedvaxHIB By Age Groups Age (Months)at First Dose Primary Age (Months)at Booster Dose 2–10 2 doses, 2 mo. apart 12–15 11–14 2 doses, 2 mo. apart — 15–71 1 dose —
Interchangeability

PedvaxHIB may be interchanged with other licensed Haemophilus b Conjugate Vaccines for the primary and booster doses.{52} (See CLINICAL PHARMACOLOGY.)

Use with Other Vaccines

Results from clinical studies indicate that Liquid PedvaxHIB can be administered concomitantly with DTP, OPV, eIPV (enhanced inactivated poliovirus vaccine), VARIVAX [Varicella Virus Vaccine Live (Oka/Merck)], M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) or RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)]. No impairment of immune response to these individually tested vaccine antigens was demonstrated.

The type, frequency and severity of adverse experiences observed in these studies with PedvaxHIB were similar to those seen with the other vaccines when given alone. (See CLINICAL PHARMACOLOGY.)

In addition, a PRP-OMPC-containing product, COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with a booster dose of DTaP [diphtheria, tetanus, acellular pertussis] at approximately 15 months of age, using separate sites and syringes for injectable vaccines. No impairment of immune response to these individually tested vaccine antigens was demonstrated. COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. PRP antibody responses are satisfactory for COMVAX, but immune responses are currently unavailable for DTaP (see Manufacturer's Product Circular for COMVAX). No serious vaccine-related adverse events were reported.{33}

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit.

Liquid PedvaxHIB is a slightly opaque white suspension. (See DESCRIPTION.)

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Inject 0.5 mL intramuscularly, preferably into the anterolateral thigh or the outer aspect of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve.
Comvax

Comvax

FOR INTRAMUSCULAR ADMINISTRATION

Do not inject intravenously, intradermally, or subcutaneously.

Recommended Schedule

Infants born to HBsAg negative mothers should be vaccinated with three 0.5 mL doses of COMVAX, ideally at 2, 4, and 12-15 months of age. If the recommended schedule cannot be followed, the interval between the first two doses should be at least six weeks and the interval between the second and third dose should be as close as possible to eight to eleven months.

Infants born to HBsAg-positive mothers should receive Hepatitis B Immune Globulin and Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).

Infants born to mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) at birth and should complete the hepatitis B vaccination series given according to a particular schedule (see manufacturer's circular for Hepatitis B Vaccine [Recombinant]).

The subsequent administration of COMVAX for completion of the hepatitis B vaccination series in infants who were born to HBsAg positive mothers and received HBIG or infants born to mothers of unknown status has not been studied.

COMVAX should not be administered to any infant before the age of 6 weeks.

Modified Schedules

Children previously vaccinated with one or more doses of either hepatitis B vaccine or Haemophilus b conjugate vaccine

Children who receive one dose of hepatitis B vaccine at or shortly after birth may be administered COMVAX on the schedule of 2, 4, and 12-15 months of age. There are no data to support the use of a three-dose series of COMVAX in infants who have previously received more than one dose of hepatitis B vaccine. However, COMVAX may be administered to children otherwise scheduled to receive concurrent RECOMBIVAX HB and PedvaxHIB.

Children not vaccinated according to recommended schedule for COMVAX

Vaccination schedules for children not vaccinated according to the recommended schedule should be considered on an individual basis. The number of doses of a PRP-OMPC-containing product (i.e., COMVAX, PedvaxHIB) depends on the age that vaccination is begun. An infant 2 to 10 months of age should receive three doses of a product containing PRP-OMPC. An infant 11 to 14 months of age should receive two doses of a product containing PRP-OMPC. A child 15 to 71 months of age should receive one dose of a product containing PRP-OMPC. Infants and children, regardless of age, should receive three doses of an HBsAg-containing product.

COMVAX is for intramuscular injection. The anterolateral thigh is the recommended site for intramuscular injection in infants. Data suggests that injections given in the buttocks frequently are given into fatty tissue instead of into muscle. Such injections have resulted in a lower seroconversion rate (for hepatitis B vaccine) than was expected.

Injection must be accomplished with a needle long enough to ensure intramuscular deposition of the vaccine. The ACIP has recommended that for intramuscular injections, the needle should be of sufficient length to reach the muscle mass itself. In a clinical trial with COMVAX (see CLINICAL PHARMACOLOGY, Antibody Responses to COMVAX in Infants Not Previously Vaccinated with Hib or Hepatitis B Vaccine, Table 1) vaccination was accomplished with a needle length of 5/8 inches in accordance with ACIP recommendations in effect at that time.{62} ACIP currently recommends that needles of longer length (7/8 to 1 inch) be used.{63}

The vaccine should be used as supplied; no reconstitution is necessary.

Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.

Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. After thorough agitation, COMVAX is a slightly opaque, white suspension.

It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one person to another.

Interchangeability of COMVAX and Licensed Haemophilus b Conjugate Vaccines or Recombinant Hepatitis B Vaccines

Since 1990, the Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have recommended routine immunization of infants starting at 2 months of age with a polysaccharide-protein conjugate vaccine to prevent invasive Hib disease.{32,33}

Three Hib vaccines are licensed for infant vaccination: 1) oligosaccharide conjugate Hib vaccine (HbOC) (HibTITER®1), 2) polyribosylribitol phosphate-tetanus toxoid conjugate (PRP-T) (ActHIB®1 and OmniHIB®1), and 3) Haemophilus b conjugate vaccine (meningococcal protein conjugate) (PRP-OMPC) (PedvaxHIB). According to the ACIP, these products are now considered interchangeable for primary as well as booster vaccination.{66}

Because vaccination recommendations limited to high-risk individuals have failed to substantially lower the overall incidence of hepatitis B infection, both the Advisory Committee on Immunization Practices (ACIP) and the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP) have endorsed universal infant immunization as part of a comprehensive strategy for the control of hepatitis B infection.{32,50}
1
HibTITER is a registered trademark of Lederle Laboratories, ActHIB is a registered trademark of Aventis Pasteur Inc. and OmniHIB is a registered trademark of GlaxoSmithKline.
Proquad

Proquad

2.1 Recommended Dose and Schedule

FOR SUBCUTANEOUS ADMINISTRATION ONLY

Each 0.5-mL dose of ProQuad is administered subcutaneously.

The first dose is usually administered at 12 to 15 months of age but may be given anytime through 12 years of age.

If a second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is usually administered at 4 to 6 years of age. At least 1 month should elapse between a dose of a measles-containing vaccine such as M-M-R® II (measles, mumps, and rubella virus vaccine live) and a dose of ProQuad. At least 3 months should elapse between a dose of varicella-containing vaccine and ProQuad.

2.2 Preparation for Administration

CAUTION: Preservatives, antiseptics, detergents, and other anti-viral substances may inactivate the vaccine. Use only sterile syringes that are free of preservatives, antiseptics, detergents, and other anti-viral substances for reconstitution and injection of ProQuad.

Withdraw the entire volume of the supplied diluent into a syringe. Use only the diluent supplied with the vaccine since it is free of preservatives or other anti-viral substances.

Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid.

Withdraw the entire amount of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.

TO MINIMIZE LOSS OF POTENCY, THE VACCINE SHOULD BE ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION. IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES. DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

2.3 Method of Administration

Inject the vaccine subcutaneously into the outer aspect of the deltoid region of the upper arm or into the higher anterolateral area of the thigh.

Use With Other Vaccines

Use different injection sites to administer each vaccine if other vaccines are administered concomitantly. [See Drug Interactions (7.5).]
Integrilin

Integrilin

Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.

The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.

2.1 Dosage in Acute Coronary Syndrome (ACS)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy Aspirin, 160 to 325 mg, should be given daily
INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:
During Medical Management: Target aPTT 50 to 70 seconds If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h. If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h. During PCI: Target ACT 200 to 300 seconds If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds. Heparin infusion after the PCI is discouraged.
2.2 Dosage in Percutaneous Coronary Intervention (PCI)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended. In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery. Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI. Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.
Patients requiring thrombolytic therapy should discontinue INTEGRILIN.

2.3 Important Administration Instructions
Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top. Discard any unused portion left in the vial.
Administer INTEGRILIN by volume according to patient weight (see Table 1).
Table 1: INTEGRILIN Dosing Charts by Weight Patient Weight 180-mcg/kgBolus Volume 2-mcg/kg/minInfusion Volume(CrCl greater than or equal to 50 mL/min) 1-mcg/kg/minInfusion Volume(CrCl less than 50 mL/min) (kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) 37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h 42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h 47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h 54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h 60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h 66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h 72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h 79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h 85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h 91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h 97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h 104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h 110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h 116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h >121 >267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h
Clarinex

Clarinex

Although an orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX® RediTabs® Tablets are no longer marketed.

CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister.

The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).

2.1 Adults and Adolescents 12 Years of Age and Over

The recommended dose of CLARINEX Tablets or CLARINEX RediTabs Tablets is one 5-mg tablet once daily. The recommended dose of CLARINEX Oral Solution is 2 teaspoonfuls (5 mg in 10 mL) once daily.

2.2 Children 6 to 11 Years of Age

The recommended dose of CLARINEX Oral Solution is 1 teaspoonful (2.5 mg in 5 mL) once daily. The recommended dose of CLARINEX RediTabs Tablets is one 2.5-mg tablet once daily.

2.3 Children 12 Months to 5 Years of Age

The recommended dose of CLARINEX Oral Solution is ½ teaspoonful (1.25 mg in 2.5 mL) once daily.

2.4 Children 6 to 11 Months of Age

The recommended dose of CLARINEX Oral Solution is 2 mL (1 mg) once daily.

2.5 Adults with Hepatic or Renal Impairment

In adult patients with liver or renal impairment, a starting dose of one 5-mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology (12.3)].
Lotrisone

Lotrisone

Treatment of tinea corporis or tinea cruris:
Apply a thin film of LOTRISONE cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with LOTRISONE cream, the diagnosis should be reviewed. Do not use longer than 2 weeks.
Treatment of tinea pedis:
Gently massage a sufficient amount of LOTRISONE cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 weeks of treatment with LOTRISONE cream, the diagnosis should be reviewed. Do not use longer than 4 weeks.
LOTRISONE cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Asmanex Hfa

Asmanex Hfa

2.1 General

ASMANEX HFA should be administered only by the orally inhaled route [see Instructions for Use in the Patient Information leaflet]. After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.

The cap from the mouthpiece of the actuator should be removed before using ASMANEX HFA.

ASMANEX HFA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

The ASMANEX HFA canister should only be used with the ASMANEX HFA actuator. The ASMANEX HFA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the ASMANEX HFA canister.

2.2 Dosing

ASMANEX HFA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.

Shake well prior to each inhalation.

The recommended doses for ASMANEX HFA treatment based on prior asthma therapy are provided in Table 1.
TABLE 1: Recommended Dosages for ASMANEX HFA Treatment Previous Therapy Recommended Dose * For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be weaned slowly, beginning after at least 1 week of ASMANEX HFA therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.4)]. Inhaled medium-dose corticosteroids ASMANEX HFA 100 mcg, 2 inhalations twice daily Inhaled high-dose corticosteroids ASMANEX HFA 200 mcg, 2 inhalations twice daily Oral corticosteroids* ASMANEX HFA 200 mcg, 2 inhalations twice daily
If a dosage regimen of ASMANEX HFA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of ASMANEX HFA with a higher strength, initiating an inhaled corticosteroid and long-acting beta2-agonist combination product, or initiating oral corticosteroids, should be considered.

The maximum daily recommended dose is two inhalations of ASMANEX HFA 200 mcg twice daily (maximum of 800 mcg a day). If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. For patients who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.

After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects.
P.g. 600

P.g. 600

One dose (5 mL) of reconstituted P.G. 600, containing 400 IU serum gonadotropin (PMSG) and 200 IU chorionic gonadotropin (HCG), should be injected into the gilt or sow's neck behind the ear.

Prepuberal gilts should be injected when they are selected for addition to the breeding herd. Sows should be injected at weaning during periods of delayed return to estrus.

SINGLE DOSE VIALS

Using a sterile syringe and a sterile 0.90 × 38 mm (20 G × 1 ½") hypodermic needle, transfer the contents of one vial of sterile diluent (5 mL) into one vial of freeze-dried powder. Shake gently to dissolve the powder. Inject the contents of the vial into the gilt or sow's neck behind the ear.

FIVE DOSE VIAL

Using a sterile syringe and a sterile 0.90 × 38 mm (20 G × 1 ½") hypodermic needle, transfer approximately 5 mL of the sterile diluent into the vial of freeze-dried powder. Shake gently to dissolve the powder. Transfer the dissolved product back into the vial of diluent and shake gently to mix. Inject one dose (5 mL) of the reconstituted solution into the gilt or sow's neck behind the ear.
Recombivax Hb

Recombivax Hb

For intramuscular administration. See Section 2.2 for subcutaneous administration in persons with hemophilia.

2.1 Dosage and Schedule

RECOMBIVAX HB:

Persons from birth through 19 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule.

Adolescents 11 through 15 years of age: A series of 3 doses (0.5 mL each) given on a 0-, 1-, and 6-month schedule or a series of 2 doses (1.0 mL each) on a 0- and 4- to 6-month schedule.

Persons 20 years of age and older: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

RECOMBIVAX HB Dialysis Formulation:

Adults on predialysis and dialysis: A series of 3 doses (1.0 mL each) given on a 0-, 1-, and 6-month schedule.

Table 1 summarizes the dose and formulation of RECOMBIVAX HB for specific populations, regardless of the risk of infection with hepatitis B virus.
Table 1: RECOMBIVAX HB Recommended Dose and Administration Schedules Group Dose/Regimen * For specific recommendations for infants see ACIP recommendations.{1} † Adolescents (11 through 15 years of age) may receive either regimen: 3 × 5 mcg (Pediatric Formulation) or 2 × 10 mcg (Adult Formulation). ‡ If the suggested dose (10 mcg) is not available, the appropriate dosage can be achieved with two 5 mcg doses. However, the Dialysis Formulation may be used only for adult predialysis/dialysis patients. § See also recommendations for revaccination of predialysis and dialysis patients in [Dosage and Administration (2.4)]. Infants*, Children and Adolescents0-19 years of age(Pediatric/Adolescent Formulation) 5 mcg (0.5 mL)3 doses at 0, 1, and 6 months Adolescents† 11 through 15 years of age(Adult formulation) 10 mcg‡ (1.0 mL)2 doses at 0 and 4-6 months Adults≥20 years of age(Adult formulation) 10 mcg‡ (1.0 mL)3 doses at 0, 1, and 6 months Predialysis and Dialysis Patients§ (Dialysis formulation) 40 mcg (1.0 mL)3 doses at 0, 1, and 6 months
2.2 Preparation and Administration

Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the suspension does not appear homogeneous or if extraneous particulate matter remains or if discoloration is observed.

For single-dose vials, withdraw and administer entire dose of RECOMBIVAX HB intramuscularly using a sterile needle and syringe.

For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of RECOMBIVAX HB intramuscularly.

The deltoid muscle is the preferred site for intramuscular injection for adults, adolescents and children 1 year of age and older whose deltoid is large enough for intramuscular injection. The anterolateral aspect of the thigh is the preferred site for intramuscular injection for infants younger than 1 year of age. RECOMBIVAX HB should not be administered in the gluteal region, as injections given in the buttocks have resulted in lower seroconversion rates than expected.{2}

RECOMBIVAX HB may be administered subcutaneously to persons at risk for hemorrhage following intramuscular injections (e.g., hemophiliacs). However, hepatitis B vaccines are known to result in lower antibody response when administered subcutaneously.{3} Additionally, when other aluminum-adsorbed vaccines have been administered subcutaneously, an increased incidence of local reactions including subcutaneous nodules has been observed. Therefore, consider subcutaneous administration only in persons who are at risk of hemorrhage following intramuscular injections.

Do not administer intravenously or intradermally

2.3 Known or Presumed Exposure to Hepatitis B Virus

Known or Presumed Exposure to HBsAg

Refer to recommendations of the Advisory Committee on Immunization Practices (ACIP) and to the package insert for hepatitis B immune globulin (HBIG) for management of persons with known or presumed exposure to the hepatitis B virus (e.g., neonates born of infected mothers or persons who experienced percutaneous or permucosal exposure to the virus). When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites (e.g., opposite anterolateral thighs for exposed neonates) as soon as possible after exposure. Administer additional doses of RECOMBIVAX HB (to complete a vaccination series) in accordance with ACIP recommendations.

2.4 Booster Vaccinations

The duration of the protective effect of RECOMBIVAX HB in healthy vaccinees is unknown at present and the need for booster doses is not yet defined. The ACIP provides recommendations for use of a booster dose or revaccination series in previously vaccinated individuals with known or presumed exposure to Hepatitis B Virus.

Consider a booster dose or revaccination with RECOMBIVAX HB Dialysis Formulation (blue color code) in predialysis/dialysis patients if the anti-HBs level is less than 10 mIU/mL at 1 to 2 months after the third dose. Assess the need for a booster dose annually by antibody testing, and give a booster dose when the anti-HBs level declines to less than 10 mIU/mL.{3}
Gardasil

Gardasil

2.1 General

DULERA should be administered only by the orally inhaled route (see Patient Instructions for Use in the Medication Guide). After each dose, the patient should be advised to rinse his/her mouth with water without swallowing.

The cap from the mouthpiece of the actuator should be removed before using DULERA.

DULERA should be primed before using for the first time by releasing 4 test sprays into the air, away from the face, shaking well before each spray. In cases where the inhaler has not been used for more than 5 days, prime the inhaler again by releasing 4 test sprays into the air, away from the face, shaking well before each spray.

The DULERA canister should only be used with the DULERA actuator. The DULERA actuator should not be used with any other inhalation drug product. Actuators from other products should not be used with the DULERA canister.

2.2 Dosing

DULERA should be administered as two inhalations twice daily every day (morning and evening) by the orally inhaled route.

Shake well prior to each inhalation.

The recommended starting dosages for DULERA treatment are based on prior asthma therapy.
Table 1: Recommended Dosages for DULERA Previous Therapy Recommended Dose Maximum Recommended Daily Dose Inhaled medium dose corticosteroids DULERA 100 mcg/5 mcg, 2 inhalations twice daily 400 mcg/20 mcg Inhaled high dose corticosteroids DULERA 200 mcg/5 mcg, 2 inhalations twice daily 800 mcg/20 mcg
The maximum daily recommended dose is two inhalations of DULERA 200 mcg/5 mcg twice daily. Do not use more than two inhalations twice daily of the prescribed strength of DULERA as some patients are more likely to experience adverse effects with higher doses of formoterol. If symptoms arise between doses, an inhaled short-acting beta2-agonist should be taken for immediate relief.

If a previously effective dosage regimen of DULERA fails to provide adequate control of asthma, the therapeutic regimen should be re-evaluated and additional therapeutic options, e.g., replacing the current strength of DULERA with a higher strength, adding additional inhaled corticosteroid, or initiating oral corticosteroids, should be considered.

The maximum benefit may not be achieved for 1 week or longer after beginning treatment. Individual patients may experience a variable time to onset and degree of symptom relief. For patients ≥12 years of age who do not respond adequately after 2 weeks of therapy, higher strength may provide additional asthma control.
Celestone Soluspan

Celestone Soluspan

Benzyl alcohol as a preservative has been associated with a fatal "Gasping Syndrome" in premature infants and infants of low birth weight. Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant. The initial dosage of parenterally administered CELESTONE® SOLUSPAN® Injectable Suspension may vary from 0.25 to 9.0 mg per day depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended (see PRECAUTIONS, Neuro-psychiatric section).

In pediatric patients, the initial dose of betamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m2bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:
Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4
These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

If coadministration of a local anesthetic is desired, CELESTONE SOLUSPAN Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided, since these compounds may cause flocculation of the steroid. The required dose of CELESTONE SOLUSPAN Injectable Suspension is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe shaken briefly. Do not inject local anesthetics into the vial of CELESTONE SOLUSPAN Injectable Suspension.

Bursitis, Tenosynovitis, Peritendinitis

In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1.0 mL CELESTONE SOLUSPAN Injectable Suspension can relieve pain and restore full range of movement. Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis. Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections. Chronic bursitis may be treated with reduced dosage once the acute condition is controlled. In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases. Injections should be made into the affected tendon sheaths rather than into the tendons themselves. In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions.

Rheumatoid Arthritis and Osteoarthritis

Following intra-articular administration of 0.5 to 2.0 mL of CELESTONE SOLUSPAN Injectable Suspension, relief of pain, soreness, and stiffness may be experienced. Duration of relief varies widely in both diseases. Intra-articular Injection of CELESTONE SOLUSPAN Injectable Suspension is well tolerated in joints and periarticular tissues. There is virtually no pain on injection, and the "secondary flare" that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with CELESTONE SOLUSPAN Injectable Suspension. Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint. The aspirating syringe is replaced by a syringe containing CELESTONE SOLUSPAN Injectable Suspension and injection is then made into the joint.
Recommended Doses for Intra-articular Injection Size of joint Location Dose (mL) Very large Hip 1.0-2.0 Large Knee, ankle, shoulder 1.0 Medium Elbow, wrist 0.5-1.0 Small (metacarpophalangeal, interphalangeal)(sternoclavicular) Hand, chest 0.25-0.5
A portion of the administered dose of CELESTONE SOLUSPAN Injectable Suspension is absorbed systemically following intra-articular injection. In patients being treated concomitantly with oral or parenteral corticosteroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining intra-articular dosage.

Dermatologic Conditions

In intralesional treatment, 0.2 mL/cm2 of CELESTONE SOLUSPAN Injectable Suspension is injected intradermally (not subcutaneously) using a tuberculin syringe with a 25-gauge, ½-inch needle. Care should be taken to deposit a uniform depot of medication intradermally. A total of no more than 1.0 mL at weekly intervals is recommended.

Disorders of the Foot

A tuberculin syringe with a 25-gauge, ¾-inch needle is suitable for most injections into the foot. The following doses are recommended at intervals of 3 days to a week.
Diagnosis CELESTONE SOLUSPANInjectable Suspension Dose (mL) Bursitis under heloma durum or heloma molle 0.25-0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5-1.0
Pneumovax 23

Pneumovax 23

For intramuscular or subcutaneous injection only.

2.1 Preparation
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered. Do not mix PNEUMOVAX 23 with other vaccines in the same syringe or vial. Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another. Single-Dose and Multidose Vials Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.Single-Dose, Prefilled Syringe The package does not contain a needle. Attach a sterile needle to the prefilled syringe by twisting in a clockwise direction until the needle fits securely on the syringe.
2.2 Administration

Administer PNEUMOVAX 23 intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.

Single-Dose and Multidose Vials

Administer a single 0.5-mL dose of PNEUMOVAX 23 using a sterile needle and syringe.

Single-Dose, Prefilled Syringe

Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle.

2.3 Revaccination

The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with PNEUMOVAX 23. Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine, is not recommended.{1,2}
Ragwitek

Ragwitek

For sublingual use only.

2.1 Dose

One RAGWITEK tablet daily.

2.2 Administration

Administer the first dose of RAGWITEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of RAGWITEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.
Take the tablet from the blister unit after carefully removing the foil with dry hands.
Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute.

Wash hands after handling the tablet.

Do not take the tablet with food or beverage. Food or beverage should not be taken for the following 5 minutes after taking the tablet.

Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season. The safety and efficacy of initiating treatment in season have not been established.

Data regarding the safety of restarting treatment after missing a dose of RAGWITEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.

Prescribe auto-injectable epinephrine to patients prescribed RAGWITEK and instruct them in the proper use of emergency self-injection of epinephrine [see Warnings and Precautions (5.2)].
M-m-r Ii

M-m-r Ii

FOR SUBCUTANEOUS ADMINISTRATION

Do not inject intravascularly.

The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm.

The recommended age for primary vaccination is 12 to 15 months.

Revaccination with M-M-R II is recommended prior to elementary school entry. See also INDICATIONS AND USAGE, Recommended Vaccination Schedule.

Children first vaccinated when younger than 12 months of age should receive another dose between 12 to 15 months of age followed by revaccination prior to elementary school entry.{32} See also INDICATIONS AND USAGE, Measles Outbreak Schedule.

Immune Globulin (IG) is not to be given concurrently with M-M-R II (see PRECAUTIONS, General and PRECAUTIONS, Drug Interactions).

CAUTION: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 5/8" needle is recommended.

To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine.

Single Dose Vial — First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. M-M-R II, when reconstituted, is clear yellow.

Use With Other Vaccines

M-M-R II should be given one month before or after administration of other live viral vaccines.

M-M-R II has been administered concurrently with VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)], and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes. No impairment of immune response to individually tested vaccine antigens was demonstrated. The type, frequency, and severity of adverse experiences observed with M-M-R II were similar to those seen when each vaccine was given alone.

Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.

However, other schedules have been used. The ACIP has stated "Although data are limited concerning the simultaneous administration of the entire recommended vaccine series (i.e., DTaP [or DTwP], IPV [or OPV], Hib with or without Hepatitis B vaccine, and varicella vaccine), data from numerous studies have indicated no interference between routinely recommended childhood vaccines (either live, attenuated, or killed). These findings support the simultaneous use of all vaccines as recommended."{61}
Noxafil

Noxafil

General

The prescriber should follow the specific dosing instructions for each formulation.

Noxafil injection should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC), by slow intravenous infusion over approximately 90 minutes. If a central venous catheter is not available, Noxafil injection may be administered through a peripheral venous catheter by slow intravenous infusion over 30 minutes only as a single dose in advance of central venous line placement or to bridge the period during which a central venous line is replaced or is in use for other intravenous treatment. When multiple dosing is required, the infusion should be done via a central venous line. Never give Noxafil injection as an intravenous bolus injection.

The delayed-release tablet and oral suspension are not to be used interchangeably due to the differences in the dosing of each formulation.

Noxafil delayed-release tablets must be swallowed whole, and not be divided, crushed, or chewed. Noxafil delayed-release tablets should be taken with food [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].

Noxafil oral suspension should be administered with a full meal or with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale) in patients who cannot eat a full meal.

Coadministration of drugs that can decrease the plasma concentrations of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections [see Drug Interactions (7.6, 7.7, 7.8, 7.9, 7.13)].

Patients who have severe diarrhea or vomiting should be monitored closely for breakthrough fungal infections when receiving Noxafil delayed-release tablets or oral suspension.

2.1 Instructions for Use with Noxafil Injection

Dosing:
Table 1: Dosing for Noxafil Injection Indication Dose and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections Loading dose:300 mg Noxafil injection intravenously twice a day on the first day. Maintenance dose:300 mg Noxafil injection intravenously once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression.
Preparation:
Equilibrate the refrigerated vial of Noxafil (posaconazole) injection to room temperature. Aseptically transfer 16.7 mL of posaconazole solution to an intravenous bag (or bottle) containing approximately 150 mL of 5% dextrose in water or sodium chloride 0.9%. Noxafil injection should only be administered with these diluents. Use of other infusion solutions may result in particulate formation. Noxafil injection is a single dose sterile solution without preservatives. Once admixed, the product should be used immediately. If not used immediately, the solution can be stored up to 24 hours refrigerated 2-8°C (36-46°F). This medicinal product is for single use only and any unused solution should be discarded. Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Once admixed, the solution of Noxafil ranges from colorless to yellow. Variations of color within this range do not affect the quality of the product.
Intravenous Line Compatibility:

A study was conducted to evaluate physical compatibility of Noxafil injection with injectable drug products and commonly used intravenous diluents during simulated Y-site infusion. Compatibility was determined through visual observations, measurement of particulate matter and turbidity.

Based on the results of the study, the following drug products and diluents can be infused at the same time through the same intravenous line (or cannula) as Noxafil injection. Co-administered drug products should be prepared in 5% dextrose in water or sodium chloride 0.9%. Co-administration of drug products prepared in other infusion solutions may result in particulate formation.
5% dextrose in water Amikacin sulfate Caspofungin Ciprofloxacin Daptomycin Dobutamine hydrochloride Famotidine Filgrastim Gentamicin sulfate Hydromorphone hydrochloride Levofloxacin Lorazepam Meropenem Micafungin Morphine sulfate Norepinephrine bitartrate Potassium chloride Sodium chloride 0.9% Vancomycin hydrochloride
Any products or diluents not listed in the table above should not be coadministered through the same intravenous line (or cannula).

Administration:
Noxafil injection must be administered through a 0.22 micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter. Administer via a central venous line, including a central venous catheter or PICC by slow infusion over approximately 90 minutes. Noxafil injection is not for bolus administration.If a central venous catheter is not available, Noxafil injection may be administered through a peripheral venous catheter only as a single dose in advance of central venous line placement or to bridge the period during which a central venous line is replaced or is in use for other treatment. When multiple dosing is required, the infusion should be done via a central venous line. When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes. Note: In clinical trials, multiple peripheral infusions given through the same vein resulted in infusion site reactions [see Adverse Reactions (6.2)].
2.2 Instructions for Use with Noxafil Delayed-Release Tablets
Table 2: Dosing for Noxafil Delayed-Release Tablets Indication Dose and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections Loading dose: 300 mg (three 100 mg delayed-release tablets) twice a day on the first day. Maintenance dose: 300 mg (three 100 mg delayed-release tablets) once a day, starting on the second day. Duration of therapy is based on recovery from neutropenia or immunosuppression.
2.3 Instructions for Use with Noxafil Oral Suspension
Table 3: Dosing for Noxafil Oral Suspension Indication Dose and Duration of Therapy Prophylaxis of invasive Aspergillus and Candida infections 200 mg (5 mL) three times a day. The duration of therapy is based on recovery from neutropenia or immunosuppression. Oropharyngeal Candidiasis Loading dose: 100 mg (2.5 mL) twice a day on the first day. Maintenance dose: 100 mg (2.5 mL) once a day for 13 days. Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole 400 mg (10 mL) twice a day. Duration of therapy should be based on the severity of the patient's underlying disease and clinical response.
Administration Instructions for Noxafil oral suspension

Shake Noxafil oral suspension well before use.

Figure 1: A measured dosing spoon is provided, marked for doses of 2.5 mL and 5 mL.

It is recommended that the spoon is rinsed with water after each administration and before storage.

2.4 Administration Information

Noxafil delayed-release tablets:
Noxafil delayed-release tablets should be taken with food to enhance the oral absorption of posaconazole and optimize plasma concentrations. Noxafil delayed-release tablets should be used only for the prophylaxis indication. Noxafil delayed-release tablets generally provide higher plasma drug exposures than Noxafil oral suspension under both fed and fasted conditions, and therefore is the preferred oral formulation for the prophylaxis indication.
Noxafil oral suspension:
Each dose of Noxafil oral suspension should be administered during or immediately (i.e., within 20 minutes) following a full meal to enhance the oral absorption of posaconazole and optimize plasma concentrations. In patients who cannot eat a full meal and for whom Noxafil delayed-release tablets or Noxafil injection are not options, each dose of Noxafil oral suspension should be administered with a liquid nutritional supplement or an acidic carbonated beverage. In patients who cannot eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage and who do not have the option of taking Noxafil delayed-release tablets or Noxafil injection, an alternative antifungal therapy should be considered or patients should be monitored closely for breakthrough fungal infections.
2.5 Use in Patients with Renal Impairment

The pharmacokinetics of Noxafil oral suspension are not significantly affected by renal impairment. Therefore, no adjustment is necessary for oral dosing in patients with mild to severe renal impairment.

Noxafil injection should be avoided in patients with moderate or severe renal impairment (eGFR <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use of Noxafil injection. In patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <50 mL/min), receiving the Noxafil injection, accumulation of the intravenous vehicle, Betadex Sulfobutyl Ether Sodium (SBECD), is expected to occur. Serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to changing to oral Noxafil therapy.
Oxycodone And Acetamino...

Oxycodone And Acetaminophen

2.1 Asthma

SINGULAIR should be taken once daily in the evening. The following doses are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.

For pediatric patients 12 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.

There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.

2.2 Exercise-Induced Bronchoconstriction (EIB)

For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. The following doses are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose. Patients already taking SINGULAIR daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 6 years of age have not been established. Daily administration of SINGULAIR for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.

2.3 Allergic Rhinitis

For allergic rhinitis, SINGULAIR should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.

The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.

The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:

For adults and adolescents 15 years of age and older: one 10-mg tablet.

For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.

For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one packet of 4-mg oral granules.

For pediatric patients 6 to 23 months of age: one packet of 4-mg oral granules.

Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.

2.4 Asthma and Allergic Rhinitis

Patients with both asthma and allergic rhinitis should take only one SINGULAIR dose daily in the evening.

2.5 Instructions for Administration of Oral Granules

SINGULAIR 4-mg oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice, or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with baby formula, breast milk, or food) must be administered within 15 minutes. If mixed with baby formula, breast milk, or food, SINGULAIR oral granules must not be stored for future use. Discard any unused portion. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration. SINGULAIR oral granules can be administered without regard to the time of meals.
Fosamax Plus D

Fosamax Plus D

2.1 Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic women, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3) once weekly.

2.2 Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is one 70 mg alendronate/2800 international units vitamin D3 or one 70 mg alendronate/5600 international units vitamin D3 tablet once weekly. For most osteoporotic men, the appropriate dose is FOSAMAX PLUS D (70 mg alendronate/5600 international units vitamin D3) once weekly.

2.3 Important Administration Instructions

Instruct patients to do the following:
Take FOSAMAX PLUS D at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of alendronate [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking FOSAMAX PLUS D with food, beverages (other than plain water) or other medications will lessen the effect of alendronate by decreasing its absorption into the body. Take FOSAMAX PLUS D upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX PLUS D tablet should be swallowed with a full glass of water (6-8 ounces). Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX PLUS D should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)].
2.4 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

The recommended intake of vitamin D is 400-800 international units daily. FOSAMAX PLUS D 70 mg/2800 international units and 70 mg/5600 international units are intended to provide seven days' worth of 400 and 800 international units daily vitamin D in a single, once-weekly dose, respectively.

2.5 Administration Instructions for Missed Doses

If a once-weekly dose of FOSAMAX PLUS D is missed, instruct patients to take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet once a week, as originally scheduled on their chosen day.
Fosamax

Fosamax

Although alendronate tablets 5 mg, 10 mg, 35 mg, and 40 mg are available in the marketplace, FOSAMAX is no longer marketed in the 5 mg, 10 mg, 35 mg, and 40 mg strengths.

Although an oral solution of alendronate may be available in the marketplace, FOSAMAX oral solution is no longer marketed.

2.1 Treatment of Osteoporosis in Postmenopausal Women

The recommended dosage is:
one 70 mg tablet once weekly      or one bottle of 70 mg oral solution once weekly      or one 10 mg tablet once daily
2.2 Prevention of Osteoporosis in Postmenopausal Women

The recommended dosage is:
one 35 mg tablet once weekly      or one 5 mg tablet once daily
2.3 Treatment to Increase Bone Mass in Men with Osteoporosis

The recommended dosage is:
one 70 mg tablet once weekly      or one bottle of 70 mg oral solution once weekly      or one 10 mg tablet once daily
2.4 Treatment of Glucocorticoid-Induced Osteoporosis

The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.

2.5 Treatment of Paget's Disease of Bone

The recommended treatment regimen is 40 mg once a day for six months.

Re-treatment of Paget's Disease

Re-treatment with FOSAMAX may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. Re-treatment may also be considered in those who failed to normalize their serum alkaline phosphatase.

2.6 Important Administration Instructions

Instruct patients to do the following:
Take FOSAMAX at least one-half hour before the first food, beverage, or medication of the day with plain water only [see Patient Counseling Information (17.2)]. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of FOSAMAX [see Drug Interactions (7.1)]. Waiting less than 30 minutes, or taking FOSAMAX with food, beverages (other than plain water) or other medications will lessen the effect of FOSAMAX by decreasing its absorption into the body. Take FOSAMAX upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, a FOSAMAX tablet should be swallowed with a full glass of water (6-8 ounces). To facilitate gastric emptying FOSAMAX oral solution should be followed by at least 2 ounces (a quarter of a cup) of water. Patients should not lie down for at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failure to follow these instructions may increase the risk of esophageal adverse experiences [see Warnings and Precautions (5.1) and Patient Counseling Information (17.2)].
2.7 Recommendations for Calcium and Vitamin D Supplementation

Instruct patients to take supplemental calcium if dietary intake is inadequate [see Warnings and Precautions (5.2)]. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home-bound, or chronically ill) may need vitamin D supplementation. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.

2.8 Administration Instructions for Missed Doses

If a once-weekly dose of FOSAMAX is missed, instruct patients to take one dose on the morning after they remember. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
Entereg

Entereg

For hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery until discharge for a maximum of 7 days. Patients should not receive more than 15 doses of ENTEREG.
Imipenem And Cilastatin...

Imipenem And Cilastatin

2.1 Recommended Dosing

The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

2.2 Patients with Renal Insufficiency

For patients with mild renal insufficiency (creatinine clearance [CrCl] greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl greater than or equal to 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. [See Clinical Pharmacology (12.3).] There have been postmarketing reports of worsening renal function in patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

2.3 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin

When JANUVIA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia. [See Warnings and Precautions (5.3).]
Bacteria Plus

Bacteria Plus

RESFLOR GOLD® should be administered once by subcutaneous injection at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site. The injection should be given only in the neck. Injection sites other than the neck have not been evaluated. For the 500 mL vial, do not puncture the stopper more than 20 times.
* Do not administer more than 10 mL at each site. RESFLOR GOLD® Dosage Guide* ANIMAL WEIGHT(lb) DOSAGE(mL) 100 6.0 RecommendedInjectionLocation 200 12.0 300 18.0 400 24.0 500 30.0 600 36.0 700 42.0 800 48.0 900 54.0 1000 60.0
Sinemet

Sinemet

The optimum daily dosage of SINEMET must be determined by careful titration in each patient. SINEMET tablets are available in a 1:4 ratio of carbidopa to levodopa (SINEMET 25-100) as well as 1:10 ratio (SINEMET 25-250 and SINEMET 10-100). Tablets of the two ratios may be given separately or combined as needed to provide the optimum dosage.

Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

Usual Initial Dosage

Dosage is best initiated with one tablet of SINEMET 25-100 three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of SINEMET 25-100 a day is reached.

If SINEMET 10-100 is used, dosage may be initiated with one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets q.i.d.) is reached.

How to Transfer Patients from Levodopa

Levodopa must be discontinued at least twelve hours before starting SINEMET. A daily dosage of SINEMET should be chosen that will provide approximately 25% of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on one tablet of SINEMET 25-100 three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one tablet of SINEMET 25-250 three or four times a day.

Maintenance

Therapy should be individualized and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one tablet of SINEMET 25-100 may be substituted for each tablet of SINEMET 10-100. When more levodopa is required, SINEMET 25-250 should be substituted for SINEMET 25-100 or SINEMET 10-100. If necessary, the dosage of carbidopa levodopa 25-250 may be increased by one-half or one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.

Because both therapeutic and adverse responses occur more rapidly with SINEMET than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with SINEMET than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

Addition of Other Antiparkinsonian Medications

Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while SINEMET is being administered, although dosage adjustments may be required.

Interruption of Therapy

Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of SINEMET. Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, SINEMET may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.
Sinemet Cr

Sinemet Cr

SINEMET CR contains carbidopa and levodopa in a 1:4 ratio as either the 50-200 tablet or the 25-100 tablet. The daily dosage of SINEMET CR must be determined by careful titration. Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of involuntary movements, dyskinesias or nausea. SINEMET CR should not be chewed or crushed.

Standard drugs for Parkinson's disease, other than levodopa without a decarboxylase inhibitor, may be used concomitantly while SINEMET CR is being administered, although their dosage may have to be adjusted.

Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, SINEMET CR can be given to patients receiving supplemental pyridoxine (vitamin B6).

Initial Dosage

Patients currently treated with conventional carbidopa levodopa preparations: Studies show that peripheral dopa-decarboxylase is saturated by the bioavailable carbidopa at doses of 70 mg a day and greater. Because the bioavailabilities of carbidopa and levodopa in SINEMET and SINEMET CR are different, appropriate adjustments should be made, as shown in Table 2.
Table 2: Approximate Bioavailabilities at Steady State* Tablet Amount ofLevodopa (mg)in Each Tablet ApproximateBioavailability Approximate Amountof BioavailableLevodopa (mg) inEach Tablet * This table is only a guide to bioavailabilities since other factors such as food, drugs, and inter-patient variabilities may affect the bioavailability of carbidopa and levodopa. † The extent of availability of levodopa from SINEMET CR was about 70-75% relative to intravenous levodopa or standard SINEMET in the elderly. ‡ The extent of availability of levodopa from SINEMET was 99% relative to intravenous levodopa in the healthy elderly. SINEMET CR50-200 200 0.70-0.75† 140-150 SINEMET25-100 100 0.99‡ 99
Dosage with SINEMET CR should be substituted at an amount that provides approximately 10% more levodopa per day, although this may need to be increased to a dosage that provides up to 30% more levodopa per day depending on clinical response (see DOSAGE AND ADMINISTRATION, Titration with SINEMET CR). The interval between doses of SINEMET CR should be 4-8 hours during the waking day. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)

A guideline for initiation of SINEMET CR is shown in Table 3.
Table 3: Guidelines for Initial Conversion from SINEMET to SINEMET CR * For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION, Initial Dosage — Patients currently treated with conventional carbidopa levodopa preparations. SINEMETTotal Daily Dose* Levodopa (mg) SINEMET CRSuggestedDosage Regimen 300-400 200 mg b.i.d. 500-600 300 mg b.i.d. or 200 mg t.i.d. 700-800 A total of 800 mg in 3 or more divided doses (e.g., 300 mg a.m., 300 mg early p.m., and 200 mg later p.m.) 900-1000 A total of 1000 mg in 3 or more divided doses (e.g., 400 mg a.m., 400 mg early p.m., and 200 mg later p.m.)
Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with SINEMET CR is started. SINEMET CR should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of SINEMET CR 50-200 b.i.d.

Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of SINEMET CR 50-200 b.i.d. Initial dosage should not be given at intervals of less than 6 hours.

Titration with SINEMET CR

Following initiation of therapy, doses and dosing intervals may be increased or decreased depending upon therapeutic response. Most patients have been adequately treated with doses of SINEMET CR that provide 400 to 1600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of SINEMET CR (2400 mg or more of levodopa per day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended.

When doses of SINEMET CR are given at intervals of less than 4 hours, and/or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day.

An interval of at least 3 days between dosage adjustments is recommended.

Maintenance

Because Parkinson's disease is progressive, periodic clinical evaluations are recommended; adjustment of the dosage regimen of SINEMET CR may be required.

Addition of Other Antiparkinson Medications

Anticholinergic agents, dopamine agonists, and amantadine can be given with SINEMET CR. Dosage adjustment of SINEMET CR may be necessary when these agents are added.

A dose of carbidopa levodopa immediate release 25-100 or 10-100 (one half or a whole tablet) can be added to the dosage regimen of SINEMET CR in selected patients with advanced disease who need additional immediate-release levodopa for a brief time during daytime hours.

Interruption of Therapy

Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of SINEMET or SINEMET CR.

Patients should be observed carefully if abrupt reduction or discontinuation of SINEMET CR is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

If general anesthesia is required, SINEMET CR may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual dosage should be administered as soon as the patient is able to take oral medication.
Family Wellness Laxativ...

Family Wellness Laxative

2.1 Recommended Dosage

The recommended dosage of SIVEXTRO is 200 mg administered once daily for six (6) days either orally (with or without food) or as an intravenous (IV) infusion in patients 18 years of age or older.

The recommended dosage and administration is described in Table 1.
Table 1 Dosage of SIVEXTRO Infection Route Dosage Frequency Infusion Time Duration of Treatment Acute Bacterial Skin and Skin Structure Infection (ABSSSI) Intravenous 200 mg Once daily 1 hour 6 days Oral 200 mg Once daily Not Applicable
No dose adjustment is necessary when changing from intravenous to oral SIVEXTRO.

If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

2.2 Preparation and Administration of Intravenous Solution

SIVEXTRO is supplied as a sterile, lyophilized powder for injection in single-use vials of 200 mg. Each 200 mg vial must be reconstituted with Sterile Water for Injection and subsequently diluted only with 0.9% Sodium Chloride Injection, USP.

SIVEXTRO vials contain no antimicrobial preservatives and are intended for single use only.

Preparation

The contents of the vial should be reconstituted using aseptic technique as follows:

Note: To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
Reconstitute the SIVEXTRO vial with 4 mL of Sterile Water for Injection. Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Inspect the vial to ensure the solution contains no particulate matter and no cake or powder remains attached to the sides of the vial. If necessary, invert the vial to dissolve any remaining powder and swirl gently to prevent foaming. The reconstituted solution is clear and colorless to pale-yellow in color; the total storage time should not exceed 24 hours at either room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F). Tilt the upright vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 4 mL of the reconstituted solution. Do not invert the vial during extraction. The reconstituted solution must be further diluted in 250 mL of 0.9% Sodium Chloride Injection, USP. Slowly inject the 4 mL of reconstituted solution into a 250 mL bag of 0.9% Sodium Chloride Injection, USP. Invert the bag gently to mix. Do NOT shake the bag as this may cause foaming.
Administration

Administer as an intravenous infusion only.

Do not administer as an intravenous push or bolus. Do not mix SIVEXTRO with other drugs when administering. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

The intravenous bag containing the reconstituted and diluted intravenous solution should be inspected visually for particulate matter prior to administration. Discard if visible particles are observed. The resulting solution is clear and colorless to pale-yellow in color.

After reconstitution and dilution, SIVEXTRO is to be administered via intravenous infusion using a total time of 1 hour.

The total time from reconstitution to administration should not exceed 24 hours at room temperature or under refrigeration at 2°C to 8°C (36°F to 46°F).

2.3 Compatible Intravenous Solutions

SIVEXTRO is compatible with 0.9% Sodium Chloride Injection, USP.

2.4 Incompatibilities

SIVEXTRO for injection is incompatible with any solution containing divalent cations (e.g., Ca2+, Mg2+), including Lactated Ringer's Injection and Hartmann's Solution.

Limited data are available on the compatibility of SIVEXTRO for injection with other intravenous substances, additives or other medications and they should not be added to SIVEXTRO single-use vials or infused simultaneously. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of SIVEXTRO with 0.9% Sodium Chloride Injection, USP.
Orbax

Orbax

DOSAGE AND ADMINISTRATION: For routine out-patient treatment of infection caused by a susceptible organism, in an otherwise healthy dog or cat, the dose of ORBAX® (orbifloxacin) Tablets is 2.5 to 7.5 mg/kg of body weight administered once daily. (See DRUG INTERACTIONS and TARGET ANIMAL SAFETY). In the cat, ORBAX® (orbifloxacin) Tablets and ORBAX® (orbifloxacin) Oral Suspension are not bioequivalent. On a mg/kg basis, ORBAX® (orbifloxacin) Oral Suspension provides lower and more variable plasma levels of orbifloxacin than ORBAX® (orbifloxacin) Tablets. The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organism, and the integrity of the patient's host-defense mechanisms. Antibiotic susceptibility of the pathogenic organism(s) should be determined prior to use of this preparation. Therapy with ORBAX® (orbifloxacin) Tablets may be initiated before results of these tests are known. Once results become available, continue with appropriate therapy.

For the treatment of skin and associated soft tissue infections, ORBAX® (orbifloxacin) Tablets should be given for two (2) to three (3) days beyond the cessation of clinical signs to a maximum of 30 days. For the treatment of urinary tract infections, ORBAX® (orbifloxacin) Tablets should be administered for at least 10 consecutive days. If no improvement is seen within five (5) days, the diagnosis should be re-evaluated and a different course of therapy considered.

To administer a total daily dose of 2.5 mg/kg, ORBAX® (orbifloxacin) Tablets may be dispensed as indicated in Table 1.
Table 1: Dose Table for ORBAX® (orbifloxacin) Tablets (2.5 mg/kg total daily dose) WEIGHT OF DOG/CAT (lbs) 5 10 20 30 40 50 60 90 120 No. of 22.7 mg tablets ½ 1 1½ 2 2½ No. of 68 mg tablets ½ 1 1½ 2
Victrelis

Victrelis

VICTRELIS must be administered in combination with peginterferon alfa and ribavirin. The dose of VICTRELIS is 800 mg (four 200-mg capsules) three times daily (every 7 to 9 hours) with food [a meal or light snack] (see Table 1). Refer to the prescribing information for peginterferon alfa and ribavirin for instructions on dosing.

The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials [see Clinical Studies (14)]. Response-Guided Therapy (RGT) is recommended for most individuals, but longer dosing is recommended in targeted subgroups (e.g., patients with cirrhosis).

2.1 VICTRELIS/Peginterferon alfa/Ribavirin Combination Therapy: Patients Without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy
Initiate therapy with peginterferon alfa and ribavirin for 4 weeks (Treatment Weeks 1–4). Add VICTRELIS 800 mg (four 200-mg capsules) orally three times daily (every 7 to 9 hours) to peginterferon alfa and ribavirin regimen after 4 weeks of treatment. Based on the patient's HCV-RNA levels at Treatment Week (TW) 8, TW12 and TW24, use the following guidelines to determine duration of treatment (see Table 1). Table 1 Duration of Therapy in Patients Without Cirrhosis Who Are Previously Untreated or Who Previously Failed Interferon and Ribavirin Therapy ASSESSMENT* (HCV-RNA Results†) RECOMMENDATION At Treatment Week 8 At Treatment Week 24 * TREATMENT FUTILITY If the patient has HCV-RNA results greater than or equal to 1000 IU/mL at TW8, then discontinue three-medicine regimen. If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW12, then discontinue three-medicine regimen. If the patient has confirmed, detectable HCV-RNA at TW24, then discontinue three-medicine regimen. † "Not Detected" refers to HCV-RNA assay results reported as "Target Not Detected" or "HCV-RNA Not Detected". In clinical trials, HCV-RNA in plasma was measured using a Roche COBAS ® TaqMan ® assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. See Warnings and Precautions (5.7) for a description of HCV-RNA assay recommendations. ‡ See Clinical Studies (14) for definitions of previous response to interferon and ribavirin therapy. Previously Untreated Patients Not Detected Not Detected Complete three-medicine regimen at TW28. Detected Not Detected Continue all three medicines and finish through TW36; and then Administer peginterferon alfa and ribavirin and finish through TW48. Previous Partial Responders or Relapsers‡ Not Detected Not Detected Complete three-medicine regimen at TW36. Detected Not Detected Continue all three medicines and finish through TW36; and then Administer peginterferon alfa and ribavirin and finish through TW48. Previous Null Responders‡ Detected or Not Detected Not Detected Continue all three medicines and finish through TW48.
Consideration should be given to treating previously untreated patients who are poorly interferon responsive (as determined at TW4) with 4 weeks peginterferon alfa and ribavirin followed by 44 weeks of VICTRELIS 800 mg orally three times daily (every 7 to 9 hours) in combination with peginterferon alfa and ribavirin in order to maximize rates of SVR.

2.2 VICTRELIS/Peginterferon alfa/Ribavirin Combination Therapy: Patients with Cirrhosis

Prior to initiating therapy in patients with compensated cirrhosis, see Use in Specific Populations (8.7) for additional information.

Patients with compensated cirrhosis should receive 4 weeks peginterferon alfa and ribavirin followed by 44 weeks VICTRELIS 800 mg (four 200-mg capsules) three times daily (every 7 to 9 hours) in combination with peginterferon alfa and ribavirin.

2.3 Dose Modification

Dose reduction of VICTRELIS is not recommended.

If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the prescribing information for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose. VICTRELIS must not be administered in the absence of peginterferon alfa and ribavirin. If peginterferon alfa or ribavirin is permanently discontinued, VICTRELIS must also be discontinued.

2.4 Discontinuation of Dosing Based on Treatment Futility

Discontinuation of therapy is recommended in all patients with 1) HCV-RNA levels of greater than or equal to 1000 IU per mL at TW8; or 2) HCV-RNA levels of greater than or equal to 100 IU per mL at TW12; or 3) confirmed detectable HCV-RNA levels at TW24.
Nasonex

Nasonex

Administer NASONEX Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of NASONEX Nasal Spray, 50 mcg, the pump must be primed by actuating ten times or until a fine spray appears. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.

2.1 Treatment of Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older:

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age:

The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

2.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older:

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is two sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

Children 2 to 11 Years of Age:

The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

2.3 Prophylaxis of Seasonal Allergic Rhinitis

Adults and Adolescents 12 Years of Age and Older:

The recommended dose for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).

In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with NASONEX Nasal Spray 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

2.4 Treatment of Nasal Polyps

Adults 18 Years of Age and Older:

The recommended dose for the treatment of nasal polyps is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg). A dose of 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.
Isentress

Isentress

2.1 General Dosing Recommendations
ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food [see Clinical Pharmacology (12.3)]. Because the formulations are not bioequivalent, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension. During coadministration of ISENTRESS 400 mg film-coated tablets with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily in adults. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age [see Drug Interactions (7.2)]. Maximum dose of chewable tablets is 300 mg twice daily. Maximum dose of oral suspension is 100 mg twice daily. Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 5 mL of water giving a final concentration of 20 mg/mL.
2.2 Adults

For the treatment of adult patients with HIV-1 infection, the dosage of ISENTRESS is one 400 mg film-coated tablet administered orally, twice daily.

2.3 Pediatrics
If at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 1. Table 1: Alternative Dose* with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg Body Weight(kg) Dose Number of Chewable Tablets * The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)]. † The 100 mg chewable tablet can be divided into equal halves. 25 to less than 28 150 mg twice daily 1.5 × 100 mg† twice daily 28 to less than 40 200 mg twice daily 2 × 100 mg twice daily At least 40 300 mg twice daily 3 × 100 mg twice daily If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2. For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2. Patients can remain on the oral suspension as long as their weight is below 20 kg. Refer to Table 2 for appropriate dosing [see Clinical Studies (14.3)]. Table 2: Recommended Dose* for ISENTRESS For Oral Suspension and Chewable Tablets in Pediatric Patients Weighing Less than 25 kg Body Weight(kg) Volume (Dose) of Suspension to be Administered Number of Chewable Tablets * The weight-based dosing recommendation for the chewable tablet and oral suspension is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)]. † For weight between 11 and 20 kg either formulation can be used. Note: The chewable tablets are available as 25 mg and 100 mg tablets. ‡ The 100 mg chewable tablet can be divided into equal halves. 3 to less than 4 1 mL (20 mg) twice daily 4 to less than 6 1.5 mL (30 mg) twice daily 6 to less than 8 2 mL (40 mg) twice daily 8 to less than 11 3 mL (60 mg) twice daily 11 to less than 14† 4 mL (80 mg) twice daily 3 × 25 mg twice daily 14 to less than 20† 5 mL (100 mg) twice daily 1 × 100 mg twice daily 20 to less than 25 1.5 × 100 mg‡ twice daily
2.4 Method of Administration

ISENTRESS Film-Coated Tablets
Film-Coated Tablets must be swallowed whole
ISENTRESS Chewable Tablets
Chewable Tablets may be chewed or swallowed whole
ISENTRESS For Oral Suspension

Each single-use ISENTRESS packet for oral suspension contains 100 mg of raltegravir which is to be suspended in 5 mL of water giving a final concentration of 20 mg/mL.
Pour packet contents of ISENTRESS for oral suspension into 5 mL of water and mix Once mixed, measure the recommended volume (dose) of suspension with a syringe and administer the dose orally The volume (dose) of suspension should be administered orally within 30 minutes of mixing Discard any remaining suspension For more details on preparation and administration of the suspension, see Instructions for Use.
Invanz

Invanz

2.1 Instructions for Use in All Patients

For Intravenous or Intramuscular Use

DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

INVANZ may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, INVANZ should be infused over a period of 30 minutes. Intramuscular administration of INVANZ may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.

2.2 Treatment Regimen

13 years of age and older

The dose of INVANZ in patients 13 years of age and older is 1 gram (g) given once a day [see Clinical Pharmacology (12.3)].

3 months to 12 years of age

The dose of INVANZ in patients 3 months to 12 years of age is 15 mg/kg twice daily (not to exceed 1 g/day).

Table 1 presents treatment guidelines for INVANZ.
Table 1: Treatment Guidelines for Adults and Pediatric Patients With Normal Renal Function* and Body Weight Infection† Daily Dose(IV or IM)Adults and Pediatric Patients 13 years of age and older Daily Dose(IV or IM)Pediatric Patients 3 months to 12 years of age Recommended Duration of Total Antimicrobial Treatment * defined as creatinine clearance >90 mL/min/1.73 m 2 † due to the designated pathogens [see Indications and Usage (1)] ‡ not to exceed 1 g/day § INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis [see Clinical Studies (14.1)]. ¶ adult patients with diabetic foot infections received up to 28 days of treatment (parenteral or parenteral plus oral switch therapy) # duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. Complicated intra-abdominal infections 1 g 15 mg/kg twice daily‡ 5 to 14 days Complicated skin and skin structure infections, including diabetic foot infections§ 1 g 15 mg/kgtwice daily‡ 7 to 14 days¶ Community acquired pneumonia 1 g 15 mg/kgtwice daily‡ 10 to 14 days# Complicated urinary tract infections, including pyelonephritis 1 g 15 mg/kgtwice daily‡ 10 to 14 days# Acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections 1 g 15 mg/kg twice daily‡ 3 to 10 days
2.3 Prophylactic Regimen in Adults

Table 2 presents prophylaxis guidelines for INVANZ.
Table 2: Prophylaxis Guidelines for Adults Indication Daily Dose(IV)Adults Recommended Duration of Total Antimicrobial Treatment Prophylaxis of surgical site infection following elective colorectal surgery 1 g Single intravenous dose given 1 hour prior to surgical incision
2.4 Patients with Renal Impairment

INVANZ may be used for the treatment of infections in adult patients with renal impairment. In patients whose creatinine clearance is >30 mL/min/1.73 m2, no dosage adjustment is necessary. Adult patients with severe renal impairment (creatinine clearance ≤30 mL/min/1.73 m2) and end-stage renal disease (creatinine clearance ≤10 mL/min/1.73 m2) should receive 500 mg daily. A supplementary dose of 150 mg is recommended if ertapenem is administered within 6 hours prior to hemodialysis. There are no data in pediatric patients with renal impairment.

2.5 Patients on Hemodialysis

When adult patients on hemodialysis are given the recommended daily dose of 500 mg of INVANZ within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is recommended following the hemodialysis session. If INVANZ is given at least 6 hours prior to hemodialysis, no supplementary dose is needed. There are no data in patients undergoing peritoneal dialysis or hemofiltration. There are no data in pediatric patients on hemodialysis.

When only the serum creatinine is available, the following formula1 may be used to estimate creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males: (weight in kg) x (140-age in years) (72) x serum creatinine (mg/100 mL)

Females: (0.85) x (value calculated for males)
1
Cockcroft and Gault equation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976

2.6 Patients with Hepatic Impairment

No dose adjustment recommendations can be made in patients with hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

2.7 Preparation and Reconstitution for Administration

Vials

Adults and pediatric patients 13 years of age and older

Preparation for intravenous administration:

DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

INVANZ MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.
Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection. Shake well to dissolve and immediately transfer contents of the reconstituted vial to 50 mL of 0.9% Sodium Chloride Injection. Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:

INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
Reconstitute the contents of a 1 g vial of INVANZ with 3.2 mL of 1.0% lidocaine HCl injection2 (without epinephrine). Shake vial thoroughly to form solution. Immediately withdraw the contents of the vial and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). The reconstituted IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.
Pediatric patients 3 months to 12 years of age

Preparation for intravenous administration:

DO NOT MIX OR CO-INFUSE INVANZ WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE).

INVANZ MUST BE RECONSTITUTED AND THEN DILUTED PRIOR TO ADMINISTRATION.
Reconstitute the contents of a 1 g vial of INVANZ with 10 mL of one of the following: Water for Injection, 0.9% Sodium Chloride Injection or Bacteriostatic Water for Injection. Shake well to dissolve and immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and dilute in 0.9% Sodium Chloride Injection to a final concentration of 20 mg/mL or less. Complete the infusion within 6 hours of reconstitution.
Preparation for intramuscular administration:

INVANZ MUST BE RECONSTITUTED PRIOR TO ADMINISTRATION.
Reconstitute the contents of a 1 g vial of INVANZ with 3.2 mL of 1.0% lidocaine HCl injection2 (without epinephrine). Shake vial thoroughly to form solution. Immediately withdraw a volume equal to 15 mg/kg of body weight (not to exceed 1 g/day) and administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh). The reconstituted IM solution should be used within 1 hour after preparation. NOTE: THE RECONSTITUTED SOLUTION SHOULD NOT BE ADMINISTERED INTRAVENOUSLY.
ADD-Vantage®3 Vials

INVANZ in ADD-Vantage® vials should be reconstituted with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection.
2
Refer to the prescribing information for lidocaine HCl.
3
Registered trademark of Hospira Laboratories, Inc.

INSTRUCTIONS FOR USE OFINVANZ® (Ertapenem for Injection)IN ADD-Vantage VIALS

For I.V. Use Only.

To Open Diluent Container:

Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container:

(Use Aseptic Technique)

Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening. (SEE FIGURE 1.) Pull the ring approximately half way around the cap and then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: DO NOT ACCESS VIAL WITH SYRINGE.

To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.)

Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

Label appropriately.

To Prepare Admixture:

Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

Mix container contents thoroughly and use within the specified time.

Preparation for Administration:

(Use Aseptic Technique)

Confirm the activation and admixture of vial contents.

Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.

Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

Open flow control clamp and clear air from set. Close clamp.

Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

Storage

INVANZ (Ertapenem for Injection) 1 g single dose ADD-Vantage® vials should be prepared with ADD-Vantage® diluent containers containing 50 mL or 100 mL of 0.9% Sodium Chloride Injection. When prepared with this diluent, INVANZ (Ertapenem for Injection) maintains satisfactory potency for 6 hours at room temperature (25°C) or for 24 hours under refrigeration (5°C) and used within 4 hours after removal from refrigeration. Solutions of INVANZ should not be frozen.

Before administering, see accompanying package circular for INVANZ (Ertapenem for Injection).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use, whenever solution and container permit. Solutions of INVANZ range from colorless to pale yellow. Variations of color within this range do not affect the potency of the product.
Prastera

Prastera

2.1 Dosage

GARDASIL should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. [See Clinical Studies (14.8).]

2.2 Method of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

GARDASIL should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use

This package does not contain a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.
Sylatron

Sylatron

2.1 Recommended Dosing
The recommended starting dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years. Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of SYLATRON and as needed for subsequent doses. The recommended starting doses of SYLATRON in patients with moderate or severe renal impairment or end-stage renal disease (ESRD) are listed in Table 1 [see Use in Specific Populations (8.7)]. No dose adjustment is needed for patients with a creatinine clearance (CLcr) > 50 mL/min/1.73m2. Table 1: Recommended Starting Dose for Moderate and Severe Renal Impairment and End-Stage Renal Disease Degree of Renal Impairment Creatinine Clearance (mL/min/1.73m2) Initial doses for 8 weeks Follow-up doses for 5 years Moderate 30 – 50 4.5 mcg/kg/week 2.25 mcg/kg/week Severe <30 3 mcg/kg/week 1.5 mcg/kg/week End-Stage Renal Disease On dialysis 3 mcg/kg/week 1.5 mcg/kg/week
2.2 Dose Modification Guidelines

Guidelines for Dose Modification provided below are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0).
Permanently discontinue SYLATRON for: Persistent or worsening severe neuropsychiatric disorders Grade 4 non-hematologic toxicity Inability to tolerate a dose of 1 mcg/kg/wk New or worsening retinopathy Withhold SYLATRON dose for any of the following: Absolute Neutrophil Count (ANC) less than 0.5×109/L Platelet Count (PLT) less than 50×109/L ECOG PS greater than or equal to 2 Non-hematologic toxicity greater than or equal to Grade 3 Resume dosing at a reduced dose (see Table 1) when all of the following are present: Absolute Neutrophil Count (ANC) greater than or equal to 0.5×109/L Platelet Count (PLT) greater than or equal to 50×109/L ECOG PS 0–1 Non-hematologic toxicity has completely resolved or improved to Grade 1 Table 2: SYLATRON Dose Modifications Starting Dose Dose Modifications for Doses 1 to 8 6 mcg/kg/week First Dose Modification: 3 mcg/kg/week Second Dose Modification: 2 mcg/kg/week Third Dose Modification: 1 mcg/kg/week Permanently discontinue if unable to tolerate 1 mcg/kg/week Starting Dose Dose Modifications for Doses 9 to 260 3 mcg/kg/week First Dose Modification: 2 mcg/kg/week Second Dose Modification: 1 mcg/kg/week Permanently discontinue if unable to tolerate 1 mcg/kg/week
2.3 Preparation and Administration

Reconstitute SYLATRON with 0.7 mL of Sterile Water for Injection, USP.
Table 3: Reconstitution of SYLATRON Single-Use Vials SYLATRON Single-Use Vial Diluent (Sterile Water for Injection, USP) Deliverable Product and Volume Final Concentration * Total vial content of SYLATRON is 296 mcg. † Total vial content of SYLATRON is 444 mcg. ‡ Total vial content of SYLATRON is 888 mcg. 200 mcg* add 0.7 mL = 200 mcg in 0.5 mL 40 mcg/0.1 mL 300 mcg† add 0.7 mL = 300 mcg in 0.5 mL 60 mcg/0.1 mL 600 mcg‡ add 0.7 mL = 600 mcg in 0.5 mL 120 mcg/0.1 mL Swirl gently to dissolve the lyophilized powder. DO NOT SHAKE. Visually inspect the solution for particulate matter and discoloration prior to administration. Discard if solution is discolored, cloudy, or if particulates are present. Do not withdraw more than 0.5 mL of reconstituted solution from each vial. Administer SYLATRON subcutaneously. Rotate injection sites. If reconstituted solution is not used immediately, store at 2°–8°C (36°–46°F) for no more than 24 hours. Discard reconstituted solution after 24 hours. DO NOT FREEZE. For single-use only. DISCARD ANY UNUSED PORTION.
Maxalt

Maxalt

2.1 Dosing Information in Adults

The recommended starting dose of MAXALT is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1)].

Redosing in Adults

Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established.

2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years)

Dosing in pediatric patients is based on the patient's body weight. The recommended dose of MAXALT is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more.

The efficacy and safety of treatment with more than one dose of MAXALT within 24 hours in pediatric patients 6 to 17 years of age have not been established.

2.3 Administration of MAXALT-MLT Orally Disintegrating Tablets

For MAXALT-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.

2.4 Dosage Adjustment for Patients on Propranolol

Adult Patients

In adult patients taking propranolol, only the 5-mg dose of MAXALT is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Pediatric Patients

For pediatric patients weighing 40 kg (88 lb) or more, taking propranolol, only a single 5-mg dose of MAXALT is recommended (maximum dose of 5 mg in a 24-hour period). MAXALT should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 lb) [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Emend

Emend

2.1 Prevention of Nausea and Vomiting Associated with Highly Emetogenic Chemotherapy (HEC)

EMEND for Injection 150 mg (Single Dose Regimen of EMEND):

EMEND for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. No capsules of EMEND are administered on Days 2 and 3. EMEND for Injection should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 1. The recommended dosage of dexamethasone with EMEND for Injection 150 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 115 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.
Table 1: Recommended dosing (Single Dose Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy Day 1 Day 2 Day 3 Day 4 * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions. EMEND 150 mg intravenous none none none Dexamethasone* 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none
EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 2. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.
Table 2: Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy Day 1 Day 2 Day 3 Day 4 * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. The dose of dexamethasone accounts for drug interactions. EMEND 115 mg intravenous 80 mg orally 80 mg orally none Dexamethasone* 12 mg orally 8 mg orally 8 mg orally once daily 8 mg orally once daily 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none none
2.2 Prevention of Nausea and Vomiting Associated with Moderately Emetogenic Chemotherapy (MEC)

EMEND for Injection 115 mg (3-Day Dosing Regimen of EMEND):

EMEND for Injection 115 mg is administered on Day 1 only as an infusion over 15 minutes initiated 30 minutes prior to chemotherapy. Capsules of EMEND 80 mg should be administered on Days 2 and 3. EMEND for Injection 115 mg should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in Table 3. The recommended dosage of dexamethasone with EMEND for Injection 115 mg differs from the recommended dosage of dexamethasone with EMEND for Injection 150 mg on Days 3 and 4. The package insert for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with EMEND for Injection.

Capsules of EMEND 125 mg may be substituted for EMEND for Injection 115 mg on Day 1.
Table 3: Recommended dosing (3-Day Dosing Regimen of EMEND) for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy * Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for drug interactions. Day 1 Day 2 Day 3 EMEND 115 mg intravenous 80 mg orally 80 mg orally Dexamethasone* 12 mg orally none none 5-HT3 antagonist See the package insert for the selected 5-HT3 antagonist for appropriate dosing information. none none
2.3 Preparation of EMEND for Injection
Table 4: Preparation Instructions for EMEND for Injection (115 mg and 150 mg) 115 mg 150 mg Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. Aseptically inject 5 mL 0.9% Sodium Chloride for Injection (normal saline) into the vial. Assure that normal saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. Step 2 Aseptically prepare an infusion bag filled with 110 mL of normal saline. Aseptically prepare an infusion bag filled with 145 mL of normal saline. Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 110 mL of normal saline to yield a total volume of 115 mL and a final concentration of 1 mg/1 mL. Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of normal saline to yield a total volume of 150 mL and a final concentration of 1 mg/1 mL. Step 4 Gently invert the bag 2-3 times. Gently invert the bag 2-3 times. Note: The differences in preparation for each dose are displayed as bolded text.
The reconstituted final drug solution is stable for 24 hours at ambient room temperature (at or below 25°C).

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Caution: EMEND for Injection should not be mixed or reconstituted with solutions for which physical and chemical compatibility have not been established. EMEND for Injection is incompatible with any solutions containing divalent cations (e.g., Ca2+, Mg2+), including Lactated Ringer's Solution and Hartmann's Solution.
Rebetol

Rebetol

Under no circumstances should REBETOL capsules be opened, crushed, or broken. REBETOL should be taken with food [see Clinical Pharmacology (12.3)]. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

2.1 REBETOL/PegIntron Combination Therapy

Adult Patients

The recommended dose of PegIntron is 1.5 mcg/kg/week subcutaneously in combination with 800 to 1400 mg REBETOL capsules orally based on patient body weight (see Table 1). The volume of PegIntron to be injected depends on the strength of PegIntron and patient's body weight, refer to labeling for PegIntron for additional dosing information.

Duration of Treatment – Interferon Alpha-naïve Patients

The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.

Duration of Treatment – Re-treatment with PegIntron/REBETOL of Prior Treatment Failures

The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at Week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered [see Clinical Studies (14.1)].
Table 1: Recommended Dosing for REBETOL in Combination Therapy with PegIntron (Adults) Body Weightkg(lbs) REBETOL Daily Dose REBETOL Number of Capsules <66(<144) 800 mg/day 2 × 200-mg capsules A.M.2 × 200-mg capsules P.M. 66-80(145-177) 1000 mg/day 2 × 200-mg capsules A.M.3 × 200-mg capsules P.M. 81-105(178-231) 1200 mg/day 3 × 200-mg capsules A.M.3 × 200-mg capsules P.M. >105(231) 1400 mg/day 3 × 200-mg capsules A.M.4 × 200-mg capsules P.M.
Pediatric Patients

Dosing for pediatric patients is determined by body surface area for PegIntron and by body weight for REBETOL. The recommended dose of PegIntron is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of REBETOL orally in two divided doses (see Table 2) for pediatric patients ages 3-17 years. Patients who reach their 18th birthday while receiving PegIntron/REBETOL should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.
Table 2: Recommended REBETOL* Dosing in Combination Therapy (Pediatrics) Body Weightkg(lbs) REBETOL Daily Dose REBETOL Number of Capsules * REBETOL to be used in combination with PegIntron 60 mcg/m 2 weekly. † REBETOL Oral Solution may be used for any patient regardless of body weight. <47(<103) 15 mg/kg/day Use REBETOL Oral Solution† 47-59(103-131) 800 mg/day 2 × 200-mg capsules A.M.2 × 200-mg capsules P.M. 60-73(132-162) 1000 mg/day 2 × 200-mg capsules A.M.3 × 200-mg capsules P.M. >73(>162) 1200 mg/day 3 × 200-mg capsules A.M.3 × 200-mg capsules P.M.
2.2 REBETOL/INTRON A Combination Therapy

Adults

Duration of Treatment – Interferon Alpha-naïve Patients

The recommended dose of INTRON A is 3 million IU three times weekly subcutaneously. The recommended dose of REBETOL capsules depends on the patient's body weight (refer to Table 3). The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy, and tolerability of the regimen [see Indications and Usage (1.1), Adverse Reactions (6.1), and Clinical Studies (14)]. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population.

Duration of Treatment – Re-treatment with INTRON A/REBETOL in Relapse Patients

In patients who relapse following nonpegylated interferon monotherapy, the recommended duration of treatment is 24 weeks.
Table 3: Recommended Dosing Body Weight REBETOL Capsules ≤75 kg 2 × 200-mg capsules AM 3 × 200-mg capsules PM daily orally >75 kg 3 × 200-mg capsules AM 3 × 200-mg capsules PM daily orally
Pediatrics The recommended dose of REBETOL is 15 mg/kg per day orally (divided dose AM and PM). Refer to Table 2 for Pediatric Dosing of REBETOL in combination with INTRON A. INTRON A for Injection by body weight of 25 kg to 61 kg is 3 million IU/m2 three times weekly subcutaneously. Refer to adult dosing table for greater than 61 kg body weight.

The recommended duration of treatment is 48 weeks for pediatric patients with genotype 1. After 24 weeks of treatment, virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV-RNA below the limit of detection of the assay by this time. The recommended duration of treatment for pediatric patients with genotype 2/3 is 24 weeks.

2.3 Laboratory Tests

The following laboratory tests are recommended for all patients treated with REBETOL, prior to beginning treatment and then periodically thereafter.
Standard hematologic tests - including hemoglobin (pretreatment, Week 2 and Week 4 of therapy, and as clinically appropriate [see Warnings and Precautions (5.2, 5.7)], complete and differential white blood cell counts, and platelet count. Blood chemistries - liver function tests and TSH. Pregnancy - including monthly monitoring for women of childbearing potential. ECG [see Warnings and Precautions (5.2)].
2.4 Dose Modifications

If severe adverse reactions or laboratory abnormalities develop during combination REBETOL/INTRON A therapy or REBETOL/PegIntron therapy, modify, or discontinue the dose until the adverse reaction abates or decreases in severity [see Warnings and Precautions (5)]. If intolerance persists after dose adjustment, combination therapy should be discontinued. Dose reduction of PegIntron in adult patients on REBETOL/PegIntron combination therapy is accomplished in a two-step process from the original starting dose of 1.5 mcg/kg/week, to 1 mcg/kg/week, then to 0.5 mcg/kg/week, if needed. Refer to labeling for PegIntron for additional information regarding dose reduction of PegIntron.

In the adult combination therapy Study 2, dose reductions occurred in 42% of subjects receiving PegIntron 1.5 mcg/kg and REBETOL 800 mg daily, including 57% of those subjects weighing 60 kg or less. In Study 4, 16% of subjects had a dose reduction of PegIntron to 1 mcg/kg in combination with REBETOL, with an additional 4% requiring the second dose reduction of PegIntron to 0.5 mcg/kg due to adverse events [see Adverse Reactions (6.1)].

Dose reduction in pediatric patients is accomplished by modifying the recommended PegIntron dose in a two-step process from the original starting dose of 60 mcg/m2/week, to 40 mcg/m2/week, then to 20 mcg/m2/week, if needed (see Table 4). In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving PegIntron 60 mcg/m2 weekly and REBETOL 15 mg/kg daily. Dose reduction in pediatric patients is accomplished by modifying the recommended REBETOL dose from the original starting dose of 15 mg/kg daily in a two-step process to 12 mg/kg/day, then to 8 mg/kg/day, if needed (see Table 4).

REBETOL should not be used in patients with creatinine clearance less than 50 mL/min. Patients with impaired renal function and those over the age of 50 should be carefully monitored with respect to development of anemia [see Warnings and Precautions (5.2), Use in Specific Populations (8.5), and Clinical Pharmacology (12.3)].

REBETOL should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

For patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by greater than or equal to 2 g/dL during any 4-week period. In addition, for these cardiac history patients, if the hemoglobin remains less than 12 g/dL after 4 weeks on a reduced dose, the patient should discontinue combination therapy.

It is recommended that a patient whose hemoglobin level falls below 10 g/dL have his/her REBETOL dose modified or discontinued per Table 4 [see Warnings and Precautions (5.2)].
Table 4: Guidelines for Dose Modification and Discontinuation of REBETOL in combination with PegIntron or INTRON A Based on Laboratory Parameters in Adults and Pediatrics Laboratory Parameters Reduce REBETOL Daily Dose (see note 1) if: Reduce PegIntron or INTRON A Dose (see note 2) if: Discontinue Therapy if:
Note 1: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1,400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day.

Note 2: Adult patients treated with REBETOL and PegIntron: 1st dose reduction of PegIntron is to 1 mcg/kg/week. If needed, 2nd dose reduction of PegIntron is to 0.5 mcg/kg/week.Pediatric patients treated with REBETOL and PegIntron: 1st dose reduction of PegIntron is to 40 mcg/m2/week, 2nd dose reduction of PegIntron is to 20 mcg/m2/week.For patients on REBETOL/INTRON A combination therapy: reduce INTRON A dose by 50%.
* Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing. † These guidelines are for patients with stable cardiac disease. Patients with a history of significant or unstable cardiac disease should not be treated with PegIntron /REBETOL combination therapy [see Warnings and Precautions (5.2)]. WBC N/A 1.0 to <1.5 × 109/L <1.0 × 109/L Neutrophils N/A 0.5 to <0.75 × 109/L <0.5 × 109/L Platelets N/A 25 to < 50 × 109/L (adults) <25 × 109/L (adults) N/A 50 to <70 × 109/L (pediatrics) <50 × 109/L (pediatrics) Creatinine N/A N/A >2 mg/dL (pediatrics) Hemoglobin in patients without history of cardiac disease 8.5 to <10 g/dL N/A <8.5 g/dL Reduce REBETOL Dose by 200 mg/day and PegIntron or INTRON A Dose by Half if: Hemoglobin in patients with history of stable cardiac disease*† ≥2 g/dL decrease in hemoglobin during anyfour week period during treatment <8.5 g/dL or<12 g/dL after four weeks of dose reduction
Refer to labeling for INTRON A or PegIntron for additional information about how to reduce an INTRON A or PegIntron dose.

2.5 Discontinuation of Dosing

Adults In HCV genotype 1, interferon-alfa-naïve patients receiving PegIntron in combination with ribavirin, discontinuation of therapy is recommended if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24 are highly unlikely to achieve SVR and discontinuation of therapy should be considered.

Pediatrics (3-17 years of age) It is recommended that patients receiving PegIntron/REBETOL combination (excluding HCV Genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV-RNA dropped less than 2 log10 compared to a pretreatment or at 24 weeks if they have detectable HCV-RNA at treatment Week 24.
Belsomra

Belsomra

2.1 Dosing Information

Use the lowest dose effective for the patient.

The recommended dose for BELSOMRA is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg once daily.

2.2 Special Populations

Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose [see Clinical Pharmacology (12.3)].

2.3 Use with CNS Depressants

When BELSOMRA is combined with other CNS depressant drugs, dosage adjustment of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects [see Warnings and Precautions (5.1)].

2.4 Use with CYP3A Inhibitors

The recommended dose of BELSOMRA is 5 mg when used with moderate CYP3A inhibitors and the dose generally should not exceed 10 mg in these patients. BELSOMRA is not recommended for use with strong CYP3A inhibitors [see Drug Interactions (7.2)].

2.5 Food Effect

Time to effect of BELSOMRA may be delayed if taken with or soon after a meal.
Pegintron

Pegintron

2.1 PegIntron Combination Therapy

Adults

The recommended dose of PegIntron is 1.5 mcg/kg/week. The volume of PegIntron to be injected depends on the strength of PegIntron and patient's body weight (see Table 1).

The recommended dose of REBETOL for use with PegIntron is 800 to 1400 mg orally based on patient body weight. REBETOL should be taken with food. REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

See labeling of the specific HCV NS3/4A protease inhibitor for information regarding dosing regimen and administration of the protease inhibitor in combination with PegIntron and ribavirin.

Duration of Treatment – Treatment with PegIntron/REBETOL of Interferon Alpha-naïve Patients

The treatment duration for patients with genotype 1 is 48 weeks. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks, or if HCV-RNA remains detectable after 24 weeks of therapy. Patients with genotype 2 and 3 should be treated for 24 weeks.

Duration of Treatment – Re-treatment with PegIntron/REBETOL of Prior Treatment Failures

For patients with genotype 1 infection, PegIntron and REBETOL without an HCV NS3/4A protease inhibitor should only be used if there are contraindications, significant intolerance or other clinical factors that would not warrant use of an HCV NS3/4A protease inhibitor. The treatment duration for patients who previously failed therapy is 48 weeks, regardless of HCV genotype. Re-treated patients who fail to achieve undetectable HCV-RNA at Week 12 of therapy, or whose HCV-RNA remains detectable after 24 weeks of therapy, are highly unlikely to achieve SVR and discontinuation of therapy should be considered [see Clinical Studies (14.1)].
Table 1: Recommended PegIntron Combination Therapy Dosing (Adults) Body Weight kg (lbs) PegIntron REDIPEN Pre-filled pen or Vial Strength to Use Amount of PegIntron to Administer (mcg) Volume* of PegIntron to Administer (mL) REBETOL Daily Dose REBETOL Number of Capsules * When reconstituted as directed. † For patients weighing greater than 105 kg (greater than 231 pounds), the PegIntron dose of 1.5 mcg/kg/week should be calculated based on the individual patient weight. This may require combinations of various PegIntron dose strengths and volumes. <40(<88) 50 mcg per 0.5 mL 50 0.5 800 mg/day 2 × 200 mg capsules A.M.2 × 200 mg capsules P.M. 40-50(88-111) 80 mcg per 0.5 mL 64 0.4 800 mg/day 2 × 200 mg capsules A.M.2 × 200 mg capsules P.M. 51-60(112-133) 80 0.5 800 mg/day 2 × 200 mg capsules A.M.2 × 200 mg capsules P.M. 61-65(134-144) 120 mcg per 0.5 mL 96 0.4 800 mg/day 2 × 200 mg capsules A.M.2 × 200 mg capsules P.M. 66-75(145-166) 96 0.4 1000 mg/day 2 × 200 mg capsules A.M.3 × 200 mg capsules P.M. 76-80(167-177) 120 0.5 1000 mg/day 2 × 200 mg capsules A.M.3 × 200 mg capsules P.M. 81-85(178-187) 1200 mg/day 3 × 200 mg capsules A.M.3 × 200 mg capsules P.M. 86-105(188-231) 150 mcg per 0.5 mL 150 0.5 1200 mg/day 3 × 200 mg capsules A.M.3 × 200 mg capsules P.M. >105(>231) † † † 1400 mg/day 3 × 200 mg capsules A.M.4 × 200 mg capsules P.M.
Pediatric Patients

Dosing for pediatric patients is determined by body surface area for PegIntron and by body weight for REBETOL. The recommended dose of PegIntron is 60 mcg/m2/week subcutaneously in combination with 15 mg/kg/day of REBETOL orally in 2 divided doses (see Table 2) for pediatric patients ages 3 to 17 years. Patients who reach their 18th birthday while receiving PegIntron/REBETOL should remain on the pediatric dosing regimen. The treatment duration for patients with genotype 1 is 48 weeks. Patients with genotype 2 and 3 should be treated for 24 weeks.
Table 2: Recommended REBETOL* Dosing in Combination Therapy (Pediatrics) Body Weightkg (lbs) REBETOL Daily Dose REBETOL Number of Capsules * REBETOL to be used in combination with PegIntron 60 mcg/m 2 weekly. † REBETOL oral solution may be used for any patient regardless of body weight. <47(<103) 15 mg/kg/day Use REBETOL oral solution† 47-59(103-131) 800 mg/day 2 × 200 mg capsules A.M.2 × 200 mg capsules P.M. 60-73(132-162) 1000 mg/day 2 × 200 mg capsules A.M.3 × 200 mg capsules P.M. >73(>162) 1200 mg/day 3 × 200 mg capsules A.M.3 × 200 mg capsules P.M.
2.2 PegIntron Monotherapy

The recommended dose of PegIntron regimen is 1 mcg/kg/week subcutaneously for 1 year administered on the same day of the week. Discontinuation of therapy should be considered in patients who do not achieve at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or whose HCV-RNA levels remain detectable after 24 weeks of therapy. The volume of PegIntron to be injected depends on patient weight (see Table 3).
Table 3: Recommended PegIntron Monotherapy Dosing Body Weight kg (lbs) PegIntron REDIPEN Pre-filled pen or Vial Strength to Use Amount of PegIntron to Administer (mcg) Volume of PegIntron to Administer(mL)* * When reconstituted as directed. ≤45(≤100) 50 mcg per 0.5 mL 40 0.4 46-56(101-124) 50 0.5 57-72(125-159) 80 mcg per 0.5 mL 64 0.4 73-88(160-195) 80 0.5 89-106(196-234) 120 mcg per 0.5 mL 96 0.4 107-136(235-300) 120 0.5 137-160(301-353) 150 mcg per 0.5 mL 150 0.5
2.3 Dose Reduction

If a serious adverse reaction develops during the course of treatment discontinue or modify the dosage of PegIntron and REBETOL until the adverse event abates or decreases in severity [see Warnings and Precautions (5)]. If persistent or recurrent serious adverse events develop despite adequate dosage adjustment, discontinue treatment. For guidelines for dose modifications and discontinuation based on depression or laboratory parameters see Tables 4 and 5. Dose reduction of PegIntron in adult patients on PegIntron/REBETOL combination therapy is accomplished in a two-step process from the original starting dose of 1.5 mcg/kg/week, to 1 mcg/kg/week, then to 0.5 mcg/kg/week, if needed. Dose reduction in patients on PegIntron monotherapy is accomplished by reducing the original starting dose of 1 mcg/kg/week to 0.5 mcg/kg/week. Instructions for dose reductions in adults are outlined in Tables 6 (Monotherapy: REDIPEN/Vial) and 7 (Combination therapy: REDIPEN/Vial).

In the adult combination therapy Study 2, dose reductions occurred in 42% of subjects receiving PegIntron 1.5 mcg/kg plus REBETOL 800 mg daily, including 57% of those subjects weighing 60 kg or less. In Study 4, 16% of subjects had a dose reduction of PegIntron to 1 mcg/kg in combination with REBETOL, with an additional 4% requiring the second dose reduction of PegIntron to 0.5 mcg/kg due to adverse events [see Adverse Reactions (6.1)].

Dose reduction in pediatric patients is accomplished by modifying the recommended dose in a 2-step process from the original starting dose of 60 mcg/m2/week, to 40 mcg/m2/week, then to 20 mcg/m2/week, if needed (see Tables 4 and 5). In the pediatric combination therapy trial, dose reductions occurred in 25% of subjects receiving PegIntron 60 mcg/m2 weekly plus REBETOL 15 mg/kg daily.
Table 4: Guidelines for Modification or Discontinuation of PegIntron or PegIntron/REBETOL and for Scheduling Visits for Patients with Depression Depression Severity* Initial Management (4-8 weeks) Depression Status Dose Modification Visit Schedule Remains Stable Improves Worsens * See DSM-IV for definitions. For patients on PegIntron/REBETOL combination therapy: 1 st dose reduction of PegIntron is to 1 mcg/kg/week, 2 nd dose reduction (if needed) of PegIntron is to 0.5 mcg/kg/week. For patients on PegIntron monotherapy: decrease PegIntron dose to 0.5 mcg/kg/week. Mild No change Evaluate once weekly by visit or phone Continue weekly visit schedule Resume normal visit schedule See moderate or severe depression Moderate Adults: Adjust Dose* Pediatrics: Decrease dose to 40 mcg/m2/week, then to 20 mcg/m2/week, if needed Evaluate once weekly (office visit at least every other week) Consider psychiatric consultation. Continue reduced dosing If symptoms improve and are stable for 4 weeks, may resume normal visit schedule. Continue reduced dosing or return to normal dose See severe depression Severe Discontinue PegIntron/REBETOL permanently Obtain immediate psychiatric consultation Psychiatric therapy as necessary Table 5: Guidelines for Dose Modification and Discontinuation of PegIntron or PegIntron/REBETOL Based on Laboratory Parameters in Adults and Pediatrics Laboratory Parameters Reduce PegIntron Dose (see note 1) if: Reduce ribavirin Daily Dose (see note 2) if: Discontinue Therapy if: Note 1: Adult patients on combination therapy: 1st dose reduction of PegIntron is to 1 mcg/kg/week. If needed, 2nd dose reduction of PegIntron is to 0.5 mcg/kg/week.Adult patients on PegIntron monotherapy: decrease PegIntron dose to 0.5 mcg/kg/week.Pediatric patients: 1st dose reduction of PegIntron is to 40 mcg/m2/week, 2nd dose reduction of PegIntron is to 20 mcg/m2/week. Note 2: Adult patients: 1st dose reduction of ribavirin is by 200 mg/day (except in patients receiving the 1400 mg, dose reduction should be by 400 mg/day). If needed, 2nd dose reduction of ribavirin is by an additional 200 mg/day. Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.Pediatric patients: 1st dose reduction of ribavirin is to 12 mg/kg/day, 2nd dose reduction of ribavirin is to 8 mg/kg/day. * Pediatric patients who have pre-existing cardiac conditions and experience a hemoglobin decrease greater than or equal to 2 g/dL during any 4-week period during treatment should have weekly evaluations and hematology testing. † These guidelines are for patients with stable cardiac disease. Patients with a history of significant or unstable cardiac disease should not be treated with PegIntron /REBETOL combination therapy [see Warnings and Precautions (5.3)]. WBC 1.0 to <1.5 × 109/L N/A <1.0 × 109/L Neutrophils 0.5 to <0.75 × 109/L N/A <0.5 × 109/L Platelets 25 to <50 × 109/L (adults) N/A <25 × 109/L (adults) 50 to <70 × 109/L (pediatrics) N/A <50 × 109/L (pediatrics) Creatinine N/A N/A >2 mg/dL (pediatrics) Hemoglobin in patients without history of cardiac disease N/A 8.5 to <10 g/dL <8.5 g/dL Reduce PegIntron Dose by Half and the Ribavirin Dose by 200 mg/day if: Hemoglobin in patients with history of cardiac disease*† ≥2 g/dL decrease in hemoglobin during anyfour week period during treatment <8.5 g/dL or <12 g/dL after four weeks of dose reduction Table 6: Reduced PegIntron Dose (0.5 mcg/kg) for (1 mcg/kg) Monotherapy in Adults Body Weightkg (lbs) PegIntron REDIPEN/Vial Strength to Use Amount to Administer (mcg) Volume* to Administer (mL) * When reconstituted as directed. † Must use vial. Minimum delivery for REDIPEN 0.3 mL. ≤45(≤100) 50 mcg per 0.5 mL† 20 0.2 46-56(101-124) 50 mcg per 0.5 mL† 25 0.25 57-72(125-159) 50 mcg per 0.5 mL 30 0.3 73-88(160-195) 50 mcg per 0.5 mL 40 0.4 89-106(196-234) 50 mcg per 0.5 mL 50 0.5 107-136(235-300) 80 mcg per 0.5 mL 64 0.4 ≥137(≥301) 80 mcg per 0.5 mL 80 0.5 Table 7: Two-Step Dose Reduction of PegIntron REDIPEN/Vial in Combination Therapy in Adults First Dose Reduction to PegIntron 1 mcg/kg Second Dose Reduction to PegIntron 0.5 mcg/kg Body weightkg (lbs) PegIntron REDIPEN/Vial Strength to Use Amount of PegIntron (mcg) to Administer Volume (mL) * of PegIntron to Administer Body weightkg (lbs) PegIntron REDIPEN/ Vial Strength to Use Amount of PegIntron (mcg) to Administer Volume (mL) * of PegIntron to Administer * When reconstituted as directed. † Must use vial. Minimum delivery for REDIPEN 0.3 mL. <40(<88) 50 mcg per 0.5 mL 35 0.35 <40(<88) 50 mcg per 0.5 mL† 20 0.2 40-50(88-111) 45 0.45 40-50(88-111) 25 0.25 51-60(112-133) 50 0.5 51-60(112-133) 50 mcg per 0.5 mL 30 0.3 61-75(134-166) 80 mcg per 0.5 mL 64 0.4 61-75(134-166) 35 0.35 76-85(167-187) 80 0.5 76-85(167-187) 45 0.45 86-104(188-230) 120 mcg per 0.5 mL 96 0.4 86-104(188-230) 50 0.5 105-125(231-275) 108 0.45 105-125(231-275) 80 mcg per 0.5 mL 64 0.4 >125(>275) 150 mcg per 0.5 mL 135 0.45 >125(>275) 72 0.45
2.4 Discontinuation of Dosing

Adults

See labeling of the specific HCV NS3/4A protease inhibitor for information regarding discontinuation of dosing based on treatment futility.

In HCV genotype 1, interferon-alfa-naïve patients receiving PegIntron, alone or in combination with REBETOL, discontinuation of therapy is recommended if there is not at least a 2 log10 drop or loss of HCV-RNA at 12 weeks of therapy, or if HCV-RNA levels remain detectable after 24 weeks of therapy. Regardless of genotype, previously treated patients who have detectable HCV-RNA at Week 12 or 24, are highly unlikely to achieve SVR and discontinuation of therapy is recommended.

Pediatrics (3-17 years of age)

It is recommended that patients receiving PegIntron/REBETOL combination (excluding those with HCV genotype 2 and 3) be discontinued from therapy at 12 weeks if their treatment Week 12 HCV-RNA dropped less than 2 log10 compared to pretreatment or at 24 weeks if they have detectable HCV-RNA at treatment Week 24.

2.5 Renal Function

In patients with moderate renal dysfunction (creatinine clearance 30-50 mL/min), the PegIntron dose should be reduced by 25%. Patients with severe renal dysfunction (creatinine clearance 10-29 mL/min), including those on hemodialysis, should have the PegIntron dose reduced by 50%. If renal function decreases during treatment, PegIntron therapy should be discontinued. When PegIntron is administered in combination with REBETOL, subjects with impaired renal function or those over the age of 50 should be more carefully monitored with respect to the development of anemia. PegIntron/REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.

2.6 Preparation and Administration

A patient should self-inject PegIntron only if the physician determines that it is appropriate and the patient agrees to medical follow-up as necessary and has been trained in proper injection technique [see illustrated FDA-approved Medication Guide and Instructions for Use for directions on injection site preparation and injection instructions].

Reconstitute PegIntron Powder for Solution with 0.7 mL of Sterile Water for Injection, USP. The Sterile Water for Injection supplied contains 5 mL and is intended for single use only. Discard the unused portion. The reconstituted solution should be visually inspected for discoloration and particulate matter prior to administration. Do not use the solution if it is discolored or not clear, or if particulates are present.

DO NOT REUSE THE VIAL OR PRE-FILLED PEN; DISCARD THE UNUSED PORTION. Pooling of unused portions of some medications has been linked to bacterial contamination and morbidity.
Incurin

Incurin

The dose of INCURIN™ Tablets is not dependent upon body weight. All dogs should receive an initial dose of 2 mg INCURIN™ Tablets (2 tablets) orally once per day for a minimum of 14 days. After urinary incontinence is controlled, the lowest effective daily dose of INCURIN™ Tablets should be determined by decreasing the dose in a step-wise manner from 2 mg once daily (2 tablets) to 1 mg once daily (1 tablet), then 0.5 mg once daily (1/2 tablet) depending upon the response of the individual dog. There should be a minimum of 7 days between each dose adjustment. After the lowest daily dose that controls urinary incontinence is identified, the dose may be decreased further by administering once every two days. Dogs should not receive more than 2 mg INCURIN™ Tablets per day (2 tablets). If the dog does not respond to 2 mg of INCURIN™ Tablets per day, the diagnosis should be re-assessed.
Careone Original Streng...

Careone Original Strength Triple Antibiotic

2.1 Dosage

Administer GARDASIL 9 intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months.

2.2 Method of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. GARDASIL 9 should not be diluted or mixed with other vaccines. After thorough agitation, GARDASIL 9 is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored.

Administer GARDASIL 9 intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Observe patients for 15 minutes after administration [see Warnings and Precautions (5)].

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use

This package does not contain a needle. Shake well before use. Attach a needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

2.3 Administration of GARDASIL 9 in Individuals Who Have Been Previously Vaccinated with GARDASIL®

Safety and immunogenicity of GARDASIL 9 were assessed in individuals who previously completed a three-dose vaccination series with GARDASIL [see Adverse Reactions (6.1) and Clinical Studies (14.4)]. Studies using a mixed regimen of HPV vaccines to assess interchangeability were not performed for GARDASIL 9.
Fluoxetine

Fluoxetine

2.1 Recommended Dosing and Dose Modification Guidelines

The recommended dose for TEMODAR as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when TEMODAR for Injection was given over 90 minutes [see Clinical Pharmacology (12.3)]. Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For TEMODAR dosage calculations based on body surface area (BSA) see Table 5. For suggested capsule combinations on a daily dose see Table 6.

Patients with Newly Diagnosed High Grade Glioma:

Concomitant Phase:

TEMODAR is administered at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions) followed by maintenance TEMODAR for 6 cycles. Focal RT includes the tumor bed or resection site with a 2- to 3-cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The TEMODAR dose should be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 × 109/L, platelet count greater than or equal to 100 × 109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 1. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of TEMODAR and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC Grade less than or equal to 1).
TABLE 1: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide Toxicity TMZ Interruption* TMZ Discontinuation TMZ=temozolomide; CTC=Common Toxicity Criteria. * Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 × 10 9/L; platelet count greater than or equal to 100 × 10 9/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting). Absolute Neutrophil Count greater than or equal to 0.5 and less than 1.5 × 109/L less than 0.5 × 109/L Platelet Count greater than or equal to 10 and less than 100 × 109/L less than 10 × 109/L CTC Nonhematological Toxicity(except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4

Maintenance Phase:

Cycle 1:

Four weeks after completing the TEMODAR+RT phase, TEMODAR is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.

Cycles 2–6:

At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 × 109/L, and the platelet count is greater than or equal to 100 × 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.

Dose Reduction or Discontinuation During Maintenance:

Dose reductions during the maintenance phase should be applied according to Tables 2 and 3.

During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of TEMODAR) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2 and 3.
TABLE 2: Temozolomide Dose Levels for Maintenance Treatment Dose Level Dose (mg/m2/day) Remarks −1 100 Reduction for prior toxicity 0 150 Dose during Cycle 1 1 200 Dose during Cycles 2–6 in absence of toxicity TABLE 3: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment Toxicity Reduce TMZ by 1 Dose Level* Discontinue TMZ TMZ=temozolomide; CTC=Common Toxicity Criteria. * TMZ dose levels are listed in Table 2. † TMZ is to be discontinued if dose reduction to less than 100 mg/m 2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. Absolute Neutrophil Count less than 1.0 × 109/L See footnote† Platelet Count less than 50 × 109/L See footnote† CTC Nonhematological Toxicity(except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4†

Patients with Refractory Anaplastic Astrocytoma:

For adults the initial dose is 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) ANC are greater than or equal to 1.5 × 109/L (1500/µL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 109/L (100,000/µL), the TEMODAR dose may be increased to 200 mg/m2/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/µL) and the platelet count exceeds 100 × 109/L (100,000/µL). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 × 109/L (1000/µL) or the platelet count is less than 50 × 109/L (50,000/µL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose (see Table 4). TEMODAR therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.
TABLE 4: Dosing Modification Table TABLE 5: Daily Dose Calculations by Body Surface Area (BSA) Total BSA(m2) 75 mg/m2 (mg daily) 150 mg/m2 (mg daily) 200 mg/m2 (mg daily) 1.0 75 150 200 1.1 82.5 165 220 1.2 90 180 240 1.3 97.5 195 260 1.4 105 210 280 1.5 112.5 225 300 1.6 120 240 320 1.7 127.5 255 340 1.8 135 270 360 1.9 142.5 285 380 2.0 150 300 400 2.1 157.5 315 420 2.2 165 330 440 2.3 172.5 345 460 2.4 180 360 480 2.5 187.5 375 500 TABLE 6: Suggested Capsule Combinations Based on Daily Dose in Adults Number of Daily Capsules by Strength (mg) Total Daily Dose (mg) 250 mg 180 mg 140 mg 100 mg 20 mg 5 mg 75 0 0 0 0 3 3 82.5 0 0 0 0 4 0 90 0 0 0 0 4 2 97.5 0 0 0 1 0 0 105 0 0 0 1 0 1 112.5 0 0 0 1 0 2 120 0 0 0 1 1 0 127.5 0 0 0 1 1 1 135 0 0 0 1 1 3 142.5 0 0 1 0 0 0 150 0 0 1 0 0 2 157.5 0 0 1 0 1 0 165 0 0 1 0 1 1 172.5 0 0 1 0 1 2 180 0 1 0 0 0 0 187.5 0 1 0 0 0 1 195 0 1 0 0 0 3 200 0 1 0 0 1 0 210 0 0 0 2 0 2 220 0 0 0 2 1 0 225 0 0 0 2 1 1 240 0 0 1 1 0 0 255 1 0 0 0 0 1 260 1 0 0 0 0 2 270 1 0 0 0 1 0 280 0 0 2 0 0 0 285 0 0 2 0 0 1 300 0 0 0 3 0 0 315 0 0 0 3 0 3 320 0 1 1 0 0 0 330 0 1 1 0 0 2 340 0 1 1 0 1 0 345 0 1 1 0 1 1 360 0 2 0 0 0 0 375 0 2 0 0 0 3 380 0 1 0 2 0 0 400 0 0 0 4 0 0 420 0 0 3 0 0 0 440 0 0 3 0 1 0 460 0 2 0 1 0 0 480 0 1 0 3 0 0 500 2 0 0 0 0 0
2.2 Preparation and Administration

TEMODAR Capsules:

In clinical trials, TEMODAR was administered under both fasting and nonfasting conditions; however, absorption is affected by food [see Clinical Pharmacology (12.3)], and consistency of administration with respect to food is recommended. There are no dietary restrictions with TEMODAR. To reduce nausea and vomiting, TEMODAR should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of TEMODAR.

TEMODAR (temozolomide) Capsules should not be opened or chewed. They should be swallowed whole with a glass of water.

If capsules are accidentally opened or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes [see How Supplied/Storage and Handling (16.1)].

TEMODAR for Injection:

Each vial of TEMODAR for Injection contains sterile and pyrogen-free temozolomide lyophilized powder. When reconstituted with 41 mL Sterile Water for Injection, the resulting solution will contain 2.5 mg/mL temozolomide. Bring the vial to room temperature prior to reconstitution with Sterile Water for Injection. The vials should be gently swirled and not shaken. Vials should be inspected, and any vial containing visible particulate matter should not be used. Do not further dilute the reconstituted solution. After reconstitution, store at room temperature (25°C [77°F]). Reconstituted product must be used within 14 hours, including infusion time.

Using aseptic technique, withdraw up to 40 mL from each vial to make up the total dose based on Table 5 above and transfer into an empty 250 mL infusion bag {2}. TEMODAR for Injection should be infused intravenously using a pump over a period of 90 minutes. TEMODAR for Injection should be administered only by intravenous infusion. Flush the lines before and after each TEMODAR infusion.

TEMODAR for Injection may be administered in the same intravenous line with 0.9% Sodium Chloride injection only.

Because no data are available on the compatibility of TEMODAR for Injection with other intravenous substances or additives, other medications should not be infused simultaneously through the same intravenous line.
Metoclopramide Hydrochl...

Metoclopramide Hydrochloride

General

IMPORTANT: INTRON® A is supplied as 1) Powder for Injection/Reconstitution; 2) Solution for Injection in Vials. Not all dosage forms and strengths are appropriate for some indications. It is important that you carefully read the instructions below for the indication you are treating to ensure you are using an appropriate dosage form and strength.

To enhance the tolerability of INTRON A, injections should be administered in the evening when possible.

To reduce the incidence of certain adverse reactions, acetaminophen may be administered at the time of injection.

The solution should be allowed to come to room temperature before using.

Hairy Cell Leukemia

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose for the treatment of hairy cell leukemia is 2 million IU/m2 administered intramuscularly or subcutaneously 3 times a week for up to 6 months. Patients with platelet counts of less than 50,000/mm3 should not be administered INTRON A intramuscularly, but instead by subcutaneous administration. Patients who are responding to therapy may benefit from continued treatment.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 18 MIU multidose 6 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
If severe adverse reactions develop, the dosage should be modified (50% reduction) or therapy should be temporarily withheld until the adverse reactions abate and then resume at 50% (1 MIU/m2 TIW). If severe adverse reactions persist or recur following dosage adjustment, INTRON A should be permanently discontinued. INTRON A should be discontinued for progressive disease or failure to respond after six months of treatment.
Malignant Melanoma

(see DOSAGE AND ADMINISTRATION, General)

INTRON A adjuvant treatment of malignant melanoma is given in two phases, induction and maintenance.

Induction Recommended Dose

The recommended daily dose of INTRON A in induction is 20 million IU/m2 as an intravenous infusion, over 20 minutes, 5 consecutive days per week, for 4 weeks (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU 10 MIU/mL IV Powder 18 MIU 18 MIU/mL IV Powder 50 MIU 50 MIU/mL IV
NOTE: INTRON A Solution for Injection in vials is NOT recommended for intravenous administration and should not be used for the induction phase of malignant melanoma.

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests).
INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5-10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal
Maintenance Recommended Dose

The recommended dose of INTRON A for maintenance is 10 million IU/m2 as a subcutaneous injection three times per week for 48 weeks (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses * Patients receiving 50% dose reduction only † Patients receiving full dose only Powder 10 MIU (single dose)* 10 MIU/mL SC N/A Powder 18 MIU (single dose)† 18 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests).
INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5-10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal
Follicular Lymphoma

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of follicular lymphoma is 5 million IU subcutaneously three times per week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
Doses of myelosuppressive drugs were reduced by 25% from a full-dose CHOP regimen, and cycle length increased by 33% (e.g., from 21 to 28 days) when alpha interferon was added to the regimen. Delay chemotherapy cycle if neutrophil count was less than 1500/mm3 or platelet count was less than 75,000/mm3. INTRON A should be permanently discontinued if SGOT exceeds greater than 5× the upper limit of normal or serum creatinine greater than 2.0 mg/dL (see WARNINGS). Administration of INTRON A therapy should be withheld for a neutrophil count less than 1000/mm3, or a platelet count less than 50,000/mm3. INTRON A dose should be reduced by 50% (2.5 MIU TIW) for a neutrophil count greater than 1000/mm3, but less than 1500/mm3. The INTRON A dose may be re-escalated to the starting dose (5 million IU TIW) after resolution of hematologic toxicity (ANC greater than 1500/mm3).
Condylomata Acuminata

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose is 1.0 million IU per lesion in a maximum of 5 lesions in a single course. The lesions should be injected three times weekly on alternate days for 3 weeks. An additional course may be administered at 12 to 16 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU (single dose) 10 MIU/mL IL Solution 25 MIU multidose 10 MIU/mL IL
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

NOTE: Do not use the following formulations for this indication:
the 18 million or 50 million IU Powder for Injection the 18 million IU multidose INTRON A Solution for Injection
Dose Adjustment

None

Technique for Injection

The injection should be administered intralesionally using a Tuberculin or similar syringe and a 25- to 30-gauge needle. The needle should be directed at the center of the base of the wart and at an angle almost parallel to the plane of the skin (approximately that in the commonly used PPD test). This will deliver the interferon to the dermal core of the lesion, infiltrating the lesion and causing a small wheal. Care should be taken not to go beneath the lesion too deeply; subcutaneous injection should be avoided, since this area is below the base of the lesion. Do not inject too superficially since this will result in possible leakage, infiltrating only the keratinized layer and not the dermal core.

AIDS-Related Kaposi's Sarcoma

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for Kaposi's Sarcoma is 30 million IU/m2/dose administered subcutaneously or intramuscularly three times a week until disease progression or maximal response has been achieved after 16 weeks of treatment. Dose reduction is frequently required (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Powder 50 MIU 50 MIU/mL IM, SC
NOTE: INTRON A Solution for Injection in vials should NOT be used for AIDS-Related Kaposi's Sarcoma.

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
INTRON A dose should be reduced by 50% or withheld for severe adverse reactions. INTRON A may be resumed at a reduced dose if severe adverse reactions abate with interruption of dosing. INTRON A should be permanently discontinued if severe adverse reactions persist or if they recur in patients receiving a reduced dose.
Chronic Hepatitis C

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis C is 3 million IU three times a week (TIW) administered subcutaneously or intramuscularly. In patients tolerating therapy with normalization of ALT at 16 weeks of treatment, INTRON A therapy should be extended to 18 to 24 months (72 to 96 weeks) at 3 million IU TIW to improve the sustained response rate (see CLINICAL PHARMACOLOGY, Chronic Hepatitis C). Patients who do not normalize their ALTs or have persistently high levels of HCV RNA after 16 weeks of therapy rarely achieve a sustained response with extension of treatment. Consideration should be given to discontinuing these patients from therapy.

When INTRON A is administered in combination with REBETOL®, patients with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to the development of anemia. See REBETOL prescribing information for dosing when used in combination with REBETOL for adults and pediatric patients.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Solution 18 MIU multidose 6 MIU/mL IM, SC N/A
Dose Adjustment

If severe adverse reactions develop during INTRON A treatment, the dose should be modified (50% reduction) or therapy should be temporarily discontinued until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

Chronic Hepatitis B Adults

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis B is 30 to 35 million IU per week, administered subcutaneously or intramuscularly, either as 5 million IU daily (QD) or as 10 million IU three times a week (TIW) for 16 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Chronic Hepatitis B Pediatrics

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis B is 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) administered subcutaneously for a total duration of 16 to 24 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

If severe adverse reactions or laboratory abnormalities develop during INTRON A therapy, the dose should be modified (50% reduction) or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

For patients with decreases in white blood cell, granulocyte or platelet counts, the following guidelines for dose modification should be followed:
INTRON A Dose White Blood Cell Count Granulocyte Count Platelet Count Reduce 50% <1.5 × 109/L <0.75 × 109/L <50 × 109/L Permanently Discontinue <1.0 × 109/L <0.5 × 109/L <25 × 109/L
INTRON A therapy was resumed at up to 100% of the initial dose when white blood cell, granulocyte, and/or platelet counts returned to normal or baseline values.
Intron A

Intron A

General

IMPORTANT: INTRON® A is supplied as 1) Powder for Injection/Reconstitution; 2) Solution for Injection in Vials. Not all dosage forms and strengths are appropriate for some indications. It is important that you carefully read the instructions below for the indication you are treating to ensure you are using an appropriate dosage form and strength.

To enhance the tolerability of INTRON A, injections should be administered in the evening when possible.

To reduce the incidence of certain adverse reactions, acetaminophen may be administered at the time of injection.

The solution should be allowed to come to room temperature before using.

Hairy Cell Leukemia

(see DOSAGE AND ADMINISTRATION, General)

Dose

The recommended dose for the treatment of hairy cell leukemia is 2 million IU/m2 administered intramuscularly or subcutaneously 3 times a week for up to 6 months. Patients with platelet counts of less than 50,000/mm3 should not be administered INTRON A intramuscularly, but instead by subcutaneous administration. Patients who are responding to therapy may benefit from continued treatment.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 18 MIU multidose 6 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
If severe adverse reactions develop, the dosage should be modified (50% reduction) or therapy should be temporarily withheld until the adverse reactions abate and then resume at 50% (1 MIU/m2 TIW). If severe adverse reactions persist or recur following dosage adjustment, INTRON A should be permanently discontinued. INTRON A should be discontinued for progressive disease or failure to respond after six months of treatment.
Malignant Melanoma

(see DOSAGE AND ADMINISTRATION, General)

INTRON A adjuvant treatment of malignant melanoma is given in two phases, induction and maintenance.

Induction Recommended Dose

The recommended daily dose of INTRON A in induction is 20 million IU/m2 as an intravenous infusion, over 20 minutes, 5 consecutive days per week, for 4 weeks (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU 10 MIU/mL IV Powder 18 MIU 18 MIU/mL IV Powder 50 MIU 50 MIU/mL IV
NOTE: INTRON A Solution for Injection in vials is NOT recommended for intravenous administration and should not be used for the induction phase of malignant melanoma.

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests).
INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5–10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal
Maintenance Recommended Dose

The recommended dose of INTRON A for maintenance is 10 million IU/m2 as a subcutaneous injection three times per week for 48 weeks (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses * Patients receiving 50% dose reduction only † Patients receiving full dose only Powder 10 MIU (single dose)* 10 MIU/mL SC N/A Powder 18 MIU (single dose)† 18 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests section).
INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5–10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal
Follicular Lymphoma

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of follicular lymphoma is 5 million IU subcutaneously three times per week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
Doses of myelosuppressive drugs were reduced by 25% from a full-dose CHOP regimen, and cycle length increased by 33% (e.g., from 21 to 28 days) when alpha interferon was added to the regimen. Delay chemotherapy cycle if neutrophil count was less than 1500/mm3 or platelet count was less than 75,000/mm3. INTRON A should be permanently discontinued if SGOT exceeds greater than 5× the upper limit of normal or serum creatinine greater than 2.0 mg/dL (see WARNINGS). Administration of INTRON A therapy should be withheld for a neutrophil count less than 1000/mm3, or a platelet count less than 50,000/mm3. INTRON A dose should be reduced by 50% (2.5 MIU TIW) for a neutrophil count greater than 1000/mm3, but less than 1500/mm3. The INTRON A dose may be re-escalated to the starting dose (5 million IU TIW) after resolution of hematologic toxicity (ANC greater than 1500/mm3).
Condylomata Acuminata

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose is 1.0 million IU per lesion in a maximum of 5 lesions in a single course. The lesions should be injected three times weekly on alternate days for 3 weeks. An additional course may be administered at 12 to 16 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU (single dose) 10 MIU/mL IL Solution 25 MIU multidose 10 MIU/mL IL
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

NOTE: Do not use the following formulations for this indication:
the 18 million or 50 million IU Powder for Injection the 18 million IU multidose INTRON A Solution for Injection
Dose Adjustment

None

Technique for Injection

The injection should be administered intralesionally using a Tuberculin or similar syringe and a 25-to 30-gauge needle. The needle should be directed at the center of the base of the wart and at an angle almost parallel to the plane of the skin (approximately that in the commonly used PPD test). This will deliver the interferon to the dermal core of the lesion, infiltrating the lesion and causing a small wheal. Care should be taken not to go beneath the lesion too deeply; subcutaneous injection should be avoided, since this area is below the base of the lesion. Do not inject too superficially since this will result in possible leakage, infiltrating only the keratinized layer and not the dermal core.

AIDS-Related Kaposi's Sarcoma

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for Kaposi's Sarcoma is 30 million IU/m2/dose administered subcutaneously or intramuscularly three times a week until disease progression or maximal response has been achieved after 16 weeks of treatment. Dose reduction is frequently required (see Dose Adjustment below).
Dosage Forms for This Indication Dosage Form Concentration Route Powder 50 MIU 50 MIU/mL IM, SC
NOTE: INTRON A Solution for Injection in vials should NOT be used for AIDS-Related Kaposi's Sarcoma.

NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment
INTRON A dose should be reduced by 50% or withheld for severe adverse reactions. INTRON A may be resumed at a reduced dose if severe adverse reactions abate with interruption of dosing. INTRON A should be permanently discontinued if severe adverse reactions persist or if they recur in patients receiving a reduced dose.
Chronic Hepatitis C

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis C is 3 million IU three times a week (TIW) administered subcutaneously or intramuscularly. In patients tolerating therapy with normalization of ALT at 16 weeks of treatment, INTRON A therapy should be extended to 18 to 24 months (72 to 96 weeks) at 3 million IU TIW to improve the sustained response rate (see CLINICAL PHARMACOLOGY, Chronic Hepatitis C). Patients who do not normalize their ALTs or have persistently high levels of HCV RNA after 16 weeks of therapy rarely achieve a sustained response with extension of treatment. Consideration should be given to discontinuing these patients from therapy.

When INTRON A is administered in combination with REBETOL®, patients with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to the development of anemia. See REBETOL prescribing information for dosing when used in combination with REBETOL for adults and pediatric patients.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Solution 18 MIU multidose 6 MIU/mL IM, SC N/A
Dose Adjustment

If severe adverse reactions develop during INTRON A treatment, the dose should be modified (50% reduction) or therapy should be temporarily discontinued until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

Chronic Hepatitis B Adults

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis B is 30 to 35 million IU per week, administered subcutaneously or intramuscularly, either as 5 million IU daily (QD) or as 10 million IU three times a week (TIW) for 16 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Chronic Hepatitis B Pediatrics

(see DOSAGE and ADMINISTRATION, General)

Dose

The recommended dose of INTRON A for the treatment of chronic hepatitis B is 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) administered subcutaneously for a total duration of 16 to 24 weeks.
Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A
NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

Dose Adjustment

If severe adverse reactions or laboratory abnormalities develop during INTRON A therapy, the dose should be modified (50% reduction) or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

For patients with decreases in white blood cell, granulocyte or platelet counts, the following guidelines for dose modification should be followed:
INTRON A Dose White Blood Cell Count Granulocyte Count Platelet Count Reduce 50% <1.5 × 109 /L <0.75 × 109 /L <50 × 109 /L Permanently Discontinue <1.0 × 109 /L <0.5 × 109 /L <25 × 109 /L
INTRON A therapy was resumed at up to 100% of the initial dose when white blood cell, granulocyte, and/or platelet counts returned to normal or baseline values.
Sylatron

Sylatron

2.1 Recommended Dosing
The recommended starting dose is 6 mcg/kg/week subcutaneously for 8 doses, followed by 3 mcg/kg/week subcutaneously for up to 5 years. Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of SYLATRON and as needed for subsequent doses. The recommended starting doses of SYLATRON in patients with moderate or severe renal impairment or end-stage renal disease (ESRD) are listed in Table 1 [see Use in Specific Populations (8.7)]. No dose adjustment is needed for patients with a creatinine clearance (CLcr) > 50 mL/min/1.73m2. Table 1: Recommended Starting Dose for Moderate and Severe Renal Impairment and End-Stage Renal Disease Degree of Renal Impairment Creatinine Clearance (mL/min/1.73m2) Initial doses for 8 weeks Follow-up doses for 5 years Moderate 30 – 50 4.5 mcg/kg/week 2.25 mcg/kg/week Severe <30 3 mcg/kg/week 1.5 mcg/kg/week End-Stage Renal Disease On dialysis 3 mcg/kg/week 1.5 mcg/kg/week
2.2 Dose Modification Guidelines

Guidelines for Dose Modification provided below are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 2.0).
Permanently discontinue SYLATRON for: Persistent or worsening severe neuropsychiatric disorders Grade 4 non-hematologic toxicity Inability to tolerate a dose of 1 mcg/kg/wk New or worsening retinopathy Withhold SYLATRON dose for any of the following: Absolute Neutrophil Count (ANC) less than 0.5×109/L Platelet Count (PLT) less than 50×109/L ECOG PS greater than or equal to 2 Non-hematologic toxicity greater than or equal to Grade 3 Resume dosing at a reduced dose (see Table 1) when all of the following are present: Absolute Neutrophil Count (ANC) greater than or equal to 0.5×109/L Platelet Count (PLT) greater than or equal to 50×109/L ECOG PS 0-1 Non-hematologic toxicity has completely resolved or improved to Grade 1 Table 2: SYLATRON Dose Modifications Starting Dose Dose Modifications for Doses 1 to 8 6 mcg/kg/week First Dose Modification: 3 mcg/kg/week Second Dose Modification: 2 mcg/kg/week Third Dose Modification: 1 mcg/kg/week Permanently discontinue if unable to tolerate 1 mcg/kg/week Starting Dose Dose Modifications for Doses 9 to 260 3 mcg/kg/week First Dose Modification: 2 mcg/kg/week Second Dose Modification: 1 mcg/kg/week Permanently discontinue if unable to tolerate 1 mcg/kg/week
2.3 Preparation and Administration

Reconstitute SYLATRON with 0.7 mL of Sterile Water for Injection, USP. The Sterile Water for Injection supplied contains 5 mL. Each vial of Sterile Water for Injection is intended for single use. Discard any unused Sterile Water for Injection, USP.
Table 3: Reconstitution of SYLATRON Single-Use Vials SYLATRON Single-Use Vial Diluent (Sterile Water for Injection, USP) Deliverable Product and Volume Final Concentration * Total vial content of SYLATRON is 296 mcg. † Total vial content of SYLATRON is 444 mcg. ‡ Total vial content of SYLATRON is 888 mcg. 200 mcg* add 0.7 mL = 200 mcg in 0.5 mL 40 mcg/0.1 mL 300 mcg† add 0.7 mL = 300 mcg in 0.5 mL 60 mcg/0.1 mL 600 mcg‡ add 0.7 mL = 600 mcg in 0.5 mL 120 mcg/0.1 mL Swirl gently to dissolve the lyophilized powder. DO NOT SHAKE. Visually inspect the solution for particulate matter and discoloration prior to administration. Discard if solution is discolored, cloudy, or if particulates are present. Do not withdraw more than 0.5 mL of reconstituted solution from each vial. Administer SYLATRON subcutaneously. Rotate injection sites. If reconstituted solution is not used immediately, store at 2°-8°C (36°-46°F) for no more than 24 hours. Discard reconstituted solution after 24 hours. DO NOT FREEZE. For single-use only. DISCARD ANY UNUSED PORTION.
Asmanex

Asmanex

Administer ASMANEX TWISTHALER by the orally inhaled route only. Instruct patients to inhale rapidly and deeply. Advise patients to rinse the mouth after inhalation. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after initiation of treatment. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients ≥12 years of age who do not respond adequately to the starting dose after 2 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ASMANEX TWISTHALER when administered in excess of recommended doses have not been established.

2.1 Recommended Dosages in Patients 4 Years of Age and Older

The recommended starting doses and highest recommended daily dose for ASMANEX TWISTHALER treatment based on prior asthma therapy are provided in Table 1.
Table 1: Recommended Dosages for ASMANEX TWISTHALER Treatment Previous Therapy Recommended Starting Dose Highest Recommended Daily Dose * When administered once daily, ASMANEX TWISTHALER should be taken only in the evening. † The 440 mcg daily dose may be administered in divided doses of 220 mcg twice daily or as 440 mcg once daily. ‡ For Patients Currently Receiving Chronic Oral Corticosteroid Therapy: Prednisone should be reduced no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of ASMANEX TWISTHALER therapy. Monitor patients carefully for signs of asthma instability, including serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.5)]. § Recommended pediatric dosage is 110 mcg once daily in the evening regardless of prior therapy. Patients ≥12 years who received bronchodilators alone 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received inhaled corticosteroids 220 mcg once daily in the evening* 440 mcg† Patients ≥12 years who received oral corticosteroids‡ 440 mcg twice daily 880 mcg Children 4-11 years of age§ 110 mcg once daily in the evening* 110 mcg*
Vaqta

Vaqta

FOR INTRAMUSCULAR ADMINISTRATION ONLY.

2.1 Dosage and Schedule

Children/Adolescents (12 months through 18 years of age): The vaccination schedule consists of a primary 0.5-mL dose administered intramuscularly, and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later.

Adults (19 years of age and older): The vaccination schedule consists of a primary 1-mL dose administered intramuscularly, and a 1-mL booster dose administered intramuscularly 6 to 18 months later.

Booster Immunization Following Another Manufacturer's Hepatitis A Vaccine: A booster dose of VAQTA may be given at 6 to 12 months following a primary dose of HAVRIX [see Clinical Studies (14.6)].

2.2 Preparation and Administration

Shake the single-dose vial or single-dose prefilled syringe well to obtain a slightly opaque, white suspension before withdrawal and use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the suspension does not appear homogenous or if extraneous particulate matter remains or discoloration is observed.

For single-dose vials, withdraw and administer entire dose of VAQTA intramuscularly using a sterile needle and syringe.

For single-dose prefilled syringes, securely attach a needle by twisting in a clockwise direction and administer dose of VAQTA intramuscularly.

For adults, adolescents, and children older than 2 years of age, the deltoid muscle is the preferred site for intramuscular injection. For children 12 through 23 months of age, the anterolateral area of the thigh is the preferred site for intramuscular injection.
Cozaar

Cozaar

Adult Hypertensive Patients

COZAAR may be administered with other antihypertensive agents, and with or without food.

Dosing must be individualized. The usual starting dose of COZAAR is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see PRECAUTIONS, General). COZAAR can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.

If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).

If blood pressure is not controlled by COZAAR alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).

No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.

Pediatric Hypertensive Patients greater than or equal to 6 years of age

The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension — Volume-Depleted Patients.)

COZAAR is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).

Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)

Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg COZAAR tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.

Hypertensive Patients with Left Ventricular Hypertrophy

The usual starting dose is 50 mg of COZAAR once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of COZAAR should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).

Nephropathy in Type 2 Diabetic Patients

The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). COZAAR may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
Varivax

Varivax

Subcutaneous administration only

2.1 Recommended Dose and Schedule

VARIVAX is administered as an approximately 0.5-mL dose by subcutaneous injection into the outer aspect of the upper arm (deltoid region) or the anterolateral thigh.

Do not administer this product intravascularly or intramuscularly.

Children (12 months to 12 years of age)

If a second dose is administered, there should be a minimum interval of 3 months between doses [see Clinical Studies (14.1)].

Adolescents (≥13 years of age) and Adults

Two doses of vaccine, to be administered with a minimum interval of 4 weeks between doses [see Clinical Studies (14.1)].

2.2 Reconstitution Instructions

When reconstituting the vaccine, use only the sterile diluent supplied with VARIVAX. The sterile diluent does not contain preservatives or other anti-viral substances which might inactivate the vaccine virus.

Use a sterile syringe free of preservatives, antiseptics, and detergents for each reconstitution and injection of VARIVAX because these substances may inactivate the vaccine virus.

To reconstitute the vaccine, first withdraw the total volume of provided sterile diluent into a syringe. Inject all of the withdrawn diluent into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents into the syringe and inject the total volume (approximately 0.5 mL) of reconstituted vaccine subcutaneously. VARIVAX, when reconstituted, is a clear, colorless to pale yellow liquid.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the product if particulates are present or if it appears discolored.

To minimize loss of potency, administer VARIVAX immediately after reconstitution. Discard if reconstituted vaccine is not used within 30 minutes.

Do not freeze reconstituted vaccine.

Do not combine VARIVAX with any other vaccine through reconstitution or mixing.
Hyzaar

Hyzaar

Hypertension

Dosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as HYZAAR.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

The side effects (see WARNINGS) of losartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not adequately controlled with losartan monotherapy (see above) or hydrochlorothiazide alone may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to HYZAAR 100/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.

A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to HYZAAR 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to HYZAAR 50/12.5 should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.

The usual dose of HYZAAR is one tablet of HYZAAR 50/12.5 once daily. More than two tablets of HYZAAR 50/12.5 once daily or more than one tablet of HYZAAR 100/25 once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.

Use in Patients with Renal Impairment: The usual regimens of therapy with HYZAAR may be followed as long as the patient's creatinine clearance is greater than 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so HYZAAR is not recommended.

Patients with Hepatic Impairment: HYZAAR is not recommended for titration in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given.

Severe Hypertension

The starting dose of HYZAAR for initial treatment of severe hypertension is one tablet of HYZAAR 50/12.5 once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to HYZAAR 50/12.5 after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of HYZAAR 100/25 once daily. The maximum dose is one tablet of HYZAAR 100/25 once daily. HYZAAR is not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension — Volume-Depleted Patients).

Hypertensive Patients with Left Ventricular Hypertrophy

Treatment should be initiated with COZAAR 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or HYZAAR 50/12.5 substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, COZAAR 100 mg and hydrochlorothiazide 12.5 mg or HYZAAR 100/12.5 may be substituted, followed by COZAAR 100 mg and hydrochlorothiazide 25 mg or HYZAAR 100/25. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).

HYZAAR may be administered with other antihypertensive agents.

HYZAAR may be administered with or without food.
Zostavax

Zostavax

Subcutaneous administration only. Do not inject intravascularly or intramuscularly.

2.1 Recommended Dose and Schedule

Administer ZOSTAVAX as a single 0.65-mL dose subcutaneously in the deltoid region of the upper arm.

2.2 Preparation for Administration

Use only sterile syringes free of preservatives, antiseptics, and detergents for each injection and/or reconstitution of ZOSTAVAX. Preservatives, antiseptics and detergents may inactivate the vaccine virus.

ZOSTAVAX is stored frozen and should be reconstituted immediately upon removal from the freezer.

When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.

Reconstitution:
Use only the diluent supplied. Withdraw the entire contents of the diluent into a syringe. To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents of reconstituted vaccine into a syringe and inject the total volume subcutaneously. ADMINISTER IMMEDIATELY AFTER RECONSTITUTION to minimize loss of potency. Discard reconstituted vaccine if not used within 30 minutes. Do not freeze reconstituted vaccine.

Merck Sharp & Dohme Corp.

Manufacturer Details

Share This Page

Merck Sharp & Dohme Corp. Drugs