Graceway Pharmaceuticals, Llc

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Graceway Pharmaceuticals, Llc Drugs

Nitroglycerin Transderm...

Nitroglycerin Transdermal Delivery System

The suggested starting dose is between 0.2 mg/hr and 0.4 mg/hr. Doses between 0.4 mg/hr and 0.8 mg/hr have shown continued effectiveness for 10-12 hours daily for at least one 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 10-12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12-14 hours and a daily patch-off period of 10-12 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 (i.e., 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.
Norflex

Norflex

INJECTION: Adults - One 2 mL ampul (60 mg) intravenously or intramuscularly; may be repeated every 12 hours.
Calcium Disodium Versen...

Calcium Disodium Versenate

When a source for the lead intoxication has been identified, the patient should be removed from the source, if possible. The recommended dose of Calcium Disodium Versenate for asymptomatic adults and pediatric patients whose blood lead level is <70 mcg/dl but >20 mcg/dl (World Health Organization recommended upper allowable level) is 1000 mg/m2/day whether given intravenously or intramuscularly. (See Surface Area Nomogram.)

For adults with lead nephropathy, the following dosing regimen has been suggested: 500 mg/m2 every 24 hours for 5 days for patients with serum creatinine levels of 2-3 mg/dl, every 48 hours for 3 doses for patients with creatinine levels of 3-4 mg/dl, and once weekly for patients with creatinine levels above 4 mg/dl. These regimens may be repeated at one month intervals.12

Calcium Disodium Versenate, used alone, may aggravate symptoms in patients with very high blood lead levels. When the blood lead level is >70 mcg/dl or clinical symptoms consistent with lead poisoning are present, it is recommended that Calcium Disodium Versenate be used in conjunction with BAL (dimercaprol). Please consult published protocols and specialized references for dosage recommendations of combination therapy.14-18

Therapy of lead poisoning in adults and pediatric patients with Calcium Disodium Versenate is continued over a period of five days. Therapy is then interrupted for 2 to 4 days to allow redistribution of the lead and to prevent severe depletion of zinc and other essential metals. Two courses of treatment are usually employed; however, it depends on severity of the lead toxicity and the patient's tolerance of the drug.

Calcium Disodium Versenate is equally effective whether administered intravenously or intramuscularly. The intramuscular route is used for all patients with overt lead encephalopathy and this route is preferred by some for young pediatric patients.

Acutely ill individuals may be dehydrated from vomiting. Since edetate calcium disodium is excreted almost exclusively in the urine, it is very important to establish urine flow with intravenous fluid administration before the first dose of the chelating agent is given; however, excessive fluid must be avoided in patients with encephalopathy. Once urine flow is established, further intravenous fluid is restricted to basal water and electrolyte requirements. Administration of Calcium Disodium Versenate should be stopped whenever there is cessation of urine flow in order to avoid unduly high tissue levels of the drug. Edetate calcium disodium must be used in reduced doses in patients with pre-existing mild renal disease.

Intravenous Administration: Add the total daily dose of Calcium Disodium Versenate (1000 mg/m2/day) to 250-500 ml of 5% dextrose or 0.9% sodium chloride injection. The total daily dose should be infused over a period of 8-12 hours. Calcium Disodium Versenate injection is incompatible with 10% dextrose, 10% invert sugar in 0.9% sodium chloride, lactate Ringer's, Ringer's, one-sixth molar sodium lactate injections, and with injectable amphotericin B and hydralazine hydrochloride.

Intramuscular Administration: The total daily dosage (1000 mg/m2/day) should be divided into equal doses spaced 8-12 hours apart. Lidocaine or procaine should be added to the Calcium Disodium Versenate injection to minimize pain at the injection site. The final lidocaine or procaine concentration of 5 mg/ml (0.5%) can be obtained as follows: 0.25 ml of 10% lidocaine solution per 5 ml concentrated Calcium Disodium Versenate; 1 ml of 1% lidocaine or procaine solution per ml of concentrated Calcium Disodium Versenate. When used alone, regardless of method of administration, Calcium Disodium Versenate should not be given at doses larger than those recommended.

Diagnostic Test: Several methods have been described for lead mobilization tests using edetate calcium disodium to assess body stores. 7, 9,12,13,18

These procedures have advantages and disadvantages that should be reviewed in current references. Edetate calcium disodium mobilization tests should not be performed in symptomatic patients and in patients with blood lead levels above 55 mcg/dl for whom appropriate therapy is indicated.

Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Minitran

Minitran

The suggested starting dose is between 0.2 mg/hr and 0.4 mg/hr. Doses between 0.4 mg/hr and 0.8 mg/hr have shown continued effectiveness for 10-12 hours daily for at least one 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 10-12 hours is sufficient (see CLINICAL PHARMACOLOGY). Thus, an appropriate dosing schedule for nitroglycerin patches would include a daily patch-on period of 12-14 hours and a daily patch-off period of 10-12 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 (i.e., 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.
Maxair Autohaler

Maxair Autohaler

The usual dose for adults and children 12 years and older is two inhalations (400 mcg) repeated every 4-6 hours. One inhalation (200 mcg) repeated every 4-6 hours may be sufficient for some patients.

A total daily dose of 12 inhalations should not be exceeded.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma which would require reassessment of therapy.
Aldara

Aldara

The application frequency for Aldara Cream is different for each indication.

Aldara is not for oral, ophthalmic, or intravaginal use.

2.1 Actinic Keratosis

Aldara Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., 5 cm x 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of 2 times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara Cream should be applied to the contiguous treatment area at each application. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream. Before applying the cream, the patient should wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes).

Contact with the eyes, lips and nostrils should be avoided.

Local skin reactions in the treatment area are common [see Adverse Reactions (6.1, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, the treatment period should not be extended beyond 16 weeks due to missed doses or rest periods. Response to treatment cannot be adequately assessed until resolution of local skin reactions. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 36 packets for the 16-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

2.2 Superficial Basal Cell Carcinoma

Aldara Cream should be applied 5 times per week for a full 6 weeks to a biopsy-confirmed superficial basal cell carcinoma. An example of a 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream. The patient should wash the treatment area with mild soap and water before applying the cream, and allow the area to dry thoroughly.

The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). The treatment area should include a 1 cm margin of skin around the tumor. Sufficient cream should be applied to cover the treatment area, including 1 centimeter of skin surrounding the tumor. Aldara Cream should be rubbed into the treatment area until the cream is no longer visible.
Table 1. Amount of Aldara Cream to Use for sBCC
Target Tumor Diameter

Size of Cream Droplet to be Used (diameter)

Approximate Amount of Aldara to be Used

0.5 to < 1.0 cm

4 mm

10 mg

≥ 1.0 to < 1.5 cm

5 mm

25 mg

≥ 1.5 to 2.0 cm

7 mm

40 mg

Contact with the eyes, lips and nostrils should be avoided.

Local skin reactions in the treatment area are common [see Adverse Reactions (6.2, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction.

Early clinical clearance cannot be adequately assessed until resolution of local skin reactions (e.g. 12 weeks post-treatment). Local skin reactions or other findings (e.g. infection) may require that a patient be seen sooner than the post-treatment assessment for clinical clearance. If there is clinical evidence of persistent tumor at the post-treatment assessment for clinical clearance, a biopsy or other alternative intervention should be considered. Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered; the safety and efficacy of a repeat course of Aldara Cream treatment have not been established. If any suspicious lesion arises in the treatment area at any time after a determination of clinical clearance, the patient should seek a medical evaluation [see Clinical Studies (14.2)].

Aldara Cream is packaged in single-use packets, with 12 packets supplied per box. Patients should be prescribed no more than 36 packets for the 6-week treatment period. Unused packets should be discarded. Partially-used packets should be discarded and not reused.

2.3 External Genital Warts

Aldara Cream should be applied 3 times per week to external genital/perianal warts. Aldara Cream treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for 6 -10 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.

It is recommended that patients wash their hands before and after applying Aldara Cream.

A thin layer of Aldara Cream should be applied to the wart area and rubbed in until the cream is no longer visible. The application site should not be occluded. Following the treatment period the cream should be removed by washing the treated area with mild soap and water.

Local skin reactions at the treatment site are common [see Adverse Reactions (6.3, 6.5)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

Aldara Cream is packaged in single-use packets which contain sufficient cream to cover a wart area of up to 20 cm2; use of excessive amounts of cream should be avoided.
Metrogel-vaginal

Metrogel-vaginal

The recommended dose is one applicator full of METROGEL-VAGINAL (approximately 5 grams containing approximately 37.5 mg of metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, METROGEL-VAGINAL should be administered at bedtime.
Zyclara

Zyclara

For topical use only; ZYCLARA Cream is not for oral, ophthalmic, intra-anal or intravaginal use.

2.1 Actinic Keratosis

ZYCLARA Cream should be applied once daily before bedtime to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. ZYCLARA Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (2 packets or 2 full actuations of the pump) of ZYCLARA Cream may be applied to the treatment area at each application. ZYCLARA Cream should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.

Patients should wash their hands before and after applying ZYCLARA Cream.

Avoid use in or on the lips and nostrils. Do not use in or near the eyes.

Local skin reactions in the treatment area are common [see Adverse Reactions (6.1)]. A rest period of several days may be taken if required by the patient's discomfort or severity of the local skin reaction. However, neither 2-week treatment cycle should be extended due to missed doses or rest periods. A transient increase in lesion counts may be observed during treatment. Response to treatment cannot be adequately assessed until resolution of local skin reactions. The patient should continue dosing as prescribed. Treatment should continue for the full treatment course even if all actinic keratoses appear to be gone. Lesions that do not respond to treatment should be carefully re-evaluated and management reconsidered.

Prescribe no more than 2 boxes (56 packets), two 7.5g pumps or one 15g pump for the total 2-cycle treatment course.Partially-used packets should be discarded and not reused.

2.2 External Genital Warts

Patients should apply a thin layer of ZYCLARA Cream once a day to the external genital/perianal warts until total clearance or for up to 8 weeks. Patients should use up to 0.25 grams (one packet or one full actuation of the pump) at each application, which is a sufficient amount of cream to cover the wart area. ZYCLARA Cream should be appliedprior to normal sleeping hours and left on the skin for approximately 8 hours, then removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of ZYCLARA Cream therapy.

Patients should wash their hands before and after applying ZYCLARA Cream.

Local skin reactions at the treatment site are common [see Adverse Reactions (6.2)], and may necessitate a rest period of several days; resume treatment once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions.

Prescribe up to 2 boxes (56 packets), two 7.5g pumps or one 15g pump for the total treatment course. Use of excessive amounts of cream should be avoided. Partially-used packets should be discarded and not reused.

2.3 Pump Administration

ZYCLARA (imiquimod) Cream 3.75% pumps should be primed before using for the first time by repeatedly depressing the actuator until cream is dispensed. It is not necessary to repeat this priming process during treatment.

Graceway Pharmaceuticals, Llc

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Graceway Pharmaceuticals, Llc Drugs