Cleocin Phosphate

Cleocin Phosphate Manufacturers

• General Injectables & Vaccines, Inc
  

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  Cleocin Phosphate | General Injectables & Vaccines, Inc

  

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  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Adults: Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens): 600-1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens: 1200-2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution and Infusion Rates section below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels

  Rapid infusion rate

  Maintenance infusion rate

  Above 4 mcg/mL

  10 mg/min for 30 min

  0.75 mg/min

  Above 5 mcg/mL

  15 mg/min for 30 min

  1.00 mg/min

  Above 6 mcg/mL

  20 mg/min for 30 min

  1.25 mg/min

  Neonates (less than 1 month): 15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients 1 month of age to 16 years: Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral CLEOCIN PEDIATRIC® Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCL® Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of B-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution and Infusion Rates: Clindamycin phosphate must be diluted prior to IV administration. The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute.

  The usual infusion dilutions and rates are as follows:

  Dose

  Diluent

  Time

  300 mg

  50 mL

  10 min

  600 mg

  50 mL

  20 min

  900 mg

  50-100 mL

  30 min

  1200 mg

  100 mL

  40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility: Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of CLEOCIN PHOSPHATE Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the Medical and Drug Information Unit, Pharmacia & Upjohn Company (Division of Pfizer Inc).

  Physico-Chemical Stability of diluted solutions of CLEOCIN PHOSPHATE

  Room temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C. IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  DIRECTIONS FOR DISPENSING

  Pharmacy Bulk Package-Not for Direct Infusion

  The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only under a laminar flow hood. Entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique. Multiple entries with a needle and syringe are not recommended. AFTER ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS AFTER INITIAL ENTRY.

  DIRECTIONS FOR USE

  CLEOCIN PHOSPHATE IV Solution in Galaxy Plastic Container

  Premixed CLEOCIN PHOSPHATE IV Solution is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.

  Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set.

  Preparation of CLEOCIN PHOSPHATE in ADD-Vantage System-For IV Use Only. CLEOCIN PHOSPHATE 600 mg and 900 mg may be reconstituted in 50 mL or 100 mL, respectively, of dextrose injection 5% or sodium chloride injection 0.9% in the ADD-diluent container. Refer to separate instructions for ADD-Vantage ‡ System.

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• Pharmacia And Upjohn Company
  

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  Cleocin Phosphate | Pharmacia And Upjohn Company

  

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  If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

  Clindamycin phosphate IM administration should be used undiluted.

  Clindamycin phosphate IV administration should be diluted (see Dilution for IV use and IV infusion rates below).

  Adults

  Parenteral (IM or IV Administration): Serious infections due to aerobic gram-positive cocci and the more susceptible anaerobes (NOT generally including Bacteroides fragilis, Peptococcus species and Clostridium species other than Clostridium perfringens):

  600–1200 mg/day in 2, 3 or 4 equal doses.

  More severe infections, particularly those due to proven or suspected Bacteroides fragilis, Peptococcus species, or Clostridium species other than Clostridium perfringens:

  1200–2700 mg/day in 2, 3 or 4 equal doses.

  For more serious infections, these doses may have to be increased. In life-threatening situations due to either aerobes or anaerobes these doses may be increased. Doses of as much as 4800 mg daily have been given intravenously to adults. See Dilution for IV use and IV Infusion Rates section below.

  Single intramuscular injections of greater than 600 mg are not recommended.

  Alternatively, drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion as follows:

  To maintain serum clindamycin levels Rapid infusion rate Maintenance infusion rate Above 4 mcg/mL 10 mg/min for 30 min 0.75 mg/min Above 5 mcg/mL 15 mg/min for 30 min 1.00 mg/min Above 6 mcg/mL 20 mg/min for 30 min 1.25 mg/min Neonates (less than 1 month)

  15 to 20 mg/kg/day in 3 to 4 equal doses. The lower dosage may be adequate for small prematures.

  Pediatric patients 1 month of age to 16 years

  Parenteral (IM or IV) Administration: 20 to 40 mg/kg/day in 3 or 4 equal doses. The higher doses would be used for more severe infections. As an alternative to dosing on a body weight basis, pediatric patients may be dosed on the basis of square meters body surface: 350 mg/m2/day for serious infections and 450 mg/m2/day for more severe infections.

  Parenteral therapy may be changed to oral CLEOCIN PEDIATRIC® Flavored Granules (clindamycin palmitate hydrochloride) or CLEOCIN HCl® Capsules (clindamycin hydrochloride) when the condition warrants and at the discretion of the physician.

  In cases of β-hemolytic streptococcal infections, treatment should be continued for at least 10 days.

  Dilution for IV use and IV Infusion Rates

  The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL. Infusion rates should not exceed 30 mg per minute. The usual infusion dilutions and rates are as follows:

  Dose Diluent Time 300 mg 50 mL 10 min 600 mg 50 mL 20 min 900 mg 50–100 mL       30 min 1200 mg   100 mL 40 min

  Administration of more than 1200 mg in a single 1-hour infusion is not recommended.

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

  Dilution and Compatibility

  Physical and biological compatibility studies monitored for 24 hours at room temperature have demonstrated no inactivation or incompatibility with the use of CLEOCIN PHOSPHATE Sterile Solution (clindamycin phosphate) in IV solutions containing sodium chloride, glucose, calcium or potassium, and solutions containing vitamin B complex in concentrations usually used clinically. No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

  The following drugs are physically incompatible with clindamycin phosphate: ampicillin sodium, phenytoin sodium, barbiturates, aminophylline, calcium gluconate, and magnesium sulfate.

  The compatibility and duration of stability of drug admixtures will vary depending on concentration and other conditions. For current information regarding compatibilities of clindamycin phosphate under specific conditions, please contact the Medical and Drug Information Unit, Pharmacia & Upjohn Company (Division of Pfizer Inc).

  Physico-Chemical Stability of Diluted Solutions of CLEOCIN PHOSPHATE

  Room Temperature: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 16 days at 25°C. Also, 18 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, in minibags, demonstrated physical and chemical stability for at least 16 days at 25°C.

  Refrigeration: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in glass bottles or minibags, demonstrated physical and chemical stability for at least 32 days at 4°C.

  IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Frozen: 6, 9 and 12 mg/mL (equivalent to clindamycin base) in dextrose injection 5%, sodium chloride injection 0.9%, or Lactated Ringers Injection in minibags demonstrated physical and chemical stability for at least eight weeks at -10°C.

  Frozen solutions should be thawed at room temperature and not refrozen.

  DIRECTIONS FOR DISPENSING Pharmacy Bulk Package — Not for Direct Infusion

  The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only under a laminar flow hood. Entry into the vial should be made with a small diameter sterile transfer set or other small diameter sterile dispensing device, and contents dispensed in aliquots using aseptic technique. Multiple entries with a needle and syringe are not recommended. AFTER ENTRY USE ENTIRE CONTENTS OF VIAL PROMPTLY. ANY UNUSED PORTION MUST BE DISCARDED WITHIN 24 HOURS AFTER INITIAL ENTRY.

  DIRECTIONS FOR USE CLEOCIN PHOSPHATE IV Solution in GALAXY Plastic Container

  Premixed CLEOCIN PHOSPHATE IV Solution is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.

  Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

  Preparation for Administration:

  Suspend container from eyelet support. Remove protector from outlet port at bottom of container. Attach administration set. Refer to complete directions accompanying set. Preparation of CLEOCIN PHOSPHATE in ADD-Vantage System

  For IV Use Only. CLEOCIN PHOSPHATE 300 mg, 600 mg and 900 mg may be reconstituted in 50 mL (for 300 mg and 600 mg) or 100 mL (for 900 mg) of dextrose injection 5% or sodium chloride injection 0.9% in the ADD-diluent container. Refer to separate instructions for ADD-Vantage System.

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• Pharmacia And Upjohn Company
  

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  Cleocin Phosphate | Teva Pharmaceuticals Usa Inc

  

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  2.1 Recommended Dosing

  The recommended dosage is one 60 mg raloxifene hydrochloride tablet USP daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology (12.3)].

  2.2 Recommendations for Calcium and Vitamin D Supplementation

  For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones. The recommended intake of vitamin D is 400 to 800 IU daily. 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 supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.

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