Clindamycin Palmitate Hydrochloride (Page 4 of 5)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed with clindamycin to evaluate carcinogenic potential. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Both tests were negative.

Fertility studies in rats treated orally with up to 300 mg/kg/day (approximately 1.6 times the highest recommended adult human oral dose based on mg/m2) revealed no effects on fertility or mating ability.

Pregnancy

Teratogenic Effects

Pregnancy Category B

Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.

Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m2 ,respectively) revealed no evidence of teratogenicity.

Nursing Mothers

Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. Because of the potential for serious adverse reactions in nursing infants, clindamycin should not be taken by nursing mothers.

Pediatric Use

When clindamycin palmitate hydrochloride for oral solution (pediatric) is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.

Geriatric Use

Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridium difficile) seen in association with most antibiotics occur more frequently in the elderly (> 60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.

Pharmacokinetic studies with clindamycin have shown no clinically important differences between young subjects (18 to 39 years) and elderly subjects (61 to 79 years) with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.

ADVERSE REACTIONS

The following reactions have been reported with the use of clindamycin.

Infections and Infestations

Clostridium difficile colitis

Gastrointestinal

Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). An unpleasant or metallic taste has been reported after oral administration.

Hypersensitivity Reactions

Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (See WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported.

Skin and Mucous Membranes

Pruritus, vaginitis, angioedema, and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions.)

Liver

Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Renal

Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed.

Hematopoietic

Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune System

Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Musculoskeletal

Cases of polyarthritis have been reported.

OVERDOSAGE

Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

DOSAGE AND ADMINISTRATION

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

Concomitant administration of food does not adversely affect the absorption of clindamycin palmitate hydrochloride contained in clindamycin palmitate hydrochloride for oral solution (pediatric).

Serious infections: 8 mg/kg/day to 12 mg/kg/day (4 mg/lb/day to 6 mg/lb/day) divided into 3 or 4 equal doses.

Severe infections: 13 mg/kg/day to 16 mg/kg/day (6.5 mg/lb/day to 8 mg/lb/day) divided into 3 or 4 equal doses.

More severe infections: 17 mg/kg/day to 25 mg/kg/day (8.5 mg/lb/day to 12.5 mg/lb/day) divided into 3 or 4 equal doses.

In pediatric patients weighing 10 kg or less, ½ teaspoon (37.5 mg) 3 times a day should be considered the minimum recommended dose.

Serious infections due to anaerobic bacteria are usually treated with clindamycin injection. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin palmitate hydrochloride for oral solution (pediatric).

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

Reconstitution Instructions

When reconstituted with water as follows, each 5 mL (teaspoonful) of solution contains clindamycin palmitate hydrochloride equivalent to 75 mg of clindamycin.

Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the water and shake vigorously; add the remainder of the water and shake until the solution is uniform.

Storage Conditions: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

HOW SUPPLIED

Clindamycin Palmitate Hydrochloride for Oral Solution, USP (Pediatric) is available as a white to off-white granular powder. When reconstituted with water as directed, each bottle will contain 100 mL of a solution providing clindamycin palmitate hydrochloride, USP equivalent to 75 mg of clindamycin per each 5 mL. Clindamycin palmitate hydrochloride for oral solution, USP (pediatric) is supplied as follows:

NDC 0378-8730-35
75 mg/5 mL in 100 mL amber, glass bottles

Storage Conditions: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Do NOT refrigerate the reconstituted solution; when chilled, the solution may thicken and be difficult to pour. The solution is stable for 2 weeks at room temperature.

Rx only

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