Drug: Cleocin

Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. CLEOCIN HCl Capsules contain clindamycin hydrochloride equivalent to 75 mg, 150 mg or 300 mg of clindamycin. Inactive ingredients: 75 mg-corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate and talc; 150 mg-corn starch, FD&C blue no. 1, FD&C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; 300 mg-corn starch, FD&C blue no. 1, gelatin, lactose, magnesium stearate, talc and titanium dioxide. The structural formula is represented below: The chemical name for clindamycin hydrochloride is Methyl 7-chloro-6,7,8-trideoxy-6-(1methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranosidemonohydrochloride.

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The following reactions have been reported with the use of clindamycin. Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting and diarrhea (see WARNING box). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). 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. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, and a few cases of anaphylactoid reactions have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, 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 in rare instances. 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. Musculoskeletal: Rare instances of polyarthritis have been reported. Read the Cleocin (clindamycin) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box). Adults Serious infections—150 to 300 mg every 6 hours. More severe infections—300 to 450 mg every 6 hours. Pediatric Patients: Serious infections—8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections—16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. To avoid the possibility of esophageal irritation, CLEOCIN (clindamycin) HCl Capsules should be taken with a full glass of water. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN (clindamycin) PHOSPHATE® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with CLEOCIN (clindamycin) HCl Capsules. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.

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Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents. Antagonism has been demonstrated between clindamycin and erythromycin in vitro. Because of possible clinical significance, these two drugs should not be administered concurrently. Last reviewed on RxList: 1/13/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tuboovarian abscess, pelvic cellulitis and postsurgical vaginal cuff infection. Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections. Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN (clindamycin) HCl and other antibacterial drugs, CLEOCIN (clindamycin) HCl should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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CLEOCIN (clindamycin) HCl is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. Last reviewed on RxList: 1/13/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

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CLEOCIN (clindamycin) HCl Capsules are available in the following strengths, colors and sizes: 75 mg Green      Bottles of 100 NDC 0009-0331-02 150 mg Light Blue and Green    Bottles of 16 NDC 0009-0225-01    Bottles of 100 NDC 0009-0225-02    Unit dose package of 100 NDC 0009-0225-03 300 mg Light Blue    Bottles of 16 NDC 0009-0395-13    Bottles of 100 NDC 0009-0395-14    Unit dose package of 100 NDC 0009-0395-02 Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP]. Manufactured by: Pharmacia and Upjohn Company Last reviewed on RxList: 1/13/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When clindamycin is indicated in these patients, they should be carefully monitored for change in bowel frequency. CLEOCIN (clindamycin) HCl should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. CLEOCIN (clindamycin) HCl should be prescribed with caution in atopic individuals. Indicated surgical procedures should be performed in conjunction with antibiotic therapy. The use of CLEOCIN (clindamycin) HCl occasionally results in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. Clindamycin dosage modification may not be necessary in patients with renal disease. In patients with moderate to severe liver disease, prolongation of clindamycin half-life has been found. However, it was postulated from studies that when given every eight hours, accumulation should rarely occur. Therefore, dosage modification in patients with liver disease may not be necessary. However, periodic liver enzyme determinations should be made when treating patients with severe liver disease. The 75 mg and 150 mg capsules contain FD&C yellow no. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C yellow no. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Prescribing CLEOCIN (clindamycin) HCl in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Laboratory Tests During prolonged therapy, periodic liver and kidney function tests and blood counts should be performed. 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 dose based on mg/m2) revealed no effects on fertility or mating ability. Pregnancy Teratogenic effects - Pregnancy category B 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. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers Clindamycin has been reported to appear in breast milk in the range of 0.7 to 3.8 mcg/mL. Pediatric Use When CLEOCIN (clindamycin) HCl 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 and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.Last reviewed on RxList: 1/13/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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