Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)
Contract Pharmacy Services-PA
CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN 150 mg
ORAL
PRESCRIPTION DRUG
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). 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 clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected t
Clindamycin hydrochloride capsules 150 mg are supplied as light blue, opaque, hard gelatin capsules, imprinted with “cor” over “153” on cap and body.
Abbreviated New Drug Application
CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE, GELATIN COATED CONTRACT PHARMACY SERVICES-PA ---------- CLINDAMYCIN HYDROCHLORIDE CAPSULES USP 150 MG AND 300 MG RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules and other antibacterial drugs, clindamycin hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING PSEUDOMEMBRANOUS COLITIS HAS BEEN REPORTED WITH NEARLY ALL ANTIBACTERIAL AGENTS, INCLUDING CLINDAMYCIN, AND MAY RANGE IN SEVERITY FROM MILD TO LIFE THREATENING. THEREFORE, IT IS IMPORTANT TO CONSIDER THIS DIAGNOSIS IN PATIENTS WHO PRESENT WITH DIARRHEA SUBSEQUENT TO THE ADMINISTRATION OF ANTIBACTERIAL AGENTS. Because Clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by clostridium difficile is one primary cause of “antibiotic- associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. _difficile colitis._ Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of therapy with Clindamycin. DESCRIPTION Clindamycin hydrochloride is the hydrated hydrochloride salt of clinda Read the complete document