Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)
Lake Erie Medical DBA Quality Care Products LLC
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 (e.g., 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
Clindamycin Hydrochloride Capsules USP (equivalent to 150 mg of Clindamycin) are opaque gray and opaque pink capsules imprinted DAN 5708 supplied in bottles of 100. Clindamycin Hydrochloride Capsules USP (equivalent to 300 mg of Clindamycin) are opaque pink capsules imprinted DAN 3120 supplied in bottles of 16 and 100. Dispense in a tight container with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]
Abbreviated New Drug Application
CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC REFERENCE LABEL SET ID: BE26FF29-B06E-4AE6-BD17-65AB2730A014 ---------- CLINDAMYCIN HYDROCHLORIDE CAPSULES USP REVISED : MARCH 2009 RX ONLY 184276 SPL UNCLASSIFIED SECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin HCl and other antibacterial drugs, clindamycin hydrochloride 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. DESCRIPTIO Прочетете целия документ