Clindamycin 150 MG Oral Capsule
INDICATIONS AND USAGE Clindamycin hydrochloride capsules, USP are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules, USP are 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 BOXED WARNING , 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, nongonococcal tubo-ovarian 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 clindamycin hydrochloride capsules, USP and other antibacterial drugs, clindamycin hydrochloride capsules, USP 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.
Ranbaxy Pharmaceuticals Inc.
CAPSULE RX692
RX692 CAPSULE
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HOW SUPPLIED
CLINDAMYCIN HYDROCHLORIDE capsules, USP are available in the following strengths, colors and sizes:
CLINDAMYCIN HYDROCHLORIDE capsules, USP, 150 mg are size ‘1’ capsules with turquoise blue opaque cap and light green body imprinted with “RX692†on cap and body in black ink containing white to off white powder. They are supplied as follows: NDC 63304-692-03 Bottles of 10 NDC 63304-692-01 Bottles of 100 NDC 63304-692-05 Bottles of 500 NDC 63304-692-77 Carton of 100 (10 X 10 Unit-Dose blister)
CLINDAMYCIN HYDROCHLORIDE capsules, USP, 300 mg are size ‘0’ capsules with turquoise blue opaque cap and turquoise blue opaque body imprinted with “RX693†on cap and body in black ink containing white to off white powder. They are supplied as follows: NDC 63304-693-03 Bottles of 10 NDC 63304-693-16 Bottles of 16 NDC 63304-693-01 Bottles of 100 NDC 63304-693-62 Carton of 60 (3 X 20 Unit-Dose blister) NDC 63304-693-77 Carton of 100 (10 X 10 Unit-Dose blister) NDC 63304-693-05 Bottles of 500 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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