Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)
Preferred Pharmaceuticals, Inc.
CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN 150 mg
ORAL
PRESCRIPTION DRUG
Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules are also indicated in the treatment of seri‑ous 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 gastroin‑testinal tract); infecti
Clindamycin Hydrochloride Capsules USP, 150 mg are light blue opaque/light green transparent size ‘1’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘39’ on light green transparent body with black ink. Bottle of 12 - 68788-9703-0 Bottle of 14 - 68788-9703-1 Bottle of 20 - 68788-9703-2 Bottle of 21 - 68788-9703-7 Bottle of 28 - 68788-9703-8 Bottle of 30 - 68788-9703-3 Bottle of 56 - 68788-9703-5 Bottle of 60 - 68788-9703-6 Clindamycin Hydrochloride Capsules USP, 300 mg are light blue opaque/light blue opaque size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘40’ on light blue opaque body with black ink. Bottle of 14 - 68788-0616-1 Bottle of 20 - 68788-0616-2 Bottle of 21 - 68788-0616-8 Bottle of 30 - 68788-0616-3 Bottle of 40 - 68788-0616-4 Bottle of 60 - 68788-0616-6 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight container with child-resistant closure. Trademarks are the property of their respective owners. Distributed by: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 038, India Revised: 04/2018 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
CLINDAMYCIN HYDROCHLORIDE- CLINDAMYCIN HYDROCHLORIDE CAPSULE PREFERRED PHARMACEUTICALS, INC. ---------- CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride 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 _Clostridium difficile_ associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of _C. difficile_. Because clindamycin hydrochloride therapy has been asso ciated with severe colitis which may end fatally, it should be reserved for serious infec tions where less toxic antimicrobial agents are inappropriate, as described in the INDICA TIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. _C. difficile_ produces toxins A and B, which contribute to the development of CDAD. Hypertoxin producing strains of _C. difficile_ cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against _C. difficile _may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of _C. difficile_, and surgical evaluation should be instituted as clinically indicated. DESCRIPTION Clindamycin hydrochloride is the hydrated hydrochlo ride salt of clindamycin. Clindamycin Přečtěte si celý dokument