Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)
Henry Schein, Inc.
INTRAMUSCULAR
PRESCRIPTION DRUG
This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
Lincomycin Injection, USP is available in the following strength and package sizes: 300 mg/mL 2 mL Vials NDC 39822-0350-1 Packaged as 10 vials per carton NDC 39822-0350-2 10 mL Vials NDC 39822-0353-5 Packaged as 10 vials per carton NDC 39822-0353-6 Each mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]
Abbreviated New Drug Application
LINCOMYCIN- LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION HENRY SCHEIN, INC. ---------- LINCOMYCIN SPL UNCLASSIFIED SECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. BOXED WARNINIG WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin 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 lincomycin 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. C.diffficile 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 antibacterial 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 antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. DESCRIPTION Lincomycin Injection is a sterile solution which contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth Perskaitykite visą dokumentą