Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
LINCOMYCIN (UNII: BOD072YW0F) (LINCOMYCIN - UNII:BOD072YW0F)
Slate Run Pharmaceuticals, LLC
INTRAVENOUS
PRESCRIPTION DRUG
Lincomycin Injection sterile solution is 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 CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin Injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin Injection is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin injection and other antibacterial drugs, lincomycin injection should be used only to treat or prevent infection
Lincomycin Injection, USP is available as a sterile, clear, and colorless solution in the following strength and package sizes: NDC Lincomycin Injection, USP Package Size 70436-034-82 600 mg/2 mL (300 mg/mL), 2 mL multiple-dose vial 10 vials per carton 70436-035-80 3,000 mg/10 mL (300 mg/mL), 10 mL multiple-dose vial 1 vial per carton 70436-035-82 3,000 mg/10 mL (300 mg/mL), 10 mL multiple-dose vial 10 vials per carton Each mL of lincomycin hydrochloride contains 300 mg lincomycin (equivalent to 340 mg lincomycin hydrochloride, USP); also benzyl alcohol, 9.45 mg added as a preservative. 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].
Abbreviated New Drug Application
LINCOMYCIN- LINCOMYCIN INJECTION, SOLUTION SLATE RUN PHARMACEUTICALS, LLC ---------- LINCOMYCIN INJECTION, USP Sterile Solution for Intramuscular and Intravenous Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin injection and other antibacterial drugs, lincomycin injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING _Clostridioides difficile_ associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including lincomycin injection 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, USP is a sterile solution containing lincomycin hydrochloride which is the m Citiți documentul complet