FDA label 121cb853-ab09-459c-b5ea-ab2c8535a240

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.

WARNINGS See WARNING Box. Clostridium difficile associated diarrhea 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. 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 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. Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of Lincomycin Injection. If an allergic reaction to Lincomycin occurs, discontinue the drug. (See ADVERSE REACTIONS ) Benzyl Alcohol Toxicity in Pediatric Patients ("Gasping Syndrome") Lincomycin Injection Sterile Solution contains benzyl alcohol as a preservative. The preservative benzyl alcohol has been associated with serious adverse events, including the "gasping syndrome", and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the "gasping syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidney's capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Use in Meningitis — Although lincomycin appears to diffuse into cerebrospinal fluid, levels of lincomycin in the CSF may be inadequate for the treatment of meningitis.

ADVERSE REACTIONS The following reactions have been reported with the use of lincomycin and are listed by System Organ Class. Frequencies are defined as: commom (≥1% and<10%) uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%) and not known (cannot be estimated from the available data). Gastrointestinal disorders Common: persistent diarrhea (4.3%), nausea (1.8%), vomiting (1.6%) Rare: stomatitis (0.04%) Not known: glossitis, abdominal discomfort, and pruritus Skin and subcutaneous tissue disorders Uncommon: rash (0.8%), urticaria (0.1%) Rare: pruritus (0.4%) Infections and infestations Uncommon: vaginal infection (0.12%) Not known: pseudomembranous colitis, Clostridium difficile colitis (see WARNINGS ) Blood and lymphatic system disorders Not known: pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura Immune system disorders Not known: anaphylactic reaction (see WARNINGS ) angioedema, serum sickness Hepatobiliary disorders Not known: jaundice, liver function test abnormal, transaminases increased Renal and urinary disorders Not known: renal impairment, oliguria, proteinuria, azotemia ¹No direct relationship of LINCOCIN to renal damage has been established. Cardiac disorders Not known: cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION) Vascular disorders Not known: hypotension (see DOSAGE AND ADMINISTRATION ), thrombophlebitis² ²Event has been reported with intravenous injection. Ear and labyrinth disorders Not known: vertigo, tinnitus Not known: injection site abscess sterile³, injection site induration³, injection site pain³, injection site irritation³ ³Reported with intramuscular injection.