Lincomycin

INDICATIONS AND USAGE 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 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.

DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, lincomycin injection should be discontinued. (see BOXED WARNING ) INTRAMUSCULAR— Adults: Serious infections —600 mg (2 mL) intramuscularly every 24 hours. More severe infections —600 mg (2 mL) intramuscularly every 12 hours or more often. Pediatric patients over 1 month of age: Serious infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often. INTRAVENOUS— Adults: The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of lincomycin (2 mL of lincomycin injection) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations daily intravenous doses of as much as 8 grams have been given. Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES ) and infused over a period of not less than one hour. Dose Vol. Diluent Time 600 mg 100 mL 1 hr 1 gram 100 mL 1 hr 2 grams 200 mL 2 hr 3 grams 300 mL 3 hr 4 grams 400 mL 4 hr These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin. Pediatric patients over 1 month of age: 10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults. NOTE: Severe cardiopulmonary reactions have occurred when lincomycin injection has been given at greater than the recommended concentration and rate (see PRECAUTIONS ). SUBCONJUNCTIVAL INJECTION— 0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid concentrations of antibacterial (lasting for at least 5 hours) sufficient for most susceptible pathogens. Patients with Renal Impairment When therapy with lincomycin injection is required in individuals with severe renal impairment, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys (see PRECAUTIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

CONTRAINDICATIONS Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

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.

Drug Interactions Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents; therefore, it should be used with caution in patients receiving such agents.

Mechanism of Action Lincomycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the bacterial ribosome. Lincomycin is predominantly bacteriostatic in vitro .

DESCRIPTION Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae ). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C 18 H 34 N 2 O 6 S•HCl•H 2 O and the molecular weight is 461.01. The structural formula is represented below: Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg/mL, and water for injection. Lincomycin Injection is a sterile solution for intramuscular and intravenous use. Lincomycin injection is supplied in 2 mL and 10 mL multiple-dose vials containing the equivalent of 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP). Lincomycin HCl Chemical Structure

OVERDOSAGE Serum concentrations of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

HOW SUPPLIED 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] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 39822-0353-6 10 Pack NDC 0404-9901-10 1 10 mL Vial in a bag (Vial bears NDC 39822-0353-5) 300 mg/mL