Drug Facts
Composition & Profile
Identifiers & Packaging
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; Sample Package Label Label1.jpg
- 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
- Sample Package Label Label1.jpg
Overview
Lincomycin Injection is a sterile solution which contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance 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 C18H34N2O6S.HCl.H2O 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. Image1.jpg
Dosage & Administration
DOSAGE AND ADMINISRATION If significant diarrhea occurs during therapy, this antibacterial should be discontinued. (See WARNING box.) 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. 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 this drug has been given at greater than the recommended concentration and rate. SUBCONJUNCTIVAL INJECTION- 0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibacterial (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens. Patients with diminished renal function: When therapy with Lincomycin is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys. Image2.jpg
Warnings & Precautions
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.
Boxed Warning
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.
Contraindications
This drug 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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.