Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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].; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70436-034-80 Lincomycin Injection, USP, 600 mg/2 mL (300 mg/mL) 2 mL Multiple-Dose Vial 10000072_01_v01.9; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70436-035-82 Lincomycin Injection, USP, 3,000 mg/10 mL (300 mg/mL) 10 mL Multiple-Dose Vial, 10 vials per carton 3000mgper10mL carton; Package/Label Principal Display Panel NDC 70436-035-80 Lincomycin Injection, USP, 3,000 mg/10 mL (300 mg/mL) 10 mL Mulitple-Dose Vial, 1 vial per carton vial 3000mgper10mL v01.8
- HOW SUPPLIED 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].
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70436-034-80 Lincomycin Injection, USP, 600 mg/2 mL (300 mg/mL) 2 mL Multiple-Dose Vial 10000072_01_v01.9
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 70436-035-82 Lincomycin Injection, USP, 3,000 mg/10 mL (300 mg/mL) 10 mL Multiple-Dose Vial, 10 vials per carton 3000mgper10mL carton
- Package/Label Principal Display Panel NDC 70436-035-80 Lincomycin Injection, USP, 3,000 mg/10 mL (300 mg/mL) 10 mL Mulitple-Dose Vial, 1 vial per carton vial 3000mgper10mL v01.8
Overview
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, USP 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, USP is a sterile solution for intramuscular and intravenous use. Lincomycin Injection, USP is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg/mL of lincomycin (equivalent to 340 mg/mL of lincomycin hydrochloride, USP). structural formula
Indications & 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 & Administration
If significant diarrhea occurs during therapy, Lincomycin injection should be discontinued. (see BOXED WARNING ) INTRAMUSCULAR – Adults: serious infection s - 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 ) and infused over a period of not less than one hour. Dose Vol. Diluent Time 600 mg100 mL1 hr1 gram100 mL1 hr2 grams200 mL2 hr3 grams300 mL3 hr4 grams400 mL4 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 ). 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.
Warnings & Precautions
WARNINGS See BOXED WARNING. Clostridioides difficile associated diarrhea Clostridioides 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 Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and erythema multiforme (EM) have been reported in patients receiving lincomycin injection therapy. If an anaphylactic reaction or severe skin reaction occurs, lincomycin injection should be discontinued and appropriate therapy should be initiated. (see ADVERSE REACTIONS ) Benzyl Alcohol Toxicity in Pediatric Patients (Gasping Syndrome) Lincomycin Injection 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 kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Inadequate for Use in Meningitis Although lincomycin appears to diffuse into cerebrospinal fluid, concentrations of lincomycin in the CSF may be inadequate for the treatment of meningitis.
Boxed 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.
Contraindications
Lincomycin Injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
Adverse Reactions
The following adverse reactions have been reported with the use of lincomycin. Gastrointestinal disorders Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort Event has been reported with intravenous injection. , anal pruritus Skin and subcutaneous tissue disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see WARNINGS ), rash, urticaria, pruritus Infections and infestations Vaginal infection, pseudomembranous colitis, Clostridioides difficile colitis (see WARNINGS ) Blood and lymphatic system disorders Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura Immune system disorders Anaphylactic reaction (see WARNINGS ), angioedema, serum sickness Hepatobiliary disorders Jaundice, liver function test abnormal, transaminases increased Renal and urinary disorders Renal impairment, oliguria, proteinuria, azotemia Cardiac disorders Cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION ) Vascular disorders Hypotension (see DOSAGE AND ADMINISTRATION ), thrombophlebitis 1 Ear and labyrinth disorders Vertigo, tinnitus Neurologic disorders Headache, dizziness, somnolence General disorders and administration site conditions Injection site abscess sterile 2 , injection site induration 1 Event has been reported with intravenous injection. Reported with intramuscular injection. , injection site pain 2 , injection site irritation 2
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.
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