Data from FDA - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

INDICATIONS AND USAGE LINCOCIN 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 antibacterial associated pseudomembranous colitis, as described in the WARNING box, before selecting lincomycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Indicated surgical procedures should be performed in conjunction with antibacterial therapy. The drug may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin 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 LINCOCIN and other antibacterial drugs, LINCOCIN 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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Alkaline Phosphatase (ALP) Lab Assessment

Alkaline Phosphatase (ALP) Lab Assessment

Discover an overview of hypophosphatasia and details required to facilitate the timely and accurate detection of low alkaline phosphatase.

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
Special warnings and precautions
PRECAUTIONS General Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When LINCOCIN is indicated in these patients, they should be carefully monitored for change in bowel frequency. LINCOCIN should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. LINCOCIN should be used with caution in patients with a history of asthma or significant allergies. Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy. The use of LINCOCIN may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with LINCOCIN, concomitant antimonilial treatment should be given. The serum half-life of lincomycin may be prolonged in patients with severe impairment of renal function compared to patients with normal renal function. In patients with abnormal hepatic function, serum half-life may be twofold longer than in patients with normal hepatic function. Patients with severe impairment of renal function and/or abnormal hepatic function should be dosed with caution and serum lincomycin levels monitored during high-dose therapy. (see DOSAGE AND ADMINISTRATION ) Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the DOSAGE AND ADMINISTRATION Section. Prescribing LINCOCIN in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including LINCOCIN should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When LINCOCIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by LINCOCIN or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterial which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterial, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible Laboratory Tests During prolonged therapy with LINCOCIN, periodic liver and kidney function tests and blood counts should be performed. 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 in caution in patients receiving such agents. Antagonism between lincomycin and erythromycin in vitro has been demonstrated. Because of possible clinical significance, the two drugs should not be administered concurrently. Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of lincomycin has not been evaluated. Lincomycin was not found to be mutagenic in the Ames Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes. In vivo, lincomycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male Drosophila. However, lincomycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes. Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of lincomycin (0.36 times the highest recommended human dose based on mg/m2). Pregnancy Pregnancy Category C LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS . Teratogenic Effects There are no studies on the teratogenic potential of lincomycin in animals or adequate and well-controlled studies of pregnant women. Nonteratogenic Effects Reproduction studies have been performed in rats using oral doses of lincomycin up to 1000 mg/kg (1.2 times the maximum daily human dose based on mg/m2) and have revealed no adverse effects on survival of offspring from birth to weaning. Nursing Mothers Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 µg/mL. Because of the potential for serious adverse reactions in nursing infants from LINCOCIN, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants. See WARNINGS . Safety and effectiveness in pediatric patients below the age of one month have not been established. (see DOSAGE AND ADMINISTRATION )
Adverse reactions
ADVERSE REACTIONS The following reactions have been reported with the use of lincomycin and are listed by System Organ Class. Gastrointestinal disorders Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfortEvent 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, Clostridium 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 Ear and labyrinth disorders Vertigo, tinnitus Neurologic disorders Headache, dizziness, somnolence General disorders and administration site conditions Injection site abscess sterileReported with intramuscular injection., injection site induration, injection site pain, injection site irritation

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 LINCOCIN) 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 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 LINCOCIN 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.
Pregnancy and lactation
Nursing Mothers Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 µg/mL. Because of the potential for serious adverse reactions in nursing infants from LINCOCIN, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother.

Interactions

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 in caution in patients receiving such agents. Antagonism between lincomycin and erythromycin in vitro has been demonstrated. Because of possible clinical significance, the two drugs should not be administered concurrently.

More information

Category Value
Authorisation number NDA050317
Agency product number M6T05Z2B68
Orphan designation No
Product NDC 0009-0555
Date Last Revised 26-04-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 239212
Storage and handling Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Marketing authorisation holder Pharmacia and Upjohn Company LLC
Warnings 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.