Lincomycin

Preview FDA label, Pharmacia & Upjohn Company LLC, intramuscular, effective 2025-03-10. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using. Not yet reviewed by a ClinDose pharmacist.

Boxed warning

Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LINCOCIN 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.

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.

Dosing in kidney impairment

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 LINCOCIN 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 ).

Preparation and administration

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Basis

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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. [See table below.] 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 LINCOCIN has been given at greater than the recommended concentration and rate (see PRECAUTIONS ).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DoseVol. DiluentTime
600 mg100 mL1 hr
1 gram100 mL1 hr
2 grams200 mL2 hr
3 grams300 mL3 hr
4 grams400 mL4 hr

Drug interactions

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Label text (1 paragraph)

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.

Contraindications

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

Pregnancy and lactation

Pregnancy

Pregnancy There are no adequate and well-controlled studies in pregnant women. LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS . LINCOCIN should be used during pregnancy only if clearly needed. Teratogenic Effects In a study with 60 pregnant women, cord serum concentrations were approximately 25% of the maternal serum concentrations, indicating that lincomycin crosses the placenta, and no substantial accumulation occurred in the amniotic fluid. Experience with 345 obstetrical patients receiving LINCOCIN revealed no ill effects related to pregnancy.

There was no evidence of teratogenicity when lincomycin was administered in diet to pregnant Sprague Dawley rats during the period of major organogenesis at doses up to 5000 mg/kg (approximately 6 times the maximum recommended human dose [MRHD], respectively, based on body surface area comparison). Nonteratogenic Effects Reproduction studies performed in rats administered oral lincomycin in diet for 2 weeks prior to mating, throughout pregnancy and lactation, revealed no adverse effects on survival of offspring from birth to weaning at doses up to 1000 mg/kg (1.2 times the MRHD based on body surface area comparison) up to 2 generations.

Lactation

Nursing Mothers Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 mcg/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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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