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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.diffficile.
C.diffficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.diffficile 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.diffficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C.diffficile, and surgical evaluation should be instituted as clinically indicated.
Serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of LINCOCIN. If an allergic reaction to LINCOCIN occurs, discontinue the drug. (See ADVERSE REACTIONS)
Benzyl Alcohol Toxicity In Pediatric Patients (Gasping Syndrome”)
This product 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 hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity.
Use in Meningitis
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 Section.)
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.
During prolonged therapy with LINCOCIN, periodic liver and kidney function tests and blood counts should be performed.
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 Category C
LINCOCIN Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS.
There are no studies on the teratogenic potential of lincomycin in animals or adequate and well-controlled studies of pregnant women.
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.
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.
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 Section.)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/31/2014
Additional Lincocin Information
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