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Lincomycin Hydrochloride: Cautions

GI Effects

Adverse GI effects frequently occur with oral, IM, or IV lincomycin and may be severe enough to necessitate discontinuance of the drug. Adverse GI effects of lincomycin include nausea, vomiting, diarrhea, abdominal pain, tenesmus, glossitis, stomatitis, and pruritus ani. Nonspecific colitis and diarrhea, as well as potentially fatal Clostridium difficile-associated diarrhea and colitis (also known as antibiotic-associated pseudomembranous colitis), also have occurred in patients receiving lincomycin.

Lincomycin-induced colitis usually is characterized by severe diarrhea and abdominal cramps and may be associated with the passage of blood or mucus; endoscopic examination is necessary to reveal the presence of pseudomembranes. Data from animal and clinical studies suggest that C. difficile-associated diarrhea and colitis may be caused by toxin-producing clostridia resistant to the antibiotic being administered.

Lincomycin Hydrochloride

The role of these bacteria in antibiotic-associated diarrhea in the absence of colitis is unclear. If colitis occurs, symptoms usually develop 2-9 days following initiation of lincomycin therapy, but may not occur until several weeks after the drug has been discontinued. Mild cases of colitis may respond to discontinuance of the drug alone, but diagnosis and management of moderate to severe cases should include sigmoidoscopy (or other appropriate endoscopic examination), appropriate bacteriologic studies, and treatment with fluid, electrolyte, and protein supplementation as indicated. Isolation of the patient may also be advisable.

Other causes of colitis also should be considered. If colitis is moderate to severe or is not relieved by discontinuance of lincomycin, appropriate anti-infective therapy (e.g., oral metronidazole or vancomycin) should be administered.

Sensitivity and Dermatologic Reactions

Hypersensitivity reactions, including angioedema, serum sickness, and anaphylactic or anaphylactoid reactions, have occurred in patients receiving lincomycin. Rash, urticaria, pruritus, vaginitis, and, rarely, exfoliative and vesiculobullous dermatitis, have also occurred during lincomycin therapy. Rarely, erythema multiforme, sometimes resembling Stevens-Johnson syndrome, has been reported with the drug.

Local Effects

Thrombophlebitis, erythema, and pain and swelling have occurred rarely with IV administration of the drug. The manufacturer states that IV administration of lincomycin in 250-500 mL of 5% dextrose injection or 0.9% sodium chloride injection generally does not produce local irritation or phlebitis. IM administration of lincomycin usually is well tolerated, but pain, induration, sterile abscess, and reversible increases in serum creatine kinase (CK, creatine phosphokinase, CPK) concentrations have been reported. Local reactions can be minimized by giving deep IM injections or avoiding the prolonged use of indwelling IV catheters.

Other Adverse Effects

Rapid IV administration of lincomycin has caused hypotension, syncope, and rarely cardiac arrest. Severe cardiopulmonary reactions have occurred when lincomycin was administered in dosages exceeding the recommended concentration and rate of administration. Other reported adverse effects of lincomycin include transient increases in serum bilirubin, alkaline phosphatase, and AST (SGOT) concentrations; jaundice; transient leukopenia; neutropenia; eosinophilia; thrombocytopenia; and agranulocytosis. Thrombocytopenic purpura and rarely aplastic anemia and pancytopenia have also occurred.

The relationship of liver function and hematologic abnormalities to lincomycin is not known. Headache, myalgia, tinnitus, dizziness, and vertigo have been reported occasionally. Although renal damage has not been directly attributed to lincomycin, renal dysfunction manifested as azotemia, oliguria, and/or proteinuria has been observed rarely in patients receiving the drug.

Precautions and Contraindications

If clinically important or persistent diarrhea occurs during lincomycin therapy, the drug should be discontinued or, if necessary, continued only with close observation of the patient. Appropriate therapy should be instituted if necessary.In addition to C. difficile-associated diarrhea and colitis, other causes of colitis should be considered in these patients. During prolonged lincomycin therapy, liver function tests and blood cell counts should be performed periodically.

The use of lincomycin may cause overgrowth of nonsusceptible organisms, particularly fungi. If superinfection occurs, appropriate measures should be taken. Patients receiving the drug who have a preexisting monilial infection should receive concomitant antifungal treatment. If a hypersensitivity reaction occurs during lincomycin therapy, the drug should be discontinued and appropriate therapy (e.g., antihistamines, epinephrine, oxygen, corticosteroids) instituted as necessary.

Lincomycin should be used with caution in patients with a history of GI disease, particularly colitis. Lincomycin also should be used with caution in patients with severe renal and/or hepatic impairment. Lincomycin should be used with caution in individuals with a history of asthma or allergies and is contraindicated in patients who are hypersensitive to either lincomycin or clindamycin.

Pediatric Precautions

Safety and efficacy of lincomycin hydrochloride in infants younger than 1 month of age have not been established. Each 1 mL of lincomycin hydrochloride injection contains 9.45 mg of benzyl alcohol as a preservative. Although a causal relationship has not been established, administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates. Toxicity appears to have resulted from administration of large amounts (i.e., 100-400 mg/kg daily) of benzyl alcohol in these neonates.

Although use of drugs preserved with benzyl alcohol should be avoided in neonates whenever possible, the American Academy of Pediatrics states that the presence of small amounts of the preservative in a commercially available injection should not proscribe its use when indicated in neonates.

Geriatric Precautions

Clinical experience indicates that a subgroup of geriatric patients with associated severe illness may tolerate diarrhea less well than younger individuals. Therefore, geriatric patients receiving lincomycin should be carefully monitored for the development of diarrhea (e.g., changes in bowel frequency).

Mutagenicity and Carcinogenicity

Lincomycin was not mutagenic in the Ames Salmonella reversion assay or V79 Chinese hamster lung cells at the HGPRT locus. In addition, the drug 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 rat and mouse micronucleus assays and 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. Studies in animals have not been performed to date to evaluate the carcinogenic potential of clindamycin.

Pregnancy, Fertitlity and Lactation

Animal reproduction studies have not been performed with lincomycin to evaluate the teratogenic potential of the drug, and there are no adequate and well-controlled studies using the drug in pregnant women. Lincomycin should be used during pregnancy only when clearly needed. Reproduction studies in rats using oral lincomycin dosages up to 1000 mg/kg (1. times the maximum daily human dosage based on mg/m2 have not revealed adverse effects on survival of offspring from birth to weaning. In addition, there was no evidence of impaired fertility when the drug was used in male or female rats in oral dosages of 300 mg/kg (0.36 times the maximum human dosage based on mg/m2.

Lincomycin is distributed into milk; concentrations of 0.5-2.4 mcg/mL have been reported in human milk. Because of the potential for serious adverse reactions from lincomycin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

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