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.

ued. 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.

en. the serum half-life of lincomycin may be prolonged in patients with severe renal impairment compared to patients with normal renal function. in patients with hepatic impairment, serum half-life may be twofold longer than in patients with normal hepatic function. patients with severe renal impairment and/or hepatic impairment should be dosed with caution and serum lincomycin concentrations monitored during high-dose therapy. (see dosage and administration ) lincomycin must be diluted prior to intravenous infusion. for intravenous infusion, infuse over at least 60 minutes as directed in the dosage and administration section. do not administer as an intravenous bolus. severe cardiopulmonary reactions have occurred at greater than the recommended concentration and rate. prescribing lincomycin injection 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.

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 lincomycin injection has been given at greater than the recommended concentration and rate (see precautions ). 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.

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 sterile ‡ , injection site induration ‡ , injection site pain ‡ , injection site irritation ‡ † event has been reported with intravenous injection. ‡ reported with intramuscular injection.

n 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.

ion. hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum. tissue distribution studies indicate that bile is an important route of excretion. significant concentrations have been demonstrated in most body tissues. although lincomycin appears to diffuse into cerebrospinal fluid (csf), concentrations of lincomycin in the csf appear inadequate for the treatment of meningitis. microbiology: mechanism of action lincomycin inhibits bacterial protein synthesis by binding to the 23s rna of the 50s subunit of the bacterial ribosome. lincomycin is predominantly bacteriostatic in vitro . resistance cross resistance has been demonstrated between clindamycin and lincomycin. resistance is most often due to methylation of specific nucleotides in the 23s rna of the 50s ribosomal subunit, which can determine cross resistance to macrolides and streptogramins b (mls b phenotype). macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the d-zone test or other appropriate method. antimicrobial activity lincomycin has been shown to be active against most strains of the following bacteria both in vitro and in clinical infections: (see indications and usage ). staphylococcus aureus streptococcus pneumoniae the following in vitro data are available, but their clinical significance is unknown. lincomycin has been shown to be active in vitro against the following microorganisms; however, the safety and efficacy of lincomycin injection in treating clinical infections due to these organisms have not been established in adequate and well controlled trials. gram-positive bacteria: corynebacterium diphtheriae streptococcus pyogenes viridans group streptococci anaerobic bacteria: clostridium tetani clostridium perfringens susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

as two or more months after taking the last dose of the antibacterial. if this occurs, patients should contact their physician as soon as possible.