Lincomycin Injection

Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum levels of 11.6 µg/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent).

A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum levels of 15.9 µg/mL and yields therapeutic levels for 14 hours for most susceptible gram-positive organisms. Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent).

The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. 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. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum.

Tissue level studies indicate that bile is an important route of excretion. Significant levels have been demonstrated in the majority of body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), levels of lincomycin in the CSF appear inadequate for the treatment of meningitis.

Microbiology

Lincomycin has been shown to be active against most strains of the following organisms 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 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

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 (MLSB 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.

There are currently no antimicrobial susceptibility testing (AST) interpretive criteria for Lincomycin

This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

The following reactions have been reported with the use of lincomycin:

Gastrointestinal

Glossitis, stomatitis, nausea, vomiting, antibacterial -associated diarrhea and colitis, and pruritus ani. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).

Hematopoietic

Neutropenia, leukopenia, agranulocytosis and thrombocytopenic purpura have been reported. There have been rare reports of aplastic anemia and pancytopenia in which Lincomycin could not be ruled out as the causative agent.

Hypersensitivity Reactions

Hypersensitivity reactions such as angioneurotic edema, serum sickness and anaphylaxis have been reported. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with Lincomycin (see WARNINGS).

Skin and Mucous Membranes

Skin rashes, urticaria and vaginitis and rare instances of exfoliative and vesiculobullous dermatitis have been reported.

Liver

Although no direct relationship of Lincomycin to liver dysfunction has been established, jaundice and abnormal liver function tests (particularly elevations of serum transaminase) have been observed.

Renal

Although no direct relationship of lincomycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.

Cardiovascular

After too rapid intravenous administration, rare instances of cardiopulmonary arrest and hypotension have been reported. (See DOSAGE AND ADMINISTRATION.)

Special Senses

Tinnitus and vertigo have been reported occasionally.

Local Reactions

Patients have demonstrated excellent local tolerance to intramuscularly administered Lincomycin. Reports of pain following injection have been infrequent. Intravenous administration of Lincomycin in 250 to 500 mL of 5% dextrose injection or 0.9% sodium chloride injection produced no local irritation or phlebitis.

Lincomycin Injection, USP is available in the following strength and package sizes:

 300 mg/mL

2 mL Vials NDC 39822-0350-1 Packaged as 10 vials per carton NDC 39822-0350-2

10 mL Vials NDC 39822-0353-5 Packaged as 10 vials per carton NDC 39822-0353-6

 Each mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. 

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Experience with 345 obstetrical patients receiving this drug revealed no ill effects related to pregnancy. (See PRECAUTIONS, Pregnancy)

Consult your pharmacist.