pharmacopeia

Lincomycin

LincosamidesUnknown Cellular or Molecular InteractionUS-FDASourced from openFDA
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Boxed warning

Clostridioides 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. 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. diffficile 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.

Mechanism of action

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Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

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  • Lincomycin injection is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Contraindications

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  • Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.contraindicated

Dosage & administration

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If significant diarrhea occurs during therapy, lincomycin should be discontinued. (see BOXED WARNING ) INTRAMUSCULAR - Adults: Serious infections —600 mg (2 mL) intramuscularly every 24 hours. More severe infections —600 mg (2 mL) intramuscularly every 12 hours or more often. Pediatric patients over 1 month of age: Serious infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections — one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often. INTRAVENOUS - Adults: The intravenous dose will be determined by the severity of the infection. For serious infections doses of 600 mg of lincomycin (2 mL of lincomycin) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. 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. 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.

Warnings & precautions

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See BOXED WARNING . Clostridioides difficile associated diarrhea Clostridioides 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. difficile . 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. 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 therapy.

Adverse reactions

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The following adverse reactions have been reported with the use of lincomycin. Gastrointestinal disorders Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort†, anal pruritus Skin and subcutaneous tissue disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see WARNINGS ), rash, urticaria, pruritus Infections and infestations Vaginal infection, pseudomembranous colitis, Clostridioides difficile colitis (see WARNINGS ) Blood and lymphatic system disorders Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura Immune system disorders Anaphylactic reaction (see WARNINGS ), angioedema, serum sickness Hepatobiliary disorders Jaundice, liver function test abnormal, transaminases increased Renal and urinary disorders Renal impairment, oliguria, proteinuria, azotemia Cardiac 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. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc.

Use in specific populations

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Pregnancy There are no adequate and well-controlled studies in pregnant women. Lincomycin Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta. See WARNINGS . Lincomycin 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 lincomycin 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.

Overdosage

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Serum concentrations of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

Approval history

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  • Dec 29, 1964NDANDA050317Pfizer
  • Jun 4, 2015ANDAANDA201746Xgen Pharms
  • Mar 12, 2021ANDAANDA212770Arthur Grp
  • Nov 8, 2021ANDAANDA215082Micro Labs
  • Sep 26, 2022ANDAANDA215657Gland
  • Dec 21, 2022ANDAANDA216662Slate Run Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
289 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Hypersensitivity6723%
  2. 2Drug Ineffective3612%
  3. 3Diarrhoea238.0%
  4. 4Dyspnoea165.5%
  5. 5Rash155.2%
  6. 6Pyrexia144.8%
  7. 7Cellulitis124.2%
  8. 8Condition Aggravated113.8%
  9. 9Off Label Use113.8%
  10. 10Tachycardia113.8%
  11. 11Nausea103.5%
  12. 12Stevens-johnson Syndrome103.5%
  13. 13Acute Kidney Injury93.1%
  14. 14Asthenia93.1%
  15. 15Dizziness93.1%

Literature

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Recent PubMed references pinned to Lincomycin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 157 ClinicalTrials.gov registrations naming Lincomycin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lincomycin work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Lincomycin used for?
According to FDA labeling, Lincomycin carries indications including: Lincomycin injection is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lincomycin?
Lincomycin is classified as Lincosamides, Unknown Cellular or Molecular Interaction.
What are the brand names for Lincomycin?
Lincomycin is marketed under brand names including Lincobac, Lincocin, Lincomed.
What are the contraindications for Lincomycin?
Lincomycin labeling lists contraindications including: Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.. Always consult the full prescribing information and a clinician.
Note. Data for lincomycin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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