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 for which less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections, such as most upper respiratory tract infections.
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 because CDAD has been reported to occur more than 2 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.
Bacterial infection, serious: Note: Administration frequency may be increased if needed due to severity of infection.
IM: 600 mg every 12 to 24 hours.
IV: 600 mg to 1 g every 8 to 12 hours (maximum dose: 8 g daily).
Ophthalmic: Subconjunctival injection: 75 mg as a single dose (ocular fluid levels with sufficient minimum inhibitory concentrations [MICs] last for at least 5 hours).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.
Severe impairment: Use with caution; decrease dose by 70% to 75%.
End stage renal disease (ESRD) on hemodialysis: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; not removed by hemodialysis.
Peritoneal dialysis: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; not removed by peritoneal dialysis.
There are no dosage adjustments provided in manufacturer’s labeling; use with caution.
Refer to adult dosing.
(For additional information see "Lincomycin: Pediatric drug information")
Bacterial infection, serious:
Infants, Children, and Adolescents:
IM: 10 mg/kg/dose every 12 to 24 hours; usual adult dose: 600 mg/dose. Note: Administration frequency may be increased if needed due to severity of infection.
IV: 10 to 20 mg/kg/day in divided doses every 8 to 12 hours; usual adult dose: 600 to 1,000 mg/dose (maximum daily dose: 8 g/day) (Ref). Note: Doses as high as 100 mg/kg/day in divided doses (maximum reported dose: 2,400 mg/dose) every 6 hours have been reported in a cohort of 265 pediatric patients (ages: 3 weeks to 15 years) with a variety of infections; therapy was administered for 5 to 63 days and was reported to be well tolerated (Ref).
Ophthalmic: Subconjunctival injection: 75 mg as a single dose (ocular fluid concentrations sufficient for most pathogens last for at least 5 hours).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants, Children, and Adolescents:
Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.
Severe impairment: Use with caution; administer 25% to 30% of usual dose.
End-stage renal disease (ESRD) on hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; not removed by hemodialysis.
Peritoneal dialysis: There are no dosage adjustments provided in the manufacturer's labeling; use with caution; not removed by peritoneal dialysis.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Cardiovascular: Hypotension, thrombophlebitis
Dermatologic: Acute generalized exanthematous pustulosis, bullous dermatitis, erythema multiforme, exfoliative dermatitis, pruritus, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
Gastrointestinal: Abdominal distress, abdominal pain, Clostridioides difficile-associated diarrhea, colitis (including Clostridioides difficile colitis or severe colitis) (Kokkini 1983), diarrhea, glossitis, nausea, pruritus ani, stomatitis, vomiting
Genitourinary: Azotemia, oliguria, proteinuria, vaginal infection
Hematologic & oncologic: Agranulocytosis, aplastic anemia, immune thrombocytopenia, leukopenia, neutropenia, pancytopenia, sideroblastic anemia (Kokkini 1983)
Hepatic: Abnormal hepatic function tests, increased serum transaminases, jaundice
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (Walker 1969), serum sickness
Local: Abscess at injection site, induration at injection site, irritation at injection site, pain at injection site
Nervous system: Dizziness, drowsiness, headache, vertigo
Otic: Tinnitus
Renal: Renal insufficiency
Hypersensitivity to lincomycin, clindamycin, or any component of the formulation.
Canadian labeling: Additional contraindications (not in US labeling): Preexisting monilial (candida) infections; use in newborn patients.
Concerns related to adverse effects:
• Colitis: [US Boxed Warning]: C. difficile-associated diarrhea (CDAD) has been reported. May range in severity from mild to severe (and possibly fatal). Lincomycin therapy should be reserved for serious infections for which less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections, such as most upper respiratory tract infections. CDAD has been observed more than 2 months postantibiotic treatment.
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis and severe cutaneous adverse reactions (including Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP], and erythema multiforme), have been reported. Discontinue use and institute appropriate therapy if allergic reaction occurs.
• Superinfection: Prolonged use may result in bacterial or fungal superinfection, particularly yeasts. Concomitant antimonilial infection treatment should be given in patients with preexisting monilial infections.
Disease-related concerns:
• Allergies: Use with caution in patients with significant allergies.
• Asthma: Use with caution in patients with a history of asthma.
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease (particularly colitis).
• Hepatic impairment: Use with caution in patients with hepatic impairment; half-life may be prolonged 2-fold.
• Renal impairment: Use with caution in patients with renal impairment; half-life may be prolonged; dosage adjustment necessary with severe impairment.
Special populations:
• Older adult: Use with caution in the elderly; monitor closely for bowel changes.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Other warnings/precautions:
• Administration: Do not use undiluted as an IV bolus.
• Appropriate use: Generally reserved for use when treatment with other antibiotics is inappropriate. Not appropriate for use in the treatment of meningitis due to inadequate penetration into the cerebrospinal fluid.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Injection, as hydrochloride:
Lincocin: 300 mg/mL (2 mL, 10 mL) [contains benzyl alcohol]
Generic: 300 mg/mL (2 mL, 10 mL)
Yes
Solution (Lincocin Injection)
300 mg/mL (per mL): $15.31
Solution (Lincomycin HCl Injection)
300 mg/mL (per mL): $9.60 - $11.88
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IV: Must be diluted prior to administration. Administer as an intermittent infusion over at least 1 hour per gram; cardiopulmonary arrest and hypotension have been reported following too rapid IV infusion. Avoid IV bolus administration.
IM: Inject deep IM into large muscle mass.
Ophthalmic, subconjunctival: Administer beneath the conjunctiva.
Parenteral:
IM: Administer undiluted by deep IM injection into large muscle mass.
IV: Must be diluted prior to administration. Administer as an intermittent infusion over ≥1 hour; maximum rate: 1,000 mg/hour; cardiopulmonary arrest and hypotension have been reported following too rapid IV infusion. Avoid IV bolus injection of undiluted drug.
Subconjunctival, ophthalmic injection: Administer beneath the conjunctiva.
Bacterial infection, serious: Treatment of serious infections caused by susceptible strains of streptococci, pneumococci, and staphylococci. Use should be reserved for patients with penicillin allergy or other patients for whom a penicillin is inappropriate.
Lincocin may be confused with Cleocin, Indocin, Minocin
Lincocin [US., Canada, and multiple international markets] may be confused with Lidosen brand name for lidocaine [Italy] and Limoxin brand name for ambroxol [Indonesia]; amoxicillin [Mexico]
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Doxofylline: Lincomycin may increase the serum concentration of Doxofylline. Risk C: Monitor therapy
Erythromycin (Systemic): May diminish the therapeutic effect of Lincomycin. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Kaolin: May decrease the absorption of Lincosamide Antibiotics. Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Mecamylamine: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Neuromuscular-Blocking Agents: Lincosamide Antibiotics may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Pectin: May decrease the absorption of Lincosamide Antibiotics. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Lincomycin crosses the placenta at term and can be detected in cord blood and the amniotic fluid (Medina 1963). Lincomycin injection may also contain benzyl alcohol, which may cross the placenta.
Lincomycin is present in breast milk.
The manufacturer reports concentrations ranging from 0.5 to 2.4 mcg/mL. Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.
Change in bowel frequency or consistency (eg, diarrhea); baseline serum creatinine and liver function tests (LFTs); periodically during prolonged therapy: renal function and LFTs, complete blood cell count (CBC) with differential; serum lincomycin during high-dose therapy in patients with renal and/or hepatic impairment (limited data; no goal therapeutic range reported).
Lincosamide antibiotic isolated from a strain of Streptomyces lincolnensis; lincomycin, like clindamycin, inhibits bacterial protein synthesis by specifically binding on the 50S subunit and affecting the process of peptide chain initiation. Since only one molecule of antibiotic can bind to a single ribosome, the concomitant use of erythromycin and lincomycin is not recommended.
Metabolism: Hepatic
Half-life elimination, serum: ~5 hours; prolonged with renal or hepatic impairment
Time to peak, serum: IM: 1 hour
Excretion: Urine (2% to 30%); bile
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