Lincomycin Prescribing Information
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
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. Because of the risk of CDAD, as described in the
Indicated surgical procedures should be performed in conjunction with antibacterial therapy.
Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated.
Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin and other antibacterial drugs, lincomycin should be used only 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.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
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. Because of the risk of CDAD, as described in the
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
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
Indicated surgical procedures should be performed in conjunction with antibacterial therapy.
Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated.
Lincomycin is not indicated in the treatment of minor bacterial infections or viral infections.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin and other antibacterial drugs, lincomycin should be used only 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.
If significant diarrhea occurs during therapy, lincomycin should be discontinued. (see
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
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
Physically compatible for 24 hours at room temperature unless otherwise indicated.
5% Dextrose Injection
10% Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride Injection
10% Dextrose and 0.9% Sodium Chloride Injection
Ringer’s Injection
1/6 M Sodium Lactate Injection
Travert 10%-Electrolyte No. 1
Dextran in Saline 6% w/v
B-Complex
B-Complex with Ascorbic Acid
Penicillin G Sodium (Satisfactory for 4 hours)
Cephalothin
Tetracycline HCl
Cephaloridine
Colistimethate (Satisfactory for 4 hours)
Ampicillin
Methicillin
Chloramphenicol
Polymyxin B Sulfate
Novobiocin
Kanamycin
IT SHOULD BE EMPHASIZED THAT THE COMPATIBLE AND INCOMPATIBLE DETERMINATIONS ARE PHYSICAL OBSERVATIONS ONLY, NOT CHEMICAL DETERMINATIONS. ADEQUATE CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF THESE COMBINATIONS HAS NOT BEEN PERFORMED.
Rx only
Manufactured by:
Bangalore-560099, INDIA.
Distributed by:
Freehold, NJ 07728 (USA)
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.
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When lincomycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Lincomycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Lincomycin should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.
The use of lincomycin may result in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing
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
Lincomycin MUST be diluted prior to intravenous infusion. For intravenous infusion, infuse over at least 60 minutes as directed in the
Prescribing lincomycin 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.
When therapy with lincomycin 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
Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When lincomycin is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Lincomycin should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Lincomycin should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.
The use of lincomycin may result in overgrowth of nonsusceptible organisms, particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing
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
Lincomycin MUST be diluted prior to intravenous infusion. For intravenous infusion, infuse over at least 60 minutes as directed in the
Prescribing lincomycin 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
The following adverse reactions have been reported with the use of lincomycin.
Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort†, anal pruritus
Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see
See BOXED WARNING.
Clostridioides difficile
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
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. If an anaphylactic reaction or severe skin reaction occurs, lincomycin should be discontinued and appropriate therapy should be initiated. (see
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.
Although lincomycin appears to diffuse into cerebrospinal fluid, concentrations of lincomycin in the CSF may be inadequate for the treatment of meningitis.
Vaginal infection, pseudomembranous colitis,
See BOXED WARNING.
Clostridioides difficile
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
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. If an anaphylactic reaction or severe skin reaction occurs, lincomycin should be discontinued and appropriate therapy should be initiated. (see
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.
Although lincomycin appears to diffuse into cerebrospinal fluid, concentrations of lincomycin in the CSF may be inadequate for the treatment of meningitis.
Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura
Anaphylactic reaction (see
See BOXED WARNING.
Clostridioides difficile
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against
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. If an anaphylactic reaction or severe skin reaction occurs, lincomycin should be discontinued and appropriate therapy should be initiated. (see
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.
Although lincomycin appears to diffuse into cerebrospinal fluid, concentrations of lincomycin in the CSF may be inadequate for the treatment of meningitis.
Jaundice, liver function test abnormal, transaminases increased
Renal impairment, oliguria, proteinuria, azotemia
Cardio-respiratory arrest (see
If significant diarrhea occurs during therapy, lincomycin should be discontinued. (see
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.
When therapy with lincomycin 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
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Hypotension (see
If significant diarrhea occurs during therapy, lincomycin should be discontinued. (see
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.
When therapy with lincomycin 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
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Vertigo, tinnitus
Headache, dizziness, somnolence
Injection site abscess sterile‡, injection site induration‡, injection site pain‡, injection site irritation‡
†Event has been reported with intravenous injection.
‡Reported with intramuscular injection.
Lincomycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents; therefore, it should be used with caution in patients receiving such agents.