Lincomycin
Lincomycin Injection, USP Sterile Solution for Intramuscular and Intravenous Use
fd2838b7-f8c9-4049-a306-ea620a9c0fe2
HUMAN PRESCRIPTION DRUG LABEL
May 8, 2023
Armas Pharmaceuticals Inc.
DUNS: 098405973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lincomycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (2)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
If significant diarrhea occurs during therapy, lincomycin should be discontinued. (seeBOXED 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 of1 gram of lincomycin diluted in not less than 100 mL of appropriate solution(seePHYSICAL 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 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 withRenal Impairment
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 (seePRECAUTIONS).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.