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Lincocin

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Lincocin

Lincocin

INDICATIONS

LINCOCIN (lincomycin hcl) Sterile Solution 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 antibiotic-associated pseudomembranous colitis, as described in the WARNING box, before selecting lincomycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (eg, erythromycin).

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to lincomycin.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

Lincomycin has been demonstrated to be effective in the treatment of staphylococcal infections resistant to other antibiotics and susceptible to lincomycin. Staphylococcal strains resistant to LINCOCIN (lincomycin hcl) have been recovered; culture and susceptibility studies should be done in conjunction with therapy with LINCOCIN (lincomycin hcl) . In the case of macrolides, partial but not complete cross resistance may occur (see Microbiology). The drug 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 LINCOCIN (lincomycin hcl) and other antibacterial drugs, LINCOCIN (lincomycin hcl) 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.

DOSAGE AND ADMINISTRATION

If significant diarrhea occurs during therapy, this antibiotic should be discontinued. (See WARNING box.)

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 LINCOCIN (lincomycin hcl) ) 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. NOTE: Severe cardiopulmonary reactions have occurred when this drug has been given at greater than the recommended concentration and rate.

SUBCONJUNCTIVAL INJECTION-0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid levels of antibiotic (lasting for at least 5 hours) with MICs sufficient for most susceptible pathogens.

Patients with diminished renal function: When therapy with LINCOCIN (lincomycin hcl) is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys.

HOW SUPPLIED

LINCOCIN (lincomycin hcl) Sterile Solution is available in the following strength and package sizes: 300 mg

2 mL Vials - NDC 0009-0555-01
10 mL Vials - NDC 0009-0555-02

Each mL of LINCOCIN Sterile Solution 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].

PHYSICAL COMPATIBILITIES

Physically compatible for 24 hours at room temperature unless otherwise indicated.

Infusion Solutions

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

Vitamins in Infusion Solutions

B-Complex
B-Complex with Ascorbic Acid

ANTIBIOTICS IN INFUSION SOLUTIONS

Penicillin G Sodium (Satisfactory for 4 hours)
Cephalothin
Tetracycline HCl
Cephaloridine
Colistimethate (Satisfactory for 4 hours)
Ampicillin
Methicillin
Chloramphenicol
Polymyxin B Sulfate

Physically Incompatible with:

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.

Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised June 2007. FDA revision date: 2/27/2008

Last reviewed on RxList: 4/7/2008
This monograph has been modified to include the generic and brand name in many instances.

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