Rx Item-Lincocin 300Mg/Ml Vial 10Ml By Pfizer Pharma

LINCOCIN- lincomycin hydrochloride injection, solution
Pharmacia and Upjohn Company


To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Clostridium 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. difficile , and surgical evaluation should be instituted as clinically indicated.

DESCRIPTION

LINCOCIN Sterile Solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-?-D-galacto-octopyranoside monohydrochloride monohydrate. The molecular formula of lincomycin hydrochloride is C18 H34 N2 O6 S.HCl.H2 O and the molecular weight is 461.01. Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory. Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone.

CLINICAL PHARMACOLOGY

Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum levels of 11.6 �g/mL at 60 minutes and maintains therapeutic levels for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent).

RX ITEM-Lincocin 300Mg/Ml Vial 10Ml By P
NDC 00009-0555-02 UPC/GTIN No.3-00090-55502-3 Mfg.Part No.1591. Generic Name: LINCOMYCIN HCL Description: LINCOCIN MD 300MG/ML 10ML NDC: 00009-0555-02 UPC: 300090-555023

Lincocin 300Mg/Ml Vial 10Ml By Pfizer Ph
BRAND: LINCOCIN NDC: 00009-0555-02,9055502 UPC: 3-00090-55502-3,300090555023 Pfizer Pharmaceutical

LINCOMYCIN HCL INJECTION
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