देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)
Zoetis Inc.
ORAL
PRESCRIPTION
LINCOCIN products are indicated in infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci. The drug has proven effective in eradicating causative organisms in most of the common upper respiratory tract infections, in septicemia, and in infections of the skin and adjoining tissues. Systemic therapy with LINCOCIN has been shown to be of benefit in many animals with pustular dermatitis. As with all antibiotics, in vitro sensitivity studies should be performed before LINCOCIN is utilized as sole antibiotic therapy. LINCOCIN has been demonstrated to be effective in the treatment of staphylococcal infections resistant to other antibiotics and sensitive to lincomycin. The drug may be administered in combination therapy with other antimicrobial agents when indicated. No serious hypersensitivity reactions have been reported and many animals have received LINCOCIN repeatedly without developing evidence of hypersensitivity. LINCOCIN has demonstrated e
LINCOCIN products for veterinary use are available in the following dosage forms and strengths: AQUADROPS® Each mL containing lincomycin hydrochloride equivalent to lincomycin, 50 mg; preserved with methylparaben 0.075%, propylparaben 0.025%, and sorbic acid 0.1%. Supplied in 20 mL bottles with graduated dropper. NADA #40-587, Approved by FDA. Sterile Solution Each mL containing lincomycin hydrochloride equivalent to lincomycin, 100 mg; also Benzyl Alcohol, 9.45 mg added as preservative. Supplied in 20 mL vials. NADA #34-025, Approved by FDA.
New Animal Drug Application
LINCOCIN AQUADROPS- LINCOMYCIN HYDROCHLORIDE LIQUID ZOETIS INC. ---------- LINCOCIN® LINCOMYCIN HYDROCHLORIDE LIQUID AND LINCOMYCIN INJECTION, USP FOR USE IN ANIMALS ONLY FOR INTRAMUSCULAR, INTRAVENOUS, AND ORAL USE IN DOGS AND CATS. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION LINCOCIN products contain lincomycin hydrochloride, an antibiotic produced by _Streptomyces_ _lincolnensis var. lincolnensis_, which is chemically distinct from all other clinically available antibiotics and is isolated as a white crystalline solid. It is stable in the dry state and in aqueous solution for at least 24 months. Lincomycin hydrochloride is readily soluble in water at room temperature in concentrations up to 500 mg/mL. Physical stability of aqueous solutions can be maintained at drug concentrations up to 345 mg/mL at temperatures as low as 4° C. The solubility in 95 percent ethanol is 80 mg/mL. LINCOCIN products have been shown to be effective against most of the common gram-positive pathogens. Depending on the sensitivity of the organism and concentration of the antibiotic, it may be either bactericidal or bacteriostatic. It has not shown cross resistance with other available antibiotics. Microorganisms have not developed resistance to LINCOCIN rapidly when tested by _in vitro _or _in vivo_ methods. CLINICAL PHARMACOLOGY CLINICAL ABSORPTION AND EXCRETION Administered intramuscularly, LINCOCIN Sterile Solution is very rapidly absorbed. In studies with dogs, peak serum levels were reached in from ten minutes to two hours with detectable levels for 16 to 24 hours. The concentration of LINCOCIN in the blood serum varies with the dose administered and with the individual animal. Levels are maintained above the _in vitro _minimum inhibitory concentration for most gram-positive organisms for six to eight hours following a therapeutic dose. Intravenous administration also provides very rapid absorption, but should be administered with normal saline or 5% glucose as पूरा दस्तावेज़ पढ़ें