Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ORBIFLOXACIN (UNII: 660932TPY6) (ORBIFLOXACIN - UNII:660932TPY6)
Merck Sharp & Dohme Corp.
Orbifloxacin
Orbifloxacin 22.7 mg
ORAL
PRESCRIPTION
INDICATIONS: ORBAX® (orbifloxacin) Tablets are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin. CONTRAINDICATIONS: Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested, the dog being particularly sensitive to this side effect. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase (between 2 and 8 months of age in small and medium-sized breeds, and up to 18 months of age in large and giant breeds). Orbifloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.
HOW SUPPLIED: ORBAX® (orbifloxacin) Tablets are available in the following presentations: STORAGE CONDITIONS: Store between 2° and 30°C (36° and 86°F). Protect from excessive moisture.
New Animal Drug Application
ORBAX- ORBIFLOXACIN TABLET, COATED MERCK SHARP & DOHME CORP. ---------- ORBAX TABLETS (ORBIFLOXACIN) FOR ORAL USE IN DOGS AND CATS ONLY NADA #141-081, APPROVED BY FDA. FEDERAL LAW PROHIBITS THE EXTRA LABEL USE OF THIS DRUG IN FOOD-PRODUCING ANIMALS. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN. DESCRIPTION: Orbifloxacin is a synthetic broad-spectrum antibacterial agent from the class of fluoroquinolone carboxylic acid derivatives. Orbifloxacin is the international nonproprietary name for 1-cyclopropyl-5,6,8-trifluoro-1,4-dihydro-7-(_cis_-3,5-dimethyl- 1- piperazinyl)-4-oxoquinoline-3-carboxylic acid. The chemical formula for orbifloxacin is C H F N O and its molecular weight is 395.38. The compound is slightly soluble in water; however, solubility increases in both acidic and alkaline conditions. The compound has two dissociation constants (pKa's): 5.95 and 9.01. FIGURE 1. CHEMICAL STRUCTURE OF ORBIFLOXACIN. INDICATIONS: ORBAX (orbifloxacin) Tablets are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin. EFFICACY CONFIRMATION: Clinical efficacy was established in skin and soft tissue infections (wounds and abscesses) in the dog and cat, and urinary tract infections (cystitis) in the dog, associated with bacteria susceptible to orbifloxacin. Specific bacterial pathogens isolated in clinical field trials are listed in the MICROBIOLOGY section. DOSAGE AND ADMINISTRATION: For routine out-patient treatment of infection caused by a susceptible organism, in an otherwise healthy dog or cat, the dose of ORBAX (orbifloxacin) Tablets is 2.5 to 7.5 mg/kg of body weight administered once daily. (See DRUG INTERACTIONS and TARGET ANIMAL SAFETY). In the cat, ORBAX (orbifloxacin) Tablets and ORBAX (orbifloxacin) Oral Suspension are not bioequivalent. On a mg/kg basis, ORBAX (orbifloxacin) Oral Suspension provides lower and more variable plasma levels of orbifloxacin than ORBAX (orbifloxacin) Tablets. The determinatio Pročitajte cijeli dokument