Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
Ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (Ciprofloxacin - UNII:5E8K9I0O4U)
KAISER FOUNDATION HOSPITALS
Ciprofloxacin hydrochloride
Ciprofloxacin 500 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
CIPROFLOXACIN HYDROCHLORIDE- CIPROFLOXACIN HYDROCHLORIDE TABLET KAISER FOUNDATION HOSPITALS ---------- CIPROFLOXACIN TABLETS USP RX ONLY WARNING FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, ARE ASSOCIATED WITH AN INCREASED RISK OF TENDINITIS AND TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN OLDER PATIENTS USUALLY OVER 60 YEARS OF AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS, AND IN PATIENTS WITH KIDNEY, HEART OR LUNG TRANSPLANTS (SEE WARNINGS). FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN, MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS (SEE WARNINGS). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Tablets USP and other antibacterial drugs, Ciprofloxacin Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ciprofloxacin hydrochloride USP is a synthetic broad-spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3- quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance that has the following chemical structure: C H FN O •HCl•H O M.W. 385.8 Each Ciprofloxacin Tablet USP, for oral administration, is available in 500 mg strength. In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide and triacetin. CLINICAL PHARMACOLOGY ABS ORPTION Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first 17 18 3 3 2 pass metabolism. Ciprofloxaci Læs hele dokumentet