国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)
H.J. Harkins Company, Inc.
ciprofloxacin hydrochloride
ciprofloxacin 250 mg
ORAL
PRESCRIPTION DRUG
Ciprofloxacin tablets, USP are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis. Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus. Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis. Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-sus
Ciprofloxacin tablets, USP are available as round, white to off-white film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with “CR" over "250” on one side and “>” on the other side. Ciprofloxacin tablets, USP are also available as capsule shaped, white to off-white film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with “CR500” on one side and “>” on the reverse side. The 750 mg tablet is coded with “CR750” on one side and “>” on the reverse side. Ciprofloxacin tablets, USP 250 mg, 500 mg, and 750 mg are available in the following pack types. Store at 20°- 25°C (68°- 77°F); excursions permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
H.J. Harkins Company, Inc. ---------- MEDICATION GUIDE: CIPROFLOXACIN TABLETS, USP Revised: 11/2011 Document Id: 9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a Set id: 99a81fda-81dc-40b3-b55a-165b6e4ca4ee Version: 2 Effective Time: 20111130 H.J. Harkins Company, Inc. 阅读完整的文件
CIPROFLOXACIN - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED H.J. HARKINS COMPANY, INC. ---------- CIPROFLOXACIN TABLETS, USP WARNING FLUOROQUINOLONES, INCLUDING CIPROFLOXACIN HYDROCHLORIDE, 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 HYDROCHLORIDE, MAY EXACERBATE MUSCLE WEAKNESS IN PERSONS WITH MYASTHENIA GRAVIS. AVOID CIPROFLOXACIN HYDROCHLORIDE IN PATIENTS WITH KNOWN HISTORY OF MYASTHENIA GRAVIS (SEE WARNINGS). To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin hydrochloride tablets and other antibacterial drugs, ciprofloxacin hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Ciprofloxacin tablets, 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 with a molecular weight of 385.8. Its empirical formula is C H FN O •HCl•H O and its chemical structure is as follows: Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C H FN O and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows: Ciprofloxacin film-coated tablets are available in 100 mg, 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to off-white. The inactive ingredients are cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stea 阅读完整的文件