CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

ciprofloxacin hydrochloride (UNII: 4BA73M5E37) (ciprofloxacin - UNII:5E8K9I0O4U)

Доступно од:

H.J. Harkins Company, Inc.

INN (Међународно име):

ciprofloxacin hydrochloride

Састав:

ciprofloxacin 250 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

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].                 

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

H.J. Harkins Company, Inc.
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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.

Карактеристике производа

CIPROFLOXACIN - CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
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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