CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Dr. Reddy's Laboratories Limited

INN (International Adı):

ciprofloxacin hydrochloride

Kompozisyon:

ciprofloxacin 287.5 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Ciprofloxacin extended-release tablets are indicated only for the treatment of urinary tract infections, including acute uncomplicated pyelonephritis, caused by susceptible strains of the designated microorganisms as listed below. Ciprofloxacin extended-release tablets and ciprofloxacin immediate-release tablets are not interchangeable. Please see DOSAGE AND ADMINISTRATION for specific recommendations. Uncomplicated Urinary Tract Infections (Acute Cystitis) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus  2. Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa  2. Acute Uncomplicated Pyelonephritis caused by Escherichia coli. THE SAFETY AND EFFICACY OF CIPROFLOXACIN EXTENDED-RELEASE TABLETS IN TREATING INFECTIONS OTHER THAN URINARY TRACT INFECTIONS HAS NOT BEEN DEMONSTRATED. Appropriate culture and susceptibility tests should be performed before tre

Ürün özeti:

Ciprofloxacin extended-release tablets, 500 mg are white to off-white, film coated, oblong shaped, biconvex tablets, embossed with ‘RDY’ on one side and ‘422’ on other side. They are supplied in bottles of 30's, 100's, 500's and unit-dose package of 100 (10×10). Ciprofloxacin extended-release tablets, 1000 mg are white to off-white, film coated, oblong shaped, biconvex tablets, embossed with ‘RDY’on one side and ‘423’ on other side. They are supplied in bottles of 30's, 100's, 500's and unit-dose packages of 100 (10×10). Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
DR. REDDY'S LABORATORIES LIMITED
----------
CIPROFLOXACIN EXTENDED-RELEASE TABLETS
BOXED WARNING
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
extended-release tablets and other antibacterial drugs, ciprofloxacin
extended-release tablets should be
used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Ciprofloxacin extended-release tablets contains ciprofloxacin, a
synthetic broad-spectrum
antimicrobial agent for oral administration. Ciprofloxacin
extended-release tablets are coated, bilayer
tablets consisting of an immediate-release layer and matrix type
controlled-release layer. The tablets
contain a combination of two types of ciprofloxacin drug substance,
ciprofloxacin hydrochloride, USP
and ciprofloxacin, USP. Ciprofloxacin hydrochloride is
1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-
(1-piperazinyl)-3-quinolinecarboxylic acid hydrochloride. It is
provided as monohydrate. The empirical
formula of the monohydrate is C
H FN O • HCl • H O and its molecular weight is 385.8. The drug
substance is a faintly yellowish to light yellow crystalline
substance. The chemical structure of the
monohydrate is as follows:
Ciprofloxacin, USP is 1-cyclopropyl-6-fluoro-1,
4-dihydro-4-oxo-7-(1-piperazinyl)-3-
quinolinecarboxylic acid. As the anhydrous form, its empirical formula
is C
H FN O and its
molecular weight is