CIPROFLOXACIN HYDROCHLORIDE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Blenheim Pharmacal, Inc.

INN (International ime):

Ciprofloxacin hydrochloride

Sastav:

Ciprofloxacin hydrochloride 500 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 p

Proizvod sažetak:

Ciprofloxacin Tablets USP are available as white to off-white, oval-shaped, unscored, film-coated tablets, debossed and “5311” on one side and "250" on the other side containing ciprofloxacin hydrochloride equivalent to 250 mg ciprofloxacin, packaged in bottles of 100 tablets and unit-dose boxes of 100 tablets. Ciprofloxacin Tablets USP are available as white to off-white, oval-shaped, unscored, film-coated tablets, debossed and “5312” on one side and "500" on the other side containing ciprofloxacin hydrochloride equivalent to 500 mg ciprofloxacin, packaged in bottles of 20, 100 and 500 tablets and unit-dose boxes of 100 tablets. Ciprofloxacin Tablets USP are available as white to off-white, oval-shaped, unscored, film-coated tablets, debossed and “5313” on one side and "750" on the other side containing ciprofloxacin hydrochloride equivalent to 750 mg ciprofloxacin, packaged in bottles of 100 tablets and unit-dose boxes of 100 tablets. PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CIPROFLOXACIN HYDROCHLORIDE - CIPROFLOXACIN HYDROCHLORIDE TABLET
BLENHEIM PHARMACAL, INC.
----------
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).
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 250 mg, 500 mg or 750 mg
strengths. 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
pass metabolism. Ciprofloxacin maximum serum concentrations and area
under the curve are shown in
the chart for the 250 mg to 1000 mg dose range.
DOSE (MG)
MAXIMUM SERUM
CONCENTRATION
AREA UNDER CURVE
(AUC) (MCG-
17
18
3