CIPROFLOXACIN HYDROCHLORIDE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (Ciprofloxacin - UNII:5E8K9I0O4U)

Disponível em:

State of Florida DOH Central Pharmacy

DCI (Denominação Comum Internacional):

CIPROFLOXACIN HYDROCHLORIDE

Composição:

CIPROFLOXACIN HYDROCHLORIDE 500 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

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. 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. 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. They are supplied by State of Florida DOH Central Pharmacy as follows: 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 de autorização:

Abbreviated New Drug Application

Características técnicas

CIPROFLOXACIN HYDROCHLORIDE - CIPROFLOXACIN HYDROCHLORIDE TABLET
STATE OF FLORIDA DOH CENTRAL PHARMACY
----------
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
AREA UNDER CURVE
17
18
3
3
2
CONCENTRA