CIPROFLOXACIN- ciprofloxacin tablet, film coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Lake Erie Medical DBA Quality Care Products LLC

INN (Tarptautinis Pavadinimas):

Ciprofloxacin hydrochloride

Sudėtis:

CIPROFLOXACIN 250 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates 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 koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible 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 parai

Produkto santrauka:

Ciprofloxacin Tablets USP 100 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "125" on other side and supplied in a cystitis pack containing 6 tablets for use only in female patients with acute uncomplicated cystitis. Ciprofloxacin Tablets USP 250 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "126" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. NDC: 35356-928-06  Bottles of 6 NDC: 35356-928-10  Bottles of 10 NDC: 35356-928-14  Bottles of 14 NDC: 35356-928-20  Bottles of 20 Ciprofloxacin Tablets USP 500 mg are white, oval shaped film-coated tablets debossed with "R" on one side and "127" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. Ciprofloxacin Tablets USP 750 mg are white, modified capsule shaped film-coated tablets debossed with "R" on one side and "128" on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 × 10. Store below 86°F (30°C).

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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CIPROFLOXACIN TABLETS, USP
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).
SPL UNCLASSIFIED
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin
tablets and other antibacterial drugs, ciprofloxacin tablets should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Ciprofloxacin hydrochloride tablets are synthetic broad spectrum
antimicrobial agents 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 tablets are film-coated and white in color. Each tablet,
for oral administration, contains
ciprofloxacin hydrochloride equivalent to 100 mg, 250 mg, 500 mg or
750 mg ciprofloxacin. In
addition, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol 400, sodium starch
glycolate, corn starch and titanium dioxide.
CLINICAL PHARMACOLOGY
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral administration.