CIPROFLOXACIN hydrochloride tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
10-01-2018

Aktiv bestanddel:

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

Tilgængelig fra:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

CIPROFLOXACIN HYDROCHLORIDE

Sammensætning:

CIPROFLOXACIN 250 mg

Recept type:

PRESCRIPTION DRUG

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

                                CIPROFLOXACIN- CIPROFLOXACIN HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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).
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 USP are white to
off-white. The inactive ingredients are
cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone,
magnesium stearate, polyvinyl
alcohol, talc, titanium dioxide, polyethylene glycol and purified
water.
CLINICAL PHARMACOLOGY
Absorption:
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointestinal tract after
oral administ
                                
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