CIPROFLOXACIN tablet film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Blu Pharmaceuticals, LLC

INN (Internationale Bezeichnung):

CIPROFLOXACIN HYDROCHLORIDE

Zusammensetzung:

CIPROFLOXACIN 500 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CIPROFLOXACIN- CIPROFLOXACIN TABLET, FILM COATED
BLU PHARMACEUTICALS, LLC
----------
CIPROFLOXACIN TABLETS, USP
REV. 09/13
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).
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
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 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 film-coated tablets are available in 500 mg
(ciprofloxacin equivalent) strengths.
Ciprofloxacin Tablets, USP are white to slightly yellowish. The
inactive ingredients are colloidal
silicon dioxide, corn starch, hydrogenated vegetable oil,
hypromellose, magnesium stearate,
microcrystalline cellulose, polyacrylate dispersion (methylacrylate
and ethylacrylate copolymer),
polyethylene glycol, purified water, simethicone emulsion, sodium
starch glycolate, talc, and titanium
dioxide.
CLINICAL PHARMACOLOGY
17
18
3
3
2
ABS ORPTION
Ciprofloxacin given as an oral tablet is rapidly and well absorbed
from the gastrointes