CILOSTAZOL tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

CILOSTAZOL (UNII: N7Z035406B) (CILOSTAZOL - UNII:N7Z035406B)

Tillgänglig från:

West-Ward Pharmaceuticals Corp.

INN (International namn):

CILOSTAZOL

Sammansättning:

CILOSTAZOL 50 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is contraindicated in patients with: Hypersensitivity to cilostazol or any components of cilostazol (e.g., anaphylaxis, angioedema). Teratogenic Effects: Pregnancy Category C . Cilostazol has been shown to be teratogenic in rats at doses that are greater than 5-times the human MRHD on a body surface area basis. There are no adequate and well-controlled studies in pregnant women. In a rat developmental toxicity study, oral administration of 1000 mg cilostazol/kg/day was associated with decreased fetal weights, and increased incidences of cardiovascular, renal, and skeletal anomalies (ventricular septal, aortic arch and subclavian artery abnormalities, renal pelvic dilation, 14th rib, and retarded ossification). At this dose, systemic exposure to unbound cilostazol in nonpregnant rats was about 5 times the exposure in humans given the MRHD. Increased inciden

Produktsammanfattning:

Cilostazol Tablets USP The 50 mg tablet is supplied as a round white, flat faced beveled edge tablet, debossed with product identification “54 521” on one side and plain on the other side. NDC 0054-0028-21: Bottle of 60 Tablets The 100 mg tablet is supplied as a round white, standard biconvex tablet, debossed with product identification “54 757” on one side and plain on the other side. NDC 0054-0044-21: Bottle of 60 Tablets NDC 0054-0044-29: Bottle of 500 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CILOSTAZOL- CILOSTAZOL TABLET
WEST-WARD PHARMACEUTICALS CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CILOSTAZOL TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CILOSTAZOL TABLETS.
CILOSTAZOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
WARNING: CONTRAINDICATED IN HEART FAILURE PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CILOSTAZOL TABLETS ARE CONTRAINDICATED IN PATIENTS WITH HEART FAILURE
OF ANY SEVERITY.
CILOSTAZOL AND SEVERAL OF ITS METABOLITES ARE INHIBITORS OF
PHOSPHODIESTERASE III. SEVERAL
DRUGS WITH THE PHARMACOLOGIC EFFECT HAVE CAUSED DECREASED SURVIVAL
COMPARED TO
PLACEBO PATIENTS WITH CLASS III-IV HEART FAILURE. (4)
INDICATIONS AND USAGE
Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III
inhibitor) indicated for the reduction of
symptoms of intermittent claudication, as demonstrated by an increased
walking distance (1)
DOSAGE AND ADMINISTRATION
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•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
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ADVERSE REACTIONS
Most common adverse reactions greater than or equal to 2% and at least
twice that for placebo in
patients on 100 mg twice daily are headache, diarrhea, abnormal
stools, and palpitation (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICALS CORP. AT 1-
800-962-8364 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND PATIENT COUNSELING
INFORMATION.
REVISED: 8/2022
The recommended dosage of cilostazol is 100 mg twice daily taken at
least half an hour before or two
hours after breakfast and dinner (2.1)
Reduce the dose to 50 mg twice daily when co-administered with CYP3A4
inhibitors such as
ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19
inhibitors such as ticlopidine,
fluconazole, and omeprazole (2.2)
Tablets: 50 mg and 100 mg (3)
Heart failure of any severity (4)
Hypersensitivity to cilostazol or a