CILOSTAZOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CILOSTAZOL

Composition:

CILOSTAZOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. 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 this pharmacologic effect have caused decreased survival compared to placebo in patients with class III-IV heart failure. - Hypersensitivity to cilostazol or any components of cilostazol tablets (e.g., anaphylaxis, angioedema) Teratogenic Effects 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 ar

Product summary:

Cilostazol tablets, USP are available as follows: 50 mg - white to off-white, pillow-shaped tablets, debossed with “TEVA” on one side and “7230” on the other, available in bottles of 60 (NDC 0093-2065-06). 100 mg - white to off-white, round tablets, debossed with “TEVA” on one side and “7231” on the other, available in bottles of 60 (NDC 0093-2064-06) and 5000 (NDC 0093-2064-50). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CILOSTAZOL- CILOSTAZOL TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
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 IS 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
The recommended dosage of cilostazol tablets 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 coadministered with CYP3A4
inhibitors such as
ketoconazole, itraconazole, erythromycin, and diltiazem, or CYP2C19
inhibitors such as ticlopidine,
fluconazole, and omeprazole (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg and 100 mg (3)
CONTRAINDICATIONS
Heart failure of any severity (4)
Hypersensitivity to cilostazol or any components of cilostazol tablets
(4)
WARNINGS AND PRECAUTIONS
Risks of tachycardia, palpitation, tachyarrhythmia or hypotension.
Risks of exacerbations of angina
pectoris or myocardial infarction in patients with a history of
ischemic heart disease (5.2)
Left ventricular outflow tract obstruction has been reported in
patients with sigmoid shaped
interventricular septum (5.1)
Risks of thrombocytopenia or leukopenia progressing to
agranulocytosis-monitor platelets and white
blood cell counts (5.3)
Avoid use in patients with he