CILOSTAZOL- cilostazol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

CILOSTAZOL

Composition:

CILOSTAZOL 100 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 is 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 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 se

Product summary:

Cilostazol tablets for oral administration are available as: 100 mg : White to off-white, round, debossed with “ E ” over “223” on one side and plain on the other and supplied as: NDC 68071-2065-3 bottles of 30 Store cilostazol tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CILOSTAZOL- CILOSTAZOL TABLET
NUCARE PHARMACEUTICALS,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 ( 5.1)
Risks of thrombocytopenia or leukopenia progressing to
agranulocytosis--monitor platelets and white blood cell counts
( 5.2)
Avoid use in patients with hemostatic disorders or active pathologic
bleeding ( 5.3)
ADVERSE REACTIONS
Most common adverse reactions greater tha