CILOSTAZOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eon Labs, Inc.

INN (International Name):

CILOSTAZOL

Composition:

CILOSTAZOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cilostazol tablets, USP are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance. Cilostazol is contraindicated in patients with: 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 incidences of ventricular septal defect and retarded ossification were also noted at 150 mg/kg/day (5

Product summary:

Cilostazol tablets, USP for oral administration are available as: 50 mg: White to off-white, round, debossed with “E ” over “123” on one side and plain on the other and supplied as: NDC 0185-0123-60 bottles of 60 NDC 0185-0123-05 bottles of 500 100 mg : White to off-white, round, debossed with “E ” over “223” on one side and plain on the other and supplied as: NDC 0185-0223-60 bottles of 60 NDC 0185-0223-05 bottles of 500 Store cilostazol tablets, USP at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. KEEP TIGHTLY CLOSED KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CILOSTAZOL- CILOSTAZOL TABLET
EON LABS, 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Left Ventricular Outflow Obstruction (5.2)
05/2017
INDICATIONS AND USAGE
Cilostazol tablets, USP 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
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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 Sandoz Inc. at
1-800-525-8747 or FDA at 1-800-FDA-1088 or
www.fda.gov/me dwatch.
DRUG INTERACTIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
The recommended dosage of cilostazol tablets, USP 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)
Tablets: 50 mg and 100 mg (3)
Heart failur