Pencil 50/Pencil 100

Pencil 50/Pencil 100

cilostazol

Manufacturer:

Cadila Pharma

Distributor:

Kaufmann

Marketer:

Ambica
Full Prescribing Info
Contents
Cilostazol.
Description
Pencil 50: Each uncoated tablet contains: Cilostazol 50 mg.
Pencil 100: Each uncoated tablet contains: Cilostazol 100 mg.
Cilostazol is a quinolinone derivatives that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III).
Indications/Uses
It is used in the management of peripheral vascular disease.
Dosage/Direction for Use
The recommended dosage of Cilostazol is 50 mg orally twice daily taken at least half an hour before or two hours after breakfast or dinner.
Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks maybe needed before a beneficial effect may experienced.
Discontinuation of Therapy: The available data suggest that the dosage of CILOSTAZOL can be reduced or discontinued without rebound (i.e., platelet hyper aggregability).
Overdosage
Information on acute overdosage with Cilostazol in human is limited. The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: severe headache, diarrhea, hypotension, tachycardia, and possibly cardiac arrhythmias.
Contraindications
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 congestive heart failure. CILOSTAZOL is contraindicated in patients with congestive heart failure of any severity.
Special Precautions
CILOSTAZOL is contraindicated in patients with congestive heart failure.
Use with Clopidogrel: There is no information with respect to the efficacy or safety of the concurrent use of Cilostazol and Clopidogrel, a platelet aggregation inhibiting drug indicated for use in patients with peripheral arterial disease. Studies of concomitant use of Cilostazol and Clopidogrel are planned.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy category C: In a rat development toxicity study, oral administration of 1000 mg of 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).
Adverse Reactions
The only adverse event resulting in discontinuation of therapy in >3% of patients treated with Cilostazol 50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in patients treated with CILOSTAZOL 50 mg b.i.d., 100 mg b.i.d. or placebo respectively.
Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo.
Storage
Store at temperatures not exceeding 25°C.
ATC Classification
B01AC23 - cilostazol ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Pencil 50: Tab 50 mg x 100's.
Pencil 100: Tab 100 mg x 100's.
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