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Vasocil

Cilostazol USP

NAME STRENGTH PACK SIZE DOSAGE FORM
Vasocil 100 100 mg 2X10 Tablet
Vasocil 50 50 mg 3X10 Tablet

Description

Vasocil (Cilostazol) is a quinolinone derivative that inhibits cellular phosphodiesterase (more specific for phosphodiesterase III). Vasocil (Cilostazol) and several of its metabolites are phosphodiesterase III inhibitors (PDE III inhibitors), inhibiting phosphodiesterase activity and suppressing cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition of platelet aggregation and vasodilation, respectively.

Vasocil-50: Each tablet contains Cilostazol USP 50 mg. Vasocil-100: Each tablet contains Cilostazol USP 100 mg.

Vasocil (Cilostazol) is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.

The recommended dosage of Vasocil (Cilostazol) is 100 mg b.i.d. taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during co-administration of such inhibitors of CYP3A4 (eg. ketoconazole, itraconazole, erythromycin and diltiazem) and during co-administration of such inhibitors of CYP2C19 as Omeprazole. Patients may respond as early as 2 to 4 weeks after the initiation of therapy, but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.

Vasocil (Cilostazol) is well tolerated with some most common side effects such as headache, vomiting, rash etc. A few less frequent side effects also been reported such as anorexia, face oedema etc.

Vasocil (Cilostazol) should be used with caution in patients with any degree of heart failure. Special caution is advised when Vasocil (Cilostazol) is used in patients with hepatic impairment. Special caution is advised when Vasocil (Cilostazol) is used in patients with severe renal impairment.

Pregnancy: There are no adequate and well controlled studies in pregnant women, so use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: As Vasocil (Cilostazol) is secreted into the milk of experimental animals, there is potential risk for the nursing infants, so a decision should be made to discontinue nursing or to discontinue Vasocil (Cilostazol).

Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of Cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of Cilostazol among patients concurrently treated with diltiazem. There is limited information with respect to the efficacy or safety of the concurrent use of Cilostazol and Clopidogrel.

Information on acute overdosage with Vasocil (Cilostazol) in humans 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 arrhythmia. The patient should be carefully observed and given supportive treatment.

Store at a cool & dry place, protected from light and moisture. Keep out of reach of the children.

Vasocil (Cilostazol) is contraindicated in patients with congestive heart failure of any severity. Vasocil (Cilostazol) is contraindicated in patients with haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding. Vasocil (Cilostazol) tablets are contraindicated in patients with known or suspected hypersensitivity to any of its components.

Vasocil-50: Each box contains 3X10 tablets in Alu-Alu blister strips. Vasocil-100: Each box contains 2X10 tablets in Alu-Alu blister strips.