Claudinil(Cilostazol)

Therapeutic Group: phosphodiesterase III (PDE III) inhibitor

Presentation

ClaudinilTM Tablet: Each tablet contains Cilostazol USP 100 mg.

Description

Cilostazol is a selective phosphodiesterase III (PDE III) inhibitor and suppresses cAMP degradation with a resultant increase in cAMP in platelets and blood vessels, leading to inhibition

of platelet aggregation and subsequently vasodilation. Cilostazol is absorbed after oral administration and eliminated predominantly by metabolism and subsequent urinary excretion of metabolites.

Indications

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

Dosage & Administration

The recommended dosage of Cilostazol is 100 mg twice daily taken at least half an hour before or
wo hours after breakfast and dinner.
Dose should be reduced 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.

Side Effects

Most common side effects are headache, diarrhea, abnormal stools and palpitation.

Precautions

Cilostazol must be administered with caution in patients with risk of tachycardia, palpitation, hypotension, risks of exacerbations of angina pectoris or myocardial infarction, risks of thrombocytopenia or leukopenia.

Use in Pregnancy & Lactation

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women.
Lactation: Transfer of Cilostazol into milk has been reported in experimental animals. Because of the potential risk to nursing infants from Cilostazol, a decision should be made to discontinue nursing or to discontinue Cilostazol.
Paediatric use: The safety and effectiveness of Cilostazol in paediatric patients have not been established.

Drug Interaction

Coadministration of strong (e.g., Ketoconazole) and moderate (e.g., Erythromycin, Diltiazem and
grapefruit juice) CYP3A4 inhibitors and CYP2C19 inhibitors (e.g., Omeprazole) can increase exposure to Cilostazol. Dose should be reduced to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 & CYP2C19.

Storage

Do not store above 300 C. Keep away from light and out of the reach of children

Commercial Pack

ClaudinilTM Tablet: Each box contains 3 blister packs of 10 tablets.