Cilostazol Tablets

Description

Cilostazol Tablets (50mg / 100mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Cilostazol Tablets in India. Cilostazol is a phosphodiesterase III (PDE3) inhibitor with antiplatelet and vasodilatory activity. It is used to improve symptoms and walking distance in patients with intermittent claudication associated with peripheral arterial disease when clinically appropriate. We offer contract manufacturing services at our WHO-GMP compliant facility, while Healthy Inc manages international export logistics.

2. Product Specifications

3. Manufacturing Technology

• Formulation & Dissolution: Cilostazol has low aqueous solubility. API particle-size and formulation parameters are controlled according to the validated manufacturing process to support consistent dissolution and product performance.
• Tablet Uniformity: Blending, compression and in-process controls are used to maintain consistent tablet weight and dosage-unit uniformity.
• Packaging: Blister and bottle configurations can be supplied according to stability, registration and destination-market requirements.
• The Exporter: Healthy Inc. Healthy Inc manages international supply and documentation for registered markets and institutional requirements.

4. Quality Assurance

• Dissolution: Finished tablets are tested against the applicable registered or compendial dissolution specification.
• Assay & Content Uniformity: Potency and dosage-unit uniformity are verified against approved specifications.
• Related Substances: Specified impurities and degradation products are monitored during batch release and stability testing.

5. Why Use Cilostazol?

Cilostazol inhibits PDE3, increasing intracellular cyclic AMP in platelets and vascular smooth muscle. This contributes to inhibition of platelet aggregation and vasodilation.

Key Indications:

• Intermittent Claudication: Used to improve walking distance and symptoms in appropriate patients with peripheral arterial disease.
• Other Vascular Uses: Additional uses vary by jurisdiction and should follow local approved indications and specialist guidance.

6. Export and Regulatory Support

• Dossier Support: CTD and ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to commercial and regulatory requirements.

7. Frequently Asked Questions

Q: Who manufactures Cilostazol Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Cilostazol Tablets in India.

Q: Is Cilostazol available under different brand names?
A: Yes. Cilostazol is marketed under various brands internationally. Generic equivalence and interchangeability depend on the registered product and local regulatory requirements.

Q: Can food affect Cilostazol?
A: Food can increase Cilostazol exposure. Patients should follow the timing instructions in the approved product label, which commonly specifies administration away from meals.

Q: Why can Cilostazol cause headache?
A: Headache is a common adverse effect and may be related in part to its vasodilatory pharmacologic action.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Intermittent Claudication: Dose and duration should follow the approved product label and individual clinical assessment.
• Administration: Cilostazol is commonly directed to be taken at least 30 minutes before or 2 hours after breakfast and the evening meal; follow the specific registered product instructions.
• Drug Interactions: Dose adjustment may be required with medicines that inhibit CYP3A4 or CYP2C19. Prescribers should review all concomitant medicines.

9. Side Effects and Precautions

• Heart Failure – Contraindication: Cilostazol is contraindicated in patients with heart failure of any severity in product labeling carrying the PDE3-inhibitor class warning. The approved local label must be followed.
• Cardiovascular: Palpitations, tachycardia and other cardiovascular effects can occur.
• CNS: Headache and dizziness are commonly reported.
• Gastrointestinal: Diarrhea and abnormal stools can occur.
• Bleeding: Because Cilostazol inhibits platelet aggregation, bleeding risk and concomitant antiplatelet/anticoagulant therapy require clinical assessment.
• Interactions: Strong or moderate CYP3A4/CYP2C19 inhibitors can increase Cilostazol exposure; dose modification may be required according to prescribing information.

10. Storage Instructions

• Store below 25°C in a dry place.
• Protect from excessive moisture and heat.
• Keep the container tightly closed where supplied in bottles.
• Keep out of reach of children.