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 quinolinone derivative that acts as a Phosphodiesterase III (PDE3) Inhibitor. It is the primary pharmacological treatment for Intermittent Claudication (leg pain while walking) caused by Peripheral Artery Disease (PAD). Unlike standard blood thinners, Cilostazol has a dual mechanism: it inhibits platelet aggregation and acts as a direct arterial vasodilator, improving blood flow to the extremities.

We offer Contract Manufacturing (Third Party) services for this specialized cardiovascular drug. Cilostazol has low water solubility and variable absorption. Our WHO-GMP certified facility in Mumbai utilizes Micronization and Spray-Dried Dispersion technologies to enhance bioavailability, ensuring consistent therapeutic levels. Healthy Inc manages the export logistics, supplying vascular surgery clinics and pharmacy chains across the USA, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Improving flow where it matters most.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bioavailability Enhancement: Cilostazol is a Class II drug (Low Solubility, High Permeability). We use Micronized API (particle size < 10 microns) to vastly increase the surface area, ensuring the drug dissolves adequately in the stomach fluids for absorption.

  • Dissolution Precision: Our formulation is engineered to meet strict USP dissolution criteria, preventing dose dumping while ensuring sufficient drug is released to maintain efficacy throughout the dosing interval.

  • Safety Measures: As a potent vasodilator, manufacturing requires strict weight control. We use automated check-weighers to ensure every tablet falls within tight tolerance limits to prevent accidental overdosing (which can cause tachycardia).

• The Exporter: Healthy Inc

  • Patient Compliance Packs: We offer 60-count bottles or blister packs designed for the standard twice-daily regimen.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products to ensure safety.

5. Why Use Cilostazol?

Walking further, pain-free.

• Mechanism: Cilostazol selectively inhibits the enzyme Phosphodiesterase III (PDE3) in platelets and vascular smooth muscle cells. This inhibition increases levels of cAMP (cyclic adenosine monophosphate).

  • In Platelets: Increased cAMP prevents activation and clumping (Antiplatelet effect).

  • In Arteries: Increased cAMP causes smooth muscle relaxation, leading to dilation of blood vessels (Vasodilator effect), specifically in the legs (femoral beds).

• Key Indications:

  • Intermittent Claudication: Significantly increases the distance a patient can walk before leg pain starts.

  • Stroke Prevention: (Secondary Prevention) Used in some Asian guidelines as an alternative to Aspirin/Clopidogrel for non-cardioembolic stroke.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Cilostazol Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Pletal?

  A: Pletal is the brand name (Otsuka). We manufacture the Generic Equivalent (Cilostazol).

• Q: Can I take it with Grapefruit Juice?

  A: NO. Grapefruit juice inhibits the enzyme (CYP3A4) that breaks down Cilostazol, causing toxic levels of the drug to build up in your body.

• Q: Why does it cause headaches?

  A: Vasodilation. Just as it widens blood vessels in your legs, it can widen vessels in your head, causing throbbing headaches. This usually improves after a few weeks.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dose: 100mg twice daily.

• Administration: Take 30 minutes before or 2 hours after breakfast and dinner. (Taking with high-fat meals increases absorption dangerously).

9. Side Effects and Precautions

• Cardiovascular: Tachycardia (fast heart rate), Palpitations.

• CNS: Headache (very common), Dizziness.

• Gastrointestinal: Diarrhea, abnormal stools.

• Contraindication (Black Box Warning): Congestive Heart Failure. Cilostazol decreases survival in patients with heart failure (Class III-IV). Do not prescribe to these patients.

• Interaction: Dose reduction (to 50mg BID) required if taking Ketoconazole, Erythromycin, or Omeprazole.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.