Description

Praziquantel Tablets (600mg)

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 Praziquantel Tablets in India. Praziquantel is the World Health Organization’s (WHO) “Drug of Choice” for the treatment of Schistosomiasis (Bilharzia), a parasitic disease caused by blood flukes, and various other tapeworm infections.

We offer Contract Manufacturing (Third Party) services for this essential anthelmintic drug. Praziquantel is notorious for its extremely bitter taste, which can cause gagging or vomiting, especially in children. Our WHO-GMP certified facility in Mumbai utilizes advanced Taste-Masking Film Coating technology to ensure palatability and compliance. Healthy Inc manages the export logistics, supplying National Control Programs, NGOs, and Ministries of Health across Africa, Southeast Asia, and South America.

2. Product Specifications

3. Manufacturing Technology

Dosing flexibility and taste are critical.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Quadrisected Design: Our 600mg tablets feature Three Score Lines, allowing the tablet to be easily split into four equal parts (150mg each). This is vital for Weight-Based Dosing in mass drug administration (MDA) programs, allowing accurate treatment for children of varying sizes using a single tablet strength.

  • Taste Masking: The API is intensely bitter. We use a specialized polymer coating that masks the bitterness in the mouth but dissolves rapidly in the stomach to ensure efficacy.

  • Micronization: Praziquantel has poor water solubility. We use micronized API to ensure it dissolves and absorbs consistently.

• The Exporter: Healthy Inc

  • Bulk Supply: We specialize in supplying high-density polyethylene (HDPE) Bulk Jars for large-scale public health campaigns, which minimizes waste and logistics costs.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 60 minutes.

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

• Related Substances: We monitor for impurities to ensure safety over the extended shelf life.

5. Why Use Praziquantel?

It is the gold standard for fluke and tapeworm infections.

• Mechanism: It increases the permeability of the parasite’s cell membrane to calcium. This causes severe spasms and paralysis of the parasite’s muscles. The worms lose their grip on the blood vessel walls and are flushed out by the body or destroyed by the immune system.

• Key Indications:

  • Schistosomiasis: Effective against all species (S. haematobium, S. mansoni, S. japonicum).

  • Liver Flukes: Clonorchiasis and Opisthorchiasis.

  • Tapeworms: Intestinal infections (Beef/Pork tapeworm) and Cysticercosis (brain/muscle cysts).

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 Praziquantel Tablets?

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

• Q: Why is the tablet scored into four parts?

  A: Praziquantel dosing is strictly based on body weight (usually 40mg/kg). Breaking the 600mg tablet allows doctors to give the exact right dose to small children without needing different tablet strengths.

• Q: Can I chew it?

  A: NO. It is extremely bitter. Chewing it may cause vomiting. Swallow whole or broken segments with water.

• Q: Is it safe for pregnancy?

  A: It is generally considered safe for treating Schistosomiasis in pregnant women (benefit of treating the infection outweighs the risk).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Schistosomiasis: 40 mg/kg body weight as a single dose (or divided into two doses 4-6 hours apart).

• Liver Flukes: 25 mg/kg three times daily for 1 to 2 days.

• Tapeworms: 5-10 mg/kg as a single dose.

• Administration: Take with a meal and plenty of fluids. Food increases the absorption of the drug and helps reduce stomach upset.

9. Side Effects and Precautions

• Neurological: Dizziness, drowsiness, and headache. Patients should not drive or operate machinery on the day of treatment.

• Gastrointestinal: Nausea, vomiting, abdominal pain.

• Neurocysticercosis: Treating brain cysts can cause inflammation/seizures due to dying parasites. Corticosteroids are often co-administered.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.