Description

Promethazine Tablets (10mg / 25mg)

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 Promethazine Tablets in India. Promethazine is a versatile First-Generation Antihistamine (Phenothiazine derivative) with strong sedative and antiemetic properties. It is widely used for the treatment of Allergic Conditions, Motion Sickness, and as a sedative for short-term management of insomnia or pre-operative anxiety.

We offer Contract Manufacturing (Third Party) services for this multi-purpose drug. Promethazine is highly sensitive to light and oxidation. Our WHO-GMP certified facility in Mumbai utilizes specialized light-shielded processing and coating technologies to ensure the product retains its potency and appearance. Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across the UK, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stability and taste masking are critical.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Oxidation Protection: Promethazine, like other phenothiazines, turns pink or brown when oxidized by air or light. We manufacture under controlled environmental conditions and apply a robust Film Coating (often Sugar Coating for 10mg) to seal the tablet core completely.

  • Taste Masking: The drug is intensely bitter and can cause numbness in the mouth. Our coating ensures the tablet can be swallowed without releasing the drug on the tongue.

  • Content Uniformity: We ensure precise dosing in the 10mg tablets using high-shear granulation to prevent segregation.

• The Exporter: Healthy Inc

  • Light-Resistant Packaging: We strictly use Alu-Alu Blisters or Amber PVDC blisters to provide maximum light protection during shipping and storage in tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 45 minutes.

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

• Related Substances: We strictly monitor for sulfoxide impurities (degradation products) to ensure safety.

5. Why Use Promethazine?

It is a reliable “All-in-One” medication for allergy and nausea.

• Mechanism: It blocks H1-Histamine receptors (stopping allergy symptoms) and has anticholinergic activity (reducing nausea and motion sickness). It also crosses the blood-brain barrier easily, causing sedation.

• Key Indications:

  • Allergies: Hay fever, hives, and skin rashes.

  • Motion Sickness: Prevention and treatment of nausea/vomiting during travel.

  • Sedation: Used as a night-time sleep aid or to calm patients before surgery.

  • Nausea: Treatment of nausea and vomiting from various causes.

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 Promethazine Tablets?

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

• Q: Will it make me sleepy?

  A: Yes, definitely. Promethazine is known for causing significant drowsiness. It is often used specifically for this effect (as a sleep aid). Do not drive after taking it.

• Q: Can I give it to my baby?

  A: NO. Black Box Warning: Promethazine is contraindicated in children under 2 years of age due to the risk of fatal respiratory depression (slowed breathing).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Allergy: 25mg at bedtime (or 12.5mg before meals).

• Motion Sickness: 25mg taken 30-60 minutes before travel.

• Sedation: 25mg to 50mg at bedtime.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Sedation: Drowsiness, dizziness, confusion (especially in the elderly).

• Anticholinergic Effects: Dry mouth, blurred vision, constipation, urinary retention.

• Photosensitivity: Skin may become more sensitive to sunlight.

• Interaction: Enhances the effects of alcohol and other CNS depressants (opioids, sedatives). Avoid alcohol.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Crucial to prevent discoloration).