Description

Prochlorperazine Tablets (5mg / 10mg / 12.5mg)

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 Prochlorperazine Tablets in India. Prochlorperazine is a potent Phenothiazine Antipsychotic and Antiemetic. While originally developed for psychosis, its primary clinical use today is for the rapid treatment of Severe Nausea and Vomiting (associated with migraine or chemotherapy) and for the management of Vertigo (dizziness) due to labyrinthitis or Meniere’s disease.

We offer Contract Manufacturing (Third Party) services for this versatile CNS drug. Prochlorperazine is highly sensitive to light and oxidation. Our WHO-GMP certified facility in Mumbai utilizes specialized light-shielded processing and coating technologies to ensuring the product retains its potency. We also manufacture Mouth Dissolving (MD) variants for rapid relief in nauseous patients who cannot swallow water. Healthy Inc manages the export logistics, supplying hospitals and vestibular clinics across the UK, Australia, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Fast action and stability are key.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Mouth Dissolving (MD) Technology: For patients vomiting or feeling too nauseous to swallow a pill, we offer MD tablets. These are manufactured using highly porous granules and super-disintegrants that allow the tablet to dissolve on the tongue in seconds without water.

  • Photosensitivity Protection: Prochlorperazine decomposes rapidly in light, turning pink/red. We use opaque Titanium Dioxide-based Film Coatings and manufacture under yellow (sodium vapor) lights to prevent degradation.

  • Content Uniformity: We ensure precise dosing in the 5mg tablets using high-shear granulation to prevent segregation.

• The Exporter: Healthy Inc

  • Light-Resistant Packaging: We strictly use Alu-Alu Blisters or amber-colored blisters to provide maximum light protection during shipping and storage.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Standard Tabs: >80% release in 30 minutes.

  • MD Tabs: Disintegration in < 30 seconds.

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

• Related Substances: We strictly monitor for sulfoxide impurities to ensure safety.

5. Why Use Prochlorperazine?

It effectively stops the brain’s signals for vomiting and dizziness.

• Mechanism: It blocks Dopamine (D2) receptors in the Chemoreceptor Trigger Zone (CTZ) of the brain (preventing nausea) and suppresses the vestibular apparatus in the inner ear (reducing vertigo).

• Key Indications:

  • Nausea & Vomiting: Due to migraine, chemotherapy, or post-surgery.

  • Vertigo: Dizziness caused by Meniere’s disease or Labyrinthitis.

  • Psychosis: (Higher doses) Schizophrenia and acute mania.

  • Anxiety: Short-term management of severe generalized anxiety.

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 Prochlorperazine Tablets?

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

• Q: Is it good for motion sickness?

  A: It can be used, but antihistamines (like Cinnarizine) are often preferred for motion sickness. Prochlorperazine is better for severe nausea or vertigo.

• Q: Does it cause sleepiness?

  A: Yes. Sedation is a very common side effect. Do not drive or operate machinery.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Nausea/Vomiting: 5mg to 10mg taken 2-3 times daily.

• Vertigo: 5mg three times daily, increased to 10mg if needed.

• Administration: Swallow whole (standard tablet) or place on tongue (MD tablet).

9. Side Effects and Precautions

• Extrapyramidal Symptoms (EPS): Muscle spasms, dystonia (twisted neck/jaw), or tremors. More common in children and young adults.

• Sedation: Drowsiness and dizziness.

• Hypotension: Can lower blood pressure (postural hypotension).

• Elderly: Use with extreme caution (increased risk of death in dementia-related psychosis).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Exposure makes the tablets ineffective).