Chlorpromazine Hydrochloride Tablets

Description

Chlorpromazine Hydrochloride Tablets (25mg / 50mg / 100mg / 200mg)

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 Chlorpromazine Hydrochloride Tablets in India. Chlorpromazine is a first-generation (typical) phenothiazine antipsychotic used for schizophrenia and certain other psychiatric or medical indications according to approved local prescribing information. Manufacturing controls include attention to low-light handling, product stability, containment and suitable coating and packaging systems.

2. Product Specifications

3. Manufacturing Technology

• Light Protection: Chlorpromazine formulations require appropriate controls against light exposure. Coating and protective packaging are selected according to validated stability requirements.
• Containment: Controlled handling and cleaning procedures help protect operators and reduce cross-contamination risk during manufacturing.
• Coating: Sugar-coated or film-coated presentations can mask the bitter taste and provide additional product protection according to the registered formulation.
• Institutional Packs: High-count packaging can be supported where permitted by stability data and destination-market registration.

4. Quality Assurance

• Related Substances: Relevant degradation products, including oxidative impurities, are monitored according to approved specifications.
• Dissolution: Finished tablets are tested against the applicable registered or pharmacopoeial dissolution requirements.
• Assay & Uniformity: Potency and dosage-unit uniformity are verified against approved specifications.

5. Chlorpromazine Pharmacology and Uses

Chlorpromazine primarily antagonizes dopamine D2 receptors and also has activity at alpha-adrenergic, histamine and muscarinic receptors. These actions contribute both to its therapeutic effects and its adverse-effect profile.

• Schizophrenia / Psychotic Disorders: Used to manage psychotic symptoms according to approved prescribing information.
• Manic States: May be used in selected acute manic presentations where locally approved.
• Nausea and Vomiting: Has antiemetic activity and may be used for selected indications.
• Persistent Hiccups: Chlorpromazine has a recognized role in selected cases under medical supervision.
• Other Uses: Additional indications differ by jurisdiction and should follow current registered labeling and clinical guidance.

6. Export and Regulatory Support

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

7. Frequently Asked Questions

Q: Who manufactures Chlorpromazine Hydrochloride Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Chlorpromazine tablet formulations in India.

Q: Is Chlorpromazine sold under different brand names?
A: Yes. It has been marketed under different brands internationally. Generic equivalence and interchangeability depend on the registered formulation and local regulatory requirements.

Q: Can Chlorpromazine cause tremor or stiffness?
A: Yes. Extrapyramidal symptoms such as tremor, rigidity, dystonia or akathisia can occur. These symptoms require clinical assessment rather than self-treatment.

Q: Does Chlorpromazine cause sun sensitivity?
A: Photosensitivity can occur. Patients should follow medical advice on limiting excessive sunlight and using appropriate sun protection.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dosing varies substantially by indication, age, response, comorbidities and local approved prescribing information.
• Titration: Treatment is generally individualized and adjusted according to clinical response and tolerability.
• Administration: Follow the instructions supplied with the specific registered product. Patients should not alter the dose without medical guidance.

9. Side Effects and Precautions

• CNS: Sedation, dizziness and impaired alertness can occur.
• Extrapyramidal Effects: Dystonia, akathisia, parkinsonism and tardive dyskinesia can occur, particularly with ongoing exposure.
• Cardiovascular: Orthostatic hypotension and tachycardia can occur; QT-related cardiac risk should also be considered where relevant.
• Neuroleptic Malignant Syndrome: Fever, severe muscle rigidity, altered mental status or autonomic instability may indicate this rare medical emergency and require urgent treatment.
• Photosensitivity: Increased sensitivity to sunlight and skin reactions can occur.
• Other Important Risks: Anticholinergic effects, hepatic reactions and ocular changes can occur. Monitoring should follow clinical circumstances and prescribing information.

10. Storage Instructions

• Store below 25°C in a dry place unless the registered label specifies otherwise.
• Protect from light and moisture.
• Keep tablets in their original protective packaging.
• Do not use tablets showing unexpected discoloration or deterioration; consult the manufacturer/pharmacist regarding product quality.
• Keep out of reach of children.