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 phenothiazine antipsychotic used for schizophrenia and certain other psychiatric and non-psychiatric indications according to approved prescribing information. We offer contract manufacturing services at our WHO-GMP compliant facility. Because Chlorpromazine is light sensitive, appropriate processing, coating and protective packaging are important for product stability. Healthy Inc manages international export logistics and institutional supply.

2. Product Specifications

3. Manufacturing Technology

• Light Protection: Chlorpromazine is photosensitive, so manufacturing and packaging controls are selected to minimize inappropriate light exposure. Opaque coating and suitable high-barrier or light-protective packaging may be used according to validated stability requirements.
• Operator & Product Protection: Appropriate containment, personal protective measures, cleaning procedures and cross-contamination controls are used according to occupational-safety and GMP requirements.
• Coating: Sugar or opaque film coating can mask the bitter taste, improve swallowability and protect the tablet core.
• The Exporter: Healthy Inc. Retail and institutional packaging configurations can be supplied according to registration, tender and destination-market requirements.

4. Quality Assurance

• Related Substances: Specified degradation products and impurities are monitored using appropriate validated or compendial analytical procedures.
• Dissolution: Finished tablets are tested against applicable pharmacopoeial or registered dissolution specifications.
• Assay & Content Uniformity: Potency and dosage-unit uniformity are verified against approved specifications.

5. Why Use Chlorpromazine?

Chlorpromazine has antipsychotic, sedative and antiemetic pharmacologic effects.

• Mechanism: Its antipsychotic effects are primarily associated with dopamine D2 receptor antagonism. Chlorpromazine also interacts with alpha-adrenergic, histamine H1 and muscarinic receptors, contributing to both therapeutic effects and adverse effects.

Key Indications:

• Psychotic Disorders: Management of schizophrenia and certain other psychotic disorders.
• Manic States: May be used in selected acute manic presentations according to approved prescribing information.
• Intractable Hiccups: An approved indication in some markets when clinically appropriate.
• Severe Nausea / Vomiting: May be used as an antiemetic for selected patients and indications.
• Other Uses: Additional indications vary by country and should follow current approved prescribing information.

6. Export and Regulatory Support

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

7. Frequently Asked Questions

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

Q: Is Chlorpromazine available under different brand names?
A: Yes. Chlorpromazine Hydrochloride is 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 and require clinical assessment and appropriate management.

Q: Does Chlorpromazine cause photosensitivity?
A: Photosensitivity can occur. Patients should follow medical advice regarding sun exposure and appropriate protective measures.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Psychiatric Indications: Dose is individualized according to diagnosis, symptom severity, patient response, age and tolerability. Initiation and titration should follow approved prescribing information.
• Other Indications: Dosing for hiccups, nausea/vomiting or other approved uses differs from psychiatric dosing and should follow indication-specific medical guidance.
• Administration: Follow the prescribed schedule. Taking the medicine with food may help reduce gastrointestinal discomfort in some patients.

9. Side Effects and Precautions

• CNS / Movement Effects: Sedation, dystonia, akathisia, parkinsonism and tardive dyskinesia can occur.
• Cardiovascular: Orthostatic hypotension, tachycardia and cardiac conduction/QT-related effects may occur in susceptible patients.
• Neuroleptic Malignant Syndrome: A rare but potentially life-threatening reaction characterized by hyperthermia, severe rigidity, altered mental status and autonomic instability requires urgent medical treatment.
• Photosensitivity & Ocular Effects: Photosensitivity and ocular changes have been reported, particularly with prolonged exposure or higher cumulative doses.
• Hepatic Effects: Cholestatic liver injury or jaundice can occur and requires medical assessment.
• Older Adults with Dementia-Related Psychosis: Antipsychotics carry important safety warnings in this population; treatment decisions must follow approved prescribing information and specialist assessment.

10. Storage Instructions

• Store below 25°C in a dry place.
• Protect from light and moisture.
• Do not use tablets showing unexpected discoloration or deterioration; follow the product label and pharmacist/manufacturer guidance.
• Keep out of reach of children.