Product Information
Clozapine Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Description
Clozapine Tablets (25mg / 50mg / 100mg)
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 Clozapine Tablets in India. Clozapine is a second-generation (atypical) antipsychotic with an important role in treatment-resistant schizophrenia. In some jurisdictions it is also approved for reducing recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder. Because Clozapine can cause serious adverse effects, treatment requires specialist prescribing, careful titration and appropriate clinical and laboratory monitoring.
2. Product Specifications
| Parameter | Specification |
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| Product Name | Clozapine Tablets |
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| Generic Name | Clozapine Tablets USP / BP / IP |
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| CAS Number | 5786-21-0 |
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| Strength | 25mg / 50mg / 100mg |
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| Dosage Form | Uncoated Tablet; appearance/scoring according to registered formulation |
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| Standard | USP / BP / IP, as applicable |
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| Therapeutic Class | Atypical Antipsychotic (Second Generation) |
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| Shelf Life | Up to 36 months, subject to validated stability data |
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| Packaging | 10×10 Blister / bottle or market-specific pack |
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3. Manufacturing Technology
- Dissolution & Content Control: Manufacturing parameters are controlled to achieve the registered dissolution, assay and dosage-unit uniformity specifications.
- Tablet Scoring: Scoring is provided only where the registered product has been validated and approved for tablet splitting.
- Alternative Dosage Forms: Orally disintegrating formulations require separate development and registration and should not be assumed interchangeable with conventional tablets.
- Safety Labeling: Export packaging can incorporate destination-market warnings and monitoring information required by the applicable regulator.
4. Quality Assurance
- Assay & Uniformity: Finished product potency and dosage-unit uniformity are tested against approved specifications.
- Dissolution: Release testing follows the applicable pharmacopoeial or registered product specification.
- Impurity Profiling: Relevant Clozapine-related impurities and degradation products are monitored according to validated analytical methods.
- Bioequivalence: Bioequivalence should only be claimed for a specific product when supported by an appropriate comparative study and regulatory approval.
5. Pharmacology and Clinical Use
Clozapine has complex activity across dopamine, serotonin, adrenergic, histamine and muscarinic receptors. Its clinical profile differs from many other antipsychotics and it generally has a lower propensity for some extrapyramidal adverse effects, but it carries other important risks requiring monitoring.
- Treatment-Resistant Schizophrenia: An established treatment option for appropriately diagnosed patients who have had an inadequate response to suitable antipsychotic treatment.
- Suicidal Behavior: Approved in some jurisdictions for reducing recurrent suicidal behavior in schizophrenia or schizoaffective disorder.
- Other Uses: Any other psychiatric or neurological use should follow local approved labeling and specialist clinical guidance.
6. Export and Regulatory Support
- Dossier Support: CTD / ACTD documentation where applicable.
- Certificates: FSC, COPP and COA where applicable.
- Study Documentation: Comparative or bioequivalence documentation can only be supplied where available for the specific registered formulation.
- Logistics: Air or sea shipment via FOB Mumbai / CIF according to destination-market requirements.
7. Frequently Asked Questions
Q: Who manufactures Clozapine Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Clozapine tablet formulations in India.
Q: Is Clozapine available under different brands?
A: Yes. Clozapine is marketed under multiple brands internationally. Generic equivalence and interchangeability depend on the specific registered formulation and applicable regulatory requirements.
Q: Why are blood tests required?
A: Clozapine can cause severe neutropenia, which reduces infection-fighting neutrophils. ANC monitoring and treatment decisions must follow the current product label and local monitoring requirements.
Q: Can Clozapine cause excessive saliva or drooling?
A: Yes. Sialorrhea, particularly during sleep, is a recognized adverse effect and should be discussed with the treating clinician if troublesome.
Clinical Pharmacology & Safety Information
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
- Initiation: Clozapine must be initiated and titrated according to the approved prescribing information and under specialist supervision.
- Titration: Gradual titration is important because rapid dose escalation can increase the risk of hypotension, syncope, seizures and other serious adverse effects.
- Interrupted Treatment: Restarting after an interruption may require dose reduction and re-titration. The exact restart procedure depends on the duration of interruption and the registered prescribing information; patients should not resume their previous dose without medical advice.
- Monitoring: ANC and other clinical monitoring should follow current local requirements and the specific product label.
9. Side Effects and Precautions
- Severe Neutropenia: Clozapine can cause potentially life-threatening neutropenia. Fever, sore throat or other signs of infection require prompt medical assessment and appropriate blood testing.
- Cardiac: Myocarditis, pericarditis and cardiomyopathy can occur. Chest pain, unexplained breathlessness, persistent tachycardia, fever or marked fatigue require urgent clinical assessment.
- Seizures: Clozapine can lower the seizure threshold, with risk influenced by dose and patient factors.
- Gastrointestinal Hypomotility: Constipation can progress to ileus, obstruction or other life-threatening complications. New or worsening constipation, abdominal pain/distension, vomiting or inability to pass stool/gas requires prompt assessment.
- Cardiovascular/CNS: Orthostatic hypotension, syncope, sedation and dizziness can occur, especially during initiation or titration.
- Metabolic: Weight gain, hyperglycemia/diabetes and lipid abnormalities can occur and may require monitoring.
- Do Not Stop Abruptly: Changes or discontinuation should be supervised because psychiatric symptoms and cholinergic rebound effects can occur.
10. Storage Instructions
- Store below 25°C unless the registered label specifies otherwise.
- Store in a dry place and keep the container or blister properly closed.
- Keep in original packaging and out of reach of children.
