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Trifluoperazine Tablets IP

Trifluoperazine Tablets IP

Antipsychotic / Phenothiazine | Film-coated tablet | Prescription CNS medicine

Product Composition

Each film-coated tablet contains: Trifluoperazine Hydrochloride IP equivalent to Trifluoperazine 5 mg; excipients q.s.

Usage: Treatment of schizophrenia under specialist prescription.

Therapeutic category: Antipsychotic / Phenothiazine / CNS medicine (not an antidepressant).

SKU: Trifluoperazine Tablets IP 5 mg

Categories: Contract Manufacturer · Manufacturing Pharmaceutical Company India · Pharmaceutical Exporter India · Pharmaceutical Formulations India · Formulations Exporter India · Tablets Manufacturer · WHO GMP Certified Formulations

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Product Information

Trifluoperazine Tablets IP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

1. Product Introduction

Trifluoperazine Tablets IP 5 mg are film-coated prescription antipsychotic tablets containing trifluoperazine hydrochloride equivalent to 5 mg trifluoperazine. Trifluoperazine is a first-generation, high-potency phenothiazine antipsychotic used in the management of schizophrenia.

The submitted business information identifies Healthy Life Pharma Pvt. Ltd. as manufacturer and Healthy Inc as exporter. Facility licences, WHO-GMP status, registrations and export permissions require documentary verification before publication. The supplied pack composition confirms the 5 mg film-coated tablet only; 1 mg, 2 mg and 10 mg strengths are not independently confirmed.

2. Product Specifications

Product nameTrifluoperazine Tablets IP 5 mg
Active ingredientTrifluoperazine Hydrochloride IP equivalent to Trifluoperazine 5 mg
Excipientsq.s., as per approved formula
Dosage formFilm-coated tablet
Pharmacopoeial referenceIP, as supplied; product compliance to be verified
Therapeutic classFirst-generation antipsychotic / phenothiazine
IndicationSchizophrenia; other uses only if locally approved
Other strengths1 mg, 2 mg and 10 mg mentioned in description but not confirmed by supplied label
PackagingSubject to approved pack specification
Shelf lifeSubject to product-specific stability data

3. Manufacturing Technology

For a low-dose antipsychotic tablet, manufacturing controls should focus on blend homogeneity, content uniformity, validated compression, coating performance, cleaning validation and protection from relevant environmental stresses. Any specific claim regarding sugar coating, oxidation resistance, high-shear processing or particular equipment requires supporting batch records and validated procedures.

Only a film-coated 5 mg presentation is supported by the supplied composition; a sugar-coated presentation should not be asserted for this SKU.

4. Quality Assurance

Product-specific testing should follow approved IP specifications and validated methods for identification, assay, uniformity of dosage units, dissolution, impurities, microbial limits where applicable, stability and pack integrity. Numerical assay or dissolution limits should be quoted only from the approved specification. Photostability and claimed shelf life require supporting studies.

5. Therapeutic Uses and Mechanism

Trifluoperazine acts primarily by blocking dopamine D2 receptors in the central nervous system and can help reduce symptoms such as hallucinations and delusions in schizophrenia. It is an antipsychotic, not an antidepressant. Some jurisdictions permit limited short-term use for non-psychotic anxiety, but indications vary by country and should not be generalized to this particular registered product.

It is not a first-choice treatment for routine anxiety or insomnia; clinical use must be based on individual benefit-risk assessment and approved labeling.

6. Export and Regulatory Support

For B2B supply, buyers should request verified manufacturing and product licences, applicable GMP documentation, product registration, batch Certificate of Analysis, approved artwork, pack specifications and stability data. CTD/ACTD dossiers, FSC, COPP and any destination-market permits should be confirmed for the specific product and facility before commitments are made.

7. Frequently Asked Questions

Q: What is the confirmed strength?
A: Trifluoperazine 5 mg, supplied as Trifluoperazine Hydrochloride IP in a film-coated tablet.

Q: Is it an antidepressant?
A: No. It is a first-generation antipsychotic medicine, primarily used for schizophrenia.

Q: Why is medical monitoring important?
A: Trifluoperazine can cause movement disorders, sedation, low blood pressure and other serious adverse effects, so a prescriber should assess and monitor treatment.

8. Dosage and Administration

Prescription only: Dosing and titration must follow the approved local product information and the treating clinician’s assessment of age, indication, response, coexisting illness and interacting medicines. No universal starting or maximum dose is suitable for all patients.

Take exactly as prescribed. Do not abruptly discontinue or change dose without medical advice. This product must not be substituted for another strength or formulation without checking the prescription.

9. Side Effects and Precautions

Common or important adverse effects: drowsiness, dizziness, orthostatic hypotension, dry mouth, blurred vision, extrapyramidal symptoms (restlessness, stiffness, tremor) and tardive dyskinesia, which may persist. Rare serious risks include neuroleptic malignant syndrome, blood dyscrasias and cardiac rhythm disturbances.

Critical warning: Antipsychotics are associated with increased mortality in older adults with dementia-related psychosis; trifluoperazine is not approved for that use. Avoid combining with alcohol or other sedating medicines without medical review. Inform the prescriber about Parkinsonism, seizures, liver disease, heart conditions and all other medicines.

10. Storage Instructions

Store in the original packaging, protected from light and moisture, under the temperature conditions printed on the approved product label. The proposed “below 25°C” condition and 36-month shelf life require product-specific verification. Keep out of reach of children.

For healthcare professional and B2B reference. Product availability, approvals, certifications, manufacturing processes, packaging and prescribing details must be verified for the relevant market.