Phenytoin Sodium Tablets – Manufacturer & Exporter India

1. Product Introduction

Phenytoin sodium is an antiseizure medicine used in the management of selected types of epilepsy, including focal seizures and generalized tonic-clonic seizures. It works primarily by stabilizing neuronal sodium channels and reducing repetitive electrical firing. It is not an antihypertensive or cardiac medicine.

Healthy Life Pharma Pvt. Ltd. and Healthy Inc are identified in the supplied material as manufacturer and exporter respectively. Any certification or product-specific manufacturing claim should be checked against current documents.

2. Product Specifications

Therapeutic category: Anticonvulsant / Antiepileptic. SKU: Phenytoin Tablets. Packaging, shelf life and registration specifications must be verified.

3. Manufacturing Technology

Manufacture of phenytoin tablets requires controlled blending, content uniformity, coating consistency and product-specific dissolution testing. The sugar-coated and film-coated 100 mg IP variants are distinct presentations and should be documented individually.

Phenytoin has formulation-sensitive absorption. Changes in formulation or manufacturer may affect blood concentrations; equivalence and interchangeability must not be assumed without regulatory and clinical assessment. Specific equipment, methods and coating materials require site-specific verification.

4. Quality Assurance

Batch release should follow approved IP or BP specifications as applicable, including identification, assay, uniformity of dosage units, dissolution, impurities, microbial requirements where relevant, and stability. No universal assay or dissolution numerical limits are asserted without the approved product specification.

Product identity, salt form, coating type and labeling should be reconciled against each approved SKU.

5. Therapeutic Information

Phenytoin reduces repetitive neuronal firing through voltage-gated sodium-channel modulation. It is used for selected focal and generalized tonic-clonic seizure disorders. It is generally not appropriate for absence seizures and may worsen certain seizure types.

Its therapeutic window is narrow and pharmacokinetics are nonlinear. Serum levels, albumin status, kidney and liver function, other medicines and clinical response may affect management. This medicine is not a treatment for hypertension.

6. Export and Regulatory Support

Export and distribution are subject to destination-country marketing authorization, approved labeling, pharmacopoeial requirements and applicable import/export rules. Ask for the current dossier, batch certificate of analysis, stability information, approved packaging and regulatory status for the exact variant.

WHO-GMP status, Star Export House status, CTD/ACTD dossiers, COPP, shelf life and shipment terms must be independently confirmed before publishing as established facts.

7. Frequently Asked Questions

Which strengths are listed? IP 100 mg (sugar-coated and film-coated), BP 25 mg (sugar-coated; grade on final label to confirm) and BP 100 mg (sugar-coated).

Can I change brands or formulations freely? No. Changes can affect phenytoin levels and seizure control; consult the treating clinician.

Can phenytoin be stopped suddenly? No. Abrupt cessation can precipitate seizures, including serious seizure emergencies.

Does phenytoin treat high blood pressure? No. It is an antiepileptic medicine.

8. Dosage and Administration

Use only as prescribed by a qualified clinician. Dose and schedule depend on age, seizure type, formulation, response, drug interactions and, when indicated, therapeutic drug monitoring. Do not apply a fixed universal dose to all patients.

Follow the approved product label for administration and whether tablets may be split or crushed. Do not change brands, coating types or dosage regimens without medical advice. Never stop abruptly.

9. Side Effects and Precautions

Potential effects include dizziness, drowsiness, unsteadiness (ataxia), nystagmus, gum enlargement, skin rash and longer-term bone-health concerns. Serious reactions may include severe skin reactions such as Stevens–Johnson syndrome / toxic epidermal necrolysis, liver injury, blood disorders and hypersensitivity reactions.

Phenytoin has major interactions with other medicines, including hormonal contraceptives and some anticoagulants. Pregnancy exposure carries fetal risk, but stopping seizure treatment suddenly is also dangerous; specialist advice is essential. Seek urgent care for a severe rash, facial swelling, jaundice, unusual bleeding or worsening seizures.

10. Storage Instructions

Store according to the approved IP/BP product-specific label, protecting from moisture and other conditions stated by the manufacturer. Keep in original packaging and out of reach of children. Exact temperature limits and shelf life require confirmation from approved stability data.