Description

Phenytoin Sodium Tablets (50mg / 100mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Phenytoin Sodium Tablets in India. This classic anticonvulsant is essential for controlling tonic-clonic and complex partial seizures. Because Phenytoin is a Narrow Therapeutic Index (NTI) drug, we manufacture it with extreme precision to ensure consistent bioavailability. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and hospital tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Phenytoin Sodium Tablets | | Generic Name | Phenytoin Sodium USP / BP / IP | | Strength | 50mg / 100mg | | Dosage Form | Film Coated / Sugar Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Anticonvulsant / Antiepileptic Drug (AED) | | Shelf Life | 36 Months | | Packaging | 10×10 Blister / 100s HDPE Bottle |

3. Manufacturing Phenytoin Sodium Tablets We divide our operations to ensure specialized focus.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Phenytoin follows non-linear pharmacokinetics, meaning small variations in the tablet can drastically alter blood levels. Therefore, we use High-Shear Granulation. This ensures the active ingredient is perfectly distributed. We also strictly control the polymorphic form of the API during processing to prevent crystallization, which would affect absorption.

• The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Phenytoin Sodium Tablets. We supply neurological institutes and government health depots. We understand that switching brands of Phenytoin carries risk, so we provide extensive stability and dissolution data to prove our product is bioequivalent to reference standards.

4. Quality Assurance We test every batch rigorously.

• Dissolution Profiling: This is critical. We ensure the tablet releases the drug at the exact specified rate (Prompt or Extended Release as per specification).

• Content Uniformity: We test individual tablets to ensure no deviation in dosage, preventing breakthrough seizures.

• Related Substances: We monitor impurities to ensure long-term safety for chronic users.

5. Why Use Phenytoin Sodium Tablets? This drug stabilizes neuronal membranes to stop seizures.

• Mechanism: It blocks voltage-dependent sodium channels in the brain.

• Effect: It prevents the spread of seizure activity from the focus to other parts of the brain.

Key Indications:

• Control of Generalized Tonic-Clonic (Grand Mal) Seizures.

• Control of Complex Partial Seizures (Psychomotor, Temporal Lobe).

• Prevention of seizures during or following neurosurgery.

6. Export and Regulatory Support We provide complete documentation for registration.

• Dossier: We offer CTD and ACTD formats.

• Certificates: We supply the Free Sale Certificate (FSC) and COPP.

• Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

• Q: Who manufactures Phenytoin Sodium Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is this a high-risk drug? A: Yes, it is an NTI drug. Our manufacturing process focuses on precision and consistency to ensure safety.

• Q: What is the difference between Phenytoin and Phenytoin Sodium? A: Phenytoin Sodium is the salt form used in most adult tablets (100mg) for better solubility. We manufacture the Sodium salt form.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Adult Dosage: Initially 100mg three times daily. Dosage is adjusted based on serum plasma levels.

• Monitoring: Therapeutic drug monitoring (blood tests) is essential. The therapeutic range is typically 10-20 mcg/mL.

• Administration: Take with food to reduce gastric irritation. Do not switch brands without doctor supervision.

9. Side Effects and Precautions

• Gum Hypertrophy: Long-term use often causes Gingival Hyperplasia (overgrowth of gums). Good dental hygiene is required.

• Neurological: Nystagmus (eye twitching), ataxia (clumsiness), or confusion may indicate toxicity.

• Pregnancy: Phenytoin is teratogenic (Fetal Hydantoin Syndrome). It should be used in pregnancy only if the benefit outweighs the risk.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.

• Keep out of reach of children.