Description
Phenytoin Sodium Tablets
Healthy Inc is a specialized global supplier and exporter of time-tested anticonvulsant therapeutics. We provide high-purity Phenytoin Sodium Tablets, sourced from WHO–GMP certified solid dosage facilities. This “Membrane Stabilizer” is a top export to neurology departments, government epilepsy programs, and hospital formularies in Africa, LATAM, and Southeast Asia, recognized as a cornerstone therapy for the control of generalized tonic-clonic (grand mal) and complex partial seizures.
[Image of Phenytoin mechanism of action blocking voltage-gated sodium channels in neurons]
Product Overview
This formulation contains Phenytoin Sodium, a hydantoin derivative anticonvulsant.
The “Seizure Stopper” Specialist:
- Mechanism: Phenytoin works by acting on the motor cortex of the brain, where it inhibits the spread of seizure activity. It does this by promoting sodium efflux from neurons, thereby stabilizing the threshold against hyperexcitability. It effectively “locks” voltage-gated sodium channels in their inactive state, preventing the repetitive firing of neurons.
- Non-Sedative: Unlike phenobarbital, Phenytoin controls seizures without causing significant sedation or hypnosis in the therapeutic range.
- Zero-Order Kinetics: Unique among drugs, Phenytoin follows “saturation kinetics.” Once the liver enzymes are saturated, small increases in dose can lead to disproportionately large increases in blood levels, requiring careful monitoring.
Product Composition & Strength
We supply this product as Film Coated Tablets (White/Pink). We offer specific strengths to allow for fine-tuning of serum levels.
| Active Ingredient | Strength (Standard) | Primary Role |
|---|---|---|
| Phenytoin Sodium USP/BP | 50 mg | Pediatric / Titration Dose |
| Phenytoin Sodium USP/BP | 100 mg | Standard Adult Dose |
| Phenytoin Sodium USP/BP | 300 mg | Extended Release (Once Daily) |
| Excipients | Q.S. | Lactose / Magnesium Stearate |
*Pack Sizes: Blister packs of 100s (Box of 10×10), or Bulk HDPE Jars of 1000s (Hospital Packs).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| CAS Number | 630-93-3 |
| Dosage Form | Tablet (Oral) |
| Packaging | PVC-Alu Blister or HDPE Bottle (Moisture Sensitive) |
| Storage | Store below 25°C. Protect from Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Bioavailability Issue: Phenytoin has poor water solubility and narrow therapeutic index. Switching brands can cause toxicity or breakthrough seizures. Our manufacturing process ensures strict batch-to-batch consistency in dissolution profiles to match innovator standards.
- Alkalinity: Phenytoin Sodium is alkaline. We use specialized excipients to buffer the tablet and prevent gastric irritation.
Therapeutic Indications (Human Use)
Indicated for the control of seizure disorders:
- Generalized Tonic-Clonic Seizures: (Grand Mal) Prevention and treatment.
- Complex Partial Seizures: (Psychomotor, temporal lobe) Prevention and treatment.
- Neurosurgery: Prevention and treatment of seizures occurring during or following neurosurgery.
- Status Epilepticus: (Loading dose) Maintenance after IV control.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist):
- Route: Oral.
- Adults: Start with 100 mg three times daily. Adjust dose every 7–10 days based on plasma levels.
- Maintenance: Usually 300 mg to 400 mg daily.
- Children: 5 mg/kg/day in 2 or 3 divided doses.
- Administration: Take with food to reduce stomach upset. Swallow whole; do not crush extended-release forms.
- Therapeutic Range: 10 to 20 mcg/mL. Levels >20 mcg/mL cause toxicity (nystagmus, ataxia).
Safety Warnings:
- Gingival Hyperplasia: Overgrowth of gum tissue is a common side effect. Good dental hygiene is essential.
- Teratogenicity: Can cause Fetal Hydantoin Syndrome (cleft lip/palate) if taken during pregnancy. Use with caution.
- SJS/TEN: Risk of severe skin reactions, especially in Asian patients (HLA-B*1502).
- Hirsutism: Excessive hair growth may occur, particularly in young patients.
- Vitamin D Deficiency: Induces liver enzymes that degrade Vitamin D, leading to osteomalacia. Supplementation is advised.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
