Diphenylhydantoin (Phenytoin) Sodium Tablets (100 mg)
Healthy Inc is a specialized global supplier and exporter of advanced neurology, neuro-pharmacology, and targeted high-precision anticonvulsant therapeutics. We provide ultra-high-purity, kinetically stabilized Diphenylhydantoin (Phenytoin) Sodium Tablets (100 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Narrow Therapeutic Index (NTI) Sodium Channel Blocker” is a massive-volume, highly strategic export to neurology centers, state-run epilepsy clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for the control of generalized tonic-clonic (grand mal) and complex partial seizures.
Product Overview
This highly advanced formulation operates as a highly specific electrical dampener for the brain’s cortex. It does not generally depress the entire central nervous system like barbiturates; instead, it aggressively targets and isolates hyperactive neurons, physically preventing a localized electrical storm from spreading across the brain and triggering a full-body convulsion.
The “Voltage-Gated Sodium Channel Blocker” Specialist:
- Mechanism 1 (The Sodium Channel Lock): During a seizure, neurons fire at incredibly rapid, uncontrolled frequencies. Diphenylhydantoin violently binds to voltage-gated sodium channels in the neuronal membrane, specifically targeting channels that are in their “inactive” state. By locking these channels shut, it physically prevents the influx of sodium ions required for the neuron to generate a new action potential.
- Mechanism 2 (High-Frequency Firing Blockade): The brilliance of this molecule is its “use-dependent” blockade. It selectively targets only the neurons that are firing too fast (the epileptogenic focus), while leaving normally firing, healthy neurons largely unaffected. This stops the cortical spread of the seizure without putting the patient into a coma.
- Mechanism 3 (The Cardiac Off-Label Utility): Because it stabilizes sodium channels, Diphenylhydantoin is also recognized as a Class Ib antiarrhythmic. While primarily an anticonvulsant, it is occasionally utilized by cardiologists to suppress ventricular arrhythmias, particularly those induced by digitalis toxicity.
Product Composition & Strength
We supply this product as a Precision-Blended, Dissolution-Optimized Macrodose Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the highly reactive sodium salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Diphenylhydantoin (Phenytoin) Sodium USP/Ph.Eur. | 100 mg | The Global Epilepsy Standard: The definitive therapeutic unit utilized globally for the chronic, daily maintenance and suppression of tonic-clonic and psychomotor seizures. |
| Excipients | Microcrystalline Cellulose / Lactose Monohydrate / Sodium Starch Glycolate / Povidone / Magnesium Stearate | Diluent / Binder / Superdisintegrant / Glidant / Lubricant (Engineered specifically utilizing Strict Particle-Size Distribution (PSD) Control. Because the drug is highly insoluble, the API is micro-milled to an exact, mathematically defined micron size to guarantee a highly predictable, extended dissolution profile in the gut, preventing toxic “dose dumping”) |
*Pack Sizes: Bottles of 100 or 10×10 Blisters (Optimized specifically for strict chronic neurology dispensing regimens and therapeutic drug monitoring protocols).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurology/Antiepileptics) |
| CAS Number | 630-93-3 (Phenytoin Sodium) / 57-41-0 (Phenytoin Base) |
| Dosage Form | Film-Coated or Uncoated Tablet (Immediate/Extended Gastric Release depending on monograph requirement) |
| Packaging | High-Density Alu-PVC Blisters or HDPE Bottles. Protects the formulation from environmental humidity across Zone IVb tropical climates. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Narrow Therapeutic Index (NTI) Precision (CRITICAL COMPLIANCE): Diphenylhydantoin follows non-linear (zero-order) pharmacokinetics. If a generic tablet releases just 10% more drug than intended, the patient’s liver enzymes become fully saturated, and blood levels spike exponentially, causing fatal neurotoxicity and ataxia. Our CNS suites utilize rigorous in-vitro dissolution profiling and strictly controlled excipient matrices to guarantee absolute bioequivalence. We ensure that changing to Healthy Inc’s brand will not trigger a toxic event in stabilized patients.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized lifelong management of severe neurological disorders:
- Epilepsy: Control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures.
- Seizure Prophylaxis: Prevention and treatment of seizures occurring during or following neurosurgery.
- Trigeminal Neuralgia (Off-Label): Management of severe, shock-like facial nerve pain when Carbamazepine is contraindicated.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist Guidelines):
- Standard Adult Dosing: Typically initiated at 100 mg three times daily (TID), adjusted meticulously based on clinical response.
- Therapeutic Drug Monitoring (TDM) Mandate: Dosing MUST be individualized based on frequent monitoring of serum phenytoin levels. The highly narrow therapeutic window is strictly between 10 mcg/mL and 20 mcg/mL. Levels above 20 mcg/mL induce severe toxicity.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Zero-Order Kinetics Toxicity (FATAL WARNING): Because the liver metabolizes this drug at a fixed maximum rate, even a tiny dose increase can cause blood levels to skyrocket. Severe toxicity manifests as nystagmus (rapid eye movement), severe ataxia (loss of coordination), slurred speech, coma, and lethal respiratory depression.
- Severe Skin Reactions (SJS/TEN): Can trigger severe, life-threatening skin reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), particularly in patients carrying the HLA-B*1502 allele (common in Asian populations).
- Fetal Hydantoin Syndrome (Pregnancy Warning): Highly teratogenic. Causes severe birth defects including craniofacial abnormalities, hypoplastic phalanges (underdeveloped fingers), and severe mental deficiency.
- Gingival Hyperplasia: Chronic use frequently causes massive, sometimes disfiguring overgrowth of the gum tissue (gingival hyperplasia), requiring strict dental hygiene and potential surgical removal.
- Hepatic Enzyme Induction: Diphenylhydantoin is a massive CYP450 liver enzyme inducer. It will rapidly destroy the blood levels of countless co-administered drugs, including oral contraceptives, causing catastrophic contraceptive failure.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anticonvulsants, NTI Therapeutics, and PSD-Optimized Formulations. Whether you are looking for a reliable Government Tender Supplier for national epilepsy programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.