Description

Zonisamide Capsules

Healthy Inc is a specialized global supplier and exporter of advanced central nervous system (CNS) and neurological therapeutics. We provide high-purity Zonisamide Capsules (25 mg / 50 mg / 100 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Multi-Mechanism Antiepileptic Drug (AED)” is a mandatory, high-value export to neurology centers, epilepsy clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a highly effective adjunctive therapy for refractory partial-onset seizures in adults.

Product Overview

This formulation contains Zonisamide, a benzisoxazole derivative that contains a sulfonamide group, structurally distinct from other anticonvulsants.

The “Multi-Channel Neuromodulator” Specialist:

• Mechanism (Sodium & Calcium Blockade): Zonisamide stabilizes neuronal membranes and suppresses neuronal hypersynchronization through a dual-channel blockade. It blocks voltage-sensitive sodium channels (reducing sustained high-frequency repetitive firing) and blocks T-type calcium channels.
• Carbonic Anhydrase Inhibition: It possesses weak carbonic anhydrase inhibitory activity (similar to Topiramate or Acetazolamide), which contributes to its antiepileptic effects but also requires careful monitoring of the patient’s acid-base balance.
• The Long Half-Life Advantage: Zonisamide has an exceptionally long elimination half-life of approximately 63 hours in plasma (and heavily binds to red blood cells). This allows for highly convenient once-daily or twice-daily dosing, providing a “built-in safety net” that prevents breakthrough seizures if a patient accidentally misses a single dose.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in moisture-resistant Alu-Alu or Alu-PVC blister strips.

*Pack Sizes: 10×10 Alu-PVC Blisters or Bulk Jars of 500/1000 Capsules for institutional dispensing.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• API Uniformity & Titration Safety: Because Zonisamide requires a slow, multi-week titration schedule to minimize neurological side effects (like severe somnolence or cognitive slowing), our 25 mg capsules undergo extreme high-shear blending to guarantee absolute content uniformity, preventing accidental over-dosing during the critical early weeks of therapy.
• Stability Assurance: Encapsulation is performed under strictly controlled humidity parameters (RH <40%) to prevent clumping of the micronized API powder inside the gelatin shell, ensuring rapid and predictable gastric dissolution.

Therapeutic Indications (Human Use)

Indicated for the management of neurological disorders:

• Partial Seizures (Epilepsy): Adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.
• Off-Label Neurology Uses: Often utilized by specialists for generalized seizures, bipolar disorder (as a mood stabilizer), essential tremor, and migraine prophylaxis.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist):

• Administration: Taken orally, once or twice daily, with or without food. Must be swallowed whole.
• Titration Protocol (CRITICAL): Initiated at 100 mg daily. After two weeks, the dose may be increased to 200 mg daily. Dose increases should be made no more frequently than every 2 weeks, up to a maximum of 400 mg daily.
• Hydration Requirement: Patients MUST drink plenty of fluids throughout the day to reduce the risk of kidney stones.

Safety Warnings (CRITICAL):

• Sulfonamide Allergy: Zonisamide is a sulfa drug. It is strictly contraindicated in patients with hypersensitivity to sulfonamides. Fatalities have occurred due to severe reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).
• Oligohidrosis & Hyperthermia: Particularly in pediatric patients, Zonisamide can cause oligohidrosis (decreased sweating), leading to life-threatening heatstroke/hyperthermia. Patients must be monitored closely in hot climates.
• Nephrolithiasis (Kidney Stones): Due to its carbonic anhydrase inhibition, it can promote the formation of kidney stones. Adequate hydration is absolutely mandatory.
• Metabolic Acidosis: Can decrease serum bicarbonate levels, leading to hyperchloremic, non-anion gap metabolic acidosis.

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 CNS and Epilepsy Medicines, 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.