Description

Sumatriptan & Naproxen Tablets

Healthy Inc is a specialized global supplier and exporter of advanced neurology, central nervous system (CNS), and acute pain therapeutics. We provide ultra-high-purity, kinetically synchronized Sumatriptan (85 mg) & Naproxen Sodium (500 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dual-Mechanism Migraine Eradication Synergy” is a highly lucrative, premium export to neurology clinics, specialized headache centers, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, definitive intervention for severe, acute migraine attacks and the prevention of rebound headaches.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes a rapid-acting 5-HT1 receptor agonist (Triptan) with a potent, long-acting Non-Steroidal Anti-Inflammatory Drug (NSAID) to target multiple pathophysiological pathways of a migraine simultaneously.

The “Abortive & Anti-Recurrence” Specialist:

• Mechanism 1 (The Cranial Vasoconstrictor – Sumatriptan 85mg): Sumatriptan acts as a highly selective agonist at the 5-HT1B and 5-HT1D serotonin receptors located on intracranial blood vessels. By stimulating these receptors, it forces the dangerously dilated blood vessels to constrict back to their normal size, instantly relieving the throbbing pressure and blocking the release of pain-inducing neuropeptides from the trigeminal nerve.
• Mechanism 2 (The Inflammatory Blocker – Naproxen 500mg): While the triptan stops the immediate neurological event, the massive 500mg dose of Naproxen Sodium violently inhibits COX-1 and COX-2 enzymes. This shuts down the localized synthesis of prostaglandins—the chemicals that cause severe, lingering neuro-inflammation and pain sensitization.
• The Synergy of Recurrence Prevention: The greatest failure of standalone migraine drugs is the “rebound” effect, where the headache returns 4 to 12 hours later. Because Naproxen has a remarkably long half-life, it maintains a continuous anti-inflammatory shield long after the Sumatriptan has worn off, providing complete, sustained, 24-hour freedom from migraine pain, photophobia, and phonophobia with a single tablet.

Product Composition & Strength

We supply this product as a Precision-Engineered Bilayer or Matrix Film-Coated Tablet, packed exclusively in highly secure, child-resistant Alu-Alu or high-density Alu-PVC blister strips to ensure the absolute kinetic stability of both active pharmaceutical ingredients.

*Pack Sizes: 1×9 or 10×9 Unit-Dose Blisters (Optimized specifically to enforce strict acute dispensing limits and prevent medication overuse).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

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

• Dual-API Dissolution Engineering: During a migraine, patients suffer from severe gastric stasis (delayed stomach emptying). Formulating a massive 500mg NSAID dose alongside an 85mg triptan requires elite superdisintegrant technology. Our facilities utilize advanced high-shear granulation to guarantee that both the Sumatriptan and the Naproxen Sodium dissolve violently and rapidly within the stomach, bypassing gastric stasis to deliver peak plasma concentrations exactly when the patient needs it most.

Therapeutic Indications (Human Use)

Indicated for the targeted, acute management of severe neurological pain:

• Acute Migraine: Acute treatment of migraine attacks with or without aura in adults and adolescents (12 years of age and older, depending on regional guidelines).
• CRITICAL LIMITATION: It is strictly NOT indicated for the prophylactic (preventative) therapy of migraine, or for the treatment of cluster headaches.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist Guidelines):

• Standard Adult Dosing: One tablet (85 mg/500 mg) taken orally at the very first sign of a migraine headache.
• The “2-Hour” Re-Dosing Rule: If the migraine symptoms return after an initial positive response, a second tablet may be taken, but only if at least 2 hours have passed since the first dose.
• Maximum Limits: Do not exceed two tablets (170 mg sumatriptan / 1000 mg naproxen sodium) in any 24-hour period.
• Administration: Swallow the tablet whole with water. Due to the high-dose NSAID component, taking it with a light snack or milk may reduce the risk of acute gastrointestinal upset.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Cardiovascular Thrombosis & Vasospasm): Both ingredients carry severe cardiovascular risks. Sumatriptan can cause fatal coronary artery vasospasm. Naproxen significantly increases the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. STRICTLY CONTRAINDICATED in patients with a history of ischemic heart disease, angina, previous heart attacks, strokes, or uncontrolled hypertension, and in the setting of CABG surgery.
• BLACK BOX WARNING (Gastrointestinal Bleeding): The Naproxen component causes an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and fatal perforation of the stomach or intestines.
• Serotonin Syndrome: Co-administration with SSRI or SNRI antidepressants (like Fluoxetine or Duloxetine) can trigger potentially fatal Serotonin Syndrome.
• Ergotamine Interaction: Must NEVER be used within 24 hours of taking another triptan or any ergotamine-containing medication.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological FDCs, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Pharmacy Chain Supplier 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.