Ergotamine & Caffeine ,Paracetamol and Prochlorperazine Tablets

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Description

Ergotamine, Caffeine, Paracetamol & Prochlorperazine Film-Coated Tablets

Healthy Inc is a specialized global supplier and exporter of advanced neurology, acute pain management, and complex multi-API FDC therapeutics. We provide ultra-high-purity, kinetically synchronized Ergotamine Tartrate (1 mg), Caffeine (100 mg), Paracetamol (250 mg) & Prochlorperazine Maleate (2.5 mg) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision quad-matrix oral solid dosage facilities. This “Acute Cranial Vasoconstrictor & Antiemetic FDC” is a massive-volume, highly strategic export to neurology centers, acute emergency wards, specialized headache clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, rapid-onset intervention for terminating severe, refractory migraine attacks accompanied by violent nausea.


Product Overview

This highly advanced formulation operates as a coordinated, four-front biochemical assault on an active migraine. It does not prevent migraines; it is engineered to violently terminate an attack that has already begun by simultaneously crushing the cranial vasospasm, killing the pain, and paralyzing the body’s urge to vomit.

The “Cranial Vasoconstrictor & CTZ-Blocker” Specialist:

  • Mechanism 1 (The Vasoconstrictor – Ergotamine & Caffeine): During a migraine, cranial blood vessels violently dilate and become inflamed. Ergotamine is a highly potent alpha-adrenergic and 5-HT (serotonin) receptor agonist. It physically forces the dilated cerebral arteries to aggressively constrict back to their normal size, instantly reducing the throbbing pressure. Caffeine is co-formulated to accelerate the gastric absorption of Ergotamine by up to 40% while providing secondary cranial vasoconstriction.
  • Mechanism 2 (The Antiemetic Shield – Prochlorperazine): Migraines cause severe gastric stasis and vomiting, a condition often worsened by Ergotamine itself. Prochlorperazine is a potent phenothiazine. It directly attacks the Chemoreceptor Trigger Zone (CTZ) in the brain, blocking dopamine (D2) receptors. This completely paralyzes the vomiting reflex, ensuring the patient keeps the pill down long enough for the active ingredients to enter the bloodstream.
  • Mechanism 3 (The Central Analgesic – Paracetamol): While the Ergotamine stops the vascular cause of the migraine, Paracetamol (Acetaminophen) acts centrally on the brain and spinal cord to rapidly elevate the pain threshold and reduce the severe fever/inflammation associated with an acute neurological attack.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Quad-API Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the sensitive ergot alkaloid and phenothiazine components.

Active IngredientStrengthPrimary Clinical Function
Ergotamine Tartrate USP/Ph.Eur.1 mgThe Vascular Terminator (Micro-Dose): The foundational ergot alkaloid required to aggressively constrict pulsing cranial arteries.
Caffeine Anhydrous USP/Ph.Eur.100 mgThe Absorption Catalyst: Enhances Ergotamine bioavailability and accelerates onset of action.
Paracetamol (Acetaminophen) USP/Ph.Eur.250 mgThe Central Analgesic (Macro-Dose): Provides immediate, broad-spectrum relief from accompanying head and neck pain.
Prochlorperazine Maleate USP/Ph.Eur.2.5 mgThe Antiemetic Anchor (Ultra-Micro-Dose): Lethally blocks the CTZ to prevent vomiting and ensure full gastrointestinal absorption of the FDC.
ExcipientsMicrocrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Magnesium Stearate / Premium Polymeric FilmDiluent / Superdisintegrant / Binder / Lubricant (Engineered utilizing extreme multi-stage geometric dilution to flawlessly blend a microscopic 1mg and 2.5mg payload into a massive 250mg/100mg base, guaranteeing absolute content uniformity and zero toxic ‘hot spots’)

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, heavily limited acute neurology dispensing to prevent ergot toxicity).


Technical & Logistics Specifications

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

HS Code3004.90.99 (Medicaments containing other active substances – Neurology/Antimigraine FDC)
CAS Numbers379-79-3 (Ergotamine) / 58-08-2 (Caffeine) / 103-90-2 (Paracetamol) / 84-02-6 (Prochlorperazine)
Dosage FormFilm-Coated Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-Alu Blisters (STRICTLY MANDATORY). Both Ergotamine and Prochlorperazine are highly sensitive to light and moisture degradation. Strict barrier packaging guarantees absolute chemical stability and maximum rapid-onset potency across Zone IVb tropical climates.
StorageStore strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light.

Manufacturing Authority

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

  • Quad-Matrix Content Uniformity (CRITICAL COMPLIANCE): The engineering challenge of this specific 4-API FDC is staggering. Standard generic manufacturers struggle to blend four different molecules with vastly different bulk densities. If Content Uniformity fails, a patient could ingest an overdose of Ergotamine, triggering severe, limb-threatening gangrene. Our neurology suites utilize elite dry-blending, high-shear wet granulation, and intensive HPLC batch-testing to guarantee 100% uniformity. This proves to major hospital boards that our complex formulations are clinically flawless and hyper-safe.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized termination of acute neurological attacks:

  • Acute Migraine Termination: Rapid abortion of severe vascular headaches, migraine attacks (with or without aura), and histaminic cephalalgia.
  • Refractory Nausea & Headaches: Management of severe, debilitating headaches deeply complicated by violent nausea, vomiting, and gastric stasis.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist Guidelines):

  • The “First Sign” Protocol: 1 to 2 tablets taken at the absolute first sign of a migraine attack. If symptoms persist, 1 additional tablet may be taken every 30 to 60 minutes.
  • The Maximum Limit Mandate (CRITICAL): Do not exceed 4 tablets in a single day, and DO NOT exceed 10 tablets in a single week. Overdosing will cause severe, irreversible Ergotism.
  • Not for Prevention: This drug must NEVER be taken daily as a preventative measure. It is strictly an acute rescue agent.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Ergotism / St. Anthony’s Fire (FATAL WARNING): Chronic overdosage or extreme sensitivity to Ergotamine causes intense, prolonged vasoconstriction. This completely cuts off blood supply to the extremities, leading to severe pain, tissue necrosis, and required amputation of the fingers and toes (gangrene).
  • Pregnancy Category X (Absolute Contraindication): Ergotamine has massive oxytocic properties. It will cause violent uterine contractions leading to catastrophic abortion or fetal death. Strictly contraindicated in pregnant women.
  • Cardiovascular Contraindications: Strictly prohibited in patients with Coronary Artery Disease (CAD), severe hypertension, peripheral vascular disease, or impaired hepatic/renal function.
  • Extrapyramidal Symptoms (Prochlorperazine): The antiemetic component can, in rare cases, trigger severe muscle spasms, locked jaw, or uncontrollable restlessness (EPS).

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology/Emergency Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antimigraine FDCs, Quad-Matrix Formulations, and Ergot-Alkaloid Therapeutics. Whether you are looking for a reliable Government Tender Supplier for acute emergency wards 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.

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