Methimazole Tablets

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Description

Methimazole (Thiamazole) Tablets (5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, metabolic, and autoimmune therapeutics. We provide ultra-high-purity, kinetically precise Methimazole (Thiamazole) Film-Coated / Uncoated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, high-precision micro-dosing oral solid dosage facilities. This “Primary Antithyroid Thionamide” is a massive-volume, highly critical export to endocrinology centers, autoimmune clinics, general hospital networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for Graves’ disease, toxic multinodular goiter, and preparation for thyroid surgery.


Product Overview

This highly advanced formulation acts as a biochemical “shut-off valve” for an overactive thyroid gland. By aggressively blocking the enzymes that build thyroid hormones, it prevents the cardiovascular, neurological, and metabolic devastation caused by severe hyperthyroidism.

The “Peroxidase Blockade & Euthyroid Restoration” Specialist:

  • Mechanism 1 (The Thyroid Peroxidase Inhibition): In patients with Graves’ disease, the thyroid gland goes rogue, producing massive, toxic amounts of T3 and T4 hormones. Methimazole physically infiltrates the thyroid gland and aggressively binds to the enzyme thyroid peroxidase. This completely blocks the oxidation of iodine and prevents the coupling of iodotyrosines, instantly halting the assembly line of new thyroid hormones.
  • Mechanism 2 (The T-Cell Immunomodulation): Beyond simply blocking hormones, long-term Methimazole therapy actively suppresses the underlying autoimmune response. It reduces the production of thyroid-stimulating immunoglobulins (TSIs) by the immune system, which is why 12 to 18 months of therapy can frequently induce a permanent remission of Graves’ disease.
  • The “Once-Daily” Compliance Advantage: Compared to older antithyroid drugs like Propylthiouracil (PTU), Methimazole boasts a significantly longer half-life and much higher potency. This allows for a highly convenient, once-daily dosing regimen, drastically increasing patient compliance and leading to faster, more stable normalization of thyroid levels.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the thionamide compound.

Active IngredientStrengthPrimary Clinical Function
Methimazole (Thiamazole) USP/Ph.Eur.5 mgMaintenance / Titration Standard: Base therapeutic unit for precisely lowering doses as the patient approaches the euthyroid (normal) state, preventing drug-induced hypothyroidism.
Methimazole (Thiamazole) USP/Ph.Eur.10 mgInitial Suppression Standard: High-efficacy adult therapy for rapidly crashing toxic thyroid hormone levels during severe, active hyperthyroidism.
ExcipientsMicrocrystalline Cellulose / Lactose Monohydrate / Sodium Starch Glycolate / Magnesium Stearate / Premium Opadry FilmDiluent / Binder / Superdisintegrant / Odor-Masking Coating (Engineered specifically using strict geometric dilution to ensure the microscopic API dose is flawlessly distributed, and film-coated to mask the compound’s inherent sulfurous taste)

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for strict 12-to-18 month chronic endocrinology dispensing regimens).


Technical & Logistics Specifications

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

HS Code3004.90.99 (Medicaments containing other active substances – Endocrinology/Antithyroid)
CAS Number60-56-0 (Methimazole)
Dosage FormFilm-Coated / Uncoated Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-PVC or Alu-Alu Blisters. Protects the delicate micro-dose formulation from environmental humidity across Zone IVb tropical climates.
StorageStore strictly below 30°C in a dry place. Protect heavily from Light and Moisture.

Manufacturing Authority

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

  • Micro-Dose Content Uniformity & Thionamide Control (CRITICAL COMPLIANCE): Methimazole is a highly potent drug where a variation of just a few milligrams can plunge a patient into severe hypothyroidism. Our facilities utilize advanced high-shear dry blending and strict, multi-stage geometric dilution. We routinely achieve Content Uniformity (CU) Relative Standard Deviations (RSD) of less than 3%, guaranteeing absolute clinical precision. Furthermore, our premium film-coating completely locks in the sulfurous thionamide taste, ensuring excellent patient compliance for therapies lasting over a year.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, highly targeted management of hyperthyroid disorders:

  • Graves’ Disease / Hyperthyroidism: The undisputed first-line medical therapy for reducing and normalizing toxic thyroid hormone levels.
  • Pre-Surgical Preparation: Administered prior to thyroidectomy (surgical removal) or radioactive iodine therapy to render the patient euthyroid and prevent a fatal intraoperative “thyroid storm.”
  • Thyroid Storm (Thyrotoxic Crisis): Used as part of acute, emergency management protocols in combination with beta-blockers and corticosteroids.

Dosage & Administration

Recommended Dosage (Strictly as per Endocrinologist Guidelines):

  • Initial Adult Dosing: 15 mg to 60 mg daily, typically divided into 3 doses at first, then consolidated into a single daily dose as the patient stabilizes.
  • Maintenance Dosing: 5 mg to 15 mg taken orally once daily.
  • Administration: Can be taken with or without food, but should be taken at the same time every day to ensure stable, continuous thyroid suppression.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • Agranulocytosis (FATAL CLINICAL ALERT): Methimazole carries a rare but catastrophic risk of completely wiping out the patient’s white blood cells (agranulocytosis), leaving them defenseless against infection. Patients must be explicitly warned to stop the drug and report to an ER immediately if they develop a sudden fever, sore throat, or mouth ulcers.
  • The 1st Trimester Pregnancy Shift (CRITICAL PROTOCOL): Methimazole is highly teratogenic in the first trimester of pregnancy, causing severe birth defects (like aplasia cutis congenita). If a hyperthyroid patient becomes pregnant, the endocrinologist MUST immediately switch them to Propylthiouracil (PTU) for the first trimester, and then switch them back to Methimazole for the second and third trimesters.
  • Hepatotoxicity: Can cause cholestatic jaundice and severe liver injury. Liver enzymes (AST/ALT/Bilirubin) must be monitored periodically.
  • Drug-Induced Hypothyroidism: Over-treatment will suppress the thyroid too much, causing weight gain, severe fatigue, and depression. TSH and Free T4 levels must be constantly monitored to titrate the dose correctly.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Endocrinology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Metabolic, Autoimmune, and Micro-Dosed Formulations. Whether you are looking for a reliable Government Tender Supplier for hyperthyroid clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.

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