methimazole

INDICATIONS AND USAGE Methimazole tablets, USP are indicated: In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option. To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.

DOSAGE AND ADMINISTRATION Methimazole tablets are administered orally. The total daily dosage is usually given in 3 divided doses at approximately 8-hour intervals. Adults - The initial daily dosage is 15 mg for mild hyperthyroidism, 30 mg to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into 3 doses at 8-hour intervals. The maintenance dosage is 5 mg to 15 mg daily. Pediatric - Initially, the daily dosage is 0.4 mg/kg of body weight divided into 3 doses and given at 8-hour intervals. The maintenance dosage is approximately 1/2 of the initial dose.

CONTRAINDICATIONS Methimazole tablets are contraindicated in the presence of hypersensitivity to the drug or any of the other product components.

ADVERSE REACTIONS Major adverse reactions (which occur with much less frequency than the minor adverse reactions) include inhibition of myelopoiesis (agranulocytosis, granulocytopenia, thrombocytopenia, and aplastic anemia), drug fever, a lupus-like syndrome, insulin autoimmune syndrome (which can result in hypoglycemic coma), hepatitis (jaundice may persist for several weeks after discontinuation of the drug), periarteritis, and hypoprothrombinemia. Nephritis occurs very rarely. There have been postmarketing case reports of acute pancreatitis. There are reports of a vasculitis, often associated with the presence of anti-neutrophilic cytoplasmic antibodies (ANCA), resulting in severe complications (see WARNINGS ). Minor adverse reactions include skin rash, urticaria, nausea, vomiting, epigastric distress, arthralgia, paresthesia, loss of taste, abnormal loss of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialadenopathy, and lymphadenopathy. To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Drug Interactions Anticoagulants (oral) : Due to potential inhibition of vitamin K activity by methimazole, the activity of oral anticoagulants (e.g., warfarin) may be increased; additional monitoring of PT/INR should be considered, especially before surgical procedures. β-adrenergic blocking agents : Hyperthyroidism may cause an increased clearance of beta blockers with a high extraction ratio. A dose reduction of beta-adrenergic blockers may be needed when a hyperthyroid patient becomes euthyroid. Digitalis glycosides : Serum digitalis levels may be increased when hyperthyroid patients on a stable digitalis glycoside regimen become euthyroid; a reduced dosage of digitalis glycosides may be needed. Theophylline : Theophylline clearance may decrease when hyperthyroid patients on a stable theophylline regimen become euthyroid; a reduced dose of theophylline may be needed.

DESCRIPTION Methimazole, USP (1-methylimidazole-2-thiol) is a white to pale buff crystalline powder that is freely soluble in water, in alcohol, and in chloroform, and slightly soluble in ether. It differs chemically from the drugs of the thiouracil series primarily because it has a 5-instead of a 6-membered ring. Methimazole tablet, USP contains 5 mg or 10 mg (43.8 μmol or 87.6 μmol) methimazole, USP an orally administered antithyroid drug. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, povidone K-30, and talc. The molecular weight is 114.2 g/mol, and the molecular formula is C 4 H 6 N 2 S. The structural formula is as follows: Methimazole Structural Formula

OVERDOSAGE Signs and Symptoms Symptoms may include nausea, vomiting, epigastric distress, headache, fever, joint pain, pruritus, and edema. Aplastic anemia (pancytopenia) or agranulocytosis may be manifested in hours to days. Less frequent events are hepatitis, nephrotic syndrome, exfoliative dermatitis, neuropathies, and CNS stimulation or depression. No information is available on the median lethal dose of the drug or the concentration of methimazole in biologic fluids associated with toxicity and/or death. Treatment To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s medical status.

HOW SUPPLIED Methimazole tablets, USP 5 mg - white to off-white, round, flat-faced, bevelled-edged tablets, debossed with “T and 80”separated by breakline on one side and plain on the other side. They are available in: Bottles of 100 NDC 33342-335-11 Bottles of 1000 NDC 33342-335-44 Cartons of 100 (10 x 10 unit-dose blister) NDC 33342-335-12 Methimazole tablets, USP 10 mg - white to off-white, round, flat-faced, bevelled-edged tablets, debossed with “T and 81”separated by breakline on one side and plain on the other side. They are available in: Bottles of 100 NDC 33342-336-11 Bottles of 1000 NDC 33342-336-44 Cartons of 100 (10 x 10 unit-dose blister) NDC 33342-336-12 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufactured by: Macleods Pharmaceuticals Ltd. At Oxalis Labs Baddi, Himachal Pradesh, INDIA OR Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh-174101 INDIA Issue: September 2025