TAPAZOLE 10 MG — DIN 02296039

What is TAPAZOLE?

TAPAZOLE 10 MG contains METHIMAZOLE : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 02296039, held by ENDO OPERATIONS LTD., supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 16-Jul-2026. This Drug Identification Number is no longer authorized for sale in Canada, so Nexara does not supply it. The record is kept here because buyers still meet the number on old formularies, purchase orders and tender documents; Nexara can help identify an authorized alternative.

What is TAPAZOLE used for?

TAPAZOLE® (methimazole tablets) is indicated in adults for: • The medical treatment of hyperthyroidism. Long-term therapy may lead to remission of the disease. • Amelioration of hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. • Use when thyroidectomy is contraindicated or not advisable.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

How is it administered?

Adult (≥18 years of age): The initial daily dose is 15 mg for mild hyperthyroidism, 30 to 40 mg for moderately severe hyperthyroidism, and 60 mg for severe hyperthyroidism, divided into three doses at eight-hour intervals. The maintenance dosage is 5 to 15 mg daily. Geriatric (≥65 years of age): Dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hepatic impairment: The dose should be kept as low as possible, and patients should be closely monitored as the plasma clearance of methimazole is reduced. Renal impairment: The dose should be kept as low as possible and careful individual dose adjustment under close monitoring is recommended as there is a lack of data regarding the pharmacokinetic behaviour of methimazole in patients with renal impairment. Administration: • TAPAZOLE is administered orally. • TAPAZOLE is usually given in three equal doses per day at approximately eight-hour intervals. Missed Dose: If a dose is missed, patients should contact their healthcare professional. Patients should not take a double dose to make up for a forgotten dose. Patients should take their next scheduled dose as usual.

Included because it drives pack selection and wastage. Consult the monograph.

Contraindications

Methimazole is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. • Breastfeeding women, as the drug is excreted in breast milk. • Patients with history of acute pancreatitis after administration of methimazole.

Warnings and precautions

Serious Warnings and Precautions: • Agranulocytosis: Treatment with TAPAZOLE can cause agranulocytosis. Patients should be monitored for signs and symptoms of agranulocytosis. • Liver toxicity: Treatment with TAPAZOLE can cause liver toxicity problems, including fulminant hepatitis, hepatic necrosis, encephalopathy, and cholestatic jaundice. Patients should report any signs or symptoms of liver toxicity, and liver function should be monitored. General: Patients receiving methimazole should be under close surveillance and report any illness or unusual clinical symptoms (sore throat, skin eruptions, fever, headache, general malaise). White blood cell and differential counts should be made to determine agranulocytosis. Particular care should be exercised with patients receiving additional drugs known to cause agranulocytosis. Arthralgias: Development of arthralgias should prompt drug discontinuation. Carcinogenesis and Mutagenesis: Animal data has shown thyroid hyperplasia, thyroid adenoma, and carcinoma formation. Cardiovascular (Vasculitis): Cases of vasculitis (leukocytoclastic cutaneous vasculitis, glomerulonephritis, systemic vasculitis) have been observed. Patients should report symptoms such as rash, hematuria, decreased urine output, dyspnea, or hemoptysis. Discontinue methimazole if vasculitis is suspected. Driving and Operating Machinery: Patients should exercise caution due to reported vertigo and drowsiness. Hypothyroidism: TAPAZOLE can cause hypothyroidism, necessitating routine monitoring of TSH and free T4 levels. Excess dosage can lead to sub-clinical or clinical hypothyroidism and goitre growth. Hematologic (Agranulocytosis): Potentially serious side effect. Patients should report symptoms like fever or sore throat. Leukopenia, thrombocytopenia, and aplastic anemia may also occur. Discontinue drug in presence of agranulocytosis or aplastic anemia. Bone marrow function should be monitored. Hepatic/Biliary/Pancreatic: Hepatotoxicity is a rare adverse reaction. Patients should report symptoms of hepatic dysfunction (jaundice, anorexia, pruritus, right upper-quadrant pain). Discontinue drug if clinically significant evidence of liver abnormality. Post-marketing reports of acute pancreatitis have occurred; discontinue immediately if acute pancreatitis occurs. Do not start treatment in patients with a history of acute pancreatitis attributed to methimazole. Monitoring and Laboratory Tests: Liver function, hepatic transaminase levels, and complete blood count should be closely monitored. Prothrombin time/INR should be monitored during therapy, especially before surgical procedures. Periodic monitoring of thyroid function is warranted. Respiratory: Caution and monitoring are needed for patients with intrathoracic goitres due to risk of tracheal obstruction from goitre growth. Skin: Discontinue TAPAZOLE in the presence of exfoliative dermatitis.