Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**4.2.Posology and method of administration** Propylthiouracil is administered by the oral route. Management of Hyperthyroidism Adults The initial dose of propylthiouracil is between 300mg and 600mg given as a single daily dose. This dose should be maintained until the patient euthyroid. The dose should then be reduced gradually to a maintenance dose of between 50mg and 150mg, taken as a single daily dose. Daily doses can be divided if preferred. Children: Children aged 6 – 10 years: Initial dose of 50–150mg daily Children over 10 years:Initial dose of 150–300mg (or 150mg/m2) daily Maintenance dose is determined by the patient’s response. Preparation for Surgery As for management of hyperthyroidism, until the patient becomes euthyroid. Adjunct to Radioactive Iodine Therapy As for management of hyperthyroidism, for several weeks prior to radio-iodine treatment. Withdraw propylthiouracil 2 to 4 days before irradiation. The dosage of radio-iodine may need to be adjusted because propylthiouracil may have a radioprotective effect. Management of Thyrotoxic Crisis 200mg every 4 to 6 hours for the first 24 hours, decrease the dose as the crisis subsides. Elderly The adult dose should apply, but caution is advised in the presence of renal or hepatic impairment, where a dosage reduction may be justified. Renal impairment Decrease the dose of propylthiouracil in renal failure. If the glomerular filtration rate is 10–50ml/min, decrease dose by 25%. If the GFR is <10ml/min. decrease dose by 50%.
ORAL
Medical Information
**4.1 Therapeutic indications** 1. Management of hyperthyroidism, including the treatment of Graves’ disease and thyrotoxicosis. 2. Preparation of the hyperthyroid patient prior to surgery. 3. An adjunct to radioactive iodine therapy.
**4.3 Contraindications** A known hypersensitivity to propylthiouracil and thioamide derivatives
H03BA02
propylthiouracil
Manufacturer Information
ZIWELL MEDICAL (S) PTE LTD
RECIPHARM LIMITED
Active Ingredients
Documents
Package Inserts
Propylthiouracil tablet 50mg PI.pdf
Approved: January 5, 2021