- Approval Id
- d6695fe26f2a2620
- Drug Name
- PROPYLTHIOURACIL TABLET BP 50 mg
- Product Name
- PROPYLTHIOURACIL TABLET BP 50 mg
- Approval Number
- SIN04664P
- Approval Date
- 1990-06-14
- Registrant
- ZIWELL MEDICAL (S) PTE LTD
- Licence Holder
- ZIWELL MEDICAL (S) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET
- Dosage
- **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%.
- Route Of Administration
- ORAL
- Indication Info
- **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.
- Contraindications
- **4.3 Contraindications**
A known hypersensitivity to propylthiouracil and thioamide derivatives
- Atc Code
- H03BA02
- Atc Item Name
- propylthiouracil
- Pharma Manufacturer Name
- ZIWELL MEDICAL (S) PTE LTD
- Company Detail Path
- /organization/ziwell-medical-s-pte-ltd
