PROPYLTHIOURACIL TABLET BP 50 mg

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

PROPYLTHIOURACIL

Dostupno od:

ZIWELL MEDICAL (S) PTE LTD

ATC koda:

H03BA02

Doziranje:

50 mg

Farmaceutski oblik:

TABLET

Sastav:

PROPYLTHIOURACIL 50 mg

Administracija rute:

ORAL

Tip recepta:

Prescription Only

Proizveden od:

RECIPHARM LIMITED

Status autorizacije:

ACTIVE

Datum autorizacije:

1990-06-14

Svojstava lijeka

_PROPYLTHIOURACIL TABLETS BP _
1 NAME OF THE MEDICINAL PRODUCT
Propylthiouracil Tablets BP 50mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Propylthiouracil BP 50 mg
3 PHARMACEUTICAL FORM
White biconvex uncoated tablets engraved Evans 184 on one face and
plain on the other.
4.CLINICAL PARTICULARS
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.
4.2.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/m
2
) 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 <10m1/min decrease dose by 50%.
4.3
Contraindicatio