PROPYLTHIOURACIL Tablet Ref.[8060] Active ingredients: Propylthiouracil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, U.K.

Therapeutic indications

Hyperthyroidism.

Posology and method of administration

Adults and elderly

Initially 300 to 600mg daily, once daily or in divided doses until the patient becomes euthyroid.

When the condition is controlled (usually after 1-2 months), the dose is reduced to 50 to 150mg daily and continued for 1-2 years.

In renal impairment

GFR 10 to 50ml/min, 75% dose

GFR <10ml/min, 50% dose

In hepatic disease

Reduced dose.

Children under 6 years.

Not recommended.

Children 6-10 years.

Initially 50 to 150mg once daily or in divided doses.

Children over 10 years.

Initially 150 to 300mg once daily or in divided doses.

Overdose

Symptoms

Goitre and hypothyroidism may be induced by repeated over dosage. Single overdose is not dangerous. Overdose may manifest as vomiting, epigastric distress, headache, fever, arthralgia, pruritus, and pancytopenia.

Treatment

The treatment of propylthiouracil overdose should aim to minimise the amount of drug absorbed into the circulation. Treatment should involve liberal use of oral fluids. Activated charcoal may also be employed. General symptomatic and supportive measures should then be instituted. A full blood analysis should be considered because of the slight risk of haematological complications and appropriate therapy given if bone marrow depression develops.

There is no specific antidote for propylthiouracil.

Shelf life

2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Polypropylene or polyethylene container with tamper evident closure of 28, 30, 56, 60, 84, 90 and 100 tablets.

Special precautions for disposal and other handling

The tablets are administered orally.

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