Propylthiouracil Generic Name & Formulations
Legal Class
Rx
General Description
Propylthiouracil 50mg; scored tabs; contains docusate sodium.
Pharmacological Class
Antithyroid.
How Supplied
Contact supplier.
Manufacturer
Propylthiouracil Indications
Indications
Hyperthyroidism.
Propylthiouracil Dosage and Administration
Adult
Give in 3 equally divided doses every 8hrs. Initially 300mg/day. Severe conditions: initially 400mg/day; max 900mg/day. Maintenance: 100–150mg/day.
Children
Give in 3 equally divided doses every 8hrs. <6yrs: not recommended. ≥6yrs: initially 50mg/day; may upward titrate based on response, TSH, and free T4 levels.
Propylthiouracil Contraindications
Not Applicable
Propylthiouracil Boxed Warnings
Boxed Warning
Hepatic reactions (eg, severe liver injury, acute liver failure) including cases that require liver transplantation.
Propylthiouracil Warnings/Precautions
Warnings/Precautions
Should be reserved for those intolerant to methimazole and in whom radioactive iodine therapy or surgery are not appropriate treatments. Risk of severe liver injury and acute liver failure. Monitor for signs of hepatic dysfunction esp. in the 1st 6 months of therapy; discontinue if occur and obtain LFTs and ALT/AST levels. Discontinue if agranulocytosis, aplastic anemia, ANCA-positive vasculitis, hepatitis, interstitial pneumonitis, fever, or exfoliative dermatitis is suspected. Monitor thyroid function periodically, prothrombin time esp. before surgical procedures. Pregnancy (Cat.D). Nursing mothers.
Propylthiouracil Pharmacokinetics
See Literature
Propylthiouracil Interactions
Interactions
May potentiate anticoagulants. Caution with other drugs that may cause agranulocytosis. May need to reduce doses of beta-blockers, digitalis glycosides, theophylline at euthyroid state.
Propylthiouracil Adverse Reactions
Adverse Reactions
Rash, urticaria, GI upset, arthralgia, paresthesia, taste loss/perversion, hair loss, myalgia, headache, drowsiness, neuritis, edema, vertigo, jaundice; blood dycrasias, lupus-like syndrome, drug fever, hepatitis, periarteritis, hypoprothrombinemia, bleeding.
Propylthiouracil Clinical Trials
See Literature
Propylthiouracil Note
Not Applicable
Propylthiouracil Patient Counseling
See Literature