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Propylthiouracil

    DEA Class; Rx

    Common Brand Names; PTU

    • Antithyroid Agents

    Oral thio-urea derivative antithyroid agent
    Used for various hyperthyroid conditions including Graves disease
    Due to hepatotoxicity risk reserved for patients intolerant of methimazole or in whom radioiodine therapy or surgery are not appropriate, except during the first trimester of pregnancy, when PTU is preferred over methimazole

    Indicated for the treatment of thyrotoxicosis, including hyperthyroidism, Graves’ disease, toxic multinodular goiter, and thyroid storm
    For the treatment of thyroid storm.

    Hypersensitivity

    Agranulocytosis

    Aplastic anemia

    Dermatologic reactions

    Hepatitis

    Polyarthritis

    Drowsiness

    Fever

    Headache

    Vertigo

    Alopecia

    Erythema nodosum

    Exfoliative dermatitis

    Skin rash

    Skin ulcers

    Goiter

    Weight gain

    Constipation

    Loss of taste

    Granulopenia

    Leukopenia

    Thrombocytopenia

    Risk of severe rare immunoallergenic hepatitis

    Severe dermatologic reactions reported

    Discontinue in presence of unexplained fever

    Lupus-like syndrome reported (may need to discontinue)

    Glomerulonephritis and interstitial nephritis with acute renal failure reported

    Interstitial pneumonitis may occur

    High relapse rate (more likely in smokers)

    Agranulocytosis within first 3 months of therapy reported; instruct patients to immediately report any symptoms suggestive of agranulocytoses, such as fever or sore throat; leukopenia, thrombocytopenia, and aplastic anemia (pancytopenia) may also occur; discontinue treatment if agranulocytosis, aplastic anemia (pancytopenia) suspected, and patient’s bone marrow indices obtained

    Patients who receive therapy should be under close surveillance and counseled regarding necessity of immediately reporting any evidence of illness, particularly sore throat, skin eruptions, fever, headache, or general malaise; in such cases, white blood cell and differential counts should be obtained to determine whether agranulocytosis has developed; particular care should be exercised with patients who are receiving concomitant drugs known to be associated with agranulocytosis

    Cases of vasculitis resulting in severe complications and death reported; cases of vasculitis include: glomerulonephritis, leukocytoclastic cutaneous vasculitis, alveolar/pulmonary hemorrhage, cerebral angiitis, and ischemic colitis; severe cases require treatment with corticosteroids, immunosuppressant therapy, and plasmapheresis; if vasculitis is suspected, discontinue therapy and initiate appropriate intervention

    Propylthiouracil can cause hypothyroidism necessitating routine monitoring of TSH and free T4 levels with adjustments in dosing to maintain a euthyroid state; because drug readily crosses placental membranes, propylthiouracil can cause fetal goiter and cretinism when administered to a pregnant woman

    Pregnancy Category: D

    Lactation: distributed in breast milk, contraindicated by some sources (AAP Committee states compatible w/ nursing ; AAFP states safe for nursing)

    PTU has a narrow therapeutic window; individualize dosage. General max. doses for routine treatment of hyperthyroidism are listed. Higher doses in the treatment of thyrotoxicosis are typically necessary.

    Adults

    900 mg/day PO; 1.2 grams/day PO in severe disease.

    Geriatric

    900 mg/day PO; 1.2 grams/day PO in severe disease.

    Adolescents

    300 mg/day PO or maximum based on weight: 7 mg/kg/day PO. If growth is complete, doses used may be similar to adult dosing.

    Children

    11 years and older: 300 mg/day PO. Usual weight based maximum: 7 mg/kg/day PO.
    6 to 10 years: 150 mg/day PO. Usual weight based maximum: 7 mg/kg/day PO.
    Less than 6 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    10 mg/kg/day PO has been used off-label for neonatal Graves’ disease.

    Propylthiouracil

    tablet

    • 50mg