Bula do remedy Propilracil

the package insert of the medicine Propilracil. Active principles Propylthioracil. Sale under medical prescription.

what For?

Propilracil is indicated in the clinical treatment of hyperthyroidism. Can also be used to improve hyperthyroidism in preparation for thyroidectomy, sub-total or radioactive iodine therapy. Indicated also when thyroidectomy is contraindicated or not recommended.


When should I not use?

Propylthioracil is contraindicated in patients who are hypersensitive to the active ingredient and the period of breastfeeding, since the drug is excreted in breast milk.


How to use?

Adults: the initial dose is 1 tablet every 8 hours up to a total daily dose of 300 mg (3 tablets). in patients with hyperthyroidism is severe, large goiters, or both, the initial dose can be 2 tablets every 8 hours up to a daily dose of 600 mg (6 tablets). the maintenance dose for most patients is 100 to 200 mg per day, (1 to 2 tablets) in doses fractionated.

Children: for children 6 to 10 years of age the initial dose is 50 to 150 mg per day, in doses fractionated. children above 10 years, the initial dose is 150 to 300 mg per day, in doses fractionated. the maintenance dose will be determined according to the response of the patient.

Side Effects

What are the evils that can cause me?

The adverse reactions occur in less than 1% of treated patients. The reactions of the light include: skin rash, urticaria, nausea, vomiting, arthralgia, paresthesias, loss of taste, abnormal drop of hair, myalgia, headache, pruritus, drowsiness, neuritis, edema, vertigo, skin pigmentation, jaundice, sialoadenopatia and lymphadenopathy.

The adverse reactions are more severe, are still less frequent, and include: agranulocytosis, a syndrome similar to systemic lupus, hepatitis, periarthritis, hipoprotrombinemia, thrombocytopenia, bleeding, and fever.

it Is interesting to note that approximately 10% of patients with hyperthyroidism is not treated can present with leukopenia.

Warnings and Precautions

what should I know before using?

patients treated with propylthioracil should be controlled and informed of the need to report immediately any occurrences such as: fever, sore throat, skin rashes, headaches, or malaise. In such cases, a count, total and differential leukocytes should be performed to detect agranulocytosis. Particular attention should be given to those patients in concomitant use of other substances that are known to cause agranulocytosis. It is recommended to note the frequent prothrombin time in patients treated with propylthioracil, especially before surgery, as this drug can cause hipoprotrombinemia and bleeding.

Pregnancy – Propylthioracil, when used judiciously, is effective in hyperthyroidism complicated by pregnancy. Crosses the placental barrier and may cause goiter and even cretinism in the developing fetus; therefore, a dose sufficient, but not excessive, should be administered. The dysfunction tireioidiana tends to decrease with the course of the pregnancy, and if so, reduce the dosage. However, it is important to use the lowest dose possible during pregnancy, and to assess the thyroid function of the baby carefully. When propylthioracil is used in pregnancy or if the patient becomes pregnant during treatment, you should inform about the possible risks that the drug may cause to the fetus.

Lactation – The patients treated with propylthioracil should not breastfeed their babies, because the drug is excreted into breast milk.

Pediatrics – Using propylthioracil in children have not demonstrated response and pharmacokinetics study different from adults.

Geriatric care (elderly) – In elderly patients the sensitivity to the product is greater than in younger people. It is advisable that the physician accompany the treatment. In cases in which the patient suffers from heart disease, agents antitireodianos and/or agents, beta-blockers adrenergic agonists should be administered for 4 to 6 weeks before treatment with radioactive iodine, which helps to reduce the possible exacerbation of heart disease caused by thyroiditis induced by radiation. The antititeroidianos should be discontinued 3-4 days prior to treatment with radioactive iodine and should not be re-adiministrados up to 1 week after treatment.

If necessary, the agents beta-blockers adrenergic agonists can be used during the entire treatment period.

liver Failure – Patients with hepatic insufficiency, may have a half-life of elimination of the propylthioracil prolonged, proportional to the degree of liver failure.


Compressed. Box with 30 tablets.

Use the pediatric or adult.

Drug Interactions

concomitant use with amiodarone, glycerol, iodinated, iodine or potassium iodide may decrease the response to the propylthioracil.

The propylthioracil potentiates the action of anticoagulants and the risk of bleeding increases more in the case of associations with medicines mielodepressores and hepatotoxic.


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Interference In Laboratory Tests

The results of the diagnostics suffer interference with iodide of sodium (I123, I131) or with pertecnetato sodium (Tc-99m).

The plasma concentrations of SGOT (Serum Glutâmica oxaloacetic transaminase), SGPT (Serum Glutâmica pyruvic transaminase), alkaline phosphatase, bilirubin, and lactate dehydrogenase may be elevated. The prothrombin time is increased.


Biolab Sanus Farmacêutica Ltda.

the SAC: 0800 724 6522


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Attention: the remedy of The earth is a space character only, with issues related to health and well-being, The information here disclosed shall not be used as a substitute for a doctor’s prescription for the treatment of any disease.