Propycil^® (Tablets) Instructions for Use

Marketing Authorization Holder

Admeda Arzneimittel, GmbH (Germany)

Manufactured By

Klocke Pharma-Service, GmbH (Germany)

ATC Code

H03BA02 (Propylthiouracil)

Active Substance

Propylthiouracil (Rec.INN registered by WHO)

Dosage Form

Propycil®

Tablets 50 mg: 20 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white, round, biconvex with a score line.

Excipients: lactose monohydrate – 73.9 mg, corn starch – 50 mg, colloidal silicon dioxide – 1.5 mg, povidone – 4 mg, pregelatinized corn starch – 10 mg, magnesium stearate – 0.6 mg.

20 pcs. – glass bottles (1) – cardboard packs.
100 pcs. – glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antithyroid drug

Pharmacotherapeutic Group

Antithyroid agent

Pharmacological Action

It has a pronounced thyrostatic effect.

It prevents the process of thyroglobulin iodination, reduces the formation of the active form of iodine in the thyroid gland by blocking the peroxidase system.

It inhibits the conversion of T₄ to T₃ by forming reverse T₃.

Indications

Diffuse and mixed toxic goiter, autoimmune thyroiditis with hyperthyroidism, preoperative preparation for the treatment of toxic goiter and postoperative therapy, preparation for the treatment of toxic goiter with radioactive iodine.

ICD codes

Dosage Regimen

Determine the dosage individually based on the severity of hyperthyroidism and the patient’s clinical response.

Initiate therapy with a total daily dose of 300-400 mg, divided into 3-4 equal doses.

For severe thyrotoxicosis, increase the total daily dose to 600-900 mg, administered in 4-6 divided doses.

Administer tablets orally, always after meals, with a full glass of water.

After achieving a euthyroid state, typically within 4-8 weeks, initiate dose reduction.

Gradually titrate the dose downward to the lowest effective maintenance level.

The usual maintenance dose ranges from 50 mg to 150 mg per day, often administered as a single daily dose or in two divided doses.

For children aged 6 to 10 years, the average daily dose is 50-150 mg, divided into 3 doses.

For children over 10 years of age, the average daily dose is 150-300 mg, divided into 3 doses.

Continue therapy for a total duration of 1 to 1.5 years to maximize the chance of sustained remission.

Monitor thyroid function tests regularly and adjust the dose accordingly throughout the entire treatment course.

Adverse Reactions

Possible itching, paresthesia, alopecia, anorexia, nausea, vomiting.
Rarely hyperthermia, periarteritis.
Very rarely agranulocytosis, pancytopenia, goitrogenic effect, hypothyroidism.

Contraindications

Absolute: hypothyroidism, leukopenia, agranulocytosis, active hepatitis, liver cirrhosis, pregnancy, lactation, hypersensitivity to propylthiouracil.

Relative: persistent hepatitis, fatty liver disease, nodular goiter.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Use in Hepatic Impairment

Absolute contraindications: active hepatitis, liver cirrhosis.

Relative contraindications: persistent hepatitis, fatty liver disease.

Pediatric Use

Use in children over 6 years of age is possible according to the dosing regimen.

Special Precautions

Treatment should be carried out under the control of thyroid hormone levels, blood morphological picture, liver transaminase activity levels, bilirubin concentration, and alkaline phosphatase.

Drug Interactions

Propylthiouracil should not be used simultaneously with drugs that inhibit leukopoiesis.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.