Instruction for use: Propicil

Active substancePropylthiouracil

ATX codeH03BA02 Propylthiouracil

Pharmacological group of substance Calcitonin

Thyroid agent [Thyroid and parathyroid hormones, their analogs and antagonists (including antithyroid agents) / 67 /]

Nosological classification (ICD-10)

E05.0 Thyrotoxicosis with diffuse goiter

Goiter toxic diffuse, Toxic goiter, Diffuse thyrotoxic goiter, Graves disease, Diffuse toxic goiter, Goiter diffuse toxic, Parry's disease, Flanyani disease, Von Bazedova's disease, Toxic diffuse goiter

E05.9 Thyrotoxicosis, unspecified

tireotoksicski reaction, Enlargement of the thyroid gland with symptoms of hyperthyroidism, The phenomenon of iodine Basedow, Thyroid hyperplasia, hyperthyroid state, Hyperthyroidism, Thyroid dysfunction, Diffuse thyrotoxic goiter, The latent thyrotoxicosis, Increased thyroid function, thyrotoxicosis

Composition and form of production

Tablets 1 table.

Propylthiouracil 50 mg

Auxiliary substances: lactose monohydrate; corn starch; Silicon dioxide colloid; Povidone; Gelatinized starch; Magnesium stearate

In bottles of 20 pcs .; In the box 1 bottle.

Description of dosage form

White round biconvex tablets with separating risk.

pharmachologic effect

Pharmacological action - antithyroid.

Indications

Thyrotoxicosis (diffuse toxic goiter, toxic adenoma of the thyroid gland);

Preparation for resection of the thyroid gland;

Preparation for treatment with radioactive iodine.

To avoid complications, use only after consulting a doctor.

Contraindications

Hypersensitivity;

Leukopenia, agranulocytosis;

Hypothyroidism;

Active hepatitis, cirrhosis of the liver, impaired liver function.

pregnancy and lactation

Both thyrotoxicosis and hypothyroidism in pregnant women are associated with an increase in the incidence of miscarriages, stillbirths and developmental abnormalities.

The frequency of developmental abnormalities in cases of treatment with Propicil® does not differ from the frequency of spontaneous abnormalities of fetal development.

The dose of Propicil® should be as low as possible to avoid miscarriage, as well as the development of hypothyroidism and goiter in the fetus.

In the last three months of pregnancy, spontaneous decrease in the expression of thyrotoxicosis is often observed.

In pregnancy, treatment is carried out under strict supervision (the level of thyroid hormones should be at the upper limit of the norm, the level of thyrotropin should be below the norm).

During the period of breastfeeding, Propicil® is considered the drug of choice. Its concentration in breast milk is 1/10 of the level in the mother's blood serum. However, it is necessary to observe the newborn, since There are reports of individual cases of hypothyroidism.

When combined with diffuse toxic goiter and pregnancy, Propicil® is prescribed only as a monotherapy.

Side effects

Agranulocytosis is a serious, but rare, side effect, accompanied by septic complications.

Sometimes there are rashes on the skin, hives, pains in the stomach, arthralgia without signs of joint inflammation, the formation of goiter in a newborn; In very rare cases (especially when the drug is used in high doses), the following side effects were observed: liver damage (hepatic cell necrosis, transient cholestasis), hypersensitivity reactions, drug fever, lymphadenopathy and thrombocytopenia.

There are reports of isolated cases of neuromuscular disorders, polyarthritis, lupus-like syndrome, nodular periarteritis, gastrointestinal disorders (nausea, vomiting), dizziness, erythropoiesis disorders, hemolysis, Coombs positive reaction, interstitial pneumonia, peripheral edema and alopecia.

In the course of treatment with Propicil®, an enlargement of the thyroid gland may occur.

Interaction

In case the treatment with Propicil® is carried out according to the "block and replace" scheme in combination with thyroxine, the dose of Propicil® should be increased.

The thyrotoxic effect of propicil® decreases with simultaneous or previous use of iodine-containing drugs or radiopaque substances.

In connection with the ability of propylthiouracil to affect the effect of free active fractions of propranolol and coumarin derivatives, an additional correction of the doses of these drugs is necessary.

Dosing and Administration

Inside, not liquid, swallowing whole, with a sufficient amount of liquid, every 6-8 hours.

At the beginning of treatment, adults and children over 10 years of age are prescribed 75-100 mg (1.5 to 2 tablets) per day. In severe cases and after the previous loading with iodine, the initial daily dose is increased to 300-600 mg (6-12 tablets, divided into 4-6 single doses).

The maintenance dose is 25-150 mg (0.5 to 3 tablets) per day.

Children aged 6 to 10 years old receive 50-150 mg (1 to 3 tablets) a day at the beginning of treatment, and about 25-50 mg (0.5 to 1 table) per day with maintenance treatment.

With thyrotoxicosis, newborns are prescribed 5-10 mg / kg / day (the daily dose is divided into 3 doses). In the absence of response to treatment, an increase in the dose of 1.5-2 times (75-100%) is recommended.

The maintenance dose is 3-4 mg / kg / day.

According to existing data, patients who suffer from renal insufficiency or who are on hemodialysis do not need to adjust the dose. With liver diseases, the drug can be taken at recommended doses, taking into account the appropriate contraindications.

The duration of treatment is determined by the individual need of the patient.

The experience of therapeutic use of the drug Propicil® shows that the duration of treatment of thyrotoxicosis in diffuse toxic goiter and toxic adenoma of the thyroid gland should be 1.5-2 years.

When preparing for surgical intervention or treatment with radioactive iodine, the duration of application of the drug should correspond to the individual need of the patient. Propicil® can be used to treat diffuse toxic goiter both in the form of monotherapy, and in the "block and replace" scheme.

Overdose

No cases of acute intoxication were observed. Chronic overdose leads to the development of goiter and hypothyroidism with symptoms that are dependent on the severity of hypothyroidism due to the specific action of the antithyroid agent.

Treatment: there are no special measures / measures. Gastric lavage and endoscopic removal of tablet residues are not effective because of rapid absorption of the active substance. With the development of goiter and hypothyroidism, accompanied by symptoms that correlate with the severity of hypothyroidism, and caused by a chronic overdose of the drug, treatment with Propicil® is discontinued and the spontaneous recovery of thyroid function is expected. Substitution therapy with thyroxine is carried out if this is justified by the severity of hypothyroidism.

Precautionary measures

Agranulocytosis can develop within a few hours. Since in most cases the development of agranulocytosis can not be predicted even with constant monitoring of the morphological picture of the blood, the patient should be informed of the signs of agranulocytosis (fever, malaise, tonsillar tonsillitis, stomatitis) and the need for immediate examination of the blood picture.

During treatment with an antithyroid agent, the functional state of the thyroid gland (the level of thyroid hormones and / or thyrotropin of the blood) should be monitored.

Treatment with too high doses of an antithyroid agent leads to the appearance or increase of an already existing goiter. This should be borne in mind primarily for intrathoracic localization of goiter, which is associated with the danger of squeezing the anatomical structures in the mediastinum.

special instructions

Propicil® is contraindicated in patients who have previously experienced severe side effects of the drug (agranulocytosis, severe liver damage).

When pathological changes in the number of blood cells and the increase in transaminase activity, Propicil ® can be used only under the strict supervision of a physician.

Influence on the ability to drive a car and to control machines and mechanisms. Does not affect.

storage Conditions

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.