Propitsil

Propitsil – drug of the expressed thyreostatic action.

Form of release and structure

Dosage form of Propitsil – a tablet: round, biconvex, with dividing risky, white color (on 20 or 100 pieces in a bottle from glass, in a cardboard pack 1 bottle).

Structure of 1 tablet:

• Active ingredient: propylthiouracil – 50 mg;
• Auxiliary components: silicon dioxide colloid, povidone, starch corn, starch corn prezhelatinizirovanny, lactoses monohydrate, magnesium stearate.

Indications to use

For patients with a thyrotoxicosis the indication to Propitsil's use are the following states / diseases:

• Toxic craw or toxic adenoma of a thyroid gland;
• Preoperative preparation for a resection of a thyroid gland and postoperative treatment;
• Preparation for therapy by a radioiodine.

Contraindications

• Lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption;
• Hypothyroidism;
• Leukopenia;
• Chronic active hepatitis;
• Heavy side reactions at the previous therapy by propylthiouracil (a heavy liver failure, an agranulocytosis);
• Individual hypersensitivity.

During pregnancy therapy is allowed under strict medical observation after careful assessment of potential advantage for mother and possible risks for a fruit. Propitsil accept in the lowest dose in order to avoid an abortion and development of a craw and/or a hypothyroidism in a fruit.

When breastfeeding Propitsil is choice drug as in breast milk its concentration makes 1/10 from the content of propylthiouracil in blood serum of the feeding woman. In some cases at the newborn the hypothyroidism therefore medical control is necessary can develop.

Route of administration and dosage

Pill is taken inside, without chewing, washing down with liquid in enough. It is recommended to maintain an interval between receptions of 6-8 hours.

To children under 3 years of a tablet just before reception dissolve in water before formation of a thin suspension.

Daily dose, depending on age of the patient:

• Newborns (at a hyperthyroidism): in an initiation of treatment of 5-10 mg/kg of body weight, divided into 3 receptions (in case of lack of the response to therapy the dose is recommended to be increased by 50-100%); a maintenance therapy – 3-4 mg/kg of body weight;
• Children of 6-10 years: in an initiation of treatment – 1-3 tablets (50-150 mg); a maintenance therapy – ^1/2-1 tablet (25-50 mg);
• Children of 10 years, teenagers and adults: in an initiation of treatment – ^11/2-2 tablets (75-100 mg); a maintenance therapy – 1-3 tablets (50-150 mg); at complications and after loading iodine increase in an initial dose the tablets (300-600 mg) distributed on 4-6 receptions is necessary till 6-12.

Elimination half-life of maternal immunoglobulin – 2-3 months, by this time perhaps spontaneous recovery of functions of a thyroid gland of the newborn.

At advanced age propylthiouracil is recommended in lower doses.

With a renal failure or being on a hemodialysis dose adjustment it is not required to patients.

At liver diseases Propitsil is applied in the established doses, taking into account the recommended contraindications.

Duration of therapy is defined by individual needs of the patient and can make, for example, at a thyrotoxicosis, toxic adenoma of a thyroid gland and a diffusion toxic craw from 1,5 to 2 years.

In the preparatory period before surgical intervention or treatment by a radioiodine duration of use of drug has to correspond to individual need of the patient.

Propitsil is allowed to use both for monotherapy of a diffusion toxic craw, and as a part of complex treatment with sodium left thyroxine according to the scheme "block-replace".

Side effects

• Sometimes: skin rash, a small tortoiseshell, a stomach ache, an arthralgia (without symptoms of an inflammation of joints), formation of a craw at newborns;
• Seldom: the agranulocytosis which is followed by septic complications;
• Very seldom (it is preferential at use of high doses of propylthiouracil): damages of a liver (tranzitorny cholestasia, hepatocellular necrosis), allergic reactions, medicinal fever, thrombocytopenia, lymphadenopathy;
• Separate cases: neuromuscular frustration, polyarthritis, disturbance of sense of smell and flavoring sensitivity, vasculitis, volchanochnopodobny syndrome, hearing loss, nodular periarteritis, gastrointestinal frustration (nausea, vomiting), dizziness, disturbance of an erythrogenesis, hemolysis, positive reactions of Koombs, intersticial pneumonia, asthma, peripheral hypostases, alopecia.

During therapy by Propitsil the enlargement of the thyroid gland is possible.

In case of diagnosing of a liver failure, an agranulocytosis, a vasculitis (the states posing a potential threat of life of the patient) further therapy has to be carried out under careful medical control.

Cases of acute intoxication were not observed by propylthiouracil.

At chronic overdose the craw and a hypothyroidism which symptomatology depends on degree of depression of function of the thyroid gland caused by specific action of a tireostatik develop. For therapy of this state there are no special measures / actions. The gastric lavage and endoscopic removal of the remains of tablets are ineffective that is connected with bystry absorption of active agent.

After drug withdrawal, as a rule, recovery of function of a thyroid gland happens spontaneously.

Special instructions

Development of an agranulocytosis can proceed is almost unpredictable and is rapid (within several hours). The patient needs to be informed on clinical symptoms of a disease (an indisposition, fever, stomatitis, tonsillar quinsy) and at their emergence to conduct a blood picture research.

Prior to therapy it is necessary to make an integrated analysis of blood, and in the course of treatment to control a functional condition of a thyroid gland (concentration in blood of thyroid hormones and/or TTG).

At treatment by too high doses of propylthiouracil already existing craw can increase that in case of an intrathoracic or zagrudny craw can lead to squeezing of anatomical structures in a mediastinum.

Pathological change of number of uniform elements of blood and increase in activity of transaminases is an indicator for Propitsil's use only under strict medical control.

Medicinal interaction

Therapy according to the scheme "block and replace" in a combination with left thyroxine of sodium demands increase in a dose of propylthiouracil.

Thyreostatic action of Propitsil can reduce the simultaneous or previous use of iodinated means or X-ray contrast agents.

Additional dose adjustment of derivatives of coumarin and propranolol as propylthiouracil is capable to influence effect of their free active fractions can be required.

Miyelotoksichny drugs strengthen Propitsil's gematotoksichnost.

Terms and storage conditions

To store in unavailable to children, the dark, dry place at a temperature up to 25 °C.

Period of validity – 5 years.