Description
Latin name
Propicil ®
Release form
Tablets.
Packaging
In a bottle of 20 tablets.
Pharmacological action
Has a pronounced thyreostatic effect. It interferes with the process of thyroglobulin iodination, reduces the formation of an active form of iodine in the thyroid gland, blocking the peroxidase system. It inhibits the conversion of T4 to T3 by the formation of reversible T3.
Indications
thyrotoxicosis (diffuse toxic goiter, toxic thyroid adenoma)
preparation for thyroid resection
preparation for treatment with radioactive iodine.
To avoid complications, use only after consulting a doctor.
Contraindications
hypersensitivity
leukopenia, agranulocytosis
hypothyroidism
active hepatitis, cirrhosis, impaired liver function.
Use during pregnancy and lactation
As thyrotoxicosis, hypothyroidism in pregnant women is also associated with an increase in the frequency 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 the fetus.
The dose of Propitsil ® 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, a spontaneous decrease in the severity of thyrotoxicosis is often observed.
During pregnancy, treatment is carried out under strict supervision (the level of thyroid hormones should be at the upper limit of normal, thyrotropin level should be below normal).
During the period of breastfeeding, Propicil ® is considered the drug of choice, because its concentration in breast milk is 1/10 of the level in the mother’s blood serum. However, observation of the newborn is necessary, as There are reports of individual cases of hypothyroidism.
With a combination of diffuse toxic goiter and pregnancy, Propicil ® is prescribed only as monotherapy.
Composition
1 tab.
propylthiouracil 50 mg
excipients: lactose monohydrate starch corn silicon dioxide colloidal povidone starch gelatinized magnesium stearate
Dosing and Administration
Inside, without chewing, swallowing whole, drinking plenty of fluids, every 6 8 hours.
At the beginning of treatment, adults and children over 10 years old are prescribed 75 100 mg (1.5 to 2 mg) tab.) per day. In severe cases and after the previous iodine load, the initial daily dose is increased to 300 600 mg (6 12 tablets distributed 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 receive at the beginning of treatment 50-150 mg (1 to 3 tablets) per day, and with maintenance treatment about 25-50 mg (0.5 to 1 tablets) per day .
With thyrotoxicosis in newborns, 5 10 mg / kg / day is prescribed (the daily dose is divided into 3 doses). If there is no response to treatment, it is recommended that the dose be increased by 1.5 2 times (by 75 100%).
The maintenance dose is 3-4 mg / kg / day.
According to existing data, in patients suffering from renal failure or undergoing hemodialysis, there is no need for dose adjustment. For liver diseases, the drug can be taken in recommended doses, taking into account the relevant contraindications.
The duration of treatment is determined by the individual need of the patient.
Experience with the therapeutic use of Propicil ® shows that the duration of treatment for thyrotoxicosis with diffuse toxic goiter and toxic thyroid adenoma should be 1.5 2 years.
In preparation for surgery or treatment with radioactive iodine, the duration of the drug should be appropriate to the individual needs of the patient. Propitsil ® can be used to treat diffuse toxic goiter both in the form of monotherapy and in the block and replace regimen.
Side effects
Agranulocytosis is a serious but rare side effect, accompanied by septic complications.
Sometimes skin rashes, hives, stomach pain, arthralgia without signs of joint inflammation, goiter formation in a newborn in very rare cases (especially when using the drug 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 individual cases of neuromuscular disorders, polyarthritis, lupus-like syndrome, periarteritis nodosa, gastrointestinal disorders (nausea, vomiting), dizziness, erythropoiesis disorders, hemolysis, positive Coombs reaction, interstitial pneumonia, and peripheral edema.
During treatment with Propicil ®, an enlargement of the thyroid gland may occur.
Overdose
No acute intoxication was observed. Chronic overdose leads to the development of goiter and hypothyroidism with symptoms dependent on the severity of hypothyroidism due to the specific action of the antithyroid agent.
Treatment: There are no special measures / activities. Gastric lavage and endoscopic removal of pill residues are not effective due to rapid absorption of the active substance. With the development of goiter and hypothyroidism, accompanied by symptoms correlating with the severity of hypothyroidism, and caused by a chronic drug overdose, Propicil ® treatment is discontinued and pending the spontaneous restoration of thyroid function. Thyroxine replacement therapy is performed if justified by the severity of hypothyroidism.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C.
Expiration
5 years.
Active ingredient
Propy uracil
Terms of delivery p1756565ffafaf from
pharmacies Prescription
dosage form
dosage form
tablets
Haupt Farma Berlin GmbH, Germany
