In preclinical studies established reproductive toxicity of bosentan (teratogenic and foetotoxic effects). Clinical trials of the drug in women during pregnancy has not been evaluated. Possible risk has not been studied in pregnancy. Application of medication halotestin during pregnancy is contraindicated.
Use in women of reproductive age
before the start of treatment should confirm the absence of pregnancy, doctors are required to make recommendations for the prevention of pregnancy, and patients should be to adopt reliable methods of contraception in women of reproductive age. Patients and doctors who prescribe should be borne in mind that, due to pharmacokinetic interactions, may reduce the effectiveness of hormonal contraceptives. For this reason, women of childbearing age is not recommended to use a method of hormonal contraception (medicines used by mouth, by injection, transdermal therapeutic systems As a single; it is necessary to use an additional or alternative reliable contraceptive. If there are doubts regarding the method used contraception for individual selection of a reliable method of contraception the patient should consult a gynecologist. Given the decline in the effectiveness of hormonal contraception and the possible negative impact of pregnancy on the course of the Arab League, during therapy it is recommended to hold monthly pregnancy test that will diagnose early pregnancy.
is not known whether bosentan is excreted in breast milk. Breast-feeding is not recommended during treatment .
Dosing and Administration
Tablets are film-coated, taken orally morning and evening, regardless of the time eating, not chewing and washing down with water.
Treatment of pulmonary arterial hypertension to improve exercise capacity and symptoms in patients clinical II-IV functional class according classification
Use in Adults
The initial dose of the drug halotestin. for 4 weeks then the dose is increased to support in 125 mg 2 times / day.
In some patients after failure while taking a dose of 125 mg 2 times a day, there may be some increase in exercise tolerance by increasing the dose up to 250 mg 2 times / day. You should carefully evaluate the benefit / risk ratio, considering the negative dose-dependent effect of the drug on the liver.
Discontinuation of therapy
There is limited experience of observation of patients after the sudden cessation of therapy . Data on clinically significant deterioration in current resulting from abrupt withdrawal of the drug is not. However, to reduce the risk of deterioration of the clinical condition of patients and to prevent the “cancellation” syndrome, it is recommended to reduce the dose gradually (by reducing it by half within 3-7 days), starting at the same time carrying out alternative therapies.
Reducing the number of new digital ulcers in adults with progressive systemic sclerosis and ulcerative lesions of the extremities
clinical condition of patients need to be monitored regularly, carefully evaluating the benefit / risk ratio for further therapy and taking into account the possible negative impact of the drug on the liver function. Data on the efficacy and safety of the drug in children under 18 years are not available.
Use in special patient groups
Abnormal liver function
in patients with mild hepatic impairment (5-6 points on a scale of Chail-Pugh) do not require dose adjustment. Applications halotestinin patients with moderate severity and severe hepatic impairment should be avoided (7 points or higher on the scale of Child-Pugh).