Use in women of reproductive age is only possible when pre-treatment no pregnancy is confirmed negative test and matched reliable methods of contraception.
Before starting treatment should conduct a survey confirming the absence of pregnancy, and, on doctor’s advice to women of reproductive age Gynecology-, they should use reliable methods of contraception.
it is necessary to inform patients that due to the use of the drug pharmacokinetic interaction fluoxymesterone 10mg diazepam may reduce the efficacy of oral hormonal contraceptives. For this reason, women of childbearing age must not use a hormonal contraceptive method, as the sole; you must use an additional or an alternative reliable method of contraception (oral, injectable, and transdermal therapeutic systems, implantable intrauterine devices). Please refer to a gynecologist for individual selection of a reliable means of contraception. 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 wit is recommended 1 time per month to carry out a pregnancy test for the earliest possible diagnosis of pregnancy.
Possible effects on spermatogenesis in adult
In study investigated the effect of the drug on spermatogenesis when taken at a dose of 62.5 mg 2 times a day for 4 weeks, and then – 125 mg per day for 5 months. The study included 25 adult men and IV at baseline unchanged spermogramme; conducted analysis of data obtained in 23 patients, two patients were excluded due to the side effects that are not related to changes in spermatogenesis. The majority of patients after 6 months of treatment, the total number of sperm were observed in the normal range, do not set the morphology changes, sperm motility, changes in hormonal status. Only one patient in spermogramme marked signs oligospermia after 3 months of treatment , the total number of sperm was reduced at two subsequent analyzes over the next 6 weeks. After 2 months after the abolition total number of sperm in this patient has returned to baseline to study. The significance of the described observations to be determined, especially given the high interindividual variability of the total number of sperm in patients. Nevertheless, the data does not allow to eliminate the possibility of endothelin receptor antagonists, which include preparation , spermatogenesis in men and no systematic effect of long-term use is not contrary to the results of toxicological studies of the drug.
Venookklyuzionnaya pulmonary disease
It is necessary to consider the possibility of concomitant diseases venookklyuzionnogo if the intake of the drug Traklir ® in patients with PAH, there are signs of pulmonary edema.
Fluid retention and worsening
Peripheral edema – one of the clinical symptoms of fluoxymesterone 10mg diazepam, at the same time when applying endothelin receptor antagonists deterioration often occurs. In 20 placebo-controlled studies conducted on the testimony and digital ulcers, peripheral edema and fluid retention in the body have been observed in 13.2% of patients receiving bosentan and 10.9% -. Placebo
In addition, in the post-marketing period we received numerous reports of fluid retention in patients during the first weeks of preparation . Therefore, patients administered receiving diuretics, conduct liquid consumption control and diuresis, when deterioration of a heart failure requiring hospitalization.
If indicated clinically severe fluid retention, whether accompanied by it increases in body weight or not, should be carried out examination for clarify the causes of fluid retention in the body (the use or heart failure) as well as to assess the need for continued treatment with fluoxymesterone 10mg diazepam or its cancellation.