Since controlled clinical trials with in pregnant women has been conducted, use of the drug during pregnancy is possible only in cases of extreme necessity, taking into account the benefit / risk ratio for the woman and the fetus.
If the pregnancy during treatment with , should be consider the appropriateness tri tren side effects of discontinuation of the drug, also taking into account the benefit / risk ratio.
pregnancy should be avoided for at least one month after discontinuation of , given the long half-life of the drug and the presence of limited data about its effects on the fetus (although, according to reports , the use of at a dose of 0.5-2 mg per week over the disorders associated with hyperprolactinemia, was not accompanied by an increase in the frequency of miscarriage, premature delivery, multiple pregnancy and congenital malformations).
Data on drug excretion in breast milk is not, however, in the absence of the effect of the use of for the prevention or suppression of lactation mothers should abandon breastfeeding. When violations associated with hyperprolactinemia, should not be administered to mothers who wish to breastfeed.
Dosing and Administration
Inside, during a meal. Lactation Prevention : 1 mg once daily (two tablets of 0.5 mg) on the first day after birth. The suppression of established lactation : 0.25 mg (1/2 tablet) twice day every 12 hours in two days (total dose is 1 mg). To reduce the risk of orthostatic hypotension in breast-feeding mothers, single dose should not exceed 0.25 mg. The treatment of disorders associated with hyperprolactinemia : The recommended initial dose is 0.5 mg per week at a time (1 tablet 0.5 mg ) or in two (1/2 0.5 mg tablets, for example, on Monday and Thursday). Increase weekly dose should be carried out gradually – a 0.5 mg monthly intervals until the optimal therapeutic effect. The therapeutic dose is usually 1 mg per week, but can range from 0.25 to 2 mg per week. The maximum dose for female patients with hyperprolactinemia should not exceed 4.5 mg per week. Depending on tolerability weekly dose may be administered once or divided into two or more receptions a week. Separation of the weekly dose into several times is recommended when administering the drug in a dose of 1 mg per week. In patients with hypersensitivity to dopaminergic drugs probability of side effects can be reduced by initiation of therapy, at a lower dose (eg, 0.25 mg once once a week), followed tri tren side effects by a gradual increase to achieve its therapeutic dose. To improve the tolerability of the drug in the event of significant side effects may be a temporary reduction of the dose, followed by a more gradual increase in it (for example, increased by 0.25 mg per week every two weeks).
in clinical studies using for the prevention of physiological lactation (1 mg dose) and for the suppression of lactation (0,25 mg every 12 hours for 2 days) side effects were observed in approximately 14% of women. When applying for 6 months at a dose of 1.2 mg per week, divided into 2 doses, for treatment of disorders associated with hyperprolactinemia , the frequency of side effects was 68%. Adverse events occurred mainly during the first 2 weeks of treatment and in most cases, disappeared with continued therapy or a few days after discontinuation . Adverse events were generally transient, according to severity – mild or moderately expressed and were dose-dependent. At least once in the course of therapy, serious adverse events occurred in 14% of patients;due to side effects of the treatment was stopped in about 3% of patients.
The most frequent side effects are presented below: For the cardiovascular system : heart rate; rarely – orthostatic hypotension (with prolonged use Dostinex ® usually has a hypotensive effect); possibly asymptomatic decrease in blood pressure during the first 3-4 days after birth (systolic – more than 20 mm Hg, diastolic – by more than 10 mm Hg). From the nervous system : dizziness / vertigo, headache, fatigue, drowsiness, depression, fatigue, paresthesia, syncope. From the digestive system : nausea, vomiting, epigastric pain, abdominal pain, constipation, gastritis, dyspepsia. Other : mammalgia, nosebleeds, “tides” of blood to the skin face, transient hemianopsia, vasospasm of the fingers and lower limbs muscle cramps (like other ergot derivatives, tri tren side effects can have a vasoconstrictor effect).When long-term therapy with deviation from the norm of standard laboratory parameters are rarely mentioned; in women with amenorrhea there was a decrease in hemoglobin levels during the first few months after the restoration of menstruation. In postmarketing study also recorded the following side effects associated with taking .info: alopecia, elevated creatinine phosphokinase in the blood, delusions, dyspnea, edema, fibrosis, disorders liver function and abnormalities in liver function, hypersensitivity reactions, rash, respiratory disorder, respiratory failure, valvulopatiya.