Достинекс

Достинекс – prolactin secretion inhibitor.

Form of release and structure

Dosage form – tablets: flat oblong shape, white color, have on one party the marking "Р" and "U" divided by a notch on another – short notches from below and from above numbers "700" (on 2 or 8 pieces in bottles of dark glass, in a cardboard pack 1 bottle).

Active ingredient – каберголин, in 1 tablet – 0,5 mg.

Auxiliary components: leucine, lactose anhydrous.

Indications to use

• Suppression of the established puerperal lactation;
• Prevention of a physiological puerperal lactation;
• Prolaktinsekretiruyushchy adenomas of a hypophysis (macro - and a mikroprolaktinoma), an idiopathic giperprolaktinemiya, a syndrome combination of "an empty Turkish saddle" to a giperprolaktinemiya;
• Therapy of the disturbances connected with a giperprolaktinemiya including a galactorrhoea, anovulation, an amenorrhea and an oligomenorrhea.

Contraindications

• Age up to 16 years;
• The breastfeeding period (women, not persons interested to stop a lactation);
• Hypersensitivity to components of drug and alkaloids of an ergot.

Drug is recommended to be used with care: at a serious cardiovascular illness, Reynaud's syndrome; at a heavy liver failure (it is necessary to appoint lower doses); at gastrointestinal bleedings, a round ulcer; in case of the arterial hypertension which developed against the background of pregnancy (a preeclampsia or puerperal arterial hypertension), appointment is possible only if the potential advantage considerably exceeds probable risk; at heavy cognitive or psychotic disturbances (including data in the anamnesis); at simultaneous use with drugs of hypotensive action (there is a risk of development of orthostatic hypotension), at symptoms, including in the anamnesis, functional disturbances of breath and heart owing to fibrous changes.

Route of administration and dosage

Pill is recommended to be taken inside, during food.

The recommended dosing of reception of Dostineks:

• Suppression of the established lactation: on 0,25 mg (1/2 таб.) 2 times a day. A therapy course 2 days with the general dose of drug of 1 mg. Exceeding of the specified dose can become the reason of development of orthostatic hypotension;
• Prevention of a lactation: once 1 mg (2 таб.) in the first day after the delivery;
• Treatment of the disturbances which arose against the background of a giperprolaktinemiya: on 0,5 mg a week, with gradual increase (no more than on 0,5 mg within 4 weeks) before achievement therapeutic an effective week dose which can fluctuate from 0,25 to 2 mg. Depending on portability of drug, the dose can be accepted once or having divided into several receptions in equal shares (for example, on Monday and on Thursday). For decrease in risk of development of side effects in patients with hypersensitivity to dopaminergic means, it is recommended to begin therapy with a dose on 0,25 mg with gradual increase up to an optimum dose of treatment once a week. The maximum week dose for patients with a giperprolaktinemiya should not exceed 4,5 mg. At purpose of a dose of 1 mg a week and more, it is recommended to be accepted, in proportion having divided into several receptions within a week. In case of development in the patient of strong side effects, temporary decrease in a week dose which increase then is carried out on 0,25 mg of 1 times in 2 weeks is allowed.

Side effects

On the basis of clinical trials, Dostineks's use can become the reason of development of side effects:

• From the alimentary system: pains in epigastric area, nausea, vomiting, an abdominal pain, gastritis, a lock, dyspepsia;
• From cardiovascular system: heartbeat; seldom – a lowering of arterial pressure (asymptomatic) in the first 3-4 days after the delivery (systolic goes down more than on 20 mm, diastolic – more than on 10 mm of a mercury column), orthostatic hypotension (against the background of long therapy means has hypotensive effect);
• From a nervous system: increased fatigue, dizziness (вертиго), syncope, drowsiness, headache, depression, paresthesias, adynamy;
• From laboratory indicators: seldom – decrease in level of hemoglobin at patients with an amenorrhea was observed within the first months after recovery of a menstrual cycle;
• Others: a hyperemia, a mastodynia, a tranzitorny hemianopsia, nasal bleeding, myotonia of legs, vasospasms of fingers (drug has vasoconstrictive property).

Usually, by-effects have passing character and at most of patients pass in process of treatment continuation, and degree of their weight, as a rule, depends on a drug dose.

On the basis of post-market researches use of a kabergolin can cause side effects in a look: alopecias, increases in activity of a kreatinfosfokinaza (KFK) in blood, диспноэ, manias, hypostases, fibrosis, functional disturbances of a liver, a deviation of indicators of function of a liver, rash, hypersensitivity reactions, respiratory disturbances, a valvulopatiya, respiratory insufficiency.

Special instructions

Purpose of drug is made for treatment of the disturbances connected with a giperprolaktinemiya on the basis of data of a full research of function of a hypophysis.

Each increase in a dose should be carried out under observation of the attending physician for definition of the smallest effective dose necessary for achievement of therapeutic effect. After establishment of the mode of dosing, follows at least 1 time a month to conduct researches on determination of level of concentration in prolactin blood serum, its normalization occurs within 2-4 weeks of therapy.

Usually, after drug withdrawal at patients there comes the giperprolaktinemiya recurrence, but in certain cases there is a permanent control of level of prolactin within the next months. After the termination of reception of Dostineks ovulatory cycles at most of women remain at least within 6 months.

At women with a giperprolaktinemichesky hypogonadism drug recovers fertility and an ovulation. As fertilization can happen during the amenorrhea period, it is necessary to carry out tests for pregnancy at least 1 time a month, after recovery of a menstrual cycle – at each delay of periods more than for 3 days. The patients wishing to avoid pregnancy need to use barrier methods of contraception during treatment and after cancellation of means before repetition of anovulation. For timely detection of symptoms of increase in a hypophysis, the woman with the occurred pregnancy, have to be observed constantly by the doctor as during this period increase in the sizes of the existing hypophysis tumors is possible.

Purpose of lower doses for long therapy of patients with a heavy liver failure is recommended.

Достинекс patients are recommended to take with caution with clinical symptoms and/or the available signs of dysfunction of heart and if these states are present at the anamnesis. At patients with the diagnosis a valvulopatiya, a plastic pleuritis or a pleural exudate improvement of health after drug phase-out was noted.

Patients with Parkinson's disease at sudden backfilling against the background of administration of drug are recommended to lower a dose or to cancel treatment.

Researches on therapeutic use of drug at patients of advanced age were not conducted.

Efficiency and safety of use of drug for patients are younger than 16 years is not established.

Drug can cause drowsiness therefore during treatment it is necessary to refrain from control of vehicles and mechanisms.

Medicinal interaction

Simultaneous prolonged use of a kabergolin with other drugs of alkaloids of an ergot is not recommended.

It is impossible to appoint at the same time drug with antagonists of a dopamine, such as фенотиазин, phenyl propyl ketone, thioxanthene, Metoclopramidum as they can weaken prolaktinsnizhayushchy action of Dostineks.

The combination to makrolidny antibiotics can lead (erythromycin) to strengthening of action of a kabergolin.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 2 years.