Agalates

Agalates – drug with dofaminergichesky action.

Form of release and structure

Agalates release in the form of tablets: white, flat, oval, on one party – risk and a facet, on the one hand from risks – an engraving "0,5", with another – "CBG" (on 2 or 8 pieces in dark glass bottles, on 1 bottle in a cardboard pack).

Is a part of 1 tablet:

• Active agent: каберголин – 0,5 mg;
• Auxiliary components: A L-leucine – 3,6 mg, lactose – 75,8 mg, magnesium stearate (E572) – 0,1 mg.

Indications to use

• The disturbances connected with a giperprolaktinemiya (including an amenorrhea, an oligomenorrhea, anovulation, a galactorrhoea);
• Suppression of a lactation: physiological puerperal or already established (it is exclusive on medical indications);
• Idiopathic giperprolaktinemiya;
• Prolaktinsekretiruyushchy adenomas of a hypophysis (macro - and mikroprolaktinoma).

Contraindications

Absolute:

• Defeat of valves of heart owing to long therapy kabergoliny, confirmed EhoKG;
• Arterial hypertension (puerperal or uncontrollable);
• The undesirable phenomena from lungs, including the fibrosis or pleurisy (including in the presence of instructions in the anamnesis) connected with reception of agonists of a dopamine;
• Heavy abnormal liver functions;
• Lactose intolerance, deficit of lactase, syndrome of glyukozo-galaktozny malabsorption;
• Psychoses (including in the presence of instructions in the anamnesis) or risk of their emergence;
• Simultaneous use with antibiotics of group of macroleads;
• Pregnancy and the preeclampsia and eclampsia which developed on its background;
• Lactation period;
• Age up to 16 years;
• Hypersensitivity to components of drug and other alkaloids of an ergot.

Relative (Agalates it is necessary to appoint with care against the background of the following diseases / states):

• Diseases of cardiovascular system;
• Arterial hypotension;
• Reynaud's syndrome;
• Round ulcers or gastrointestinal bleedings;
• Drowsiness, sudden attacks of a dream;
• End-stage of a renal failure (including the patients who are on a hemodialysis);
• The age is more senior than 65 years.

Also it is necessary to be careful in case of prolonged treatment by Agalates.

Route of administration and dosage

Agalates accept inside, it is desirable – during food.

The recommended initial dose at treatment of the disturbances connected with a giperprolaktinemiya – 1 tablet a week in 1 or 2 receptions (for example, on Monday and Thursday). The dose before achievement of optimum therapeutic effect needs to be increased gradually, as a rule, by 1 tablet a week at an interval of 30 days.

The maximum daily dose – 6 tablets.

Average maintenance dose – 2 tablets a week (from 1/2 to 4 tablets; in certain cases at a giperprolaktinemiya appoint up to 9 tablets a week).

At a dose more than 2 tablets a week it should be divided into 2 or more receptions (depending on Agalates's portability).

The recommended dose for suppression of a lactation – once 2 tablets for the first days after the child's birth.

Side effects

Probable side effects (≥10% – are very frequent; ≥1%, but <10% – is frequent; ≥ 0,1%, but <1% – infrequently; ≥ 0,01%, but <0,1% – are rare; <0,01% taking into account isolated cases – are very rare):

• Nervous system: often – drowsiness, frustration of a dream, a hallucination, a headache, confusion, dizziness, dyskinesia, increase in a libido, a depression; infrequently – a passing hemianopsia, a hyperkinesia, psychotic frustration, paresthesia, nonsense, a syncope; very seldom – a morbid attraction to gamblings, a sudden attack of a dream;
• Alimentary system: very often – nausea, an abdominal pain; often – vomiting, dyspepsia, gastritis, a lock; seldom – pain in epigastric area; very seldom – retroperitoneal fibrosis;
• Respiratory system: often – an asthma; infrequently – lung fibrosis, a pleural exudate, nasal bleeding;
• Cardiovascular system: often – a heart consciousness, stenocardia, postural hypotension, defeat of valves of heart (including with regurgitation), a pericardiac exudate, a pericardis, inflows, peripheral hypostases;
• System of a hemopoiesis: infrequently – an eritromelalgiya;
• Immune system: infrequently – skin rash, hypersensitivity reactions;
• Others: often – a vision disorder, weakness, an adynamy, a mammary gland pain, an abnormal liver function; very seldom – increase in activity of a kreatinfosfokinaza, a spasm in muscles of the lower extremities.

Special instructions

For opening of a bottle at first it is necessary to press a cover, then to turn it, as shown in a cover. To take from a bottle and to use inside the capsule with silica gel it is impossible.

Influence of alcohol on the general portability of active agent – a kabergolin, was not established.

Agalates's use can lead to development of symptomatic arterial hypotension, in particular at the combined reception with the drugs reducing arterial pressure. In this regard in the first 3-4 days after an initiation of treatment regular measurement of the ABP is recommended.

At long therapy the risk of development of such serous and inflammatory and fibrous diseases as pulmonary fibrosis, exudative pleurisy, a pericardis, pleural fibrosis, retroperitoneal fibrosis, defeat of one and more valves of heart increases (aortal, mitral, three-leaved). Agalates's cancellation in these cases leads to improvement of symptoms and signs.

Before purpose of a long medical course for identification of defeat of valves of heart, definition of a functional condition of kidneys and lungs it is necessary to undergo full inspection (for prevention of deterioration in a course of the accompanying diseases).

In case of development of new clinical symptoms from respiratory system carrying out roentgenoscopy of lungs is recommended. At pleural exudates / fibroses increase in SOE (at its increase without strong clinical signs it is also necessary to conduct radiological examination) was noted.

At a long course perhaps gradual development of fibrous disturbances. In this regard during therapy it is necessary to exercise control of emergence of the following symptoms: hypostasis of the lower extremities, short wind, cough, breath shortening, thorax and waist pain, signs of existence of heart failure, retroperitoneal fibrosis.

For prevention of fibrous disturbances after the beginning of therapy within 3-6 months it is necessary to control a condition of valves of heart and to conduct an ECG examination. Further the doctor establishes the frequency of control of an ECG individually, but at least, than 1 time in 6-12 months. At emergence or deterioration in valve regurgitation, narrowing of a gleam or a thickening of a wall of the valve Agalates cancel.

The doctor defines need of the patient for other types of clinical inspection individually.

It is necessary to consider that Agalates can lead to development of drowsiness and episodes of sudden backfilling, in particular at Parkinson's disease.

Therapy can be followed by increase a libido, hyper sexuality, a morbid attraction to gamblings. These symptoms have reversible character and pass independently at reduction of a dose or cancellation of treatment.

Before Agalates's appointment it is necessary to find out the giperprolaktinemiya reason as it in combination with infertility and an amenorrhea can be connected with hypophysis tumors.

It is recommended to check the content of prolactin in blood serum every month (normal concentration of prolactin after achievement of the effective therapeutic mode remains for 2-4 weeks).

Giperprolaktinemiya after Agalates's cancellation, as a rule, arises again. However at some patients permanent decrease in concentration of prolactin is observed within several months.

Agalates's use recovers fertility and an ovulation at women with a giperprolaktinemichesky hypogonadism. Pregnancy can occur before resuming of periods therefore carrying out tests for pregnancy in the period of an amenorrhea is recommended, and after recovery of a menstrual cycle – in all cases at their delay longer, than for 3 days. To the women who are not planning pregnancy during treatment, and also after its termination it is recommended to apply effective non-hormonal contraceptive remedies. Conception is recommended to women who plan pregnancy not earlier, than in 1 month after the end of therapy.

During the driving of the car or control of mechanisms it is necessary to be careful. Patients at whom episodes of sudden backfilling and/or drowsiness were noted during Agalates's use should refuse driving or other works demanding at their performance of the increased concentration of attention and bystry psychomotor reactions.

Medicinal interaction

The combined use of Agalates is not recommended with the following drugs:

• Makrolidny antibiotics: because of probability of increase in level of a kabergolin;
• Antagonists of dopamine receptors (thioxanthenes, phenyl propyl ketones, fenotiazina, Metoclopramidum): because of direct stimulation of dopamine receptors;
• Other alkaloids of an ergot (prolonged simultaneous use): the mechanism of interaction is not studied.

At joint appointment with the drugs reducing arterial pressure it is necessary to consider hypotensive action of Agalates.

Pharmacokinetic interaction with other medicinal means / substances is not studied.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature up to 30 °C in densely closed original bottle.

Period of validity – 2 years.