TEVA #Urogenital_tract #Other_gynecology #HEALTH_CARE
Indications
Inhibition / inhibition of physiological lactation
Alactin is prescribed to inhibit physiological postpartum lactation immediately after childbirth or to suppress lactation that has been established in the following cases:
after childbirth, if the mother has decided not to breastfeed the child, or when breastfeeding is contraindicated for the mother or child for medical reasons;
after the birth of a dead fetus or after an abortion.
Cabergoline inhibits/inhibits physiological lactation by inhibiting prolactin secretion. In controlled clinical studies, a single dose of cabergoline at a dose of 1 mg on the first day after birth was effective in inhibiting milk secretion, as well as breast swelling and pain in 70-90% of women. Fewer than 5% of women experienced recovery of breast symptoms in the third week postpartum (which was generally mild in severity).
Suppression of milk secretion and relief from breast swelling and chest pain was observed in approximately 85% of women during lactation when used for two days in a total dose of cabergoline 1 mg divided into four doses. Cases of renewal of symptoms in the chest after 10 days are rare (about 2% of cases).
Treatment of hyperprolactinemic conditions
Alactin is indicated for the treatment of disorders associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea. The preparation is indicated for the treatment of patients with prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinemia or empty sella syndrome with concomitant hyperprolactinemia, which are the main pathological conditions that cause the above.
In long-term treatment at doses of 1 to 2 mg per week, cabergoline was effective in normalizing serum prolactin levels in approximately 84% of patients with hyperprolactinemia.
Regular cycles resumed in 83% of women with amenorrhea. Restoration of ovulation has been documented in 89% of women in terms of progesterone, the level of which was monitored during the luteal phase. Galactorrhea that occurred before treatment disappeared in 90% of cases. In 50-90% of women and men with micro- or macroprolactinoma, a decrease in tumor size was detected.
Contraindications
Hypersensitivity to cabergoline, other ergot alkaloids or to any component of the preparation.
A history of fibrotic disease of the lungs, pericardium and retroperitoneum.
Simultaneous use of antipsychotic preparations.
For long-term treatment: signs of heart valve damage, determined by echocardiography before treatment (see section "Peculiarities of use").
Postpartum hypertension or uncontrolled hypertension.
Preeclampsia, eclampsia.
History of psychosis or risk of developing postpartum psychosis.
The preparation is contraindicated in patients with hepatic insufficiency and pregnant women with preeclampsia.
Compound
active ingredient: cabergoline;
1 tablet contains 0.5 mg cabergoline;
other ingredients: anhydrous lactose, leucine, magnesium stearate.
Dosage and administration
Alaktin is intended for oral use. The tablet can be divided in half.
To reduce the risk of gastrointestinal side effects, it is recommended to take cabergoline with meals for all therapeutic indications.
Inhibition / inhibition of physiological lactation
To inhibit postpartum lactation, Alaktin should be used within the first 24 hours after delivery. The recommended therapeutic dose is 1 mg (2 tablets of 0.5 mg) of cabergoline once.
To suppress existing lactation - 0.25 mg (1/2 tablet of 0.5 mg) every 12 hours for 2 days (total dose - 1 mg). This dosage regimen is better tolerated by women who choose to suppress lactation than a single dose, and is associated with a lower incidence of adverse events, especially symptoms of arterial hypotension.
Treatment of hyperprolactinemic conditions
The recommended starting dose of Alactin is 0.5 mg once a week or ½ tablet of 0.5 mg 2 times a week (for example, on Monday and Thursday). If necessary, you can gradually increase the dose under the supervision of a physician by 0.5 mg per week at monthly intervals until the optimal therapeutic effect is achieved. The usual therapeutic dose is 1 mg/week and may range from 0.25 mg to 2 mg/week. For the treatment of patients with hyperprolactinemia, cabergoline has been used at doses up to 4.5 mg per week.
The maximum dose should not exceed 3 mg/day.
The weekly dose can be administered as a single dose or spread over 2 or more doses per week, depending on the tolerance of the preparation to the patient. The distribution of the weekly dose into several doses is recommended if the weekly dose is more than 1 mg, since the tolerability of the preparation in a dosage of more than 1 mg when taken as a single weekly dose was evaluated in only a few patients.
When selecting a dose, patients should be examined to determine the minimum effective therapeutic dose. Once an effective therapeutic dosage regimen has been selected, regular (monthly) determination of plasma prolactin levels is recommended, since normalization of prolactin levels is usually observed within 2-4 weeks of treatment.
After discontinuation of cabergoline, a relapse of hyperprolactinemia is usually observed. However, in some patients, the suppression of prolactin levels was observed for several months. Twenty-three of the 29 women in the follow-up group had ovulatory cycles longer than 6 months after stopping cabergoline.
Elderly patients
Experience with the use of cabergoline in the elderly is very limited due to the proposed indications for the use of cabergoline. Available data indicate no particular risk.
Dose reduction or discontinuation of treatment
Consideration should be given to reducing the dose or discontinuing treatment if patients have:
drowsiness or cases of sudden falling asleep;
liver dysfunction.
Children.
The safety and efficacy of the preparation in patients under 16 years of age have not been studied.
Overdose
Overdose symptoms may be similar to those arising from excessive stimulation of dopamine receptors (eg, nausea, vomiting, gastric disorders, arterial hypotension, impaired consciousness/psychosis, or hallucinations). In such cases, urgent medical attention is required.
In case of an overdose, it is necessary to take general measures to remove the preparation that has not yet been absorbed and, if necessary, to maintain blood pressure. In addition, it may be advisable to administer dopamine antagonist preparations.
Storage conditions
Store at a temperature not exceeding 30 C in the original packaging to protect against moisture and out of the reach of children. Moisture adsorbing mini bag of silica gel should not be removed from the bottle.
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