Bergolak instructions for use
Bergolac is a drug of the dopamine receptor agonist group that suppresses prolactin secretion. It is used to treat disorders developing in hyperprolactinemia.
Release form and composition
Bergolak is available in tablets, 2, 8, 10 and 30 tablets per pack.
The main active ingredient is cabergoline. 1 tablet contains 500 µg of cabergoline.
Auxiliary components: magnesium stearate, lactose anhydrous, leucine.
Pharmacodynamics. Cabergoline reduces the content of prolactin in the blood, helps to restore the menstrual cycle. In women, as a result of a decrease in the concentration of prolactin, the production of gonadotropins and the release of luteinizing hormone are restored. The severity of hyperandrogenic (hirsutism, acne ) and hypoandrogenic (fluid retention, osteoporosis, weight gain) symptoms decreases.
In men, such manifestations of hyperprolactinemia as impotence and decreased libido, lactorrhea, gynecomastia (decrease in the concentration of prolactin causes an increase in testosterone production) are reduced.
Pharmacokinetics. Cabergoline is well absorbed. Absorption rates do not depend on meal times. The time to reach the maximum plasma concentration of the active substance is from half an hour to 4 hours. 41–42% of cabergoline is bound to blood proteins. The half-life in patients with hyperprolactinemia ranges from 79 to 115 hours, in healthy people, this figure varies from 63 to 68 hours. Since the period of removal of cabergoline is long, the equilibrium concentration of the substance in the blood is noted after 4 weeks of treatment.
The drug is metabolized, but the metabolites are characterized by a significantly lower therapeutic effect. Excreted by the kidneys (18%, of which about 3% unchanged) and through the intestines (72%).
Indications for use
Bergolak tablets are used for:
- postpartum lactation warnings;
- oppression of established lactation;
- treatment of disorders associated with hyperprolactinemia, including aminurea, anovulation, oligomenorrhea, galactorrhea;
- treatment of pituitary prolactin-secreting adenoma;
- treatment of idiopathic hyperprolactinemia;
- treatment of empty turkish saddle syndrome with hyperprolactinemia.
The drug is not appointed:
- with hypersensitivity to cabergoline or auxiliary components, any ergot alkaloids;
- patients with galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption;
- age under 16 years old.
Dosing and Administration
Tablets are taken with meals. Dosing regimen depends on the indications.
To prevent lactation after birth , 1000 mcg (2 tablets) once, on the first day after birth.
For inhibition of steady-state lactation , 250 µg (1/2 tablet) twice a day, every 12 hours, for 2 days (total dose - 2000 µg).
For the treatment of hyperprolactinemia and related disorders - 500 µg per week (1 tablet once or ½ tablet in two doses, with an interval of 3-4 days). With a monthly interval, the dose is increased by 500 μg to achieve the expected therapeutic effect. Typically, the optimal therapeutic dose is 1000 mcg per week, but can vary from 250 mcg to 2000 mcg (from ½ tablet to 4 tablets) of cabergoline. The maximum dosage should not exceed 4500 mcg (9 tablets) per week. In the appointment of the drug in a dosage greater than 1000 micrograms (2 tablets), it is recommended to take tablets in several doses.
The drug is well tolerated by patients. In some situations, the development of side effects from various organ systems is possible:
- on the part of the digestive system - dyspeptic symptoms (heartburn, flatulence), nausea and vomiting, constipation, abnormal liver function;
- from the heart, blood vessels and hematopoietic systems - orthostatic hypotension;
- on the part of the nervous system - headache, dizziness, paresthesia, depression, nervousness, drowsiness and fatigue, impaired visual function;
- allergic reactions - skin rash, hypersensitivity reactions;
- from other systems - dysmenorrhea , hot flashes, pain in the mammary glands.
As a rule, side effects are mild or moderate. Mostly occur in the first 2 weeks of application. They take place with further treatment or after discontinuation of the drug. Patients with Parkinson's disease may additionally experience confusion and hallucinations, dyskinesia, and peripheral edema. Rarely - pulmonary fibrosis and pleural effusion, heart failure, gastric / duodenal ulcer.
Overdose of the drug causes nausea and vomiting, constipation, abdominal pain, lowering blood pressure, orthostatic hypotension, headache, nervous agitation, psychosis, hallucinations, convulsions of the calf muscles. To eliminate the toxic effects of high doses of the drug, gastric lavage, blood pressure control, prescription of a group of dopamine receptor antagonists (metoclopramide, butyrophenone, etc.) are carried out.
During the use of the drug is important to consider the following points:
- before the appointment of cabergoline, a complete study of the function of the pituitary
- during treatment requires regular (once every 30 days) determination of the concentration of prolactin in the blood;
- to reduce the risk of orthostatic hypertension, a single dose of Bergolak for nursing mothers should be no more than 250 μg;
- with the abolition of the drug may be a relapse of hyperprolactinemia;
- during treatment, it is impossible to engage in activities requiring concentration of attention and quickness of psychomotor reactions, control of transport and other mechanisms;
- with the simultaneous use of Bergolaka with antihypertensives, caution is required;
- with long-term drug treatment should not simultaneously take money based on ergot alkaloids;
- the effect of cabergoline is weakened while taking metoclopramide, thioxanthene, butyrophenone, phenothiazine derivatives;
- when Bergolak is combined with macrolide antibiotics, the concentration of cabergoline in the blood plasma increases;
- pregnant drug is prescribed only in case of emergency, when the expected benefit to the mother outweighs the potential risks to the fetus;
- During the month after the end of the therapeutic course, pregnancy should be avoided;
- during lactation when applying cabergoline breastfeeding should be stopped.
In some diseases, the drug is prescribed with caution. Among them:
- Raynaud's syndrome , severe diseases of the heart and blood vessels, fibrotic changes of the heart (valvulopathy);
- arterial hypertension on the background of pregnancy, before and / or postpartum arterial hypertension;
- severe liver failure;
- gastrointestinal bleeding, peptic ulcer;
- congenital and psychotic disorders;
- fibrotic changes of the respiratory system (pleural fibrosis, pleurisy ).
The drugs similar to the active substance include Dostinex tablets, Agalates tablets, Cabergoline tablets.
Terms and conditions of storage
Bergolak tablets are stored protected from sunlight, out of reach of children at room temperature (up to 25 ° C). The shelf life of the drug is 2 years. Do not use tablets after the expiration date indicated on the package.
Bergolak tablets 0.5 mg, 8 pcs. - from 598 rubles.