BERGOLAK INSTRUCTION MANUAL
Bergolak is a drug of a group of dopamine receptor agonists that suppresses the secretion of prolactin. It is used to treat disorders developing in hyperprolactinaemia.
Form of issue and composition
Bergolak is available in tablets, 2, 8, 10 and 30 tablets per package.
The main active substance is cabergoline. 1 tablet contains 500 micrograms of cabergoline.
Auxiliary components: magnesium stearate, anhydrous lactose, leucine.
Pharmacodynamics. Cabergoline lowers the content of prolactin in the blood, helps 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. Reduced severity of hyperandrogenic (hirsutism, acne ) and hypoandrogenic (fluid retention, osteoporosis, weight gain) signs.
In men, such manifestations of hyperprolactinaemia as impotence and decreased libido, lactorrhea, gynecomastia decrease (decrease in prolactin concentration causes an increase in testosterone production).
Pharmacokinetics. Cabergoline is well absorbed. Absorption rates do not depend on the time of ingestion. The time to reach the maximum plasma concentration of the active substance is from half an hour to 4 hours. 41-42% of cabergoline binds to blood proteins. The half-life in patients with hyperprolactinemia ranges from 79 to 115 hours, in healthy people this index varies within 63 - 68 hours. Since the withdrawal period of cabergoline is long, the equilibrium concentration of the substance in the blood is observed after 4 weeks of treatment.
The drug is metabolized, but metabolites are characterized by significantly less therapeutic effect. It is excreted by the kidneys (18%, of which about 3% is unchanged) and through the intestine (72%).
Indications for use
Bergolak tablets are used for:
- prevention of postpartum lactation;
- oppression of steady lactation;
- treatment of disorders associated with hyperprolactinaemia, including aminorrhea, anovulation, oligomenorrhoea, galactorrhea;
- treatment of prolactin secreting adenoma of the pituitary gland;
- treatment of idiopathic hyperprolactinaemia;
- treatment of the syndrome of the empty Turkish saddle with hyperprolactinemia.
The drug is not prescribed:
- with increased sensitivity to cabergoline or ancillary components, any ergot alkaloids;
- patients with intolerance to galactose, congenital deficiency of lactase or glucose-galactose malabsorption;
- age younger than 16 years.
Method of application and dosage
Tablets are taken during meals. The dosage regimen depends on the indications.
To prevent lactation after childbirth - 1000 mcg (2 tablets) once, in the first day after childbirth.
To suppress the steady lactation - 250 mcg (1/2 tablet) twice a day, every 12 hours, for 2 days (total dose - 2000 mcg).
For the treatment of hyperprolactinaemia and related disorders - 500 mcg per week (1 tablet once or 1/2 tablet in two divided doses, 3-4 days apart). With a monthly interval, a dose increase of 500 μg is carried out until the expected therapeutic effect is achieved. Usually the optimal therapeutic dose is 1000 μg per week, but can vary from 250 μg to 2000 μg (from ½ tablets to 4 tablets) of cabergoline. The maximum dosage should not exceed 4500 μg (9 tablets) per week. When appointing the drug at a dosage exceeding 1000 mcg (2 tablets), it is recommended to take the pills in several doses.
The drug is well tolerated by patients. In some situations, the development of side effects from various systems of organs is possible:
- on the part of the digestive system - dyspeptic phenomena (heartburn, flatulence), nausea and vomiting, constipation, impaired liver function;
- from the heart, blood vessels and hematopoietic systems - orthostatic hypotension;
- from the side 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 flushes, pain in the mammary glands.
As a rule, the side effects are mild or moderate. Basically occur in the first 2 weeks of the drug. Pass as the treatment continues or after the drug is discontinued. In patients with Parkinson's disease, confusion and hallucinations, dyskinesia, and peripheral edema may also occur. Rarely - pulmonary fibrosis and pleural effusion, heart failure, stomach ulcer / duodenal ulcer.
When an overdose of the drug occurs nausea and vomiting, constipation, abdominal pain, lowering blood pressure, orthostatic hypotension, headache, nervous excitement, psychosis, hallucinations, cramps calf muscles. To eliminate the toxic effect of high doses of the drug, gastric lavage, control of blood pressure, administration of preparations of the group of antagonists of dopamine receptors (metoclopramide, butirofenone and others) are carried out.
During the use of the drug it is important to consider the following points:
- Before the appointment of cabergoline, a complete examination of the pituitary gland function is mandatory;
- During treatment, a regular (once every 30 days) determination of the concentration of prolactin in the blood is required;
- To reduce the risk of orthostatic hypertension, a single dose of Bergolak for breastfeeding mothers should not exceed 250 micrograms;
- when the drug is withdrawn, relapse of hyperprolactinemia may occur;
- during the treatment it is impossible to engage in activities requiring concentration of attention and speed of psychomotor reactions, to manage transport and other mechanisms;
- while using Bergolak with hypotensive agents, care must be taken;
- with prolonged treatment with the drug should not simultaneously take funds based on ergot alkaloids;
- the effect of cabergoline is weakened by simultaneous administration of metoclopramide, thioxanthene, butyrophenone, phenothiazine derivatives;
- when Bergolak is combined with antibiotics of the macrolide group, the concentration of cabergoline in the blood plasma increases;
- pregnant drug is prescribed only in case of emergency, when the expected benefit for the mother exceeds the potential risks to the fetus;
- During the month after the end of the therapeutic course, pregnancy should be avoided;
- During lactation with the use of cabergoline breastfeeding should be stopped.
For some diseases, the drug is prescribed with caution. Among them:
- Raynaud's syndrome , severe heart and vascular disease, fibrotic changes of the heart (valvulopathy);
- arterial hypertension on the background of pregnancy, before and / or postpartum arterial hypertension;
- severe hepatic impairment;
- gastrointestinal bleeding, peptic ulcer;
- congitative and psychotic disorders;
- fibrotic changes in the respiratory system (pleural fibrosis, pleurisy ).
To similar on active substance preparations concern tablets of Dostinex, tablets Agalates, tablets Kabergolin.
Terms and conditions of storage
Bergolak tablets are stored in a place protected from the sun, out of reach of children at room temperature (up to 25 ° C). Shelf life of the drug is 2 years. Do not use the tablet at the end of the shelf life indicated on the package.
Bergalak tablets 0.5 mg, 8 pcs. - from 598 rubles.