Instructions for use BROMOCRIPTIN-RICHTER

Pharmacological properties of the drug Bromocriptine

Specific agonist of dopamine receptors (mainly type D2); is a semi-synthetic derivative of ergot alkaloid - ergocryptine. Bromocriptine suppresses the secretion of the anterior pituitary hormone, prolactin, by stimulating dopamine receptors. Bromocriptine does not affect the normal levels of other pituitary hormones, but may reduce the elevated concentrations of growth hormone (GH) in acromegaly. Prolactin is necessary for the initiation and maintenance of lactation in the postpartum period. In other cases, an increase in prolactin secretion leads to pathological lactation (galactorrhea) and/or ovulation and menstrual cycle disorders. Bromocriptine prevents or suppresses physiological lactation, and can also be used in the treatment of pathological conditions caused by increased secretion of prolactin. In amenorrhea or anovulation, with or without galactorrhea, bromocriptine helps restore the menstrual cycle and ovulation. In Stein-Leventhal syndrome, it has a beneficial clinical effect, normalizing LH secretion. For benign breast diseases, bromocriptine helps reduce the size and number of cysts or nodes, eliminating the imbalance between progesterone and estrogens; with prolactin-secreting pituitary adenomas (prolactinomas) - slowing their growth or reducing their size. In acromegaly, it reduces the concentration of growth hormone and prolactin in the blood plasma, increases tolerance to carbohydrates and has a beneficial clinical effect. Bromocriptine in higher doses is used in neurology for Parkinson's disease, characterized by specific dopamine deficiency in the region of the striatum (corpus striatum) and the black nucleus (substantia nigra) of the brain. Bromocriptine stimulates dopamine receptors, restoring neurochemical balance in these parts of the brain. The therapeutic effect of bromocriptine is manifested by a weakening of tremor, rigidity, slowing of movements and a decrease in the severity of other symptoms of parkinsonism at all stages of the disease. Bromocriptine remains clinically effective over several years of use (to date, there have been reports of positive results from its use for 8 years). Bromocriptine can be prescribed as monotherapy or in combination with other antiparkinsonian drugs (for example, levodopa), which allows you to reduce their dose and avoid some side effects. Bromocriptine has some antidepressant effect, reduces the severity of depressive symptoms in Parkinson's disease, as well as in patients with endogenous or psychogenic depression. The maximum concentration of bromocriptine in blood plasma is achieved 1–3 hours after oral administration. The binding of bromocriptine to plasma proteins is 96%. Bromocriptine and its metabolites are excreted primarily in bile and only 6% in urine.

Reviews from doctors

Anatoly, 32 years old

I work as a gynecologist, so I often prescribe Bromocriptine tablets to women with severe premenstrual syndrome. They are safe for the body, but easily eliminate unpleasant symptoms. I recommend taking the medicine 1 piece at a time. five days before the start of menstruation. This helps prevent the development of edema and engorgement of the mammary glands.

Veronica, 49 years old

I work in gynecology and often encounter female infertility. The reasons for the problem are different, sometimes it’s just stress. In combination with other drugs, I sometimes prescribe Bromocriptine to patients. It helps to get pregnant because it improves the functioning of the reproductive organs. The tablets are well tolerated and affordable.

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Elena, 45 years old

I am an oncologist, but patients also come to me with benign tumors. Women more often treat fibrous mastopathy, which is not dangerous to the body and is easily treated. I prescribe Bromocriptine to patients. It helps eliminate cysts and nodules in the mammary gland caused by an increase in prolactin levels. Within six months the tumor resolves.

Indications for use of the drug Bromocriptine

Prolactin-dependent menstrual disorders and female infertility, caused by increased and possibly normal levels of prolactin secretion - amenorrhea with or without galactorrhea, oligomenorrhea, luteal phase insufficiency; disorders due to increased secretion of prolactin caused by taking certain psychotropic, antihypertensive and other drugs; prolactin-independent female infertility - Stein-Leventhal syndrome, anovulatory cycles (an adjuvant in therapy with antiestrogens, for example clomiphene); premenstrual syndrome - breast tenderness, swelling associated with the phase of the cycle, flatulence, mood changes; suppression of lactation - prevention or cessation of postpartum lactation for medical reasons, prevention of lactation after abortion, postpartum mammary hypertrophy; benign diseases of the mammary glands - mastalgia, benign nodular or cystic mastopathy, especially fibrocystic; prolactin-dependent hypogonadism in men - oligospermia, decreased libido, impotence; pituitary prolactinomas - conservative treatment of prolactin-secreting micro- and macroadenomas of the pituitary gland, reducing the size of the tumor before its removal, postoperative treatment while maintaining an elevated level of prolactin in the blood; acromegaly - as an additional remedy (sometimes alternative) during surgical or radiation treatment; all stages of idiopathic Parkinson's disease and postencephalitic parkinsonism (as monotherapy or in combination with other antiparkinsonian drugs).

Analogs

You can replace Bromocriptine with the following medications:

1. Abergin is a domestic drug that contains bromocriptine as an active ingredient. It is produced in tablets that can be used in adults to treat female infertility, prolactin-dependent tumors, acromegaly, hyperprolactemia in men, and to suppress lactation.
2. Bromocriptine-KV is a medicinal product produced in Ukraine, which is available in tablets. They can be taken by patients over 15 years of age, including pregnant women.
3. Bromocriptine-Richter is a Hungarian drug that is available in tablets. According to indications, the drug can be prescribed to children over 15 years of age, pregnant and lactating women.
4. Agalates is an Israeli drug that is a substitute for Bromocriptine in the therapeutic group. The medication is available in tablets that can be used in patients over 16 years of age. It is contraindicated for pregnant and lactating women.

It is permissible to take a substitute instead of Bromocriptine after consulting a doctor.

Use of the drug Bromocriptine

In gynecological and endocrinological practice, the dose of bromocriptine depends on the specific indications for its use. For menstrual irregularities and female infertility, 1.25 mg 2-3 times a day is prescribed, the dose can be gradually increased to 2.5 mg 2-3 times a day. Treatment is continued until the menstrual cycle and/or ovulation normalizes. To prevent relapses, several courses of treatment can be carried out. For premenstrual syndrome, treatment begins on the 14th day of the cycle with a dose of 1.25 mg/day, increasing the dose by 1.25 mg daily to 5 mg/day in 2 divided doses. Treatment is continued until the menstrual cycle is restored. To suppress lactation, on the 1st day, 1.25 mg is prescribed 2 times a day (morning and evening), then 2.5 mg for 14 days. To prevent lactation, therapy should begin a few hours after childbirth or abortion, but only after the vital functions of the body have stabilized. 2-3 days after stopping bromocriptine, a slight secretion of milk is sometimes observed, which can be eliminated by taking the drug in higher doses for another 1 week. For postpartum mammary hypertrophy, bromocriptine is taken once at a dose of 2.5 mg; after 6 or 12 hours, this dose can be taken again, which will not cause undesirable suppression of lactation. For initial manifestations of postpartum mastitis, on the 1st day, 1.25 mg 2 times a day is prescribed, then 2.5 mg 2 times a day for 14 days. If necessary, treatment is carried out in combination with antibiotics. For benign diseases of the mammary glands, 1.25 mg is prescribed 2-3 times a day, gradually increasing the dose to 5-7.5 mg/day. For male hypogonadism, 1.25 mg is prescribed 2-3 times a day, gradually increasing the dose to 5-10 mg/day. For prolactinomas, 1.25 mg is prescribed 2-3 times a day, gradually increasing the dose until a stable suppression of prolactin secretion is achieved (depending on the level of prolactin concentration in the blood plasma), which is usually achieved by taking several tablets per day. For acromegaly, treatment begins with a dose of 1.25 mg/day, gradually increasing the daily dose to 10–20 mg, depending on the clinical effect and the presence of side effects. In Parkinson's disease and postencephalitic parkinsonism, treatment with bromocriptine begins with a daily dose of 1.25 mg for the 1st week, then the daily dose is gradually increased (by 1.25 mg/week) to the minimum effective dose. The daily dose is taken in 2-3 doses. The clinical effect is usually achieved within 6–8 weeks; if necessary, the daily dose continues to be increased by 1.25 mg/week. Therapeutic doses of bromocriptine when used alone or in combination with other antiparkinsonian drugs are 10–40 mg/day, but higher doses may be required. If side effects occur during dose selection, bromocriptine should be taken at a reduced dose for at least 1 week, and if side effects disappear, the dose can be increased. Before starting bromocriptine, patients with movement disorders while taking levodopa are recommended to reduce the dose of the latter, and after achieving a therapeutic effect as a result of using bromocriptine, a gradual reduction in its dose can be continued. In some cases, levodopa can be discontinued. Bromocriptine should be taken with meals, morning and evening, and in the evening for a single dose.

Release form and composition

Dosage form - tablets: almost white, round flat shape, with a chamfer, on one side there is a line mark, on the other - engraving “2.5” (in a cardboard box there is 1 dark glass bottle containing 30 tablets, and instructions for use of Bromocriptine- Richter).

Composition of 1 tablet:

• active substance: bromocriptine – 2.5 mg (bromocriptine mesylate – 2.87 mg);
• auxiliary components: lactose monohydrate – 41 mg; colloidal silicon dioxide – 0.65 mg; povidone K30 – 5.2 mg; corn starch – 35.08 mg; Magnesium stearate – 1.3 mg; microcrystalline cellulose – 40 mg; talc – 3.9 mg.

Side effects of the drug Bromocriptine

In the first days of treatment, mild nausea may occur, and less commonly, dizziness, weakness, irritability, headache, orthostatic hypotension, vomiting, which do not require discontinuation of bromocriptine. The occurrence of these effects can be prevented by taking a peripheral dopamine antagonist (eg domperidone) 1 hour before taking bromocriptine for several days. Sometimes, with long-term treatment with bromocriptine, sudden, reversible blanching of the skin of the fingers and toes when exposed to cold is observed, especially in patients with a history of Raynaud's disease. When treating Parkinson's disease with bromocriptine in high doses, drowsiness may occur, and less commonly, confusion, psychomotor agitation, hallucinations, dyskinesia, a feeling of dry mouth and leg muscle cramps. These side effects are dose-dependent and usually resolve when the dose is reduced, after which it can be carefully increased.

Use during pregnancy

Patients who have reached childbearing age should be aware that while taking Bromocriptine, the use of non-hormonal contraceptive methods is required. If a pregnancy has occurred, which the woman intends to continue, she should stop using this drug. A specialist may advise continuing treatment only when the potential benefit significantly outweighs the potential risk.

When used during the first one and a half months of gestation, there were no cases of negative effects on pregnancy and childbirth. But Bromocriptine still has side effects.

If pregnancy develops in a patient who has a history of pituitary adenoma, the drug should be discontinued. After this, it is necessary to monitor the adenoma throughout the entire period of gestation and constantly analyze the visual fields. If prolactinoma increases, you may need to take Bromocriptine again at the dosage prescribed by your doctor.

Special instructions for the use of the drug Bromocriptine

Caution is required when using bromocriptine in the postpartum period, since hypertension (hypertension), myocardial infarction, seizures, stroke or mental disorders have been reported occasionally (approximately 1 in 100,000) when bromocriptine was used to prevent lactation; sometimes convulsions or cerebrovascular accidents were preceded by a severe headache or temporary visual disturbances. When prescribing bromocriptine in the early postpartum period, blood pressure should be carefully monitored, especially in the first days of treatment. Particular caution is required when treating patients with bromocriptine who have recently taken or are taking medications that regulate blood pressure. If hypertension (arterial hypertension), persistent headache or any signs of neurotoxicity occur, treatment should be discontinued immediately. Bromocriptine should be prescribed in the minimum therapeutically effective doses (except for pathology caused by increased secretion of prolactin) to prevent a decrease in the concentration of prolactin in the blood plasma below normal values, which may adversely affect the function of the corpus luteum in patients. In case of mastalgia and nodular and/or cystic changes in the mammary glands, the presence of malignant neoplasms should be excluded before using bromocriptine. In case of acromegaly, before using bromocriptine, the presence of erosive and ulcerative lesions of the digestive tract should be excluded, and if they are present, it is better to refuse to use bromocriptine or recommend that the patient immediately consult a doctor if any disturbances in the digestive system occur. Caution is warranted due to isolated reports of gastrointestinal bleeding in patients with acromegaly during treatment with bromocriptine, although a causal relationship has not been established. Caution is required when prescribing bromocriptine to patients with a history of psychiatric or severe cardiovascular disease. During treatment with bromocriptine, especially in the first days, arterial hypotension may occur, so caution is required when working with various mechanisms. Tolerance to bromocriptine may be impaired by alcohol consumption. There are isolated reports of the appearance of pleural effusion in patients with parkinsonism who have been receiving bromocriptine in high doses for a long time, therefore patients with pathology of the pleura and lungs of unknown origin should be carefully examined and, if a causal relationship is confirmed, treatment should be discontinued. Several cases of the development of retroperitoneal fibrosis have been described in patients receiving bromocriptine for a number of years at a daily dose of more than 30 mg. For timely diagnosis of retroperitoneal fibrosis in the early, reversible stages of the disease, it is recommended to pay attention to its manifestations (lower back pain, swelling of the lower extremities, impaired renal function, etc.) in this category of patients. If fibrotic changes in the retroperitoneal space are suspected or confirmed, bromocriptine should be discontinued. Treatment with bromocriptine can restore fertility, so if pregnancy is not desired, it is recommended to use reliable methods of contraception. If pregnancy occurs, it is recommended to discontinue bromocriptine and continue taking it only under strict indications. When bromocriptine was discontinued in the early stages of pregnancy, its negative effect on the course and outcome of pregnancy was not noted. When pregnancy occurs in patients with pituitary adenoma, treatment with bromocriptine is discontinued, and the patient is closely monitored during pregnancy. If signs of a pronounced increase in prolactinoma appear (for example, headache or narrowing of visual fields), treatment with bromocriptine can be resumed or surgery may be performed. The use of bromocriptine in the treatment of female infertility followed by pregnancy (over 2000 cases) was not associated with an increased risk of abortion, premature birth or birth defects.

Contraindications

Absolute:

• gestosis;
• heart valve diseases;
• arterial hypertension in the postpartum period;
• essential and familial tremor;
• Huntington's chorea;
• psychoses;
• cardiovascular diseases, including arterial hyper- and hypotension;
• liver failure;
• ulcerative lesions of the gastrointestinal tract;
• age up to 15 years;
• individual intolerance to the components of the drug, as well as other ergot alkaloids.

Relative (Bromocriptine-Richter tablets are prescribed under medical supervision):

• parkinsonism accompanied by symptoms of dementia;
• combined use with drugs prescribed for antihypertensive therapy;
• pregnancy and lactation period.

Drug interactions Bromocriptine

The combined use of bromocriptine and levodopa enhances the antiparkinsonian effect, which often makes it possible to reduce the dose of levodopa. Bromocriptine is especially indicated for patients in whom the effectiveness of levodopa is reduced or complications such as pathological involuntary movements (choreoathetoid dyskinesia and/or painful dystonia) arise, the effectiveness sharply decreases towards the end of action, or the effectiveness of bromocriptine is sharply fluctuating on and off. Erythromycin or josamycin may cause an increase in bromocriptine plasma concentrations.