Bromocriptine-Richter, 30 pcs., 2.5 mg, tablets

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Bromocriptine

To prevent nausea and/or vomiting, at the beginning of treatment, a peripheral dopamine receptor antagonist, for example, domperidone, can be prescribed for several days, no later than 1 hour before taking bromocriptine.

When treating acromegaly, before prescribing the drug, the presence of gastric and duodenal ulcers should be excluded and the patient should be warned about the need to notify the doctor if gastrointestinal disorders occur.

There are reports of fatal gastrointestinal bleeding with the use of bromocriptine. There is no evidence that this is specifically related to the use of bromocriptine. Therefore, it is not recommended to use bromocriptine in patients with erosive and ulcerative lesions of the gastrointestinal tract in the acute stage.

If gastrointestinal bleeding or gastric and duodenal ulcers occur, the drug should be discontinued.

Treatment of women with prolactin-dependent dysmenorrhea leads to normalization of ovulation, and therefore the patient should be warned about the need to use contraception (except for oral contraceptives).

Bromocriptine is not recommended for use as a prophylactic agent or to reduce postpartum breast engorgement in cases where the use of antispasmodics, analgesics and wearing comfortable supportive underwear is effective.

Due to the limited amount of clinical data, the drug is not recommended for the treatment of premenstrual syndrome and benign breast diseases.

Patients are recommended to visit a gynecologist annually; for women aged before menopause - every six months.

Patients taking bromocriptine may experience symptomatic hypotension; in some cases, arterial hypotension may occur at the beginning of treatment, especially in the second week of therapy. Blood pressure should be monitored daily, especially during the first weeks of therapy. In the future, blood pressure should be monitored at regular intervals.

If arterial hypertension develops, severe persistent headaches (with or without visual disturbances) or signs of central nervous system (CNS) toxicity occur, treatment should be discontinued and the patient should be examined medically.

In some patients with acromegaly, the development of “cold” vasospasm was observed when using bromocriptine. In this case, it is necessary to reduce the dose of bromocriptine.

During long-term treatment (2-10 years) with high doses of the drug (30 mg per day), patients should be especially closely monitored for the possible appearance of signs of retroperitoneal fibrosis (for example, back pain, swelling of the lower extremities, impaired renal function), in which case it is necessary to stop treatment.

Caution should be exercised when treating patients with Parkinson's disease who may have mild dementia.

Bromocriptine, when used alone or in combination with levodopa, may cause auditory or visual hallucinations. In most cases, hallucinations can be eliminated by reducing the dose of bromocriptine; sometimes it is necessary to stop treatment.

Bromocriptine is ineffective for essential and familial tremor, as well as Huntington's chorea.

If treatment with bromocriptine is prescribed to women for pathology not associated with hyperprolactinemia, the drug should be used in the minimum effective dose necessary to relieve symptoms; this is necessary to ensure that the concentration of prolactin in the blood plasma does not decrease below the normal level, as this can cause disturbances in the development of the corpus luteum.

In patients with pituitary macroadenomas, the dynamics of tumor size should be systematically assessed.

Before initiating treatment for patients with macroprolactinoma, it is necessary to conduct a complete examination of pituitary function. In patients with secondary adrenal insufficiency, glucocorticosteroid replacement therapy has important clinical significance. It is necessary to regularly monitor the size of the pituitary tumor (macropituitary adenoma), and if its size increases, despite the therapy, it is necessary to decide on surgical treatment.

Patients who do not wish to become pregnant or who have large prolactin-secreting pituitary adenomas should be advised to use contraceptive measures other than oral contraceptives during treatment with bromocriptine. During the period of amenorrhea, it is recommended to carry out a pregnancy test at least once every 4 weeks, and, when the menstrual cycle is restored, every time there is a delay in menstruation. If pregnancy occurs during treatment with the drug in patients with a pituitary tumor, careful monitoring of the patients is necessary. Prolactin-secreting adenomas may enlarge during pregnancy. In severe cases, compression of the optic or other cranial nerves may occur, which may require emergency surgery.

Visual impairment (loss of visual fields) is a known complication of prolactinoma. Effective treatment with the drug leads to a decrease in the concentration of prolactin in the blood plasma and vision often improves. However, some patients may develop secondary visual field loss despite normal plasma prolactin concentrations and a decrease in tumor size, which may result from a displacement of the optic chiasm towards the sella turcica (formation of a hernia of the optic chiasm). Therefore, for early diagnosis of secondary visual field loss due to optic chiasm hernia, monitoring of visual fields in patients with macroprolactinoma is necessary for timely adjustment of the dose of bromocriptine.

Cerebrospinal fluid rhinorrhea has been observed in some patients with prolactin-secreting adenomas when treated with bromocriptine.

Careful oral hygiene is necessary. If dryness of the oral mucosa persists for more than 2 weeks, you should consult a doctor.

The use of bromocriptine may cause drowsiness or episodes of sudden onset of sleep (particularly in patients with Parkinson's disease) during the day, without any previous symptoms. In such cases, reducing the dose of the drug should be considered.

Use in children and adolescents

The effectiveness and safety of bromocriptine have been established in children with prolactinomas and acromegaly over 7 years of age. Given the difficult to predict sensitivity of children and adolescents, caution should be exercised when using the drug in this category of patients. The safety and effectiveness of bromocriptine in children under 7 years of age have not been confirmed.

Use in patients over 65 years of age

The number of patients aged 65 years and older in the clinical trials was insufficient to evaluate possible differences in response to treatment with bromocriptine compared with younger patients. In clinical studies and medical practice, the tolerability of the drug in patients over 65 years of age and younger patients was the same.

Given the difficult to predict tolerability of the drug in patients over 65 years of age, caution should be exercised when using the drug in this category of patients.

Use in the postpartum period

In women taking bromocriptine in the postpartum period to suppress lactation, rare cases of serious adverse events such as hypertension, myocardial infarction, seizures, stroke or mental disorders were observed, especially at the beginning of treatment.

In some patients, the development of seizures or cerebrovascular accidents was preceded by severe headaches and/or transient visual impairment.

Although the cause-and-effect relationship between the development of these phenomena and the use of bromocriptine has not been established, blood pressure should be monitored in all patients taking Bromocriptine. If arterial hypertension or severe, progressive or persistent headache (with or without visual impairment) or signs of a central nervous system disorder develop, the drug should be discontinued and immediately examined.

In patients with Parkinson's disease, when using high doses of bromocriptine, gambling addiction, increased libido and hypersexuality, compulsive shopping and spending money, and compulsive overeating are possible. Patients and their relatives should be warned about the possible development of these behavioral control disorders. In case of development of behavioral disorders, it is necessary to reduce the dose of bromocriptine or stop taking it.

There is no need for special precautions when disposing of unused drug.

Use of the drug Bromocriptine-Richter

The drug is taken orally with meals. To eliminate menstrual irregularities and treat female infertility, Bromocriptine is prescribed in a daily dose of 2.5–3.75 mg (1/2 tablet 2–3 times a day); if necessary, the daily dose is increased by 2 times. Treatment is continued until the menstrual cycle normalizes and/or ovulation occurs. In order to consolidate the effect, treatment can be continued for several cycles. To prevent physiological lactation, Bromocriptine is prescribed in a daily dose of 5 mg (1 tablet 2 times a day) for 14 days. Taking the drug should begin as soon as possible after childbirth or abortion, but not earlier than 4 hours. 2-3 days after discontinuation of the drug, a slight secretion of milk is possible, in this case, resume taking Bromocriptine at the same dose for 1 week. To reduce physiological lactation in case of engorgement of the mammary glands or the development of mastitis in the postpartum period, Bromocriptine is taken once in a dose of 2.5 mg (1 tablet). If necessary, after 6-12 hours you can re-take the drug in the same dose. For mastitis, antibiotics are used at the same time. For prolactinoma, Bromocriptine is initially used in a daily dose of 2.5–3.75 mg (1/2 tablet 2–3 times a day), then gradually increase the dose of the drug until a corresponding decrease in the level of prolactin in the blood plasma is achieved. For acromegaly, Bromocriptine is used in an initial daily dose of 2.5–3.75 mg (1/2 tablet 2–3 times a day), then, if necessary (depending on the achieved clinical effect), the dose of the drug can be increased to 10–20 mg /day For parkinsonism, Bromocriptine is taken in an initial dose of 1.25 mg (both in mono- and combination therapy), preferably in the evening. If necessary, the dose of the drug is increased by 1.25 mg every 7 days. The daily dose of the drug is divided into 2-3 doses. Typically, the therapeutic dose of the drug is (for both mono- and combination therapy) 10–40 mg. The therapeutic effect is achieved within 6–8 weeks. In exceptional cases, it may be necessary to use the drug at a higher dose (no more than 100 mg/day), and an individual approach is required. If side effects occur during the selection of the optimal dose, the dose of the drug should be reduced for a period of at least 1 week. After the side effects disappear, the dose of the drug can be increased again. When carrying out maintenance therapy, the drug should be used in the minimum effective dose. For benign tumors of the mammary glands, Bromocriptine is used in a daily dose of 2.5–3.75 mg (1/2 tablet 2–3 times a day). If necessary, the dose of the drug is doubled.

Pharmacological properties of the drug Bromocriptine-Richter

bromocriptine is a derivative of ergot alkaloids and has a dopaminomimetic effect. Activates postsynaptic dopamine receptors, which leads to a decrease in the secretion of prolactin in the anterior pituitary gland. The drug is effective for menstrual irregularities and infertility caused by or combined with hyperprolactinemia, and also has the ability to prevent or stop physiological lactation. Bromocriptine also reduces growth hormone secretion in acromegaly. In addition, Bromocriptine, by stimulating dopamine receptors in the corpus striatum, has a positive effect in parkinsonism.

Side effects of the drug Bromocriptine-Richter

At the beginning of treatment, nausea, vomiting, headache, dizziness, and increased fatigue are possible. If these side effects occur, discontinuation of the drug is not necessary. To eliminate dizziness and/or nausea, it is recommended to take an antiemetic 1 hour before taking Bromocriptine. Orthostatic hypotension is rarely observed (it is necessary to monitor blood pressure levels). If the drug is used in high doses, hallucinations, psychosis, visual disturbances, dyskinesia, dry mouth, constipation, and cramps in the calf muscles may occur; these side effects are dose-dependent. During long-term therapy with the drug in the cold, Raynaud's syndrome (transient pallor of the fingers and toes) may develop, especially in those patients who have had this syndrome before.

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