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Bromocriptine-Richter tablets 2.5 mg No. 30 No. 1

Name

Bromocriptine-Richter tablet 2.5 mg in vial. No. 30 in pack No. 1

Description

Almost white, round, flat, beveled tablets, about 7 mm in diameter, with a score line on one side and engraved “2.5” on the other.

Main active ingredient

Bromocriptine

Release form

Pills

Dosage

2.5 mg

Pharmacological properties

Pharmacodynamics

Bromocriptine, the active substance of Bromocriptine-Richter 2.5 mg tablets, is an inhibitor of prolactin secretion and a stimulator of dopamine receptors. The areas of application of bromocriptine include endocrinological and neurological indications. The pharmacological properties of the drug will be reviewed for each indication. Endocrinological indications Bromocriptine inhibits the secretion of prolactin without affecting the normal levels of other hormones secreted by the anterior pituitary gland. In patients with acromegaly, bromocriptine reduces elevated serum levels of growth hormone and thereby has a beneficial effect on clinical manifestations and glucose tolerance. Bromocriptine prevents or suppresses lactation and restores prolactin-dependent menstrual cycles and ovulation. It is an effective remedy for amenorrhea and anovulation (with or without galactorrhea). Bromocriptine does not increase the risk of thromboembolic complications; its ability to reduce the size of prolactin-secreting pituitary adenomas (prolactinomas) has been demonstrated. Bromocriptine reduces the severity of clinical symptoms of polycystic ovary syndrome. Neurological indications Due to its dopaminergic activity, bromocriptine is effective in the treatment of Parkinson's disease when prescribed in doses higher than those recommended for use for endocrinological indications. This disorder is characterized by a deficiency of dopamine in the nigrostriatal region of the brain. Stimulation of dopamine receptors by bromocriptine may restore neurochemical balance. Clinically, bromocriptine reduces the severity of parkinsonism (including tremor, rigidity, bradykinesia) and depression at all stages of the disease. Bromocriptine can be prescribed either as monotherapy or in combination with other antiparkinsonian drugs. Combination therapy allows you to reduce the required dose of levodopa and thus delays the development of fluctuations. Therefore, bromocriptine therapy allows a reduction in the dose of other drugs used in combination, mainly levodopa. This avoids some of the adverse reactions of levodopa, such as end-of-dose deterioration, on-off phenomenon, and dyskinesia.

Pharmacokinetics

Bromocriptine is quickly and well absorbed from the gastrointestinal tract after oral administration. The parent substance and its metabolites are metabolized in the liver and excreted in the feces; only 6% of the dose is excreted in the urine. The degree of binding to blood plasma proteins reaches 96%. Maximum plasma levels are achieved 1-3 hours after administration. The prolactin-lowering effect develops within 1-2 hours after taking the drug, reaching a maximum after approximately 5 hours, and lasts for 8-12 hours. The elimination of the parent substance from blood plasma is biphasic, with a terminal half-life of about 15 hours. There are no direct changes in the pharmacokinetic properties of bromocriptine in elderly people. However, in patients with impaired liver function, delayed elimination of the drug may lead to increased plasma levels, requiring dose adjustment. Biotransformation Bromocriptine undergoes active biotransformation during the “first” passage through the liver, which is reflected in the complex profile of metabolites and the almost complete absence of the parent substance in urine and feces. It shows high affinity for CYP3A, and the main route of metabolism is hydroxylation of the proline ring of the cyclopeptide molecule. Therefore, it can be expected that inhibitors and/or potent substrates of CYP3A4 are able to inhibit the elimination of bromocriptine and lead to an increase in its concentration in blood plasma. Bromocriptine is also a potent CYP3A4 inhibitor. However, given the low therapeutic concentrations of free bromocriptine in patients, significant impairment of the metabolism of another drug whose clearance is mediated by CYP3A4 should not be expected.

Indications for use

Suppression or reduction of lactation for medical reasons This drug is not recommended for routine suppression of lactation or for the relief of symptoms of postpartum pain and breast tenderness. Hyperprolactinemia Treatment of hyperprolactinemia in men and women (with and/or without concomitant galactorrhea). Infertility Treatment of infertility associated with hyperprolactinemia. Bromocriptine can be used in the treatment of cases of infertility in women without obvious hyperprolactinemia. Prolactinomas Bromocriptine may be the first choice drug in the treatment of macroadenomas and represent an alternative to surgery (transsphenoidal hypophysectomy) in patients with microadenomas. Acromegaly Used to reduce the level of growth hormone in the systemic circulation as an adjunct to surgery and/or radiation therapy. Parkinson's disease In Parkinson's disease, bromocriptine is used both as monotherapy and in combination with levodopa in previously untreated patients and in patients with the on-off phenomenon. Bromocriptine may have an effect in patients who do not respond to levodopa therapy or with a reduced response to levodopa, as well as in patients intolerant to levodopa. Cyclic benign diseases of the mammary glands; Premenstrual syndrome (see section “With caution”).

Directions for use and doses

Dosage This medicine should always be taken with food. When used for most indications, the optimal therapeutic effect with a minimum number of adverse reactions can be achieved by gradually increasing the dose. Use in adults: The maximum dose should not exceed 30 mg/day. The following dosage regimen is recommended: Initial dose - 1.25 mg before going to bed, after 2-3 days the dose should be increased to 2.5 mg before going to bed. Then the dose can be increased by 1.25 mg at 2-3-day intervals, up to a daily dose of 2.5 mg 2 times a day. Further increases in dose, if necessary, should be carried out in the same way. Prevention of lactation At a dose of 2.5 mg on the day of birth, then 2.5 mg 2 times a day for 14 days. A gradual increase in the dose of bromocriptine when prescribed for this indication is not required. Suppression of lactation At a dose of 2.5 mg on the first day, increasing the dose after 2-3 days to 2.5 mg twice a day. Treatment should be continued for 14 days; a gradual dose increase is not required when prescribed for this indication. Hypogonadism/galactorrhea syndromes/infertility Gradually increase the dose of bromocriptine according to the proposed regimen. Most patients with hyperprolactinemia achieve an adequate effect from the drug at a dose of 7.5 mg per day (in divided doses), but doses up to 30 mg / day can also be used. In infertile patients without elevated serum prolactin levels, the usual dose is 2.5 mg twice daily. Prolactinomas Gradually increase the dose of bromocriptine according to the proposed scheme. When the daily dose of 2.5 mg is reached, the dosage can be increased by 2.5 mg per day at 2-3 day intervals as follows: 2.5 mg every 8 hours, 2.5 mg every 6 hours, 5 mg every 6 hours hours. The effect in patients is observed when used in doses up to 30 mg per day. Acromegaly Gradually increase the dose of bromocriptine according to the proposed scheme. When the daily dose of 2.5 mg is reached, the dosage can be increased by 2.5 mg at 2-3 day intervals as follows: 2.5 mg every 8 hours, 2.5 mg every 6 hours, 5 mg every 6 hours. Parkinson's disease Gradually increase the dose of bromocriptine as follows: Week 1: 1.25 mg at bedtime. Week 2: 2.5 mg before bedtime. Week 3: 2.5 mg twice daily. Week 4: 2.5 mg three times a day. Subsequently, the daily dose can be increased by 2.5 mg over 3-14 days, depending on the effect noted in the patient. Dose increases can be continued until the optimal dose is reached, which is usually 10 to 30 mg per day. At the same time, the dose of levodopa can be gradually reduced until the optimal balance is determined. Use in children The use of Bromocriptine-Richter tablets in children under the age of 15 years is not recommended due to the lack of data on safety and effectiveness. Use in the elderly There is no evidence that bromocriptine poses a particular risk in the elderly. Use in patients with impaired liver function In patients with impaired liver function, the rate of elimination of the drug may slow down, and its level in the blood plasma may increase, which requires dose adjustment. Adverse reactions Nausea, vomiting, anorexia, headache, dizziness and fatigue may occur during the first days of treatment; however, these reactions usually do not require discontinuation of bromocriptine. The risk of adverse reactions can be reduced by gradually increasing the dose and taking bromocriptine tablets with food. If necessary, the daily dose can be reduced, and treatment continued at this reduced dose for several days. After the disappearance of adverse reactions, you can try again to increase the dose. Bromocriptine may cause postural hypotension, so blood pressure in outpatients should be measured in an upright position. In patients with Parkinsonism, during treatment with high doses of the drug, drowsiness, hallucinations, confusion, visual disturbances, dry mouth, leg muscle cramps and retroperitoneal fibrosis may develop (see section “With caution”). All these adverse reactions are dose-dependent. With long-term treatment, isolated cases of reversible blanching or whitening of fingers and toes in the cold have been reported, especially in patients with a history of Raynaud's phenomenon. In extremely rare cases (in postpartum women receiving bromocriptine to prevent lactation), serious adverse reactions, including hypertension, myocardial infarction or stroke, have been reported, although their causal relationship with the use of the drug has not been established. In some patients, the development of stroke was preceded by severe headache and/or transient visual disturbances. In very rare cases, heart valve pathology (including regurgitation) and associated disorders (pericarditis and pericardial effusion) have been reported. Hyponatremia and portosystemic encephalopathy may occur in patients with cirrhosis. In extremely rare cases, bromocriptine may cause people to suddenly fall asleep during the day. Patients receiving treatment with dopamine agonists, including Bromocriptine-Richter, may experience pathological gambling, increased sexual desire, hypersexuality, compulsive spending or shopping habits, constant needing to eat and compulsive overeating (see section „Precautions”). . Dopamine agonists, which belong to the group of ergot alkaloids, may increase the risk of developing heart valve regurgitation. Adverse reactions are summarized by their frequency of occurrence in the following table: Organ system class according to the Medical Dictionary of Regulatory Activities (MedDRA 12.1) Frequent ?1/100, but

Use during pregnancy and lactation

Pregnancy If pregnancy occurs, it is usually recommended to discontinue bromocriptine after the first missed menstrual cycle. In pregnant patients with pituitary adenoma, after discontinuation of the drug, careful monitoring (including repeated determination of visual fields) is necessary throughout pregnancy. If prolactinoma grows rapidly, bromocriptine should be resumed. Based on outcome assessments in more than 2,000 pregnancies, bromocriptine was not associated with an increased risk of miscarriage, preterm birth, or birth defects in infants. The cumulative evidence suggests no teratogenic or embryotoxic effects. Breastfeeding Because bromocriptine suppresses lactation and is excreted in breast milk, it should not be given to women who are breastfeeding.

Precautionary measures

Alcohol consumption may reduce bromocriptine tolerance and increase the risk of adverse reactions. Therefore, you should avoid drinking alcohol while taking this medicine.

Interaction with other drugs

Alcohol causes poor tolerance to bromocriptine. Caution should be exercised when used simultaneously with antihypertensive drugs (see section “With caution”). Concomitant use of erythromycin, other macrolide antibiotics and octreotide may increase plasma concentrations of bromocriptine. Dopamine antagonists (eg, butyrophenones, phenothiazines) may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine. Metoclopramide and domperidone may reduce the prolactin-lowering effect of bromocriptine. Sympathomimetic drugs, including phenylpropanolamine and isometheptene, increase the risk of toxicity. Concomitant use of bromocriptine with other ergot alkaloids should be avoided. Caution should be exercised when bromocriptine is used concomitantly with CYP3A4 inhibitors (for example, azole antifungals, HIV protease inhibitors) (see section “Pharmacokinetics”).

Contraindications

Hypersensitivity to the active substance, to other ergot alkaloids or to any of the excipients listed in the “Composition” section. For long-term treatment: signs of heart valve pathology according to echocardiography before treatment. Gestosis in pregnant women, arterial hypertension during and after childbirth, uncontrolled arterial hypertension, essential or familial tremor, Huntington's chorea. The use of bromocriptine is contraindicated for the suppression of lactation in patients with a history of coronary artery disease or other severe cardiovascular pathology, or symptoms/history of severe mental disorders. Patients with these conditions who are taking bromocriptine for the indication of macroadenomas should only take it if the expected benefits of treatment outweigh the potential risks (see Precautions). Bromocriptine should not be used concomitantly with other ergot alkaloids. Bromocriptine should not be prescribed to patients with a history of fibrosing disorders or signs of pathology of the heart valve apparatus according to echocardiography before treatment. For instructions on treatment during pregnancy, see section “Use during pregnancy and breastfeeding.” With caution There is insufficient evidence of the effectiveness of bromocriptine in the treatment of premenstrual syndrome and benign breast neoplasms. Therefore, the use of Bromocriptine-Richter in patients with this pathology is not recommended. Bromocriptine is not recommended for use in the postpartum period in women with hypertension, coronary artery disease and/or a history of severe cardiovascular disease or serious mental disorders. In postpartum women receiving bromocriptine, blood pressure levels should be carefully monitored at regular intervals, especially during the first days of treatment. Particular caution is required in patients receiving concomitant therapy (or who have recently received it) with drugs that can affect blood pressure. Concomitant use of bromocriptine with vasoconstrictors such as sympathomimetics or ergot alkaloids, including ergometrine or methylergometrine, is not recommended during the postpartum period. In rare cases, serious adverse reactions, including myocardial infarction, hypertension, stroke or psychiatric disorders, have been reported in postpartum women receiving bromocriptine to suppress lactation. The development of stroke in some patients was preceded by severe headache and/or transient visual disturbances. If hypertension, severe and persistent headache with visual disturbances, or any signs of central nervous system toxicity develop, treatment with bromocriptine should be discontinued immediately. Hyperprolactinemia can be idiopathic, drug-induced, or due to diseases of the hypothalamus or pituitary gland. Bromocriptine effectively reduces prolactin levels in patients with pituitary tumors; however, its use does not eliminate the need for radiation therapy or surgery for acromegaly. The drug should be prescribed in the minimum effective dose to women of childbearing age suffering from pathology not associated with hyperprolactinemia. Such precautions are necessary to avoid suppression of prolactin secretion to a level below normal with subsequent dysfunction of the corpus luteum. During treatment, such patients should use a reliable, non-hormonal method of contraception, as oral contraceptives are known to increase serum prolactin levels. Women receiving bromocriptine for an extended period of time should undergo a gynecological examination (including cytological examination). Postmenopausal women should undergo such examination every six months, while women of childbearing age should be examined once a year. In patients with acromegaly with a history of gastric ulcers, other types of treatment should be preferred, if possible. If treatment with bromocriptine is necessary, the patient should be instructed to immediately notify the physician of the occurrence of gastrointestinal adverse reactions. Patients with severe cardiovascular disease or psychiatric disorders taking bromocriptine for macroadenomas should receive it only if the expected benefits of treatment outweigh the potential risks. Because patients with pituitary macroadenomas may have concomitant hypopituitarism due to compression or destruction of pituitary tissue, a full assessment of the functional status of the pituitary gland should be performed and adequate replacement therapy should be prescribed before bromocriptine is prescribed. In patients with secondary adrenal insufficiency, corticosteroid replacement therapy is mandatory. Changes in tumor size in patients with pituitary macroadenomas should be closely monitored, and surgery should be considered if there is evidence of tumor growth. Prolactin-secreting adenomas may increase in size during pregnancy. In such patients, treatment with bromocriptine often leads to a reduction in tumor size and rapid recovery of narrowed visual fields. In severe cases, compression of the optic or other cranial nerves may require emergency pituitary surgery. Visual field impairment is a known complication of macroprolactinoma. Effective treatment with bromocriptine leads to a reduction in tumor size and severity of hyperprolactinemia, and often to the disappearance of visual impairment. However, some patients may subsequently develop secondary visual field loss despite normalization of prolactin levels and tumor shrinkage. In these cases, the visual field defect may decrease while taking bromocriptine at a reduced dosage, despite a slight increase in prolactin levels and some re-enlargement of the tumor. Thus, monitoring of visual fields in patients with macroprolactinoma is recommended for early detection of secondary visual field loss and individual dose selection. Cerebrospinal fluid rhinorrhea has been reported in some patients with prolactin-secreting adenomas treated with bromocriptine. Available evidence suggests that this phenomenon may occur due to tumor shrinkage with invasive growth. During the first few days of treatment, arterial hypotension may develop in isolated cases. Caution should be exercised when prescribing bromocriptine in high doses to patients with a history of psychotic disorders or severe cardiovascular disease. Isolated cases of pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have been reported in patients receiving bromocriptine, especially in high doses or for long periods of time. Patients with unexplained pleuropulmonary disorders should be carefully evaluated and, if necessary, bromocriptine therapy should be discontinued. Retroperitoneal fibrosis has been reported in several patients receiving bromocriptine, especially at high doses or for long periods of time. For timely recognition of retroperitoneal fibrosis at an early reversible stage, it is recommended to monitor its manifestations (such as back pain, swelling of the lower extremities, impaired renal function) in this category of patients. Bromocriptine should be discontinued if fibrosing changes in the retroperitoneum are diagnosed or suspected. You should pay attention to the following signs and symptoms: lung disease, manifested by shortness of breath, suffocation, persistent cough or chest pain; impaired renal function or obstruction of the urethra/abdominal vessels, which may be accompanied by pain in the lumbar region/lateral abdomen and swelling of the lower extremities, as well as the presence of any mass formations in the abdominal cavity or its tenderness on palpation, which may indicate retroperitoneal fibrosis; heart failure caused by pericardial fibrosis (if such symptoms occur, constrictive pericarditis should be excluded). Measurements of erythrocyte sedimentation rate (ESR) and blood creatinine concentrations, as well as chest x-rays, are helpful in diagnosing fibrosing disorder. In addition, it is advisable to determine baseline levels of other inflammatory markers and renal function indicators before starting treatment. During treatment, patients should be closely monitored for signs of progressive fibrosing disorders. If retroperitoneal fibrosis is diagnosed or suspected, bromocriptine should be discontinued. The use of bromocriptine may be accompanied by drowsiness and episodes of sudden sleep onset, especially in patients with Parkinson's disease. Sudden sleep onset during daytime activities, in some cases without any warning or warning signs, has been reported extremely rarely. Patients should be informed of the possibility of this phenomenon and should use caution when driving or operating machinery during treatment with bromocriptine. Patients who experience drowsiness and/or episodes of sudden sleep should refrain from driving vehicles or operating machinery (see section “Effects on the ability to drive vehicles and operate machinery”). In addition, the advisability of dose reduction or discontinuation of treatment should be considered. Impulse control disorder Patients should be monitored regularly for the development of impulse control disorder. Patients and their caregivers should be aware of the possibility that patients treated with dopamine agonists (including Bromocriptine-Richter) may develop behavioral symptoms of impulse control disorder, including pathological gambling, increased sexual desire, hypersexuality , compulsive spending or shopping addiction, constant need for food and compulsive overeating. If such symptoms develop, the advisability of dose reduction/gradual withdrawal of the drug should be considered. In clinical studies of cabergoline and pergolide, an increased risk of developing heart valve pathology was noted. It can be assumed that this effect may be characteristic of other ergot alkaloid derivatives, such as bromocriptine. The drug contains 41.0 mg of lactose monohydrate. Patients with rare hereditary diseases such as galactose intolerance, lactose intolerance or glucose-galactose malabsorption should not take this medicine. Use during pregnancy and breastfeeding Pregnancy If pregnancy occurs, it is usually recommended to discontinue bromocriptine after the first missed menstrual cycle. In pregnant patients with pituitary adenoma, after discontinuation of the drug, careful monitoring (including repeated determination of visual fields) is necessary throughout pregnancy. If prolactinoma grows rapidly, bromocriptine should be resumed. Based on outcome assessments in more than 2,000 pregnancies, bromocriptine was not associated with an increased risk of miscarriage, preterm birth, or birth defects in infants. The cumulative evidence suggests no teratogenic or embryotoxic effects. Breastfeeding Because bromocriptine suppresses lactation and is excreted in breast milk, it should not be given to women who are breastfeeding.

Compound

Each tablet contains: Active ingredient: 2.5 mg bromocriptine in the form of 2.87 mg bromocriptine mesylate. Excipients: lactose monohydrate, anhydrous colloidal silicon dioxide, magnesium stearate, talc, povidone, corn starch, microcrystalline cellulose.

Overdose

Bromocriptine overdose is likely to result in symptoms of dopaminergic overstimulation, which may include nausea, vomiting, hypotension, hallucinations and confusion. General supportive measures should be taken to remove all unabsorbed drug and maintain blood pressure levels, if necessary.

Side effect

Nausea, vomiting, anorexia, headache, dizziness and fatigue may occur during the first days of treatment; however, these reactions usually do not require discontinuation of bromocriptine. The risk of adverse reactions can be reduced by gradually increasing the dose and taking bromocriptine tablets with food. If necessary, the daily dose can be reduced, and treatment continued at this reduced dose for several days. After the disappearance of adverse reactions, you can try again to increase the dose. Bromocriptine may cause postural hypotension, so blood pressure in outpatients should be measured in an upright position. In patients with Parkinsonism, during treatment with high doses of the drug, drowsiness, hallucinations, confusion, visual disturbances, dry mouth, leg muscle cramps and retroperitoneal fibrosis may develop (see section “With caution”). All these adverse reactions are dose-dependent. With long-term treatment, isolated cases of reversible blanching or whitening of fingers and toes in the cold have been reported, especially in patients with a history of Raynaud's phenomenon. In extremely rare cases (in postpartum women receiving bromocriptine to prevent lactation), serious adverse reactions, including hypertension, myocardial infarction or stroke, have been reported, although their causal relationship with the use of the drug has not been established. In some patients, the development of stroke was preceded by severe headache and/or transient visual disturbances. In very rare cases, heart valve pathology (including regurgitation) and associated disorders (pericarditis and pericardial effusion) have been reported. Hyponatremia and portosystemic encephalopathy may occur in patients with cirrhosis. In extremely rare cases, bromocriptine may cause people to suddenly fall asleep during the day. Patients receiving treatment with dopamine agonists, including Bromocriptine-Richter, may experience pathological gambling, increased sexual desire, hypersexuality, compulsive spending or shopping habits, constant needing to eat and compulsive overeating (see section „Precautions”). . Dopamine agonists, which belong to the group of ergot alkaloids, may increase the risk of developing heart valve regurgitation.

Storage conditions

Store at a temperature not exceeding 25°C, in the original packaging to protect from light. Keep out of the reach of children.