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.
Bromocriptine tablets 2.5 mg 30 pcs ➤ instructions for use
Inside. Bromocriptine should always be taken with food. Typically, treatment begins with a small dose, which is then gradually increased until the optimal effect is achieved. The maximum daily dose is 30 mg. Menstrual irregularities, female infertility 1/2 tablet (1.25 mg) 2-3 times a day; if the effect is insufficient, the dose of the drug is gradually increased to 5-7.5 mg (2-3 tablets) per day until the menstrual cycle normalizes and/or ovulation is restored. To prevent relapses, treatment can be continued for several menstrual cycles. Hyperprolactinemia in men 1/2 tablet (1.25 mg) 2-3 times a day, gradually increasing the dose by 1.25 mg to 5-10 mg (2 - 4 tablets) with an interval of 2-3 weeks. Prolactinoma 1/2 tablet (1.25 mg) 2-3 times a day, gradually increasing the dose to several tablets per day necessary to maintain an adequate decrease in the concentration of prolactin in the blood plasma. The maximum recommended dose for children and adolescents aged 7-12 years is 5 mg/day, for those aged 13-18 years - 10 mg/day. Acromegaly The initial dose is 1/2 tablet (1.25 mg) 2-3 times a day, then, if necessary, gradually increase the dose to several tablets per day, then, depending on the clinical effect and side effects, the daily dose of the drug is gradually increased to 10-20 mg (4-8 tablets). The maximum daily dose in children aged 7 to 12 years is 10 mg. The maximum daily dose in adolescents (13-18 years) is 10 mg. Suppression of lactation for medical reasons On the first day, take 1/2 tablet (1.25 mg) 2 times (with meals at breakfast and dinner), then for 14 days - 1 tablet (2.5 mg) 2 once a day. Treatment should begin a few hours after childbirth or abortion, however, but not earlier than 4 hours after stabilization of vital functions. 2-3 days after discontinuation of the drug, slight secretion of milk sometimes occurs. It is eliminated by resuming the drug at the same dose for another week. Beginning postpartum mastitis It is used in the same way as for suppressing lactation. After three days, the symptoms of inflammation disappear and, if the mother decides to resume breastfeeding the child, treatment is stopped. Otherwise, treatment is continued at 1 tablet 2 times a day for 11 days. Antibiotics are prescribed if necessary. Postpartum engorgement of the mammary glands 2.5 mg once, after 6-12 hours the dose can be repeated if necessary, no unwanted stoppage of lactation occurs. Parkinson's disease The drug is prescribed to patients with Parkinson's disease in the following cases: • in case of ineffectiveness of treatment with levodopa and a decarboxylase inhibitor; • in the initial stage of treatment, in combination with levodopa/carbidopa. Treatment begins with low doses, which are slowly increased until the maximum therapeutic effect is achieved. Typically, the patient takes the initial dose of the drug (1.25 mg, i.e. 1/2 tablet) at bedtime for 1 week. The dose of the drug should then be slowly increased until the minimum effective dose is achieved for each patient. The daily dose should be increased by 2.5 mg at intervals of 1 week to a maximum daily dose of 30 mg. The daily dose is divided into 2-3 doses. An adequate therapeutic result can be achieved within 6-8 weeks of treatment. If this does not happen, the daily dose can be increased further - every week by 2.5 mg/day. If, when selecting the dose of the drug Bromocriptine, the development of undesirable reactions is noted, then the daily dose should be temporarily reduced and maintained at this low level for at least 1 week. With a decrease in adverse reactions, the daily dose of the drug can be increased again. In patients who have developed movement disorders while using levodopa, it is recommended to reduce the dose of levodopa before starting therapy with Bromocriptine. When patients with Parkinson's disease are started on treatment with bromocriptine and levodopa, the side effects of levodopa appear later than when taking levodopa alone. At the beginning of treatment, the doses of both drugs are low - they are adjusted gradually and in turn. At the beginning of combination therapy for Parkinson's disease, the average dose of the drug is 15-30 mg, while levodopa is 250 mg. With a gradual increase in the dose of Bromocriptine, the dose of levodopa should also be gradually reduced. In some patients, levodopa may be discontinued completely. Use in children and adolescents Safety and effectiveness in children under 7 years of age have not been confirmed, therefore the use of Bromocriptine in this age group is contraindicated. In children and adolescents aged 7 to 18 years, the use of Bromocriptine for menstrual disorders, female infertility, hyperprolactinemia, incipient postpartum mastitis, suppression of lactation for medical reasons and Parkinson's disease is contraindicated. Use in elderly patients Considering the decrease in liver, kidney, and cardiac function; the presence of concomitant diseases and the use of concomitant drug therapy, the drug should be used with caution in elderly patients. It is necessary to start and carry out therapy with Bromocriptine at the lowest effective dose. Use in patients with renal failure Studies of the effectiveness and safety of bromocriptine in patients with renal failure have not been conducted. Since bromocriptine and its metabolites are almost completely eliminated through the intestine, no dosage adjustment is required in patients with renal failure. Use in patients with hepatic impairment In patients with impaired liver function, the elimination rate of bromocriptine may slow down and the plasma concentration may increase, requiring dose adjustment. The use of bromocriptine in patients with severe hepatic impairment is contraindicated.
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).
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.
Instructions for use BROMOCRIPTIN-RICHTER
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 caused by 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, because It is known that oral contraceptives can 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 an examination every 6 months, while women of childbearing age need to 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 associated with it.
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 carefully 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 dose, 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 diseases 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 space-occupying lesions 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).
In the diagnosis of fibrosing disorder, it is useful to determine the ESR and creatinine concentration in the blood, as well as performing a chest x-ray. 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 experiencing drowsiness and/or episodes of sudden sleep onset should refrain from driving or operating machinery. In addition, the advisability of dose reduction or discontinuation of treatment should be considered.
Patients should be regularly monitored for the development of impulse control disorder. Patients and their caregivers should be aware of the possibility that patients receiving treatment with dopamine agonists (including Bromocriptine-Richter) may develop behavioral symptoms of impulse control disorder, including pathological gambling, increased sexual attraction, hypersexuality, compulsive spending or shopping addiction, constant need for food and compulsive gluttony. 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 mg of lactose monohydrate. Patients with rare hereditary diseases such as galactose intolerance, lactose intolerance or glucose-galactose malabsorption should not take Bromocriptine-Richter.
Alcohol consumption may reduce bromocriptine tolerance and increase the risk of adverse reactions. Therefore, you should avoid drinking alcohol while taking this drug.
Any unused product or waste must be disposed of in accordance with local regulations.
Impact on the ability to drive vehicles and operate machinery
During the first few days of treatment, arterial hypotension, visual disturbances and dizziness may occur; therefore, special care should be taken when driving vehicles and operating machinery.
Patients who experience somnolence and/or episodes of sudden sleep onset should be advised to refrain from driving and other activities in which inattention may endanger others.
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.
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.
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.
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.
