Index of drugs

Prevention or inhibition of post-partum lactation for medical reasons. Hyperprolactinemia coexisting with impotence, lack of menstruation, mlekotokiem or disorders of the menstrual cycle. Mlekotok with normoprolactinaemia. Pituitary adenomas of the prolactinoma type. Acromegaly. Parkinson's disease. Beginning puerperic inflammation of the breast. The use of Bromocriptine is not routinely recommended for the prevention or reduction of postpartum breast edema, which can be successfully treated by administering ordinary analgesics and breast compresses. There is no sufficient evidence to support the efficacy of bromocriptine in the treatment of premenstrual syndrome symptoms and benign breast diseases.

1 tabl contains 2.5 mg of bromocriptine as mesilate. The tablets contain lactose and sodium carboxymethyl starch.

Dopaminergic Dopamine agonist₂, an inhibitor of the secretion of prolactin - the hormone of the anterior pituitary gland. It does not affect the physiological levels of other pituitary hormones. In patients with acromegaly, bromocriptine may reduce elevated levels of growth hormone. It does not weaken the puerperium of the uterus and does not increase the risk of thromboembolisms. In cases of prolactin-secreting adenomas, it inhibits growth or decreases the size of adenomas. In the absence of menstruation and / or ovulation (with or without milk) restores the mentoring cycle and ovulation. It relieves clinical symptoms of polycystic ovary syndrome by restoring normal secretion of luteinizing hormone. In Parkinson's disease, bromocriptine reduces tremor, stiffness and slowness of movement. It also relieves symptoms of depression, often accompanying parkinsonism. After oral administration, it is rapidly absorbed from the gastrointestinal tract, reaching C_max in the blood within 1-3 h. After 1-2 h there is a curative effect that persists for 8-12 h. The maximum reduction in blood prolactin concentration by more than 80% of baseline occurs within 5-10 h after taking the drug. It is 96% bound to plasma proteins. Bromocriptine is extensively metabolised in the liver and almost completely excreted in the bile. Only 6% of the drug is excreted in the urine. T_0,5 is 8-20 h. In hepatic impairment the rate of excretion may be reduced.

Hypersensitivity to the preparation ingredients or other ergot alkaloids. Uncontrolled hypertension, hypertension during pregnancy (including eclampsia, pre-eclampsia or hypertension due to pregnancy), hypertension after childbirth and postpartum. Coronary heart disease and other severe cardiovascular diseases. Symptoms and / or severe psychiatric disorders in an interview.

For women without hyperprolactinemia using Bromocriptine, the drug should be administered in the lowest effective dose necessary to reduce symptoms, in order to avoid suppression of prolactin release below physiological concentration and, consequently, luteal function impairment. Patients with known or past peptic ulcer should be closely monitored during treatment. The intake of bromocriptine was associated with somnolence and episodes of suddenly falling asleep, especially in patients with Parkinson's disease. Very rare cases of sudden falling asleep or sleep during daily activities were recorded, in some cases without warning signals. In these cases, a dose reduction or termination of treatment should be considered. It is important to inform the patient about the possibility of this type of side effects. In patients treated with bromocriptine, especially long-term and high doses, pleural and pericardial effusion as well as pleural and pulmonary fibrosis and pericarditis were observed. If a patient has unexplained pulmonary or pleural disorders, he should be carefully examined and discontinued in treatment with bromocriptine. If retroperitoneal fibrosis is suspected, to ensure that it has been diagnosed at an early, reversible stage, it is recommended to closely observe symptoms (such as back pain, swelling of the lower limbs, impaired renal function).Bromocriptine should be discontinued if there is evidence of or suspected retroperitoneal fibrous lesions. In women receiving bromocriptine in the postpartum period to inhibit lactation as well as in patients treated with bromocriptine for other reasons, periodic monitoring of blood pressure is recommended. If severe hypertension intensifies or headaches persist (with or without visual impairment) or if there is an overt disorder, bromocriptine should be discontinued and the patient should be tested as soon as possible. Particular caution should be exercised in patients who have recently used or using drugs that affect blood pressure, such as vasoconstrictors, for example, sympathomimetics or ergot alkaloids, including ergometry or methylergometrine. The concomitant use of these drugs with postpartum bromocriptine is not recommended. Because pituitary hypotension may occur in patients with pituitary macroadenomas due to compression or damage to the pituitary tissues, thorough comprehensive pituitary function tests should be performed before administering bromocriptine and appropriate substitution treatment implemented. Patients with secondary adrenal insufficiency require substitution treatment with corticosteroids. Patients with macroadenomas should be systematically monitored for tumor size, and if signs of enlargement are present, surgery should be considered. If pregnancy has been diagnosed in patients with an adenoma that used bromocriptine, they should be carefully monitored. Prolactin-secreting adenomas may grow during pregnancy. In these patients, treatment with bromocriptine often causes a reduction in tumor size and a rapid reduction in visual impairment. In severe cases, pressure on the optic nerve or other cranial nerves may require urgent surgery. Treatment with bromocriptine leads to a reduction in hyperprolactinemia and often to improved visual field. Some patients may develop secondary visual field disturbances, despite normalization of prolactin concentration and reduction of tumor size, which may result in pulling the optic nerve crossing down to a partially empty Turkish saddle. In these cases, visual field disturbances may be reduced by reducing the dose of bromocriptine, which will increase the prolactin concentration and partial tumor recovery. For early recognition of secondary visual field disturbances associated with the incidence of the optic nerve crossing and adjustment of the appropriate dose of bromocriptine, monitoring of the field of view is recommended in patients with prolactin-producing pituitary macroadenoma. In some patients with prolactin-secreting pituitary adenoma using bromocriptine, cerebrospinal fluid leaked from the nose. This may be due to shrinking of invasive tumors. In children and adolescents, the dose should be carefully increased. Use with caution in elderly patients. Due to the lactose content, the preparation should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

In patients planning pregnancy, at the time of confirmed pregnancy, bromocriptine should be discontinued unless there is an indication for further treatment. After discontinuation of treatment with bromocriptine no increased number of abortions was found. Based on clinical experience, it has been shown that taking bromocriptine during pregnancy does not adversely affect its course and resolution. If the pregnancy concerns patients with pituitary adenoma and bromocriptine has been discontinued, monitoring of the pregnancy is necessary. Patients with symptoms of pronounced prolactinoma proliferation, e.g. headache or reduced visual field, should be considered for re-introduction of bromocriptine or surgery. Fertility can be restored by using bromocriptine. Women of childbearing potential who are not planning pregnancy should be advised to use effective methods of contraception. Bromocriptine inhibits lactation, therefore it should not be used during breastfeeding.

Common: pain and dizziness, lethargy, nasal congestion, nausea, vomiting, constipation.Uncommon: confusion, psychomotor agitation, hallucinations, dyskinesias, hypotension, orthostatic hypotension, dry mouth, cutaneous allergic reactions, alopecia, leg cramps, fatigue. Rarely: mental disorders, insomnia, drowsiness, paresthesias, blurred vision, pericardial discharge, pericardial effusion, pericarditis, tachycardia, bradycardia, arrhythmias, pleural effusion, pleural fibrosis, pleurisy, pulmonary fibrosis, dyspnoea, diarrhea, abdominal pain, retroperitoneal fibrosis, gastric or duodenal ulcer, gastrointestinal bleeding (drug should be discontinued), peripheral edema. Very rare: pathological propensity for gambling, increased libido, hypersexuality, excessive daytime sleepiness, sudden falling asleep, heart valve fibrosis, reversible paleness of fingers and toes caused by low temperatures (especially in patients with Raynaud's syndrome), a syndrome resembling a neuroleptic malignant syndrome during abrupt withdrawal of bromocriptine. Patients with Parkinson's disease treated with dopamine agonists, especially at high doses, have reported pathological gambling, increased libido and hypersexuality, which generally resolved after dose reduction or discontinuation of treatment. During the use of the preparation to inhibit lactation during the postnatal period, rare cases of hypertension, myocardial infarction, convulsions, strokes or mental disorders have been reported.

Orally. Treatment should be started with small doses and gradually increased. The maximum daily dose is 30 mg.Prevention or inhibition of post-partum lactation for medical reasons: on day 1 of treatment 1.25 mg (0.5 tabl) 2 times daily (during the morning and evening meal), then 2.5 mg twice daily for 14 days; to prevent the onset of lactation, treatment should be implemented within a few hours after delivery or abortion, but not prior to the stabilization of important life activities. Slight milk secretion sometimes appears on the 2nd or 3rd day of treatment. They can be stopped by continuing treatment with the same dose for another week.Hyperprolactinemia coexisting with impotence in men: 1.25 mg 2 or 3 times a day, gradually increasing the dose from 5 mg to 10 mg daily.Menstrual cycle disorders, female infertility: 1.25 mg 2-3 times a day, if the reaction is insufficient, the dose should be gradually increased to 2.5 mg 2-3 times a day; treatment should continue until normalization of the menstrual cycle and / or restoration of ovulation. If necessary, to avoid relapse, treatment should be continued for several cycles.acromegaly: initially 1.25 mg 2-3 times a day, increasing the daily dose from 10 mg to 20 mg daily, depending on the therapeutic effect and side effects.Prolactin-secreting pituitary adenomas: 1.25 mg 2-3 times a day, gradually increasing the dose to several tablets a day, to achieve the expected inhibition of prolactin secretion into the blood.Parkinson's disease: initially 1.25 mg daily for the first week, in the evening. In order to determine the minimum effective dose for each patient, the daily dose should be increased slowly by 1.25 mg daily once a week and administered in 2-3 doses. The optimal therapeutic effect is obtained within 6-8 weeks, if after this time there is no improvement in the clinical condition, the daily dose can be increased again by 2.5 mg a day once a week. Normally, the doses used for both monotherapy and combination therapy are 10-30 mg of bromocriptine per day. If adverse reactions occur during the dose escalation, the daily dose should be reduced and treatment continued for at least one week, when the adverse reactions resolve, the dose can be increased again. In patients treated with levodopa who have mobility problems, a reduction in the dose of levodopa should be considered prior to treatment with bromocriptine; after a satisfactory response to treatment with bromocriptine, a gradual further reduction of the dose of levodopa may be considered; some patients may discontinue levodopa.Beginning puerperic inflammation of the breast: on day 1 of treatment 1.25 mg twice daily (during the morning and evening meal), then 2.5 mg twice daily for 14 days; if necessary, use an antibiotic.
The tablets can be divided into halves.The tablets should always be taken with food.