Gedeon Richter


Full Prescribing Info
Bromocriptine mesylate.
Acting as a dopamine-receptor agonist in the hypothalamus and pituitary, bromocriptine reduces increased prolactin secretion, reinitiates normal menstrual cycle and manages fertility dysfunctions associated with hyperprolactinemia. It prevents and suppresses milk secretion. In acromegalic patients, bromocriptine produces a reduction of increased levels of growth hormone, thereby favourably affecting their clinical symptoms and glucose tolerance. Because of its dopaminergic activity, it promotes the release of endogenous dopamine from the still active presynaptic, nigrostriatal neurons, at the same time selectively stimulating the postsynaptic receptors as well. Consequently, bromocriptine is effective in the treatment of Parkinson's disease. Bromocriptine can be given alone to freshly diagnosed patients <60 years at the early stage of Parkinson's disease, to prevent the later expected side effect ("on-off" phenomenon) of substitution therapy. In these patients however, higher incidence of bromocriptine side effects can be expected (nausea, confusion and hypotension). It can be combined with other antiparkinsonian agents (eg, levodopa + decarboxylase inhibitor). Bromocriptine should be titrated slowly in order to provide each patient with the minimal effective dose according to the therapeutic response. The increase in daily dosage should be gradual ("slow and low" regimen) to prevent adverse effects eg, "end of dose" phenomenon and dyskinesia.
Combination with levodopa treatment often allows a concomitant reduction of the levodopa and decarboxylase inhibitor dose.
Endocrinology: Prolactin-dependent disorders of the menstrual cycle and infertility (accompanied by hyper- or normoprolactinemia), amenorrhea (with or without galactorrhea), oligomenorrhea, insufficiency of the luteal phase and drug-stimulated hyperprolactinemia (psychotropic or antihypertensive drugs).
Non-Prolactin-Dependent Infertility: Polycystic ovarium syndrome; adjunctive therapy to antiestrogenic (eg, clomifen) treatment of anovulation.
Prolactinomas: Conservative treatment of prolactin-secreting micro- and macroadenomas of the pituitary, to arrest the growth or to reduce the size of adenomas previous to surgery to ease its removal; to reduce postoperative prolactin level if it remained elevated.
Acromegaly: Alone or as adjunctive therapy with irradiation or surgery, bromocriptine lowers the plasma level of growth hormone.
Prevention of Physiological Lactation: After parturition or abortion, by suppressing lactation, bromocriptine inhibits congestion and engorgement, and may prevent puerperal mastitis.
Benign Breast Disease: Bromocriptine alleviates breast pain associated with premenstrual syndrome or with nodular or cystic alterations of the breasts.
Neurology: In all phases of idiopathic and post-encephalitic parkinsonism, alone or in combination with other antiparkinsonian agents.
Dosage/Direction for Use
Bromocriptine should always be taken with food.
Menstrual Cycle Disorders and Female Infertility: 2.5-3.75 mg daily. If necessary, the dose can be increased to 1 tab 2 or 3 times daily. Treatment is continued until the menstrual cycle returns to normal and/or ovulation is restored. If required, treatment may be continued over several cycles to prevent relapse.
Prolactinomas: 2.5-3.75 mg daily gradually increase to several tablets daily as required to keep plasma prolactin adequately suppressed.
Acromegaly: Initially, 2.5-3.75 mg daily, gradually increasing to 4-8 tabs (10-20 mg) daily depending on clinical response and side effects.
Inhibition of Lactation: 5 mg daily with morning and evening meals for 14 days.
To prevent the onset of lactation, treatment should be instituted not earlier than 4 hrs after parturition or abortion. Slight milk secretion occasionally occurs 2 or 3 days after treatment has been withdrawn. This can be stopped by resuming treatment at the same dosage for a further week.
Puerperal Breast Engorgement: Single dose of 2.5 mg; may be repeated after 6-12 hrs, if required, without inappropriate suppression of lactation.
Incipient Puerperal Mastitis: Same dosage as for inhibition of lactation. An antibiotic should be added to the regimen as required.
Benign Breast Disease: 2.5-3.75 mg daily gradually increasing to 2-3 tabs/day.
Parkinson's Disease: Treatment should be started with a low dose of 1.25 mg given preferably in the evening, over the 1st week.
In case of combined therapy, dosage is to be started concurrently with the occurrence of side effects of levodopa therapy eg, dyskinesia, "end of dose" phenomenon.
The increase of daily dosage should be gradual by increments of 1.25 mg a day every week.
The daily dosage is divided into 2 or 3 single doses. An adequate therapeutic response may be reached within 6-8 weeks.
The common therapeutic range for monotherapy or combined therapy is 10-40 mg bromocriptine/day. In some patients, higher doses may be required; this should be considered individually. It is important to maintain optimal therapeutic response as long as possible with the minimal effective dose. Should undesirable reactions occur during the titration phase, the daily dose can be increased again. For safety reasons, the maximal daily dose cannot be higher than 100 mg.
No absolute contraindications is known in endocrinology.
For usage in pregnancy, see Precautions.
Neurology: Essential and familial tremors, Huntington's chorea, severe cardiovascular disorders, various forms of endogenous psychoses, untreated hypertension, pregnancy-induced toxemia and hypersensitivity to other ergot alkaloids.
Special Precautions
Fertility may be restored by treatment with bromocriptine. Women of childbearing age who do not wish to conceive, should therefore be advised to practice a reliable method (nonhormonal) of contraception.
In patients wishing to conceive, bromocriptine should be discontinued when pregnancy is confirmed. No increased incidence of abortion has been observed following withdrawal of bromocriptine. Administered during the first 8 weeks of pregnancy, bromocriptine does not adversely affect its course or outcome. If pregnancy occurs in the presence of a pituitary adenoma and bromocriptine treatment has been stopped, close supervision throughout pregnancy and regular check of visual field is essential.
In patients showing a pronounced enlargement of a prolactinoma, bromocriptine treatment should be reinstituted. In patients to be treated for mastalgia and nodular and/or cystic breast alterations, malignancy must be excluded.
When bromocriptine is used for puerperal inhibition of lactation, particularly in the first week of therapy, occasional checking of blood pressure is recommended. In case hypertension, severe permanent headache with or without visual disturbance occur, treatment should be withdrawn and the patient should be examined.
Acromegalic patients with a history of gastrointestinal bleeding should preferably be given alternative treatment. If bromocriptine must be used in such patients, they should be instructed to report promptly any gastrointestinal reactions. Caution is required when high doses are being given to patients with a history of psychotic disorders or severe cardiovascular disease. If women with conditions not associated with hyperprolactinemia are treated, bromocriptine should be given in the lowest effective dose in order to avoid the possibility of suppressing plasma prolactin below normal levels, with a consequent impairment of luteal function.
When bromocriptine is given to parkinsonian patients, regular checking of liver, kidney and hematopoietic functions is necessary. In these patients, high doses may elicit manifestations of mental disorders and slight dementia.
Among parkinsonian patients on long-term (2-10 years), high-dose (30-140 mg) bromocriptine treatment pleural effusions have occasionally been observed. Although causal relationship between treatment and pleural symptoms has not been confirmed, patients with unexpected pleuropulmonary disorders should be examined thoroughly and bromocriptine treatment should be discontinued: Nursing mothers cannot be treated with bromocriptine. In the lack of required experience, bromocriptine cannot be prescribed for children <15 years.
After acute overdosage, metoclopramide can be given, preferably parenterally.
Effects on the Ability to Drive or Operate Machinery: Since visual disturbance may occur, particular care should be exercised when driving vehicles or operating machinery.
Side Effects
During the first few days of treatment, some patients may experience nausea, vomiting, dizziness or fatigue which are not, however, sufficiently serious to require treatment to be discontinued. Initial nausea and/or dizziness may be inhibited by the temporary intake of a suitable antiemetic (eg, dimenhydrinate, thiethylperazine or metoclopramide), 1 hr prior to the administration of bromocriptine.
In rare instances, bromocriptine may induce orthostatic hypotension; it is therefore advisable to check blood pressure in ambulant patients in standing position.
During high-dose treatment, hallucinations, confusion, visual disturbance, dyskinesia, dryness of the mouth, constipation and leg cramps may occur. All these side effects are dose-dependent and can usually be controlled by a reduction in dosage. Episodes of reversible pallor of the fingers and toes induced by cold may occur occasionally during prolonged treatment, particularly in patients previously exhibiting Raynaud's phenomenon.
Drug Interactions
Bromocriptine can be given carefully with the following drugs: Erythromycin (bromocriptine serum concentration may elevate), phenothiazines; dopamine antagonists eg, butyrophenones and phenothiazines (bromocriptine effect may decrease).
Concurrent use should be avoided with other ergot-alkaloid derivatives.
Tolerability to bromocriptine may be reduced by alcohol.
Store at room temperature. Protect from light.
ATC Classification
G02CB01 - bromocriptine ; Belongs to the class of prolactine inhibitors. Used to suppress lactation.
Tab 2.5 mg x 30's.
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