AA Pharma Bromocriptine Special Precautions

AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) may cause hypotension, primarily postural; periodic monitoring of the blood pressure, particularly during the first days of therapy, is advisable. In some patients, dizziness (vertigo) may occur with bromocriptine; patients should therefore be cautioned against activities requiring rapid and precise responses such as driving an automobile or operating dangerous machinery until their response has been determined.
Care should be exercised when administering AA PHARMA BROMOCRIPTINE concomitantly with phenothiazines or with other medications known to lower blood pressure. Dosage should be adjusted accordingly.
Alcohol should be avoided during treatment with bromocriptine. In some patients the concomitant use of bromocriptine and alcohol has given rise to alcohol intolerance and an increase in the severity and incidence of bromocriptine's possible adverse reactions.
Although there is no conclusive evidence demonstrating interactions between bromocriptine and other ergot derivatives, it is not recommended to administer AA PHARMA BROMOCRIPTINE and any drug with potentially vasoconstrictor activity concomitantly.
In patients being treated with AA PHARMA BROMOCRIPTINE for galactorrhea, prolactin induced amenorrhea, menstrual disorders or acromegaly, infertility might be reversed by restoration of normal menses and ovulation. Women who do not wish to conceive should, therefore, use a reliable method of contraception. Since pregnancy may occur prior to initiation of menses it is recommended that a pregnancy test be conducted at least every four weeks during the amenorrheic period, and, once menses are reinitiated, every time a patient misses a menstrual period.
There have been occasional reports of gastrointestinal bleeding in acromegalic patients, both in those treated with bromocriptine and those given a different or no medication. Until further data are available, therefore, acromegalic patients with a history or evidence of peptic ulceration should preferably be given alternative treatment. If bromocriptine must be used in such patients, they should be instructed to report promptly any gastrointestinal reactions.
Safety and efficacy of bromocriptine has not been established in patients with severe renal or hepatic disease.
Bromocriptine therapy has been demonstrated to be effective in the short-term management of amenorrhea/galactorrhea. Data are not available on the safety or effectiveness of its use in long-term continuous dosage in this indication or in patients given repeated courses of treatment following recurrence of amenorrhea/galactorrhea after initial treatment. Recurrence rates are reportedly very high, ranging from 70% to 80%.
Bromocriptine should always be taken with food. In cases where adverse effects, such as nausea, vomiting and vertigo are severe or persisting, the therapeutic dosage of AA PHARMA BROMOCRIPTINE should be reduced to half of one tablet daily (1.25 mg) and increased gradually to the recommended dose. The dopamine antagonist domperidone may be useful in the control of severe gastrointestinal side effects in Parkinsonian patients receiving bromocriptine (see Interactions).
Use in Parkinson's Disease: Use of AA PHARMA BROMOCRIPTINE, particularly in high doses, may be associated with mental confusion and mental disturbances. Since patients with Parkinson's Disease may manifest varying degrees of dementia, caution should be exercised when treating such patients with bromocriptine.
AA PHARMA BROMOCRIPTINE administered alone or concomitantly with levodopa may cause visual or auditory hallucinations. These usually resolve with dosage reduction, but discontinuation of bromocriptine may be required in some cases. Rarely, after high doses, hallucinations have persisted for several weeks following discontinuation of bromocriptine. Caution should be exercised when administering AA PHARMA BROMOCRIPTINE to patients with a history of myocardial infarction, particularly if they have a residual, atrial, nodal or ventricular arrhythmia.
Symptomatic hypotension can occur and, therefore, caution should be exercised when administering AA PHARMA BROMOCRIPTINE, particularly in patients receiving antihypertensive medication. Periodic evaluation of hepatic, hematopoietic, cardiovascular and renal function is recommended.
Use in Pregnancy: In patients receiving AA PHARMA BROMOCRIPTINE, immunological confirmation of suspected conception should be performed as soon as possible and treatment stopped unless, in the opinion of the treating physician, the possible benefit to the patient outweighs the potential risk to the fetus. In any event, the patient must be monitored closely throughout pregnancy for signs and symptoms which may develop if a previously undetected prolactin-secreting tumour enlarges.
In human studies with bromocriptine, there were 1410 reported pregnancies, which yielded 1236 live and 5 stillborn infants from women who took bromocriptine during early pregnancy. Among the 1241 infants, 43 cases (31 minor and 12 major) of congenital anomalies were reported. The incidence (3.46%) and type of congenital malformations and the incidence of spontaneous abortions (11.13%) in this group of pregnancies does not exceed that generally reported for such occurrences in the population at large.
Patients with pronounced enlargement of the sella turcica or a visual defect should, in the first instance, be treated by surgery and/or radiotherapy. If pregnancy occurs in the presence of a pituitary microadenoma, close supervision throughout pregnancy is essential. This includes regular checking of the visual fields.
Small prolactin-secreting adenomas not detected previously may rapidly increase in size during pregnancy. Optic nerve compression may occur and emergency pituitary surgery or other appropriate measures may be necessary.