Bromocriptine Other names: Bromocriptine mesylate 2-Bromoergocriptine

Dopamine antagonists such as antipsychotics (phenothiazines, butyrophenones and thioxanthenes) may reduce the prolactin-lowering and antiparkinsonian effects of bromocriptine.

In patients with impaired hepatic function, the speed of elimination may be retarded and plasma levels may increase, requiring dose adjustment.

Tolerance to bromocriptine may be reduced by alcohol.

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme (azole antimycotics, HIV protease inhibitors). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine.

Bromocriptine is both a substrate and an inhibitor of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors and/or substrates of this enzyme (azole antimycotics, HIV protease inhibitors).

Caution is required in patients who are on concomitant therapy with, or have recently been treated with drugs that can alter blood pressure.

Concomitant use of bromocriptine with vasoconstrictors such as sympathomimetics or ergot alkaloids including ergometrine or methylergometrine during the puerperium is not recommended.

The concomitant use of erythromycin and other macrolide antibiotics may increase bromocriptine plasma levels.

Metoclopramide and domperidone may reduce the prolactin-lowering effect.

The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine.

In a few patients on bromocriptine, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g. back pain, oedema of the lower limbs, impaired kidney function) should be watched in this category of patients. Bromocriptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.

Bromocriptine has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with bromocriptine. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.

Patients with severe cardiovascular disorders or psychiatric disorders taking bromocriptine for the indication of macro-adenomas should only take it if the perceived benefits outweigh the potential risks.

Among patients on bromocriptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported. Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of bromocriptine therapy should be contemplated.

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists, including bromocriptine. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

A few cases of gastrointestinal bleeding and gastric ulcer have been reported. If this occurs, PARLODEL should be withdrawn. Patients with a history of evidence of peptic ulceration should be closely monitored when receiving the treatment.

If pregnancy occurs it is generally advisable to withdraw bromocriptine after the first missed menstrual period.

Rapid expansion of pituitary tumours sometimes occurs during pregnancy and this may also occur in patients who have been able to conceive as a result of bromocriptine therapy. As a precautionary measure, patients should be monitored to detect signs of pituitary enlargement so that bromocriptine may be reintroduced if necessary. Based on the outcome of more than 2,000 pregnancies, the use of bromocriptine to restore fertility has not been associated with an increased risk of abortion, premature delivery, multiple pregnancy or malformation in infants. Because this accumulated evidence suggests a lack of teratogenic or embryopathic effects in humans, maintenance of bromocriptine treatment during pregnancy may be considered where there is a large tumour or evidence of expansion.

Since bromocriptine inhibits lactation, it should not be administered to mothers who elect to breast-feed.

Women of child-bearing potential

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 of contraception.

Hypotensive reactions may be disturbing in some patients during the first few days of treatment and particular care should be exercised when driving vehicles or operating machinery.

Patients being treated with bromocriptine and presenting with somnolence and/or sudden sleep episodes must be advised not to drive or engage in activities where impaired alertness may put themselves or others at risk of serious injury or death (eg. Operating machines) until such recurrent episodes and somnolence have resolved.