AA Pharma Bromocriptine Warnings

In women with non-puerperal galactorrhea, reduction of prolactin levels may lead to resumption of normal menses. Following discontinuation of medication, galactorrhea returns in some patients and leads to suspicions of pituitary adenomas; a complete investigation at specialized units to identify these patients is advisable. Treatment with specialized units to identify these patients is advisable. Treatment with AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) may effectively lower prolactin levels in patients with pituitary tumors but does not obviate the necessity for radiotherapy or surgical intervention where appropriate.
Long-term treatment (6-36 months) with bromocriptine in doses ranging from 20-100 mg/day has been associated with pulmonary infiltrates, pleural effusion and thickening of the pleura in a few patients. In those instances in which bromocriptine treatment was terminated, the changes slowly reverted towards normal.
To date, there have been seven (7) reported cases of retroperitoneal fibrosis occurring in parkinsonian patients on long-term treatment (15 months-10 years) with bromocriptine at daily doses higher than 30 mg. To recognize retroperitoneal fibrosis at an early, reversible stage it is recommended to look for its manifestations (e.g. back pain, oedema of the lower limbs, impaired kidney function) in this category of patients. AA PHARMA BROMOCRIPTINE medication should be withdrawn immediately if fibrotic changes in the retroperitoneum are diagnosed or suspected.
Bromocriptine is known to cause hypotension in some patients and rarely may cause hypertension in selected patients.
While hypotension during the start of therapy with bromocriptine occurs in some patients, 50 cases of hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy. Seizures have been reported in 38 cases (including 4 cases of status epilepticus), both with and without the prior development of hypertension. Fifteen cases of stroke during bromocriptine therapy have been reported. Many of these patients experiencing seizures and/or strokes reported developing a constant and often progressively severe headache hours to days prior to the acute event. Some cases of strokes and seizures during therapy with bromocriptine were also preceded by visual disturbances (blurred vision, and transient cortical blindness). Four cases of acute myocardial infarction have been reported. The relationship of these adverse reactions to bromocriptine administration is not certain. The use of AA PHARMA BROMOCRIPTINE (bromocriptine mesylate) is not recommended for patients with uncontrolled hypertension or toxemia of pregnancy.
Although there is no conclusive evidence which demonstrates the interaction between bromocriptine and other ergot alkaloids, the concomitant use of these medications is not recommended. Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure.
Periodic monitoring of the blood pressure, particularly during the first few days of therapy is advisable. If severe progressive or unremitting headache, other signs of CNS toxicity, or hypertension develop, AA PHARMA BROMOCRIPTINE therapy should be discontinued immediately and the patient should be evaluated promptly.