Dibor R Special Precautions

Hypotension: Can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking antihypertensive medications. Assess orthostatic vital signs prior to initiation of bromocriptine and periodically thereafter. Advise patients during early treatment to avoid situations that could lead to injury if syncope was to occur.
Psychosis: May exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended.
Somnolence: May cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.
Interaction with Dopamine Antagonists: Concomitant use with dopamine antagonists eg, neuroleptic agents may diminish the effectiveness of both drugs. Concomitant use is not recommended.
Other Dopamine Receptor Agonists: Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications. Concomitant use in not recommended.
Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with bromocriptine or any other antidiabetic drug. Bromocriptine does not increase the risk of macrovascular events.
Important Limitations of Use: Dibor R should not be used to treat type 1 diabetes or diabetic ketoacidosis; limited efficacy data in combination with thiazolidinediones; efficacy has not been confirmed in combination with insulin.
Effects on the Ability to Drive or Operate Machinery: May cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.
Use in pregnancy: Pregnancy Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women.