Important Cycloset Safety Information

 

 

Important Cycloset Safety Information

Cycloset is contraindicated in patients with hypersensitivity to ergot-related drugs, bromocriptine, or any of the excipients in Cycloset. Do not use in patients with syncopal migraines. It may precipitate hypotension. Do not use in nursing women. It may inhibit lactation. There are postmarketing reports of stroke in this patient population.

Cycloset can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use with caution in patients taking antihypertensive medications. Cycloset may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended. Cycloset may cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur. Concomitant use with dopamine antagonists such as neuroleptic agents is not recommended.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Cycloset or any other antidiabtic drug. Cycloset does not increase tile risk of macrovascular events.
In controlled clinical trials, adverse reactions reported in ≥5% of patients treated with Cycloset, and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache.

Safety and effectiveness hove not been established in pediatric patients.

Important Limitations of Use
• 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

 

 

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