Indication for CYCLOSET
CYCLOSET® (bromocriptine mesylate) Tablets are a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. CYCLOSET may be taken alone or with other medicines that also help to control blood sugar. CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. There is limited data in combination with other diabetes medications such as
thiazolidinediones (TZD) and insulin.
Important Safety Information about CYCLOSET
CYCLOSET® (bromocriptine mesylate) Tablets are not for everybody. Do not use CYCLOSET if you are allergic to bromocriptine or any other ingredient of CYCLOSET or if you are taking ergot medicines. You should not use CYCLOSET if you have fainting (syncopal) migraine headaches. If you are breastfeeding, you should not use CYCLOSET as it may inhibit lactation.
CYCLOSET can cause severe dizziness or fainting especially when starting or increasing the dose. This can happen when your blood pressure lowers rapidly after you stand up from a lying down position. You should change your posture slowly to avoid these problems. If you are taking a medication for high blood pressure, tell your healthcare provider.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take medicines for mental health conditions (particularly anti-psychotic medicines), for migraines or other types of headache, and any medications used to treat Parkinson’s disease, hyperproloactinemia, restless leg syndrome, or acromegaly. Tell your healthcare provider if you are using any medications that are dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide.
CYCLOSET may cause somnolence (fatigue) especially at the beginning of your treatment, and when your doctor increases the dose you are taking. If you have somnolence from CYCLOSET you should not drive or use other heavy machines until the somnolence is better.
There have been no clinical studies that have been able to conclude a beneficial effect of CYCLOSET or any other oral anti-diabetic drug on reducing cardiovascular outcomes. CYCLOSET does not increase the risk of cardiovascular events.
The safety and effectiveness of CYCLOSET in pediatric patients have not been established.
In clinical studies, the most common adverse reactions reported in ≥ 5% of patients treated with CYCLOSET and reported more commonly than in patients treated with placebo (sugar-pill), included nausea, fatigue, dizziness, vomiting, and headache. Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.
For product information, adverse event reports, and product complaint reports, please contact:
1-877-757-0666 or firstname.lastname@example.org.
Please see complete Prescribing Information for CYCLOSET.
*CYCLOSET is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Preclinical studies suggest that appropriately timed daily administration of bromocriptine, the active ingredient of CYCLOSET, may positively affect hypothalamic activities associated with insulin resistance and glucose intolerance. In clinical studies, morning administration of CYCLOSET improved glycemic control in adults with type 2 diabetes without increasing plasma insulin concentrations. The precise mechanism of action of CYCLOSET is unknown.
In a 52-week, randomized clinical trial of 3,070 patients, CYCLOSET was not associated with an increased risk for adverse cardiovascular events.
Santarus, Inc. is a wholly owned subsidiary of Salix Pharmaceuticals, Inc.
The information contained on this page is intended for US residents, healthcare providers, and pharmacists only.