CYCLOSET:

*Findings from a 52-week, 74-center, randomized placebo-controlled trial to evaluate the safety of CYCLOSET. 3,070 patients were randomized 2:1 to add either CYCLOSET or placebo, respectively, to their current antidiabetic regimen, which could consist of diet alone or no more than 2 agents (2 OADs or insulin + 1 OAD). Inclusion criteria: age 30-80, BMI <43 kg/m2, diagnosis of type 2 diabetes of > 6 months with an A1C ≤10.0% with no lower A1C boundary. Patients with a history of CVD and CHF were included in the trial.

CYCLOSET should not be used if you are allergic to bromocriptine, taking ergot medicines, having fainting (syncopal) migraines, or are breastfeeding.

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 veroscience@tmacmail.com.

Please see complete Prescribing Information for CYCLOSET.pdf

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

CYCLOSET is a registered trademark of VeroScience, LLC, Tiverton, RI 02878.
Manufactured for VeroScience, LLC, Tiverton, RI.
Distrubuted and Marketed by: Salix Pharmaceuticals, Inc.

Santarus, Inc, is a wholly owned subsidiary of Salix Pharmaceuticals, Inc.