- Is an FDA-approved prescription medicine for type 2 diabetes in adults
- Is a unique class of type 2 diabetes medicine that may lower your blood sugar, without increasing your body's insulin levels
- Can be used alone or as an add-on to other type 2 diabetes medicines
- There is limited data in combination with other diabetes medications such as TZDs and insulin
- Has a demonstrated cardiovascular safety profile in a clinical trial*
- In a 52-week, randomized clinical trial of 3,070 patients, CYCLOSET was not associated with increased risk for adverse cardiovascular events
- Has demonstrated no significant weight gain
*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/m, 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.
In clinical studies, CYCLOSET significantly lowered blood sugar and improved A1C in adult patients with type 2 diabetes.
- CYCLOSET has a demonstrated cardiovascular safety profile. In a year-long clinical study with 3,070 patients, CYCLOSET showed no increase in serious adverse events compared to placebo. In the same study CYCLOSET did not increase the risk of cardiovascular events such as heart attack or stroke.
Once-a-day Convenient Type 2 Diabetes Medicine
CYCLOSET tablets are taken once daily by mouth within 2 hours after waking in the morning. You can take CYCLOSET with other medications that have been prescribed for you. When you start taking CYCLOSET, you will take 1 tablet a day. The therapeutic dose of CYCLOSET is 2 to 6 tablets a day. The exact number of tablets varies. Your healthcare provider will tell you how to increase the number of tablets you take each day until you have reached a dose that is right for you.
CYCLOSET can help lower and control your blood sugar throughout the day. Get more details about:
- Glucose control and managing type 2 diabetes in adults
- How CYCLOSET is different
- Taking CYCLOSET
- Safety Information
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.