What is CYCLOSET?

CYCLOSET (bromocriptine mesylate tablets) is the first and only FDA-approved prescription medicine that works in the brain and controls blood sugar without increasing insulin levels. CYCLOSET can be used alone or with other diabetes medicines, along with diet and exercise to control blood sugar.

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What makes CYCLOSET different?

CYCLOSET is different from other medicines you may already be taking to treat type 2 diabetes. There are 3 main differences:

1. CYCLOSET works in the brain, unlike other antidiabetic medicines that predominantly work in other organs of the body.

2. CYCLOSET lowers blood sugar—without increasing your body's insulin levels.

  • Blood sugar levels can become very high for patients with type 2 diabetes. CYCLOSET lowers blood sugar levels without affecting the levels of insulin in your body

CYCLOSET can be taken alone or with other type 2 diabetes medicines that you may already be taking because it lowers blood sugar without increasing insulin. The exact way that it works is not completely understood. Please talk to your healthcare provider about CYCLOSET and take CYCLOSET tablets as directed.

3. CYCLOSET 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 an increased risk for adverse cardiovascular events*

*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.

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Who should take CYCLOSET?

CYCLOSET is a prescription medicine used with diet and exercise to lower blood glucose in adults with type 2 diabetes. CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. CYCLOSET may be taken alone or in combination with other medicines that also help control blood sugar. CYCLOSET has not been studied in children.

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Who should not take CYCLOSET?

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. Ask your healthcare provider if CYCLOSET may be right for you.

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What is CYCLOSET's Safety Profile?

In a 52-week study of 3,070 patients, CYCLOSET did not increase the risk of serious adverse events or major cardiovascular events compared with placebo. In clinical studies, the most common side effects (≥5%) that seemed to be caused by CYCLOSET were nausea, dizziness, fatigue, headache, vomiting, and diarrhea.

*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.

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What are the possible side effects of CYCLOSET?

CYCLOSET may cause serious side effects, including:

  • Low blood pressure
  • Fainting
  • Severe dizziness, which can be caused by postural hypotension. This can happen when your blood pressure lowers rapidly after you stand up from a lying down position.

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What are the most common side effects of CYCLOSET?

  • Nausea
  • Headache
  • Fatigue (somnolence). If you have somnolence from CYCLOSET you should not drive or use other heavy machinery until the somnolence is better
  • Dizziness
  • Vomiting
  • Low blood sugar (hypoglycemia), especially when used with another type of diabetes medicine known as a sulfonylurea

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How do I take CYCLOSET?

CYCLOSET tablets are taken once each morning within 2 hours after you wake up. 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. If you miss your morning dose, wait until the next morning to take your medication. Take CYCLOSET with food, within 2 hours after waking in the morning.

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How is CYCLOSET dosed?

Take CYCLOSET with food, within 2 hours after waking in the morning. When you start taking CYCLOSET, your healthcare provider will tell you how to increase the dosage from the starting dose of 1 tablet, to the dose you will be taking on a regular basis—between 2 and 6 tablets daily.

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What should I tell my healthcare provider before taking CYCLOSET?

Before taking CYCLOSET, tell your healthcare provider about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Also, tell your healthcare provider about all of your medical conditions, including if you:

  • Have type 1 diabetes mellitus
  • Have diabetic ketoacidosis
  • Have ever passed out or fainted
  • Have migraine headaches
  • Have or have had low blood pressure (hypotension)
  • Have or have had a mental health condition, especially a psychotic disorder
  • Are pregnant or plan to become pregnant. It is not known if CYCLOSET will harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant

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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.