Cycloset
Generic Name: bromocriptine mesylate
Date of Approval: May 5, 2009
Company: VeroScience and S2 Therapeutics, Inc.
Treatment for: Type 2 Diabetes
FDA Approves Cycloset
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 Feedback for Cycloset
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The U.S. Food and Drug Administration (FDA) has approved Cycloset (bromocriptine mesylate) for the treatment of Type 2 diabetes. Cycloset improves glycemic control across a broad patient population as a monotherapy or as an adjunctive therapy to sulfonylurea, metformin plus sulfonylurea, and single or dual oral hypoglycaemic agent therapies.
Cycloset is the first drug to be approved subsequent to the FDA's new guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk. A 52 week, double-blind safety trial of 3,000 patients treated with Cycloset did not show an increase in pre-specified and independently adjudicated adverse cardiovascular outcomes—a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure, and revascularization surgery—compared to patients taking a placebo (HR 0.58; CI 0.35-0.96).
Cycloset represents a new therapeutic approach in the management of Type 2 diabetes. It is the first drug for patients with diabetes that targets the body's dopamine activity, a chemical messenger between neurons, or nerve cells, within the nervous system. A dopamine agonist, Cycloset increases dopamine activity. While the specific mechanism by which Cycloset improves glycemic control in humans is unknown, the development of Cycloset for the treatment of Type 2 diabetes was based upon preclinical studies that have shown brain dopamine activity to be low in metabolic disease states and that this factor contributes to multiple metabolic dysfunctions such as insulin resistance—the loss of the body's ability to respond to the blood sugar lowering effects of insulin—observed in Type 2 diabetes. Moreover, preclinical studies of diabetic animals have shown that treatment with a dopamine agonist as in Cycloset acts upon the central nervous system to reset and improve control of peripheral metabolism.
Cycloset Patient Information
Read the Patient Information before you start taking Cycloset and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Cycloset?
Cycloset is 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 has not been studied in children.
Who should not take Cycloset?
Do not take Cycloset if you:
- are allergic to bromocriptine or any of the other ingredients in Cycloset
- take ergot medicines. Ask your healthcare provider for a list of these medicines, if you are not sure
- are breastfeeding
- have fainting (syncopal) migraine headaches
Talk to your healthcare provider before taking Cycloset if you have any of these conditions.
What should I tell my healthcare provider before taking Cycloset?
Before taking Cycloset, 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.
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, especially anti-psychotic medicines
- migraine or other types of headaches
- type 2 diabetes
Ask your healthcare provider or pharmacist for a list of medicines taken for these conditions, if you are not sure.
Cycloset may affect the way other medicines work, and other medicines may affect how Cycloset works.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take Cycloset?
- Take Cycloset exactly as your healthcare provider tells you to take it.
- Take Cycloset by mouth each day.
- Take Cycloset with food.
- Take Cycloset within 2 hours after waking in the morning.
- If you miss your morning dose, wait until the next morning to take your medication.
- Do not take a double dose of Cycloset.
- During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication needs may change. Contact your healthcare provider right away.
- If you take too much Cycloset, call your healthcare provider or go to the nearest emergency department right away.
- While taking Cycloset:
- check your blood sugar as your healthcare provider tells you to
- stay on your prescribed diet and exercise program
- learn to prevent, recognize, and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes
- see your healthcare provider for regular blood tests, including your blood sugar levels and hemoglobin HbA1c
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.
The most common side effects of Cycloset include:
- nausea
- headache
- fatigue (somnolence). If you have somnolence from Cycloset you should not drive or use other heavy machines until the somnolence is better.
- dizziness
- vomiting
- low blood sugar (hypoglycemia), especially when used with another type of diabetes medicine known as a sulfonylurea
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Cycloset. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
How Should I store Cycloset?
Store Cycloset at or below 77°F (25°C)
Keep Cycloset and all medicines out of the reach of children.
General information about the use of Cycloset
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Cycloset for a condition for which it was not prescribed. Do not give Cycloset to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Cycloset. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for additional information about Cycloset that is written for health professionals. For more information, go to www.Cycloset.com
What are the ingredients in Cycloset?
Active ingredient: bromocriptine mesylate
Inactive ingredients: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, citric acid, and other inert ingredients
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