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INDICATION
CYCLOSET® (bromocriptine mesylate) 0.8 mg tablets is a once-daily prescription pill used with diet and exercise to lower blood sugar levels in adults with type 2 diabetes.
CYCLOSET is not for people with type 1 diabetes or for people with diabetic ketoacidosis. It is not known if CYCLOSET is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take CYCLOSET if you:
- Are allergic to bromocriptine or any of the other ingredients in CYCLOSET.
- Are allergic to ergot medicines. Ask your health care provider or pharmacist for a list of these medicines, if you are not sure whether you take any.
- Have fainting migraine headaches.
- Are a woman who has recently given birth to a child (postpartum). CYCLOSET can cause serious and life-threatening problems including high blood pressure (hypertension), heart attack, seizures, stroke, and psychosis (losing touch with reality).
- Are breastfeeding.
CYCLOSET may cause serious side effects, including:
- Low blood pressure, fainting, or severe dizziness after you stand up from a lying down position. Stand up slowly when moving from a sitting or lying position. You should avoid activities that could cause injury if you feel light-headed or faint.
- Feeling tired and sleepy. If you feel tired and sleepy while taking CYCLOSET, you should not drive or operate heavy machinery.
- Uncontrollable (compulsive) behaviors that include strong urges to gamble, increased sexual urges, strong urges to spend money, binge eating or eating that you cannot control. These behaviors may go away if your dose of CYCLOSET is lowered or stopped.
- Serious and life-threatening problems in women who recently have given birth to a child.
Before taking CYCLOSET, tell your health care provider about all medical conditions, including if you:
- Have type 1 diabetes mellitus or diabetic ketoacidosis.
- Have ever passed out or fainted.
- Have migraine headaches.
- Have or have had low blood pressure (hypotension).
- Take medicines for high blood pressure (hypertension).
- 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 health care provider if you are pregnant or plan to become pregnant.
Tell your health care provider about all medicines you take and any recent changes to your medications (prescription, non-prescription, vitamins and herbal supplements), especially those for:
- Mental health conditions, especially anti-psychotic medicines called dopamine receptor antagonists.
- Migraine or other types of headaches.
- Other medicines that work like CYCLOSET (dopamine receptor agonists) to treat conditions such as Parkinson’s disease, high levels of a hormone called prolactin in your blood (hyperprolactinemia), restless leg syndrome and too much growth hormone (acromegaly).
- Type 2 diabetes.
The most common side effects of CYCLOSET were:
- Nausea, headache, dizziness, vomiting, and/or lightheadedness.
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:
Avvisto Therapeutics, LLC.
Phone: 888-621-1215
Email: contact@avvistotherapeutics.
Please click here for full Prescribing Information.
