Cycloset

What is Cycloset?

• Cycloset (Bromocriptine mesylate) is an ergot derivative used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Bromocriptine

Bromocriptine ball-and-stick

What are the uses of this medicine?

Cycloset is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Limitations of Use:

• Cycloset is not for people with type 1 diabetes.
• Cycloset is not for people with diabetic ketoacidosis.
• Limited efficacy data in combination with thiazolidinediones.
• Efficacy has not been confirmed in combination with insulin.

How does this medicine work?

• Cycloset contains bromocriptine mesylate, a sympatholytic, dopamine D2 receptor agonist.
• Bromocriptine selectively binds to and activates postsynaptic dopamine D2 receptors in the corpus striatum of the central nervous system (CNS).
• Activation of these D2 receptors activate inhibitory G-proteins, which inhibit adenylyl cyclase, preventing signal transduction mediated via cAMP and resulting in the inhibition of neurotransmission and an antidyskinetic effect.
• In patients with type 2 diabetes, timed morning administration of Cycloset is associated with increased insulin sensitivity and glucose disposal and reduced fasting and postprandial hyperglycemia throughout the meals of the day without raising plasma insulin levels.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to bromocriptine or any of the ingredients in Cycloset.
• are allergic to ergot medicines.
• have fainting (syncopal) 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.

What drug interactions can this medicine cause?

• Cycloset may affect the way other medicines work, and other medicines may affect how Cycloset works.

specially tell your healthcare provider if you take:

• medicines for mental health problems, especially anti-psychotic medicines called dopamine receptor antagonists
• medicines for 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)
• medicines for type 2 diabetes
• Cycloset in combination with ergot-related drugs may cause an increase in the occurrence of ergot-related side effects, such as nausea, vomiting, and fatigue, and may also reduce the effectiveness of these ergot therapies when used to treat migraine.
• Cycloset may increase the unbound fraction of other concomitantly used highly protein-bound therapies (e.g., salicylates, sulfonamides, chloramphenicol and probenecid), which may alter their effectiveness and risk for side effects.
• Concomitant use of dopamine receptor antagonists, such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes), or metoclopramide may diminish the effectiveness of Cycloset, and Cycloset may diminish the effectiveness of these other therapies.
• Use caution when co-administering drugs that are inhibitors or inducers of CYP3A4.
• There are limited clinical trial data supporting the safety of selective 5-hydroxytryptamine1B (5-HT1B) agonists (e.g., sumatriptan) used concurrently with Cycloset, and the concomitant use of these agents with Cycloset should be avoided.

Is this medicine FDA approved?

• It was patented in 1968 and approved for medical use in 1975.

How should this medicine be used?

Recommended dosage:

• Initial dose is one tablet (0.8 mg) daily increased weekly by one tablet until maximal tolerated daily dose of 1.6 to 4.8 mg is achieved.
• Limit dose to 1.6 mg daily during concomitant use of a moderate CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors.

Administration:

• Take Cycloset by mouth each morning 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 as your medication needs change.
• 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
• talk to your doctor about how 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 A1C

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 0.8 mg

This medicine is available in fallowing brand namesː

• Cycloset

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• headache
• dizziness
• vomiting

Cycloset may cause serious side effects, including:

• orthostatic hypotension
• somnolence
• Uncontrollable (compulsive) behaviors
• Serious and life-threatening problems in women who have recently given birth to a child

What special precautions should I follow?

• Hypotension, including orthostatic hypotension, can occur, particularly upon initiation of Cycloset therapy and with dose escalation. Use caution in patients taking antihypertensive medications. Assess orthostatic vital signs prior to initiation of Cycloset and periodically thereafter. Advise patients during early treatment to avoid situations that could lead to injury if syncope was to occur.
• Cycloset therapy may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended.
• There have been reports of patients experiencing intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including bromocriptine, that increase central dopaminergic tone. Ask patients or their caregivers about new or increased gambling urges, sexual urges, uncontrolled spending, or other urges while being treated with Cycloset. Consider dose reduction or stopping Cycloset if a patient develops such urges. Use of Cycloset in patients with impulse control/compulsive behaviors is not recommended.
• Cycloset may cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur.
• Concomitant use with dopamine antagonists such as neuroleptic agents may diminish the effectiveness of both drugs. Concomitant use is not recommended.
• Effectiveness and safety are unknown in patients already taking dopamine receptor agonists for other indications. Concomitant use is not recommended.
• Cycloset is contraindicated in postpartum patients. Serious and life-threatening adverse reactions including hypertension, myocardial infarction, seizures, stroke and psychosis have been reported postmarketing in postpartum women who were administered bromocriptine for inhibition of lactation.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, vomiting, constipation, diaphoresis, dizziness, pallor, severe hypotension, malaise, confusion, lethargy, drowsiness, delusions, hallucinations, and repetitive yawning.

Management of overdosage:

• Treatment of overdose consists of removal of the drug by emesis (if conscious), gastric lavage, activated charcoal, or saline catharsis.
• Careful supervision and recording of fluid intake and output is essential.
• Hypotension should be treated by placing the patient in the Trendelenburg position and administering intravenous fluids.
• If satisfactory relief of hypotension cannot be achieved by using the above measures to their fullest extent, vasopressors should be considered.

Can this medicine be used in pregnancy?

• There are no available data on Cycloset use in pregnant women with type 2 diabetes.

Can this medicine be used in children?

• The safety and effectiveness of Cycloset in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: bromocriptine mesylate
• Inactive ingredients: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, and citric acid

Who manufactures and distributes this medicine?

• Manufactured for:

VeroScience, LLC Tiverton, RI

• Distributed by:

Salix Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ USA

What should I know about storage and disposal of this medication?

• Store Cycloset at room temperature between 68°F and 77°F (20°C and 25°C).
• Store Cycloset in a tight, light resistant container.

• Dailymed label info on Cycloset
• FDA Cycloset

Cycloset Resources
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