Cycloset
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CYCLOSET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis.
- Limited efficacy data in combination with thiazolidinediones
- Efficacy has not been confirmed in combination with insulin.
History
There is currently no drug history available for this drug.
Other Information
CYCLOSET Tablets contain bromocriptine mesylate, a dopamine receptor agonist. Bromocriptine mesylate is chemically designated [Ergotaman-3',6',18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl)-5'-(2-methylpropyl)-, monomethanesulfonate (salt), (5'α)-]. CYCLOSET is a single enantiomer with absolute configuration 5R, 8R, 2'R, 5'S, 11'S, 12'S.
The structural formula of bromocriptine is shown below:
Bromocriptine mesylate is a white or slightly colored fine crystalline powder with a molecular formula of C32H40BrN5O5∙CH4SO3 and a molecular weight of 750.72. CYCLOSET tablets contain bromocriptine mesylate USP in an amount equivalent to 0.8 of bromocriptine. Each tablet contains the following inactive ingredients: lactose, corn starch, magnesium stearate, colloidal silicon dioxide, and citric acid.
Sources
Cycloset Manufacturers
-
Santarus, Inc.
![Cycloset (Bromocriptine Mesylate) Tablet [Santarus, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cycloset | Santarus, Inc.
2.1 Recommended DosingThe recommended dose of CYCLOSET is 1.6 mg to 4.8 mg administered once daily within two hours after waking in the morning. CYCLOSET should be taken with food to potentially reduce gastrointestinal side effects such as nausea.
2.2 TitrationCYCLOSET should be initiated at one tablet (0.8 mg) and increased by one tablet per week until a maximum daily dose of 6 tablets (4.8 mg) or until the maximal tolerated number of tablets between 2 and 6 per day is reached.
2.3 Use with Concomitant TherapyCYCLOSET dose should not exceed 1.6 mg once daily during concomitant use of a moderate CYP3A4 inhibitor (e.g., erythromycin). Avoid concomitant use of CYCLOSET and strong CYP3A4 inhibitors (e.g., azole antimycotics, HIV protease inhibitors) and ensure adequate washout of the strong CYP3A4 inhibitor drug before initiating CYCLOSET treatment.[See DRUG INTERACTIONS (7), Pharmacokinetics (12.3)]
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