"The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medi"...
Type 2 diabetes mellitus
CYCLOSET (bromocriptine mesylate tablets) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations of Use
DOSAGE AND ADMINISTRATION
The recommended dose of CYCLOSET (bromocriptine mesylate tablets) is 1.6 mg to 4.8 mg administered once daily within two hours after waking in the morning. CYCLOSET (bromocriptine mesylate tablets) should be taken with food to potentially reduce gastrointestinal side effects such as nausea.
CYCLOSET (bromocriptine mesylate tablets) 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.
Dosage Forms And Strengths
0.8 mg tablets are white and round, imprinted with “C” on one side and “9” on the other.
Storage And Handling
CYCLOSET (bromocriptine mesylate tablets) 0.8 mg tablets are WHITE and round with “C” on one side and “9” on the other. The tablets are supplied as follows:
NDC 68012-258-20 unit-of-use bottles of 200
NDC 68012-258-60 unit-of-use bottles of 600
NDC 68012-258-21 unit-of-use bottles of 21 (samples only).
Store at or below 25°C (77°F).
Issued September 2010. Manufactured for: VeroScience, LLC Tiverton, RI . Distributed and Marketed by: Santarus, Inc. San Diego, CA. Revised 09/2010
Last reviewed on RxList: 5/11/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Cycloset Information
Report Problems to the Food and Drug Administration
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