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Cycloset

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Cycloset

Cycloset

INDICATIONS

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

  • CYCLOSET (bromocriptine mesylate tablets) 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.

DOSAGE AND ADMINISTRATION

Recommended Dosing

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.

Titration

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.

HOW SUPPLIED

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).

Storage

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.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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