July 29, 2016
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Cycloset

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Cycloset




Indications
Dosage
How Supplied

INDICATIONS

Type 2 Diabetes Mellitus

CYCLOSET 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

Recommended Dosing

The 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.

Titration

CYCLOSET 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.

Use With Concomitant Therapy

CYCLOSET 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, Pharmacokinetics]

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 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).

Manufactured for: VeroScience, LLC Tiverton, RI. Distributed and Marketed by: Santarus, Inc. San Diego, CA. Revised: Oct 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/5/2015

Indications
Dosage
How Supplied

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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