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Home » Directories » FDA Approved Drugs » Juvisync (sitagliptin and simvastatin)

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Juvisync (sitagliptin and simvastatin)

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    General Information

    Juvisync is a single tablet combination of the glucose-lowering medication sitagliptin, the active component of Januvia, with the cholesterol-lowering medication simvastatin, the active component of Zocor.

    Juvisync is specifically indicated for the treatment of type II diabetes in patients for whom treatment with both sitagliptin and simvastatin is appropriate.

    Juvisync is supplied as a tablet for oral administration. The recommended initial dose is 100 mg/40 mg per day. For patients already taking simvastatin (10, 20, or 40 mg daily) with or without sitagliptin 100 mg daily, Juvisync may be initiated at the dose of 100 mg sitagliptin and the dose of simvastatin already being taken.

    Clinical Results

    FDA Approval
    The FDA approval of Juvisync was based upon clinical bioequivalence studies in healthy subjects that demonstrated administration of Juvisync is equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and simvastatin, as separate tablets.

    Side Effects

    Adverse events associated with the use of simvastatin may include, but are not limited to, the following:

    • upper respiratory infection
    • headache
    • abdominal pain
    • constipation
    • nausea

    Adverse events associated with the use of sitagliptin may include, but are not limited to, the following:
    • upper respiratory tract infection
    • nasopharyngitis
    • headache

    Mechanism of Action

    Juvisync is a single tablet combination of sitagliptin and simvastatin. Sitagliptin is a DPP-4 inhibitor and exerts a glucose-lowering effect. Simvastatin is a specific inhibitor of HMG-CoA reductase and exerts a cholesterol-lowering effect.

    Additional Information

    For additional information regarding Juvisync or type II diabetes, please visit the Juvisync web page.

    Approval Date: 2011-10-01
    Company Name: Merck
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