Zituvio

— THERAPEUTIC CATEGORIES —
  • Diabetes
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Zituvio Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sitagliptin 25mg, 50mg, 100mg; tabs.

    Pharmacological Class

    Dipeptidyl peptidase-4 (DPP-4) inhibitor.

    How Supplied

    Tabs—30, 90

    Storage

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).

    Manufacturer

    Zydus Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    Sitagliptin is believed to exert its actions in patients with type 2 diabetes mellitus by slowing the inactivation of incretin hormones. Concentrations of the active intact hormones are increased by sitagliptin, thereby increasing and prolonging the action of these hormones.

    Zituvio Indications

    Indications

    Adjunct to diet and exercise in type 2 diabetes.

    Limitations of Use

    Not for treatment of type 1 diabetes. Not studied in patients with history of pancreatitis.

    Zituvio Dosage and Administration

    Adult

    100mg once daily. Renal impairment (eGFR ≥30–<45mL/min/1.73m2): 50mg once daily; (eGFR <30mL/min/1.73m2 or ESRD on dialysis): 25mg once daily.

    Children

    Not established.

    Zituvio Contraindications

    Not Applicable

    Zituvio Boxed Warnings

    Not Applicable

    Zituvio Warnings/Precautions

    Warnings/Precautions

    Assess renal function before starting therapy and periodically thereafter. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. History of angioedema to other DPP-4 inhibitors. Elderly. Pregnancy. Nursing mothers.

    Zituvio Pharmacokinetics

    Absorption

    Absolute bioavailability: ~87%. Peak plasma concentrations (median Tmax): 1–4 hours (after 100mg oral dose).

    Distribution

    Volume of distribution: ~198 L. Plasma protein bound: 38%.

    Metabolism

    Hepatic: CYP3A4 (primary), CYP2C8.

    Elimination

    Renal (87%), fecal (13%). Half-life: ~12.4 hours.

    Zituvio Interactions

    Interactions

    May need lower dose of concomitant sulfonylurea or insulin to reduce risk of hypoglycemia.

    Zituvio Adverse Reactions

    Adverse Reactions

    Upper respiratory tract infection, nasopharyngitis, headache; pancreatitis, heart failure, hypersensitivity reactions (eg, anaphylaxis, angioedema, Stevens-Johnson syndrome), severe and disabling arthralgia, bullous pemphigoid.

    Zituvio Clinical Trials

    See Literature

    Zituvio Note

    Not Applicable

    Zituvio Patient Counseling

    See Literature

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