Label: ZITUVIMET XR- sitagliptin and metformin hydrochloride tablet, film coated, extended release

  • NDC Code(s): 70710-1804-6, 70710-1805-6, 70710-1806-3
  • Packager: Zydus Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated July 23, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ZITUVIMET XR safely and effectively. See full prescribing information for ZITUVIMET XR. ZITUVIMET XR (sitagliptin and metformin ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    BOXED WARNING

    WARNING: LACTIC ACIDOSIS

    Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1)].

    Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.

    Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration (2.2), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6, 8.7)].

    If metformin-associated lactic acidosis is suspected, immediately discontinue ZITUVIMET XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1)].

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  • 1 INDICATIONS AND USAGE
    ZITUVIMET XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use - ZITUVIMET XR is not recommended in patients ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage and Administration - Take ZITUVIMET XR orally once daily with a meal. Patients taking two ZITUVIMET XR tablets should take the two tablets together once ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Tablets: sitagliptin 100 mg and metformin HCl 1,000 mg extended-release tablets are reddish brown to brown colored, oval shaped, film-coated tablets debossed with "1806" on one side and plain on ...
  • 4 CONTRAINDICATIONS
    ZITUVIMET XR is contraindicated in patients with: Severe renal impairment (eGFR below 30 mL/min/1.73 m2) [see Warnings and Precautions (5.1)]. Acute or chronic metabolic acidosis, including ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1            Lactic Acidosis - There have been postmarketing cases of metformin-associated lactic acidosis, including fatal cases. These cases had a subtle onset and were accompanied by ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are also discussed elsewhere in the prescribing information: Lactic Acidosis [see Warnings and Precautions (5.1)] Pancreatitis [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    Table 4 presents clinically significant drug interactions with ZITUVIMET XR: Table 4: Clinically Significant Drug Interactions with ZITUVIMET XR - Carbonic Anhydrase ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1            Pregnancy - Risk Summary - The limited available data with ZITUVIMET XR in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and ...
  • 10 OVERDOSAGE
    In the event of overdose with ZITUVIMET XR, consider contacting the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ ...
  • 11 DESCRIPTION
    ZITUVIMET XR tablets for oral use contain two antihyperglycemic medications: sitagliptin and metformin hydrochloride. Sitagliptin - Sitagliptin is an orally-active inhibitor of the DPP-4 enzyme ...
  • 12 CLINICAL PHARMACOLOGY
    12.1            Mechanism of Action - ZITUVIMET XR - ZITUVIMET XR tablets combine two antihyperglycemic agents: sitagliptin and metformin extended-release. Sitagliptin - Sitagliptin is a DPP-4 ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1            Carcinogenesis, Mutagenesis, Impairment of Fertility - ZITUVIMET XR - No animal studies have been conducted with the combined products in ZITUVIMET XR to evaluate carcinogenesis ...
  • 14 CLINICAL STUDIES
    The coadministration of sitagliptin and metformin immediate-release has been evaluated in patients with type 2 diabetes mellitus inadequately controlled on diet and exercise and in combination ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Tablets supplied as follows: Contents - Description - How Supplied - NDC - 50 mg sitagliptin and - 500 mg metformin HCl - extended-release tablets - Light orange to beige ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Lactic Acidosis - Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Zydus Lifesciences Ltd. Pharmez, Matoda, Ahmedabad, India - Distributed by: Zydus Pharmaceuticals (USA) Inc. Route 31 North, Pennington, NJ 08534
  • SPL MEDGUIDE
    Medication Guide - ZITUVIMET XR (zye too' vi met XR) (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use - Read this Medication Guide carefully ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 70710-1804-6 - ZITUVIMET XR (sitagliptin and metformin hydrochloride extended-release) tablets - 50 mg/500 mg - 60 Tablets - Rx only - NDC 70710-1805-6 - ZITUVIMET XR (sitagliptin and metformin ...
  • INGREDIENTS AND APPEARANCE
    Product Information