Label: ALOGLIPTIN tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated January 28, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ALOGLIPTIN TABLETS safely and effectively. See full prescribing information for ALOGLIPTIN TABLETS. Alogliptin Tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use - Alogliptin tablet is not ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage - The recommended dosage of alogliptin tablets is 25 mg taken orally once daily. Do not spilt tablet. Alogliptin tablets may be taken with or without food. [see Clinical ...
  • 3 DOSAGE FORMS AND STRENGTHS
    25 mg tablets are light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side. 12.5 mg tablets are yellow, oval, biconvex, film-coated, with "TAK ALG-12.5" printed on one ...
  • 4 CONTRAINDICATIONS
    Alogliptin tablets is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in Alogliptin tablets. Reactions such as anaphylaxis, angioedema ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Pancreatitis - Acute pancreatitis has been reported in the postmarketing setting and in randomized clinical trials. In glycemic control trials in patients with type 2 diabetes mellitus, acute ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis [see Warnings and Precautions (5.1)] Heart Failure [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Insulin Secretagogues and Insulin - Insulin and insulin secretagogues are known to cause hypoglycemia. Coadministration of alogliptin tablets with an insulin secretagogue (e.g., sulfonylurea ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to ...
  • 10 OVERDOSAGE
    In the event of an overdose, it is reasonable to institute the necessary clinical monitoring and supportive therapy as dictated by the patient's clinical status. Per clinical judgment, it may be ...
  • 11 DESCRIPTION
    Alogliptin tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of DPP-4. Chemically, alogliptin is prepared as a ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Increased concentrations of the incretin hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are released into the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Rats were administered oral doses of 75, 400 and 800 mg/kg alogliptin for two years. No drug-related tumors were ...
  • 14 CLINICAL STUDIES
    14.1 Overview of Clinical Trials in Adults with Type 2 Diabetes Mellitus - Alogliptin tablets have been studied as monotherapy and in combination with metformin, a sulfonylurea, a ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Alogliptin tablets 25 mg tablet: light red, oval, biconvex, film-coated, with "TAK ALG-25" printed on one side. NDC: 63629-4946-1: 30 FILM COATED TABLETs in a BOTTLE - Store at 25°C (77°F) ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Pancreatitis - Inform patients that acute pancreatitis has been reported during use of alogliptin tablets ...
  • SPL UNCLASSIFIED SECTION
    ALO332 R8 - 0Q900 RC J5 - Rev 7-23
  • MEDICATION GUIDE
    This Medication Guide has been approved by the U.S. Food and Drug Administration.ALO332 R8July 2023 - MEDICATION GUIDE - Alogliptin Tablets - Read this Medication Guide carefully before ...
  • PRINCIPAL DISPLAY PANEL
    Alogliptin 25 mg Tablets #30
  • INGREDIENTS AND APPEARANCE
    Product Information