Label: DEXLANSOPRAZOLE DELAYED RELEASE- dexlansoprazole capsule, delayed release

  • NDC Code(s): 24979-703-06, 24979-704-06, 24979-704-07
  • Packager: TWI PHARMACEUTICALS, INC.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated August 3, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DEXLANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXLANSOPRAZOLE DELAYED-RELEASE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Healing of Erosive Esophagitis - Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Dosage in Patients 12 Years of Age and Older - Table 1. Recommended Dexlansoprazole Delayed-Release Capsules Dosage Regimen by Indication in Patients 12 Years of Age and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Dexlansoprazole delayed-release capsules - 30 mg: strength is an opaque, blue and gray capsule imprinted with "TAP" and "30". 60 mg: strength is an opaque, blue capsule imprinted with "TAP" and ...
  • 4 CONTRAINDICATIONS
    Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)]. Hypersensitivity reactions may ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with dexlansoprazole delayed-release capsules does not preclude the presence of gastric malignancy. Consider ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated ...
  • 7 DRUG INTERACTIONS
    Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with dexlansoprazole delayed-release capsules and ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and ...
  • 10 OVERDOSAGE
    There have been no reports of significant overdose with dexlansoprazole delayed-release capsules. Multiple doses of dexlansoprazole delayed-release capsules 120 mg and a single dose of ...
  • 11 DESCRIPTION
    The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H-benzimidazole, a ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+ ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two, 24 month carcinogenicity studies ...
  • 14 CLINICAL STUDIES
    14.1 Healing of Erosive Esophagitis in Adults - Two multicenter, double-blind, active-controlled, randomized, eight week studies were conducted in patients with endoscopically confirmed EE ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Dexlansoprazole delayed-release capsules, 30 mg, are opaque, blue and gray with "TAP" and "30" imprinted on the capsule and supplied as: NDC NumberSize - 24979-703-06Bottle of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions - Advise patients to report to their healthcare provider if they ...
  • MEDICATION GUIDE
    MEDICATION GUIDE - Dexlansoprazole - (DEX lan SOE pra zol) delayed-release capsules, for oral use - This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised ...
  • INSTRUCTIONS FOR USEDexlansoprazole (DEX lan SOE pra zol)delayed-release capsules, for oral use
    Taking dexlansoprazole delayed-release capsules with applesauce: Place 1 tablespoon of applesauce into a clean container. Carefully open the capsule and sprinkle the granules onto the ...
  • PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label
    TWi - NDC 24979-703-06 - Rx only - Dexlansoprazole - delayed-release capsules - Dispense the - accompanying - Medication Guide - to each patient. 30 mg - 30 capsules
  • PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label
    TWi - NDC 24979-704-06 - Rx only - Dexlansoprazole - delayed-release capsules - Dispense the - accompanying - Medication Guide - to each patient. 60 mg - 30 capsules
  • INGREDIENTS AND APPEARANCE
    Product Information