Label: LANSOPRAZOLE capsule, delayed release

  • NDC Code(s): 0093-7350-56, 0093-7351-56
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 31, 2022

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Treatment of Active Duodenal Ulcer - Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Adult Dosage by Indication - Indication - Recommended Dose - Frequency - Duodenal Ulcers - Short-Term Treatment - 15 mg - Once daily for 4 weeks ...
  • 3 DOSAGE FORMS AND STRENGTHS
    15 mg are hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350”. 30 mg are hard gelatin capsules, with a light-gray opaque cap and ...
  • 4 CONTRAINDICATIONS
    Lansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Presence of Gastric Malignancy - In adults, symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and ...
  • 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 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole and instructions for preventing or ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see Data) ...
  • 10 OVERDOSAGE
    Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5000 ...
  • 11 DESCRIPTION
    The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Lansoprazole 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 - In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about ...
  • 14 CLINICAL STUDIES
    14.1 Duodenal Ulcer - In a US multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of lansoprazole once daily) study of 284 patients with endoscopically documented ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Lansoprazole Delayed-Release Capsules, USP are available as follows: 15 mg - hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350” ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Tubulointerstitial Nephritis - To call their healthcare provider ...
  • MEDICATION GUIDE
    Dispense with Medication Guide available at: www.tevausa.com/medguides - MEDICATION GUIDE - Lansoprazole (lan soe’ pra zole) Delayed-Release Capsules, for oral use - What is the most ...
  • Package/Label Display Panel
    NDC 0093-7350-56 - Lansoprazole Delayed-Release Capsules, USP - 15 mg - PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only - 30 Capsules - image 1
  • Package/Label Display Panel
    NDC 0093-7351-56 - Lansoprazole Delayed-Release Capsules, USP - 30 mg - PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only - 30 Capsules - image 2
  • INGREDIENTS AND APPEARANCE
    Product Information