Label: LANSOPRAZOLE capsule, delayed release

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

Drug Label Information

Updated December 17, 2024

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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 - * Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications and Warnings and Precautions sections ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Lansoprazole delayed-release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green ...
  • 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 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 Interstitial 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 delayed-release capsules and ...
  • 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 ...
  • 10 OVERDOSAGE
    Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole delayed-release capsules with no adverse reaction. Oral ...
  • 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 one ...
  • 14 CLINICAL STUDIES
    14.1 Duodenal Ulcer - In a U.S. multi-center, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of lansoprazole delayed-release capsules once daily) study of 284 patients with ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Lansoprazole delayed release capsules USP, 15 mg are white to pale yellow colored enteric coated pellets filled in size ‘3’ hard gelatin capsules with opaque pink colored cap and opaque green ...
  • 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 ...
  • MEDICATION GUIDE
    8411121/0323 - Lansoprazole Delayed-Release Capsules, USP - (lan soe’ pra zole) What is the most important information that I should know about lansoprazole delayed-release capsules? You ...
  • Package/Label Display Panel – Carton – 15 mg
    NDC 60687- 111-21 - Lansoprazole - Delayed-Release Capsules, USP - 15 mg - 30 Capsules (3 x 10)               Rx Only - PHARMACIST: Dispense with the accompanying Medication - Guide to ...
  • Package/Label Display Panel – Blister – 15 mg
    Lansoprazole - Delayed-Release - Capsule, USP - 15 mg
  • Package/Label Display Panel – Carton – 30 mg
    NDC 60687- 123-01 - Lansoprazole - Delayed-Release Capsules, USP - 30 mg - 100 Capsules (10 x 10)               Rx Only - PHARMACIST: Dispense with the accompanying Medication - Guide to ...
  • Package/Label Display Panel – Blister – 30 mg
    Lansoprazole - Delayed-Release - Capsule, USP - 30 mg
  • INGREDIENTS AND APPEARANCE
    Product Information