CIFIC POPULATIONS
Consider dose adjustment in patients with severe liver impairment. (8.7)
PREVACID is not effective in patients with symptomatic GERD 1 month to less than 1 year of age. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Short-Term Treatment of Active Duodenal Ulcer 1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence 1.3 Maintenance of Healed Duodenal Ulcers 1.4 Short-Term Treatment of Active Benign Gastric Ulcer 1.5 Healing of NSAID-Associated Gastric Ulcer 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer 1.7 Gastroesophageal Reflux Disease (GERD) 1.8 Maintenance of Healing of Erosive Esophagitis (EE) 1.9 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) 2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose 2.2 Special Populations 2.3 Important Administration Information 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Gastric Malignancy 5.2 Bone Fracture 5.3 Hypomagnesemia 5.4 Concomitant Use of PREVACID with Methotrexate 6 ADVERSE REACTIONS
6.1 Clinical 6.2 Postmarketing Experience 6.3 Combination Therapy with Amoxicillin and Clarithromycin 6.4 Laboratory Values 7 DRUG INTERACTIONS
7.1 Drugs with pH-Dependent Absorption Kinetics 7.2 Warfarin 7.3 Tacrolimus 7.4 Theophylline 7.5 Clopidogrel 7.6 Methotrexate 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 8.8 Gender 8.9 Race 10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
1.1 Short-Term Treatment of Active Duodenal Ulcer PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14)].
1.2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer RecurrenceTriple Therapy: PREVACID/amoxicillin/clarithromycin
PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: PREVACID/amoxicillin
PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14)].
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