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View PDF Edition - U.S. Pharmacist

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BRIEF SUMMARY OF FULL PRESCRIBING INFORMATIONKAPIDEX (dexlansoprazole) delayed release capsulesINDICATIONS AND USAGEKAPIDEX is indicated for: CONTRAINDICATIONS [see Adverse Reactions]WARNINGS AND PRECAUTIONSGastric Malignancy ADVERSE REACTIONSClinical Trials Experience Table 2: Incidence of Treatment-Emergent AdverseReactions in Controlled StudiesPlaceboKAPIDEX30 mg(N=455)%KAPIDEX60 mg(N=2218)%KAPIDEXTotal(N=2621)%Lansoprazole30 mg(N=1363)%(N=896)Adverse Reaction % Tract Infection Blood and Lymphatic System Disorders: CardiacDisorders: Ear and Labyrinth Disorders: Endocrine Disorders: Eye Disorders: Gastrointestinal Disorders: General Disorders and Administration Site Conditions: Hepatobiliary Disorders: Immune System Disorders: Infections and Infestations: Injury, Poisoning and Procedural Complications: Laboratory Investigations: Metabolism and NutritionDisorders: Musculoskeletaland Connective Tissue Disorders: Nervous System Disorders: PsychiatricDisorders: Renal and Urinary Disorders: ReproductiveSystem and Breast Disorders: ; Respiratory, Thoracic and Mediastinal Disorders: Skin and Subcutaneous TissueDisorders: Vascular Disorders: DRUG INTERACTIONSDrugs with pH-Dependent Absorption Pharmacokinetics Warfarin USE IN SPECIFIC POPULATIONSPregnancyTeratogenic Effects

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