View PDF Edition - U.S. Pharmacist
View PDF Edition - U.S. Pharmacist
View PDF Edition - U.S. Pharmacist
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
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