Country: United States
Language: English
Source: NLM (National Library of Medicine)
Lidocaine 4%, Menthol 1%
Fortus Pharma, LLC
PRESCRIPTION DRUG
Abbreviated New Drug Application
ANODYNE ILE- ANODYNE ILE FORTUS PHARMA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ANODYNE ILE - (IBUPROFEN ORAL SUSPENSION USP 100MG / 5ML AND LIDOCAINE 4% / MENTHOL 1% PATCH AND ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES – 40MG) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANODYNE ILE - (IBUPROFEN ORAL SUSPENSION USP 100MG / 5ML AND LIDOCAINE 4% / MENTHOL 1% PATCH AND ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES – 40MG) INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES Warnings and Precautions, Atrophic Gastritis (5.2) removed. 10/2016 Warnings and Precautions, Cutaneous and Systemic 10/2016 Lupus Erythematosus (5.5) INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD) (1.1) Risk reduction of NSAID-associated gastric ulcer (1.2) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) DOSAGE AND ADMINISTRATION INDICATION DO SE FREQUENCY GASTROESOPHAGEALREFLUX DISEASE (GERD) Adults 12 to 17 years 1 to 11 years 20 mg or 40mg 20 mg or 40 mg 10 mg or 20 mg Once daily for 4 to 8 weeks Once daily for up to 8 weeks Once daily for up to 8 weeks 1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight). Once daily, up to 6 weeks for erosive esophagitis (EE) due to acid-mediated GERD only. RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER 20 mg or 40 mg Once daily for up to 6 months PATHOLOGICAL HYPERSECRETORY CONDITIONS 40 mg Twice daily See full prescribing information for administration options (2) Patients with severe liver impairment-do not exceed dose of 20 mg (2) DOSAGE FORMS AND STRENGTHS Esomeprazole magnesium Delayed-Release Capsules: 20 mg and 40 mg (3) CONTRAINDICATIONS Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred) (4) WARNINGS AND PRECAUTIONS Gastric Malignancy:In adults, symptoma Read the complete document