esomeprazole magnesium dihydrate

FDA Drug Profile — ESOMEPRAZOLE MAGNESIUM MINIS, esomeprazole magnesium, equate esomeprazole magnesium, Esomeprazole Magnesium

esomeprazole magnesium dihydrate is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including ESOMEPRAZOLE MAGNESIUM MINIS, esomeprazole magnesium, equate esomeprazole magnesium. Available dosage forms: powder, capsule, delayed release.

Drug Details

Generic Name
esomeprazole magnesium dihydrate
Brand Names
ESOMEPRAZOLE MAGNESIUM MINIS, esomeprazole magnesium, equate esomeprazole magnesium, Esomeprazole Magnesium
Application Number
ANDA207193
Sponsor
Jubilant Biosys limited
NDC Codes
5
Dosage Forms
POWDER, CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients
ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE

Indications and Usage

Uses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Warnings Allergy alert: • Do not use if you are allergic to esomeprazole. • Esomeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.