Naproxen and Esomeprazole Magnesium Delayed-Release Tablets

Lupin Pharmaceuticals, Inc

Revision date : 2020-02-27

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

General Information

Revision date

2020-02-27

Product name

Naproxen and Esomeprazole Magnesium Delayed-Release Tablets

CAS No.

217087-09-7

Manufacturer Name

Patheon Pharmaceuticals Inc.

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Company Information

company name

Lupin Pharmaceuticals, Inc

Section 2

SECTION 2: Hazards identification

Fire and Explosion Expected to be non-combustible. Health Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the following patients:  Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any components of the drug product, including omeprazole. Hypersensitivity reactions to esomeprazole may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.  History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients.  In the setting of coronary artery bypass graft (CABG) surgery.  Proton pump inhibitors (PPIs), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products.

Environmental hazards

No information is available about the potential of this product to produce adverse environmental effects.

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