Naproxen and Esomeprazole Magnesium Delayed-Release Tablets

ScieGen Pharmaceuticals, Inc

Revision date : 2024-06-26

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

General Information

Revision date

2024-06-26

Product name

Naproxen and Esomeprazole Magnesium Delayed-Release Tablets

Chemical name

Esomeprazole Magnesium 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2- pyridyl)methyl]sulfinyl]benzimidazole, magnesium salt (2 1)

1.2.1 Relevant identified uses

Juvenile Idiopathic Arthritis (JIA) in adolescent patients Naproxen: (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid

Manufacturer Name

ScieGen Pharmaceuticals, Inc

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Company Information

company name

ScieGen Pharmaceuticals, Inc

Section 2

SECTION 2: Hazards identification

Fire and Explosion Expected to be non-combustible

Environmental hazards

Not considered hazardous when handled under normal conditions. Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the following patients: i) 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. Health ii) Contraindicated in patients receiving rilpivirine-containing products. iii) Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazole, 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.

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