Naproxen and esomeprazole magnesium

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Naproxen and esomeprazole magnesium
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
See full prescribing information for complete Boxed Warning.
  • Cardiovascular Risk
  • Naproxen, a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal Risk
  • NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.

Overview

Naproxen and esomeprazole magnesium is a combination of NSAID and proton pump inhibitor that is FDA approved for the {{{indicationType}}} of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers. There is a Black Box Warning for this drug as shown here. Common adverse reactions include erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, and nausea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Naproxen and esomeprazole magnesium in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naproxen and esomeprazole magnesium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Naproxen and esomeprazole magnesium in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Naproxen and esomeprazole magnesium in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naproxen and esomeprazole magnesium in pediatric patients.

Contraindications

  • Condition1

Warnings

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
See full prescribing information for complete Boxed Warning.
  • Cardiovascular Risk
  • Naproxen, a component of VIMOVO, may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • VIMOVO is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal Risk
  • NSAIDs, including naproxen, a component of VIMOVO, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Naproxen and esomeprazole magnesium in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Naproxen and esomeprazole magnesium in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Naproxen and esomeprazole magnesium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Naproxen and esomeprazole magnesium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Naproxen and esomeprazole magnesium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Naproxen and esomeprazole magnesium in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Naproxen and esomeprazole magnesium in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Naproxen and esomeprazole magnesium in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Naproxen and esomeprazole magnesium in the drug label.

Pharmacology

There is limited information regarding Naproxen and esomeprazole magnesium Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Naproxen and esomeprazole magnesium in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Naproxen and esomeprazole magnesium in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Naproxen and esomeprazole magnesium in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Naproxen and esomeprazole magnesium in the drug label.

How Supplied

Storage

There is limited information regarding Naproxen and esomeprazole magnesium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Naproxen and esomeprazole magnesium in the drug label.

Precautions with Alcohol

  • Alcohol-Naproxen and esomeprazole magnesium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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  2. ↑ "http://www.ismp.org". External link in |title= (help)


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