Drugplain

Naproxen and esomeprazole magnesium 20 mg/1

Naproxen and esomeprazole magnesium · TABLET, DELAYED RELEASE · Dr. Reddy's Laboratories Limited

No Recall History
Plain English

Naproxen and esomeprazole magnesium is a tablet, delayed release containing naproxen and esomeprazole magnesium at 20 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Limited.

Key Facts

Brand Name
Naproxen and esomeprazole magnesium
Generic Name
Naproxen and esomeprazole magnesium
NDC Code (Product)
55111-289
Manufacturer
Dr. Reddy's Laboratories Limited
Strength
20 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA204206
Drug Class
Nonsteroidal Anti-inflammatory Drug [EPC]
Marketing Start
02/18/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea3 reports
off label use3 reports
asthenia2 reports
blood pressure increased2 reports
cough2 reports
gastrointestinal disorder2 reports
interstitial lung disease2 reports
rheumatoid arthritis2 reports
vomiting2 reports
adjustment disorder1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets are indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablets are indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use: Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absor…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administration Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals. ( 2.1 , 5.1 ). If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered. ( 2.1 ) Swallow naproxen and Esomeprazole magnesium delayed-release tablets whole with liquid at least 30 minutes before meals. ( 2.1 ) Recommended Dosage ( 2.2 ) Adolescents 12 years of age and older weighing 38 kg to less than 50 kg : One naproxen and esomeprazole magnesium delayed-release tablet twice daily of 375 mg naproxen/20 mg of esomeprazole Adults and adolescents 12 years of age and older greater than 50 kg : One naproxen and esomeprazole magnesium delayed-release tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg of naproxen/20 mg of esomeprazole Renal or Hepatic Impairment ( 2.3 ) Avoid in moderate/severe renal impairment or severe hepatic impairment. Consider dose reduction in mild/moderate hepatic impairment. 2.1 Important Administration Instructions Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals [see Wa…

Contraindications

4 CONTRAINDICATIONS 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 tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.7 , 5.8 , 5.9 , 5.18 ), Adverse Reactions (6.2) ] . 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 [see Warnings and Precautions (5.7 , 5.8 )] . In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ] . Proton pump inhibitors (PPIs), including esomeprazole magnesium, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . Known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any component…

Drug Interactions

7 DRUG INTERACTIONS See Table 3 and Table 4 for clinically significant drug interactions and interactions with diagnostics with naproxen and esomeprazole magnesium. Table 3: Clinically Significant Drug Interactions with Naproxen and Esomeprazole Magnesium – Affecting Drugs Co-Administered with Naproxen and Esomeprazole magnesium delayed-release tablets and Interactions with Diagnostics Clinical Impact: Naproxen • Naproxen and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Esomeprazole Magnesium • Increased INR and prothrombin time in patients treated with PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. • Concomitant use of esomeprazole 40 mg resulted in reduced plasm…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforations [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Heart Failure and Edema [see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] Anaphylactic Reactions [see Warnings and Precautions (5.7) ] Serious Skin Reactions [see Warnings and Precautions (5.9) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see Warnings and Precautions (5.10) ] Fetal Toxicity [see Warnings and Precautions (5.11) ] Hematologic Toxicity [see Warnings and Precautions (5.12) ] Active Bleeding [see Warnings and Precautions (5.15) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.18) ] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.19) ] Bone Fracture [see Warnings and Precautions (5.20) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.21) ] Cyanocobalam…

Frequently Asked Questions

What is Naproxen and esomeprazole magnesium used for?

Naproxen and esomeprazole magnesium contains Naproxen and esomeprazole magnesium. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Naproxen and esomeprazole magnesium a controlled substance?

Naproxen and esomeprazole magnesium is not classified as a controlled substance by the DEA.

What is the generic name for Naproxen and esomeprazole magnesium?

The generic name for Naproxen and esomeprazole magnesium is Naproxen and esomeprazole magnesium. There are no other listed brand versions of Naproxen and esomeprazole magnesium.

What is the NDC code for Naproxen and esomeprazole magnesium 20 mg/1?

The NDC (National Drug Code) for Naproxen and esomeprazole magnesium 20 mg/1 is 55111-289, listed by Dr. Reddy's Laboratories Limited.

Product NDC

55111-289

Package NDC

55111-289-60

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)