Naproxen and Esomeprazole Magnesium

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM- naproxen and esomeprazole magnesium tablet, delayed release
Dr. Reddy’s Laboratories Limited

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WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ].
  • Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4), and Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ].

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 tablet is 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 tablet is indicated to decrease the risk of developing naproxen-associated gastric ulcers.

Limitations of Use:

• Do not substitute naproxen and esomeprazole magnesium delayed-release tablet 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 absorption from other naproxen-containing products.

• Controlled studies do not extend beyond 6 months [see Use in Specific Populations ( 8.4), Clinical Studies ( 14)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

• Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5.1)].

• Carefully consider the potential benefits and risks of naproxen and esomeprazole magnesium delayed-release tablets and other treatment options before deciding to use naproxen and esomeprazole magnesium delayed-release tablets.

• Naproxen and esomeprazole magnesium delayed-release tablets does not allow for administration of a lower daily dose of esomeprazole magnesium. If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered.

• Swallow naproxen and esomeprazole magnesium delayed-release tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take naproxen and esomeprazole magnesium delayed-release tablets at least 30 minutes before meals.

• Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

• Antacids may be used while taking naproxen and esomeprazole magnesium delayed-release tablets.

2.2 Recommended Dosage

The recommended dosage of naproxen and esomeprazole magnesium delayed-release tablets by indication is shown in the table:

Indication Patient Population Recommended Dosage
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Adults One naproxen and esomeprazole magnesium delayed-release tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age and Older and Weighing at Least 38 kg Greater than 50 kg
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.

2.3 Use in Renal Impairment or Hepatic Impairment

Renal Impairment

Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance less than 30 mL/min) [see Warnings and Precautions (5.6), Use in Specific Populations (8.7)].

Hepatic Impairment

Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of naproxen and esomeprazole magnesium delayed-release tablets.

Naproxen and esomeprazole magnesium delayed-release tablets should be avoided in patients with severe hepatic impairment [see Warnings and Precautions (5.3), Use in Specific Populations (8.6)].

3 DOSAGE FORMS AND STRENGTHS

Naproxen and esomeprazole magnesium delayed-release tablets for oral administration are available in the following strengths:

  • 375 mg enteric-coated naproxen and 20 mg immediate-release esomeprazole magnesium tablets – Off white to yellow colored modified capsule shaped, biconvex, film-coated tablets printed with R 289 in black ink on one side and plain on other side.
  • 500 mg enteric-coated naproxen and 20 mg immediate-release esomeprazole magnesium tablets – Off white to yellow colored modified capsule shaped, biconvex, film-coated tablets printed with R 701 in black ink on one side and plain on other side.

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) ].

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