Naproxen and Esomeprazole Magnesium
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM- naproxen and esomeprazole magnesium tablet, film coated
Mylan Pharmaceuticals Inc.
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, are 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 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 tablets is 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 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 do 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 are available containing 375 mg or 500 mg of naproxen, USP and 22.25 mg of esomeprazole magnesium, USP (amorphous) equivalent to 20 mg of esomeprazole providing for the following combinations: 375 mg/20 mg and 500 mg/20 mg.
- •
- The 375 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE1 in black ink on one side of the tablet and blank on the other side.
- •
- The 500 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE2 in black ink on one side of the tablet and blank on the other side.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/naproxen-and-esomeprazole-magnesium-2/