Naproxen and esomeprazole magnesium

What is Naproxen and esomeprazole magnesium?

• Naproxen and esomeprazole magnesium (Vimovo) is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) used as a pain reliever medication.

The naproxen component of Vimovo 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 Vimovo is indicated to decrease the risk of developing naproxen-associated gastric ulcers

Naproxen

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Structure of Esomeprazole

What are the uses of this medicine?

• Vimovo is a prescription medicine used in adults and adolescents, 12 years of age and older who weigh at least 84 pounds (38 kg), who need to take naproxen for relief of symptoms of arthritis and who also need to decrease the risk of developing stomach ulcers caused by naproxen.

The naproxen in Vimovo is used for the relief of signs and symptoms of:

• osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults
• juvenile idiopathic arthritis (JIA) in adolescents

The esomeprazole magnesium in Vimovo is used to:

• decrease the risk of developing stomach ulcers in people who are taking naproxen

Limitations of use:

• It is not known if Vimovo is safe and effective in children less than 12 years of age or who weigh less than 84 pounds (38 kg).
• You should not take a naproxen tablet and an esomeprazole magnesium tablet together instead of taking Vimovo, because they will not work the same way.
• Studies in people who take Vimovo have not extended past 6 months.
• Vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products.

How does this medicine work?

• Vimovo consists of an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine.
• The enteric coating prevents naproxen release at pH levels below 5.5.
• Vimovo has analgesic, anti-inflammatory, and antipyretic properties contributed by the naproxen component.
• Naproxen is a potent inhibitor of prostaglandin synthesis in vitro.
• Prostaglandins are mediators of inflammation.
• Because naproxen is an inhibitor of prostaglandin synthesis, its mode of action may be due to an increase of prostaglandins in peripheral tissues.
• Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell.
• By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• if you are allergic to naproxen, esomeprazole magnesium, omeprazole, any other PPI medicine, or any of the ingredients in Vimovo.
• if you have had an asthma attack, hives, or other allergic reaction after taking aspirin or any other NSAIDs.
• right before or after heart bypass surgery.
• if you are taking a medicine that contains rilpivirine (Edurant, Complera, Odefsey) used to treat HIV-1 (Human Immunodeficiency Virus).

What drug interactions can this medicine cause?

• The concomitant use of naproxen and anticoagulants have increased the risk of serious bleeding compared to the use of either drug alone.
• 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.
• Monitor patients with concomitant use of Vimovo with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.
• Avoid concomitant use of clopidogrel with Vimovo. Consider use of alternative anti-platelet therapy.
• During concomitant use of Vimovo and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of Vimovo with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.
• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with esomeprazole magnesium may reduce antiviral effect and promote the development of drug resistance.
• Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) when coadministered with omeprazole magnesium, the racemate of esomeprazole
• Monitor digoxin concentrations during concomitant use of Vimovo. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.
• Concomitant use of naproxen and cyclosporine may increase cyclosporine's nephrotoxicity.

Is this medicine FDA approved?

• Vimovo is US Food and Drug Administration approved for use against osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in the year of 2010.

How should this medicine be used?

Recommended dosage:

• Adolescents 12 years of age and older weighing 38 kg to less than 50 kg: One Vimovo 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 Vimovo 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

• Avoid in moderate/severe renal impairment or severe hepatic impairment.
• Consider dose reduction in mild/moderate hepatic impairment.

Administration:

1. Take Vimovo exactly as prescribed by your healthcare provider.
2. Take 1 Vimovo tablet 2 times each day.
3. Take Vimovo at least 30 minutes before a meal.
4. Swallow Vimovo tablets whole with liquid. Do not split, chew, crush or dissolve Vimovo.
5. You may use antacids while taking Vimovo.
6. If you forget to take your dose of Vimovo, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Vimovo delayed-release tablets:

• 375 mg enteric-coated naproxen /20 mg immediate-release esomeprazole
• 500 mg enteric-coated naproxen /20 mg immediate-release esomeprazole

This medicine is available in fallowing brand namesː

• Vimovo

What side effects can this medication cause?

The most common side effects of this medicine include:

• inflammation of the lining of the stomach and diarrhea

Vimovo can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death
• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines
• A type of kidney problem (acute tubulointerstitial nephritis)
• Diarrhea caused by an infection (Clostridium difficile) in your intestines
• Bone fractures (hip, wrist, or spine)
• Certain types of lupus erythematosus
• Low vitamin B-12 levels
• Low magnesium levels
• Stomach growths (fundic gland polyps)
• liver problems, including liver failure
• new or worsening high blood pressure
• heart failure
• kidney problems, including kidney failure
• life-threatening allergic reactions
• asthma attacks in people who have asthma
• life-threatening skin reactions
• low red blood cells (anemia)
• hiding (masking) symptoms of an infection, such as swelling and fever

What special precautions should I follow?

• Hepatotoxicity may occur. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• Hypertension may occur. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
• Heart Failure and Edema may occur with Vimovo. Avoid use of Vimovo in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
• Renal Toxicity may occur with Vimovo. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of Vimovo in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
• Anaphylactic Reactions may occur with Vimovo. Seek emergency help if an anaphylactic reaction occurs.
• Exacerbation of Asthma Related to Aspirin Sensitivity may occur. Vimovo is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
• Serious Skin Reactions may occur with Vimovo. Discontinue Vimovo at first appearance of skin rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) may occur. Discontinue and evaluate clinically.
• Vimovo can cause Fetal Toxicity. Limit use of NSAIDs, including Vimovo, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
• Hematologic Toxicity with Vimovo. Monitor hemoglobin or hematocrit in patients with any signs of symptoms of anemia.
• Masking of Inflammation and Fever may occur with Vimovo. Potential for diminished utility of diagnostic signs in detecting infections.
• Obtain CBC and chemistry profile periodically during treatment. Monitor hemoglobin periodically in patients on long- term treatment who have an initial value of 10 g or less.
• Active Bleeding occurs with Vimovo. Withdraw treatment in patients who experience active and clinically significant bleeding.
• Do not use Vimovo with other naproxen- containing products or other non-aspirin NSAIDs.
• Gastric Malignancy may occur with Vimovo. In adults, symptomatic response to esomeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
• Acute Tubulointerstitial Nephritis may occur with Vimovo. Discontinue treatment and evaluate patients.
• Clostridium difficile-Associated Diarrhea may occur with PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
• Vimovo increases the risk of bone Fracture Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
• Cutaneous and Systemic Lupus Erythematosus may occur. Mostly cutaneous, new onset or exacerbation of existing disease; discontinue Vimovo and refer to specialist for evaluation.
• Avoid concomitant use with Clopidogrel.
• Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• Hypomagnesemia may occur. Reported rarely with prolonged treatment with PPIs.
• Avoid concomitant use with St. John's Wort or Rifampin.
• Increases in intragastric pH may result in hypergastrinemia, enterochromaffin-like cell hyperplasia, and increased Chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
• Concomitant use of Methotrexate with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.
• Fundic Gland Polyps may occur. Risk increases with long-term PPI use, especially beyond one year. Use the shortest duration of therapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Overdosage of naproxen:

• lethargy
• drowsiness
• nausea
• vomiting
• epigastric pain
• Gastrointestinal bleeding
• Hypertension
• acute renal failure
• respiratory depression
• seizures

Treatment of overdosage:

• Manage patients with symptomatic and supportive care following an NSAID overdosage.
• There are no specific antidotes.
• Hemodialysis does not decrease the plasma concentration of naproxen because of the high degree of its protein binding. Consider emesis and/or activated charcoal.
• Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

Overdosage of esomeprazole:

• The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.

Treatment of overdosage:

• No specific antidote for esomeprazole is known.
• Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis.
• In the event of overdosage, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
• Avoid Vimovo use at about 30 weeks of gestation and later in pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Vimovo have been established in adolescent patients 12 years of age and older weighing at least 38 kg.
• The safety and effectiveness of Vimovo in pediatric patients less than 12 years of age or less than 38 kg with JIA have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: naproxen and esomeprazole magnesium
• Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, iron oxide yellow, glyceryl monostearate, hypromellose, iron oxide black, magnesium stearate, methacrylic acid copolymer dispersion, methylparaben, polysorbate 80, polydextrose, polyethylene glycol, povidone, propylene glycol, propylparaben, titanium dioxide, and triethyl citrate

Who manufactures and distributes this medicine?

Distributed by: Horizon Medicines, LLC., Deerfield, IL

What should I know about storage and disposal of this medication?

• Store Vimovo at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
• Store Vimovo in the original container.
• Keep the bottle of Vimovo tightly closed to protect from moisture.

• Dailymed label info on Naproxen and esomeprazole magnesium
• FDA Naproxen and esomeprazole magnesium

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