Generic drug: naproxen and esomeprazole magnesium
Brand name: Vimovo
What is Vimovo (naproxen and esomeprazole magnesium), and how does it work?
Vimovo (naproxen and esomeprazole magnesium) is a prescription medicine used to treat the symptoms of Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. Vimovo may be used alone or with other medications.
It is not known if Vimovo is safe and effective in children.
What are the side effects of Vimovo?
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of Vimovo, 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.
- Vimovo is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Bleeding, Ulceration, and Perforation
- NSAIDs, a component of Vimovo 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.
Side effects of Vimovo include:
- chest pain spreading to your jaw or shoulder,
- sudden numbness or weakness on one side of the body,
- slurred speech,
- shortness of breath,
- severe stomach pain,
- diarrhea that is watery or bloody,
- bloody or tarry stools,
- coughing up blood or vomit that looks like coffee grounds,
- rapid weight gain,
- shortness of breath,
- little or no urination,
- blood in your urine,
- loss of appetite,
- stomach pain (upper right side),
- dark urine,
- yellowing of the skin or eyes (jaundice),
- fast or irregular heartrate,
- jerking muscle movements,
- feeling jittery,
- muscle cramps,
- muscle spasms in your hands and feet,
- choking feeling,
- pale skin,
- unusual tiredness,
- cold hands and feet,
- joint pain, and
- skin rash on your cheeks or arms that worsens in sunlight
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Vimovo include:
- stomach discomfort, and
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Vimovo. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Vimovo?
Important Administration Instructions
- Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals.
- Carefully consider the potential benefits and risks of Vimovo and other treatment options before deciding to use Vimovo.
- Vimovo 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 Vimovo tablets whole with liquid. Do not split, chew, crush or dissolve the tablet. Take Vimovo 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 Vimovo.
The recommended dosage of Vimovo by indication is shown in the table:
|Indication||Patient Population||Recommended Dosage|
|Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis||Adults||One Vimovo 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 Vimovo tablet twice daily of: 375 mg naproxen/20 mg of esomeprazole|
Use In Renal Impairment Or Hepatic 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).
Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of Vimovo.
Vimovo should be avoided in patients with severe hepatic impairment.
What drugs interact with Vimovo?
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
Vimovo and Interactions with Diagnostics
|Drugs That Interfere with Hemostasis|
|Intervention:||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.
Clopidogrel: Avoid concomitant use of clopidogrel with Vimovo. Consider use of alternative anti-platelet therapy.
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.|
|Intervention:||Concomitant use of Vimovo and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Vimovo is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Vimovo with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The effect of esomeprazole magnesium on antiretroviral drugs is variable. The clinical importance and mechanisms behind these interactions are not always known.
Rilpivirine-containins products: Concomitant use with Vimovo
|Clinical Impact:||Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) when coadministered with omeprazole magnesium, the racemate of esomeprazole.|
|Intervention:||Consider reducing the dose of cilostazol to 50 mg twice daily.|
|Intervention:||Monitor digoxin concentrations during concomitant use of Vimovo. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations.|
|Clinical Impact:||NSAIDs have produced elevations of plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Vimovo and lithium, monitor patients for signs of lithium toxicity.|
|Intervention:||During concomitant use of Vimovo and methotrexate, monitor patients for methotrexate toxicity. A temporary withdrawal of Vimovo may be considered in some patients receiving high-dose methotrexate.|
|Clinical Impact:||Concomitant use of naproxen and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Vimovo and cyclosporine, monitor patients for signs of worsening renal function.|
|Clinical Impact:||Concomitant use of esomeprazole magnesium and tacrolimus may increase exposure of tacrolimus|
|Intervention:||During concomitant use of Vimovo and tacrolimus, monitor tacrolimus whole blood concentrations.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of naproxen with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of Vimovo with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Vimovo and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Vimovo and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.|
|Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, mycophenoloate mofetil, ketoconazole)|
|Clinical Impact:||Esomeprazole magnesium can reduce the absorption of other drugs due to its effect on reducing intragastric acidity|
|Intervention:||Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole magnesium is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving esomeprazole and MMF. Use Vimovo with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.|
|Interactions with Investigations of Neuroendocrine Tumors|
|Clinical Impact:||Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors.|
|Intervention:||Temporarily stop Vimovo treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.|
|Clinical Impact:||Increased exposure of diazepam.|
|Intervention:||Monitor patients for increased sedation and adjust the dose of diazepam as needed.|
Table 4: Clinically Significant Interactions with Esomeprazole Magnesium --Affecting
|CYP2C19 or CYP3A4 Inducers|
|Clinical Impact:||Decreased exposure of esomeprazole when used concomitantly with strong inducers.|
|Intervention:||St. John’s Wort, rifampin: Avoid concomitant use with Vimovo.|
|CYP2C19 or CYP3A4 Inhibitors|
|Clinical Impact:||Increased exposure of esomeprazole.|
|Intervention:||Voriconazole: Avoid concomitant use with Vimovo.|
Is Vimovo safe to use while pregnant or breastfeeding?
- Use of NSAIDs, including Vimovo, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
- Avoid use of NSAIDs, including Vimovo, in pregnant women starting at 30 weeks of gestation (third trimester).
- There are no adequate and well-controlled studies of Vimovo in pregnant women.
- Limited data from published literature report that naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma.
- Esomeprazole is the S-isomer of omeprazole and limited data from published literature suggest omeprazole may be present in human milk.
- There is no information on the effects of naproxen or omeprazole on the breastfed infant or on milk production.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Vimovo and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Vimovo (naproxen and esomeprazole magnesium) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat the symptoms of Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. Serious side effects of Vimovo include increased risk of potentially fatal heart attack, stroke, and serious gastrointestinal (GI) adverse events (bleeding, ulceration, and perforation of the stomach or intestines).
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