Vimovo 375-20mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. It is thought to exert its therapeutic effects by inhibiting prostaglandin synthesis, primarily by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. Esomeprazole is a proton pump inhibitor (PPI) 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.

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, change in urine output, blood in the urine, or sudden weight gain.
Bleeding: Vomiting or coughing up blood, vomit that looks like coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruising that worsens, or uncontrollable bleeding.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Cardiovascular Issues: Chest pain or pressure, rapid heartbeat, weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Respiratory Problems: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
General Weakness: Feeling extremely tired or weak.
Bone Pain: Pain in the bones.
Hearing Changes: Ringing in the ears.
Vision Changes: Changes in eyesight.
Depression: Feeling depressed.
Confusion: Feeling confused.
Flu-like Symptoms: Experiencing flu-like symptoms.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes. (Note: Liver problems can be fatal.)
C. diff-associated Diarrhea (CDAD): Stomach pain or cramps, very loose or watery stools, or bloody stools. Do not attempt to treat diarrhea without consulting your doctor.
Severe Skin Reactions: Red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands. These reactions can be life-threatening and may affect internal organs.
Lupus: If you have lupus, this medication may worsen it. Call your doctor if you experience a rash on the cheeks or other body parts, skin color changes, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Vitamin B-12 Deficiency: If you have been taking this medication for an extended period (more than 3 years), you may be at risk for low vitamin B-12 levels. Seek medical attention if you experience shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs.

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness

If you experience any of these side effects or any others that concern you or do not go away, contact your doctor or seek medical attention.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate drugs, such as aspirin, or NSAIDs.
Presence of any of the following health issues:
+ Active bleeding
+ Bleeding in the brain or gastrointestinal (GI) tract
+ Other bleeding problems
+ Heart failure (weak heart)
+ Kidney or liver problems
+ Stomach or bowel ulcer
Recent heart attack
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed
Use of specific medications, including:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
Difficulty getting pregnant or ongoing fertility evaluation
* Pregnancy, planned pregnancy, or pregnancy during treatment with this medication. Note that this drug may harm an unborn baby if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss this with your doctor.

This medication may interfere with certain laboratory tests. Therefore, it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

There is a risk of developing high blood pressure when taking this medication. Follow your doctor's instructions for monitoring your blood pressure.

Before consuming alcohol, consult with your doctor to discuss any potential risks.

If you smoke, talk to your doctor about the potential risks and how to manage them.

Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication for longer than prescribed by your doctor.

If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

This medication may increase your risk of bleeding easily. To minimize this risk, be careful to avoid injury, use a soft toothbrush, and an electric razor.

If you are taking aspirin to prevent a heart attack, inform your doctor, as this may interact with your medication.

Take calcium and vitamin D supplements as directed by your doctor.

Long-term use of this medication, especially in high doses or for more than a year, may increase the risk of hip, spine, and wrist fractures, particularly in people with weak bones (osteoporosis). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, or a family history of osteoporosis, discuss your risks with your doctor.

Prolonged use of this medication (at least 3 months) may lead to low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.

The use of this medication may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss your risks with your doctor.

Taking this medication after a recent heart attack may increase the risk of heart attack and heart-related death. People taking this medication after a first heart attack were also more likely to die within a year. Discuss your risks with your doctor.

Long-term use of this medication (more than 1 year) may increase the risk of stomach growths called fundic gland polyps. If you have concerns, discuss them with your doctor.

This medication may affect ovulation (egg release) in women, which can impact fertility. However, this effect is reversible when the medication is stopped. Discuss your concerns with your doctor.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Aspirin (high-dose, for anti-inflammatory effect)
• Other NSAIDs (including COX-2 inhibitors)
• Patients undergoing coronary artery bypass graft (CABG) surgery (due to naproxen)

• Warfarin and other anticoagulants (increased bleeding risk)
• Methotrexate (increased methotrexate toxicity)
• Lithium (increased lithium levels)
• Diuretics (e.g., furosemide, thiazides - reduced diuretic and antihypertensive effects, increased renal toxicity)
• ACE inhibitors and Angiotensin Receptor Blockers (ARBs) (reduced antihypertensive effect, increased renal impairment risk)
• Digoxin (increased digoxin levels)
• Clopidogrel and other antiplatelet agents (increased bleeding risk)
• SSRIs/SNRIs (increased risk of GI bleeding)
• Tacrolimus, Cyclosporine (increased nephrotoxicity)
• Phenytoin, Diazepam, Citalopram, Imipramine (increased levels of these drugs due to esomeprazole's CYP2C19 inhibition)
• Atazanavir, Nelfinavir, Rilpivirine (reduced antiretroviral absorption due to esomeprazole's acid suppression)
• Voriconazole (increased esomeprazole exposure)

• Antacids (may reduce naproxen absorption)
• Iron salts (reduced iron absorption due to esomeprazole)
• Sucralfate (delays esomeprazole absorption)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Rifampin (decreased esomeprazole exposure)
• St. John's Wort (decreased esomeprazole exposure)
• Corticosteroids (increased risk of GI bleeding)

• Food (delays absorption of both components, take 30 min before meal)

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal dysfunction (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (rash, itching, swelling of face/throat, difficulty breathing)
• New or worsening hypertension
• Unexplained weight gain or edema
• Severe skin reactions (e.g., Stevens-Johnson syndrome)
• Symptoms of hypomagnesemia (e.g., muscle spasms, arrhythmias, seizures) with long-term PPI use

Vimovo is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus from the naproxen component. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest possible duration.

Naproxen is excreted in breast milk and can cause serious adverse reactions in nursing infants. Esomeprazole is also excreted in breast milk, but at low levels. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events with NSAID use. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially GI bleeding, renal impairment, and cardiovascular events.

• Vimovo combines an NSAID (naproxen) with a PPI (esomeprazole) to reduce the risk of NSAID-induced gastric ulcers, making it suitable for patients who require chronic NSAID therapy and are at high risk for GI complications.
• Always take Vimovo at least 30 minutes before a meal to ensure optimal absorption and efficacy of the esomeprazole component.
• Educate patients on the black box warnings for cardiovascular and GI risks associated with NSAIDs, and advise them to report any concerning symptoms immediately.
• Avoid concomitant use with other NSAIDs, including over-the-counter products, to prevent additive toxicity.
• Monitor renal function, liver function, and blood pressure periodically, especially in elderly patients or those with pre-existing conditions.
• Long-term PPI use (like esomeprazole) has been associated with risks such as C. difficile infection, hypomagnesemia, bone fractures, and vitamin B12 deficiency. Periodically assess the need for continued PPI therapy.

• Individual NSAID (e.g., naproxen, ibuprofen, celecoxib) taken with a separate PPI (e.g., omeprazole, lansoprazole, pantoprazole) or H2-blocker (e.g., famotidine).
• Non-NSAID analgesics (e.g., acetaminophen, opioids for severe pain).
• Topical NSAIDs for localized pain.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to facilitate prompt and appropriate treatment.