Vimovo 500-20mg Tablets

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action, like that of other NSAIDs, is thought to be due to the inhibition of prostaglandin synthesis through the inhibition of 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 Attention 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 help right away:

Allergic reactions: 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 problems: 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 uncontrolled 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.
Mental health changes: Depression or confusion.
Flu-like symptoms: Flu-like symptoms, such as fever, chills, or body aches.

Liver Problems

This medication can cause liver problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:

Dark urine
Fatigue
Loss of appetite
Upset stomach or stomach pain
Light-colored stools
Vomiting
Yellow skin or eyes

C. difficile-Associated Diarrhea (CDAD)

This medication may increase the risk of CDAD, a severe form of diarrhea. If you experience any of the following symptoms, contact your doctor immediately:

Stomach pain or cramps
Watery or bloody stools
Do not attempt to treat diarrhea without consulting your doctor first.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. If you experience any of the following symptoms, seek medical attention immediately:

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
Swollen glands

Lupus

This medication can cause lupus or worsen existing lupus. If you have lupus, inform your doctor. If you experience any of the following symptoms, contact your doctor immediately:

Rash on the cheeks or other body parts
Changes in skin color
Sun sensitivity
Muscle or joint pain
Chest pain or shortness of breath
Swelling in the arms or legs

Vitamin B12 Deficiency

Long-term treatment with this medication (typically longer than 3 years) can cause low vitamin B12 levels. If you experience any of the following symptoms, contact your doctor immediately:

Shortness of breath
Dizziness
Abnormal heartbeat
Muscle weakness
Pale skin
Fatigue
Mood changes
Numbness or tingling in the arms or legs

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Heartburn
Gas
Dizziness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or 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.
Allergies 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 any other NSAID, salicylate drug (e.g., aspirin), or pemetrexed.
Use of the following medications:
+ 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. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 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 issues 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 ways to minimize them.

Adhere to the prescribed dosage and do not exceed the recommended amount. Taking more than the prescribed dose may increase the risk of severe side effects.

Do not take this medication for longer than your doctor has prescribed.

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

This medication may increase the risk of bleeding. To minimize this risk, be cautious and avoid injury. Use a soft toothbrush and an electric razor to reduce the risk of bleeding.

If you are taking aspirin to prevent a heart attack, discuss this with your doctor.

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 osteoporosis (weak bones). This risk may be higher if you are over 50 years old.

If you have risk factors for osteoporosis, such as drinking alcohol, smoking, taking steroids, or having a family history of osteoporosis, discuss these 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, the risk of heart attack, hospitalization, and death may be higher. Discuss these 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 these risks with your doctor.

Long-term use of this medication (more than 1 year) may increase the risk of developing 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 this with your doctor if you have concerns.

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Ketorolac (other NSAIDs)
• Methotrexate (high-dose)
• Nelfinavir, Atazanavir (reduced antiviral effect with PPIs)

• Warfarin (increased bleeding risk)
• Lithium (increased lithium levels)
• Methotrexate (increased methotrexate levels)
• Diuretics (reduced diuretic effect, increased renal toxicity)
• ACE Inhibitors/ARBs (reduced antihypertensive effect, increased renal toxicity)
• SSRIs (increased GI bleeding risk)
• Clopidogrel (reduced antiplatelet effect of clopidogrel with esomeprazole)
• Digoxin (increased digoxin levels with esomeprazole)
• Tacrolimus (increased tacrolimus levels with esomeprazole)
• Corticosteroids (increased GI bleeding risk)

• Beta-blockers (reduced antihypertensive effect of beta-blockers)
• Cyclosporine (increased nephrotoxicity)
• Phenytoin (increased phenytoin levels with esomeprazole)
• Iron salts, Ketoconazole, Itraconazole (reduced absorption due to pH change with esomeprazole)
• St. John's Wort (reduced esomeprazole levels)

• Antacids (may delay naproxen absorption)
• Sucralfate (may delay esomeprazole absorption)

• Signs of gastrointestinal bleeding (black, tarry stools; vomiting blood; severe stomach pain)
• Signs 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 legs/ankles, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
• New onset or worsening hypertension
• Unexplained weight gain or edema

Vimovo is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should be avoided unless the potential benefit outweighs the potential risk to the fetus, as NSAIDs may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Naproxen is excreted in breast milk. Esomeprazole is also likely excreted in breast milk. Due to the potential for serious adverse reactions in breastfed infants from naproxen (e.g., cardiovascular, renal, GI effects) and the lack of data on esomeprazole's effects, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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

Elderly patients are at a greater risk for serious adverse events from NSAIDs, including gastrointestinal bleeding, ulceration, perforation, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Vimovo is a fixed-dose combination designed to reduce the risk of NSAID-induced gastric ulcers in patients requiring naproxen for pain/inflammation.
• It is a delayed-release tablet, meaning the esomeprazole is released first to protect the stomach, followed by the naproxen.
• Not for immediate pain relief due to its delayed-release formulation.
• Patients should be carefully screened for cardiovascular and gastrointestinal risk factors before initiation.
• Emphasize the importance of swallowing the tablet whole to maintain the integrity of the delayed-release components.
• Long-term use of PPIs (esomeprazole) has been associated with risks such as C. difficile infection, bone fractures, and hypomagnesemia.

• Other NSAIDs (e.g., ibuprofen, celecoxib, diclofenac)
• Acetaminophen (for pain relief without anti-inflammatory effect or GI risk)
• Opioid analgesics (for severe pain, with higher risk profile)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions
• Topical NSAIDs
• Physical therapy, lifestyle modifications

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.