Nexium 20mg Capsules

Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) in the gastric parietal cell. It is the S-isomer of omeprazole and is a weak base that is concentrated and converted to the active form in the acidic secretory canaliculi of the parietal cell, where it irreversibly binds to and inactivates the proton pump, leading to profound and long-lasting inhibition of acid secretion.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Change in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
C. diff-associated diarrhea (CDAD), characterized by:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
+ Do not attempt to treat diarrhea without consulting your doctor
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect internal organs and can be life-threatening
+ Symptoms may include:
- 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

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also 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:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking any of the following medications: Atazanavir, clopidogrel, methotrexate, nelfinavir, rifampin, rilpivirine, St. John's wort, or warfarin.
* If you have a history of certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food

Please note that this list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as taking this drug for longer than recommended by your doctor may lead to adverse effects.

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

Patients with weak bones (osteoporosis) should be aware that this medication may increase the risk of fractures in the hip, spine, and wrist. This risk may be higher if you take high doses of this medication, use it for more than a year, or are over 50 years old. If you have risk factors for osteoporosis, such as a history of alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, discuss your individual risks with your doctor.

Prolonged use of this medication (typically more than 3 months) may lead to rare but potentially serious side effects, including low magnesium levels. Most cases occur after at least 1 year of treatment, and low magnesium levels can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Long-term treatment with this medication (usually more than 3 years) has been associated with rare cases of low vitamin B-12 levels. Be aware of the symptoms of vitamin B-12 deficiency, which may include shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness and tingling in the arms and legs. If you experience any of these symptoms, contact your doctor immediately.

This medication has been linked to the development or worsening of lupus, an autoimmune disease. If you have a history of lupus, inform your doctor, and seek medical attention promptly if you experience symptoms such as a rash on your cheeks or other body parts, changes in skin color, increased sensitivity to sunlight, muscle or joint pain, chest pain, shortness of breath, or swelling in the arms and legs.

Taking this medication for more than 1 year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns or questions, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, it is essential to discuss the potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Rilpivirine-containing products (due to potential for reduced rilpivirine exposure)

• Clopidogrel (reduced antiplatelet effect)
• Atazanavir, Nelfinavir (reduced antiviral effect)
• Methotrexate (increased methotrexate levels, especially with high-dose)

• Digoxin (increased digoxin levels)
• Iron salts, Ketoconazole, Itraconazole, Erlotinib (reduced absorption of pH-dependent drugs)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (increased INR/prothrombin time)
• Citalopram (increased citalopram exposure)
• Diazepam (decreased diazepam clearance)
• Phenytoin (increased phenytoin levels)

• St. John's Wort (potential for reduced esomeprazole levels)

• Persistent or worsening heartburn
• Regurgitation
• Dysphagia (difficulty swallowing)
• Abdominal pain
• Diarrhea (especially severe or persistent, suggestive of C. difficile infection)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs of kidney problems (e.g., decreased urine output, swelling in legs/ankles)
• Signs of hypomagnesemia (e.g., muscle cramps, spasms, weakness, dizziness, abnormal heart rhythm)
• Unexplained weight loss
• Blood in stool or vomit

Limited human data on esomeprazole use in pregnant women are insufficient to inform a drug-associated risk of major birth defects or miscarriage. Animal studies have not shown adverse developmental outcomes. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Limited data from published literature show that esomeprazole is present in human milk. There are no data on the effects of esomeprazole 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 NEXIUM and any potential adverse effects on the breastfed infant from NEXIUM or from the underlying maternal condition. Generally considered compatible with breastfeeding by some sources, but caution advised.

Approved for use in children as young as 1 month for certain acid-related conditions. Dosing is weight-based and specific to age groups and indications. Safety and efficacy have been established for various pediatric populations.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. Consider potential for polypharmacy and increased risk of long-term side effects (e.g., bone fracture, C. difficile infection, hypomagnesemia) in this population.

• Esomeprazole is the S-isomer of omeprazole and may offer slightly improved bioavailability and consistency of acid suppression compared to racemic omeprazole.
• Advise patients to take esomeprazole at least 1 hour before the first meal of the day for optimal efficacy.
• For patients who cannot swallow capsules, the contents can be mixed with applesauce; however, the pellets should not be crushed or chewed.
• Long-term use (typically >1 year) of PPIs has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Periodically assess the need for continued therapy.
• Consider tapering PPIs for patients on long-term therapy who no longer have a clear indication, to avoid rebound acid hypersecretion.
• PPIs can interfere with the absorption of certain drugs that require an acidic gastric pH (e.g., some antifungals, iron salts, HIV antivirals).
• Monitor patients on concomitant clopidogrel closely for reduced antiplatelet effect, although the clinical significance of this interaction is debated for esomeprazole compared to omeprazole.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2-receptor antagonists (e.g., Famotidine, Cimetidine)
• Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
• Sucralfate
• Lifestyle modifications (dietary changes, weight management, avoiding triggers)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. 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 substance taken, the amount, and the time it occurred.