Esomeprazole Magnesium 20mg DR Caps

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. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, leading to a profound and long-lasting inhibition of gastric 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 also affect internal organs
+ Symptoms 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This list is not exhaustive. 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 allergic reaction you experienced, including any symptoms that occurred.
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 any of the following health issues:
+ 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 (including 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. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab personnel that you are taking this drug.

Patients with weak bones (osteoporosis) should be cautious, as 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 problems. 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 or tingling in the arms and legs. If you experience any of these symptoms, contact your doctor immediately.

In rare cases, this medication has been linked to the development or worsening of lupus. If you have a history of lupus, inform your doctor, and seek medical attention immediately if you notice any 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 or shortness of breath, or swelling in your arms or 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 inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.

• Nelfinavir
• Atazanavir (co-administration not recommended)

• Clopidogrel (potential for reduced antiplatelet effect, though clinical significance debated)
• Methotrexate (increased methotrexate levels, especially with high-dose methotrexate)
• Tacrolimus (increased tacrolimus levels)
• Erlotinib (decreased erlotinib absorption)
• Dasatinib (decreased dasatinib absorption)
• Nilotinib (decreased nilotinib absorption)
• Rilpivirine (decreased rilpivirine absorption)

• Warfarin (potential for increased INR/bleeding risk)
• Diazepam (decreased clearance of diazepam)
• Citalopram (increased citalopram exposure)
• Digoxin (increased digoxin absorption)
• Iron salts (decreased iron absorption)
• Ketoconazole (decreased ketoconazole absorption)
• Itraconazole (decreased itraconazole absorption)
• Voriconazole (increased esomeprazole exposure)
• St. John's Wort (decreased esomeprazole exposure)
• Phenytoin (potential for increased phenytoin levels)
• Cilostazol (increased cilostazol exposure)

• Sucralfate (delays and decreases absorption of esomeprazole; administer esomeprazole at least 30 minutes before sucralfate)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Recurrent vomiting
• Gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground emesis)
• Symptoms of hypomagnesemia (e.g., fatigue, muscle twitching, tremors, convulsions, dizziness, arrhythmias)
• Symptoms of C. difficile-associated diarrhea (e.g., severe, persistent diarrhea, abdominal pain, fever)

While animal studies have not shown evidence of harm, human data are limited. Generally considered low risk, but use only if clearly needed and potential benefits outweigh risks. Consult with a healthcare provider.

Esomeprazole is present in human milk. The amount is small, and adverse effects on the breastfed infant are not expected. However, monitor the infant for any adverse effects. Use with caution.

Approved for GERD in infants 1 month to 17 years. Dosing is weight-based for younger children. Long-term safety data in pediatric populations are limited, especially regarding bone health and vitamin B12 deficiency.

No overall differences in safety or effectiveness were observed between elderly and younger patients. No dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to certain adverse effects (e.g., bone fractures, C. difficile infection) and may have comorbidities or polypharmacy requiring careful consideration.

• Esomeprazole is the S-isomer of omeprazole, often marketed as a 'next-generation' PPI due to potentially more consistent metabolism and acid suppression, though clinical superiority over other PPIs is often debated.
• Advise patients to take esomeprazole at least 60 minutes before the first meal of the day to maximize absorption and efficacy.
• Long-term PPI use (especially >1 year) has been associated with increased risks of hypomagnesemia, Vitamin B12 deficiency, C. difficile infection, and bone fractures. Periodically assess the need for continued therapy.
• For patients on long-term therapy, consider monitoring magnesium levels and Vitamin B12 levels, especially if symptoms of deficiency arise.
• PPIs can mask symptoms of gastric malignancy; consider endoscopy in patients with alarm symptoms (e.g., dysphagia, weight loss, GI bleeding) or those who do not respond to therapy.
• Avoid concomitant use with clopidogrel if possible, especially in patients at high risk for cardiovascular events, due to potential for reduced antiplatelet effect via CYP2C19 inhibition. Consider alternative antiplatelet agents or PPIs with less CYP2C19 interaction (e.g., pantoprazole).

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
• H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (withdrawn in some regions), Cimetidine, Nizatidine
• Antacids (for symptomatic relief)
• Prokinetics (e.g., Metoclopramide - for motility issues, not primary acid suppression)
• Sucralfate (for ulcer coating)

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 provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.