Esomeprazole Magnesium 40mg 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 cells. It is the S-isomer of omeprazole. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity regardless of the stimulus.

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
+ Changes in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
Symptoms of C. diff-associated diarrhea (CDAD), including:
+ 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 can affect body organs and be life-threatening
+ Seek medical help immediately if you experience:
- Red, swollen, blistered, or peeling skin
- Red or irritated eyes
- Sores in your 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 may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify 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 alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, discuss your risks with your doctor and take necessary precautions.

Long-term use of this medication (typically more than 3 months) may lead to rare but potentially serious side effects. For instance, it may cause low magnesium levels, which can occur after 1 year of treatment. Low magnesium levels may trigger other electrolyte problems, so your doctor may recommend regular blood tests to monitor your condition.

Additionally, prolonged treatment with this medication (usually more than 3 years) may cause low vitamin B-12 levels. Be aware of the symptoms of low vitamin B-12 levels, which include shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor immediately.

In rare cases, this medication has been associated with the development or worsening of lupus. If you have lupus, inform your doctor, and seek medical attention promptly if you notice any signs of lupus, such as a rash on the 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 the 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, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.

• Nelfinavir
• Atazanavir
• Rilpivirine
• Clopidogrel (potential reduced antiplatelet effect, though clinical significance debated)

• Warfarin (increased INR)
• Methotrexate (increased levels)
• Tacrolimus (increased levels)
• Digoxin (increased levels)
• Citalopram (increased levels)
• Diazepam (increased levels)
• Phenytoin (increased levels)
• Iron salts (decreased absorption)
• Ketoconazole, Itraconazole, Erlotinib (decreased absorption due to increased gastric pH)

• St. John's Wort (potential decreased esomeprazole levels)
• Ginkgo biloba (potential decreased esomeprazole levels)

• Persistent or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Unexplained weight loss
• Vomiting (especially bloody or 'coffee-ground' emesis)
• Black, tarry stools (melena)
• Chest pain (rule out cardiac causes)
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, arrhythmias, seizures)
• Signs of C. difficile infection (e.g., severe diarrhea, abdominal pain, fever)

Esomeprazole is generally considered low risk during pregnancy. While older classifications listed it as Category B/C, current FDA labeling uses a risk summary approach. Human data from observational studies do not suggest an increased risk of major birth defects or adverse maternal or fetal outcomes with esomeprazole use during pregnancy. Use only if clearly needed.

Esomeprazole is present in human milk. However, the amount is low, and adverse effects on the breastfed infant are not expected. It is generally considered compatible with breastfeeding (Lactation Risk Category L2). Monitor the infant for any signs of gastrointestinal upset.

Approved for use in children 1 year and older for erosive esophagitis and GERD. Dosing is weight-based for younger children. Long-term safety data in pediatric populations are limited, and PPIs should be used for the shortest duration possible.

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 long-term adverse effects such as bone fractures and hypomagnesemia.

• Esomeprazole is the S-isomer of omeprazole, often marketed as a 'next-generation' PPI due to slightly improved pharmacokinetic profile (higher bioavailability on repeated dosing).
• Take 30-60 minutes before the first meal of the day for optimal acid suppression.
• Long-term PPI use (typically >1 year) has been associated with increased risks of C. difficile infection, bone fractures (hip, wrist, spine), hypomagnesemia, and vitamin B12 deficiency. Use the lowest effective dose for the shortest duration necessary.
• Patients on clopidogrel should be monitored if co-administered with esomeprazole, although the clinical significance of this interaction is debated and often outweighed by the benefit of PPI in high-risk patients.
• Rebound acid hypersecretion can occur upon discontinuation of PPIs, especially after long-term use. Tapering the dose may help mitigate this effect.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
• H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (withdrawn in some regions), Cimetidine, Nizatidine
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• Sucralfate (for ulcer protection)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. 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, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.