Esomeprazole Mag 20mg DR Caps (otc)

Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase 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, thus reducing gastric acidity.

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 immediate medical attention:

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
+ Difficulty 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 nausea or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
A severe form of diarrhea called 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 can affect body organs and 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor:

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 as a result of the allergy.
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 that is associated 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 that it is safe for you to take this medication in conjunction with your other treatments. 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.

People with weak bones (osteoporosis) may be at a higher risk of hip, spine, and wrist fractures when taking this medication, especially if they are over 50 years old, take high doses, or use the drug for more than a year. 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, exercise caution and discuss your risks with your doctor.

Prolonged use of this medication (typically more than 3 months, often after 1 year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your condition.

Long-term treatment with this medication (usually more than 3 years) may cause rare cases of low vitamin B-12 levels. Be aware of the symptoms, which include shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness and tingling in the arms and 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 immediately if you experience symptoms such as a rash on the cheeks or other body parts, changes in skin color, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.

The risk of developing stomach growths called fundic gland polyps may be higher in people who take this medication for more than 1 year. If you have concerns, discuss them with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you to ensure the best possible outcome for you and your baby.

• Clopidogrel (decreased antiplatelet effect)
• Nelfinavir (decreased nelfinavir exposure)
• Atazanavir (decreased atazanavir exposure)
• Rilpivirine (decreased rilpivirine exposure)
• Methotrexate (increased methotrexate levels, especially high-dose)

• Warfarin (increased INR/bleeding risk)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)
• Iron salts (decreased absorption of iron)
• Ketoconazole, Itraconazole, Erlotinib (decreased absorption due to increased gastric pH)
• Diazepam (decreased diazepam clearance)
• Citalopram (increased citalopram exposure)
• Clozapine (increased clozapine levels)
• St. John's Wort (decreased esomeprazole exposure)

• Sucralfate (may delay absorption of esomeprazole; administer esomeprazole at least 30 minutes before sucralfate)

• Heartburn relief
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Weight loss (unexplained)
• Vomiting (bloody or persistent)
• Black, tarry stools
• Chest pain (new or worsening)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Generally considered safe for use during pregnancy when clinically indicated. Consult a healthcare provider before use.

Esomeprazole is present in human milk. While the amount is small and adverse effects in breastfed infants are not expected, caution is advised. Consult a healthcare provider.

OTC use is not recommended for children under 18 years of age without consulting a doctor. Prescription formulations are available for specific pediatric conditions under medical supervision.

No specific dose adjustment is needed based on age alone. However, elderly patients may be more susceptible to long-term adverse effects (e.g., bone fractures, C. difficile infection, hypomagnesemia) with prolonged use. OTC use should adhere strictly to the 14-day limit.

• Esomeprazole is the S-isomer of omeprazole, often marketed as a 'next-generation' PPI due to potentially more consistent metabolism.
• For OTC frequent heartburn, it's crucial to emphasize the 14-day limit and the 'every 4 months' restriction to prevent inappropriate long-term use without medical supervision.
• Advise patients to take the capsule whole, at least one hour before the first meal of the day.
• Long-term use of PPIs (beyond OTC recommendations) has been associated with risks such as C. difficile infection, bone fractures, hypomagnesemia, and kidney problems. These are less relevant for short-term OTC use but important for patient education if they consider prolonged self-treatment.
• Patients should be advised to seek medical attention if they experience 'alarm symptoms' (e.g., difficulty swallowing, unexplained weight loss, bloody stools) as these may indicate a more serious underlying condition.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Blockers (e.g., Famotidine, Ranitidine [if available], Cimetidine)
• Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
• Alginates (e.g., Gaviscon)

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 whenever 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 medication taken, the amount, and the time it occurred.