Esomeprazole Pwdr 10mg DR For Susp

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 converted to its active form in the acidic secretory canaliculi of the parietal cell, where it irreversibly binds to and inactivates the proton pump, blocking the final step in acid production.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: 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.
Signs of 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.
Signs of kidney problems: inability to pass urine, change in urine output, blood in the urine, or significant weight gain.
Severe dizziness or fainting.
Bone pain.
Significant weight loss.

This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can be life-threatening and may also affect internal organs. 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 any area of 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 may only have mild ones. 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, contact 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 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. It is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all of 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 of 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 this medication in high doses, for longer than a year, or if you 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, exercise caution and discuss your risks with your doctor.

Prolonged treatment with this medication (typically at least 3 months) may lead to rare cases of low magnesium levels, often occurring after 1 year of treatment. This condition may cause other electrolyte problems, and your doctor may recommend regular blood tests to monitor your magnesium levels.

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

This medication has been linked to cases of lupus, as well as exacerbating existing lupus conditions. If you have lupus, inform your doctor, and seek medical attention promptly 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.

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, as you will need to discuss the benefits and risks of this medication to both you and your baby.

• Rilpivirine (due to significant reduction in rilpivirine plasma concentrations)

• Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
• Methotrexate (increased and prolonged methotrexate and/or its metabolite exposure)
• Atazanavir, Nelfinavir (reduced absorption and plasma concentrations of antiretrovirals)
• Erlotinib, Dasatinib, Nilotinib (reduced absorption and plasma concentrations of tyrosine kinase inhibitors)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Warfarin (increased INR and prothrombin time)
• Tacrolimus (increased tacrolimus plasma concentrations)
• Digoxin (increased digoxin absorption and plasma concentrations)
• Iron salts (reduced absorption of iron)
• Ketoconazole, Itraconazole, Posaconazole (reduced absorption of antifungals)
• Diazepam (reduced clearance of diazepam)
• Citalopram (increased citalopram exposure)

• Sucralfate (may delay absorption of esomeprazole; administer esomeprazole at least 30 minutes before sucralfate)
• St. John's Wort (may induce CYP2C19 and CYP3A4, potentially reducing esomeprazole levels)

• Persistent or worsening heartburn
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Recurrent vomiting
• Gastrointestinal bleeding (black, tarry stools or coffee-ground vomit)
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, seizures, arrhythmias)
• Signs of C. difficile-associated diarrhea (e.g., severe, persistent diarrhea, abdominal pain, fever)
• Signs of kidney problems (e.g., changes in urination, blood in urine, swelling)
• Signs of lupus erythematosus (e.g., rash on nose and cheeks, joint pain)

Limited data on esomeprazole use in pregnant women are insufficient to inform a drug-associated risk of major birth defects or miscarriage. However, published observational studies on omeprazole (a racemic mixture containing esomeprazole) have not reported an increased risk of major birth defects with its use in pregnancy. Use only if clearly needed and potential benefits outweigh potential risks.

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 esomeprazole and any potential adverse effects on the breastfed infant from esomeprazole or from the underlying maternal condition. Generally considered compatible with breastfeeding due to low levels in milk and low oral bioavailability in infants.

Approved for the treatment of GERD and erosive esophagitis in pediatric patients 1 month to 17 years of age. Dosing is weight and age-dependent. The 10mg powder for suspension is particularly useful for younger children who cannot swallow capsules.

No overall differences in safety or effectiveness were observed between geriatric and younger patients. No dosage adjustment is necessary. However, due to potential for polypharmacy and comorbidities, monitor for adverse effects and drug interactions.

• Esomeprazole is the S-isomer of omeprazole, often marketed as 'the purple pill'.
• Instruct patients to take esomeprazole at least 60 minutes before a meal, preferably the first meal of the day, for optimal acid suppression.
• For the powder for oral suspension, ensure patients understand how to properly prepare and administer the dose (e.g., mixing with water, not chewing granules).
• PPIs are not for immediate relief of heartburn; they work over several days to achieve full effect.
• Long-term use (over 1 year) has been associated with an increased risk of osteoporosis-related fractures, C. difficile infection, hypomagnesemia, and vitamin B12 deficiency. Periodically assess the need for continued therapy.
• Consider tapering PPIs for patients on long-term therapy to avoid rebound acid hypersecretion upon discontinuation.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
• Histamine H2 Receptor Antagonists (H2RAs): Famotidine, Ranitidine (withdrawn from US market due to NDMA concerns, but other H2RAs are available)
• Antacids (for symptomatic relief)
• Prokinetics (e.g., metoclopramide, for motility issues, often used adjunctively)
• Surgery (e.g., Nissen fundoplication for severe GERD refractory to medical therapy)

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 receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to discuss them with 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 seeking help, be prepared to provide critical information, including the name of the medication taken, the amount, and the time it was taken.