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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 and acts as a weak base, becoming protonated and converted to the active sulfenamide form in the acidic secretory canaliculi of the parietal cell, where it irreversibly binds to and inactivates the proton pump.

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
+ Balance changes
+ 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
Severe diarrhea (possibly due to C. difficile-associated diarrhea, or 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 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 or do not go away, contact your doctor:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This list is not exhaustive. If you have questions 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 any of the following health conditions:
+ 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. To ensure your safety, 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. Your doctor will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose 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 can have adverse effects. Additionally, this medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and lab personnel that you are taking this drug.

People with osteoporosis (weak bones) may be at a higher risk of fractures in the hip, spine, and wrist when taking this medication. This risk may increase with higher doses, prolonged treatment (more than a year), or if you 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, exercise caution and discuss your risks with your doctor.

Prolonged treatment with this medication (at least 3 months, often after 1 year) may rarely cause low magnesium levels, which can lead to other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your condition. Furthermore, long-term treatment (typically more than 3 years) may rarely result in 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, fatigue, mood changes, or numbness and tingling in the arms and legs, and contact your doctor immediately if you experience any of these symptoms.

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 the sun, muscle or joint pain, chest pain, shortness of breath, or swelling in the arms or legs.

Taking this medication for more than a year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, discuss them with your doctor. Lastly, if you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to both you and your baby.

• Rilpivirine (due to reduced absorption of rilpivirine)

• Clopidogrel (reduced antiplatelet effect)
• Nelfinavir (reduced nelfinavir exposure)
• Atazanavir (reduced atazanavir exposure)
• Methotrexate (increased methotrexate levels, especially high-dose)
• Digoxin (increased digoxin levels)
• Tacrolimus (increased tacrolimus levels)

• Warfarin (increased INR)
• Diazepam (increased diazepam levels)
• Phenytoin (increased phenytoin levels)
• Cilostazol (increased cilostazol levels)
• Iron salts (reduced iron absorption)
• Ketoconazole (reduced ketoconazole absorption)
• Itraconazole (reduced itraconazole absorption)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Erlotinib (reduced erlotinib absorption)
• Dasatinib (reduced dasatinib absorption)
• Nilotinib (reduced nilotinib absorption)
• Posaconazole (reduced posaconazole absorption)

• St. John's Wort (may reduce esomeprazole levels)

• Persistent heartburn despite treatment
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• Recurrent vomiting
• Hematemesis (vomiting blood)
• Melena (black, tarry stools)
• Severe abdominal pain
• New or worsening diarrhea (especially watery or bloody)

Esomeprazole is classified as Pregnancy Category B (older system). Human data suggest low risk of major birth defects. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

Esomeprazole is excreted into breast milk in small amounts. The risk to the infant is considered low (L3 - Moderately Safe). Monitor breastfed infants for potential adverse effects such as diarrhea or drowsiness.

Approved for GERD in infants 1 month and older. Dosing is age and weight-based. Long-term safety data in pediatric populations are limited, and risks like hypomagnesemia and bone fractures should be considered with prolonged use.

No specific dosage adjustment is required based solely on age. However, elderly patients may be at increased risk for certain adverse effects with long-term use, including C. difficile infection, hypomagnesemia, and bone fractures. Use the lowest effective dose for the shortest duration necessary.

• Esomeprazole is the S-isomer of omeprazole and may offer slightly improved bioavailability and acid suppression in some individuals, particularly CYP2C19 extensive metabolizers.
• For the powder for oral suspension, ensure proper mixing with water and administer immediately. Do not store the mixture.
• Long-term PPI use (typically >1 year) has been associated with increased risks of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Periodically assess the need for continued therapy.
• Rebound acid hypersecretion can occur upon abrupt discontinuation of PPIs, leading to worsening symptoms. Consider tapering the dose if discontinuing after prolonged use.
• PPIs can interfere with the absorption of certain medications that require an acidic gastric pH (e.g., some antifungals, HIV antivirals, iron salts).

• H2-receptor antagonists (e.g., Famotidine, Cimetidine)
• Antacids (e.g., Tums, Maalox)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• 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.