Nexium 5mg DR Pwdr Pkt For Susp

Manufacturer ASTRA ZENECA Active Ingredient Esomeprazole Powder for Suspension(es oh ME pray zol) Pronunciation es oh ME pray zol
It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat heartburn.It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.It is used to treat or prevent ulcers of the esophagus.It is used to treat syndromes caused by lots of stomach acid.It is used to treat or prevent nonsteroidal anti-inflammatory drugs (NSAID)- associated gastric ulcers in patients with a history of ulcers. Examples of NSAIDs include ibuprofen and naproxen.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Proton Pump Inhibitor (PPI)
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Pharmacologic Class
Gastric Acid Secretion Inhibitor
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Pregnancy Category
Category B
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FDA Approved
Feb 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Esomeprazole is a medicine that helps reduce the amount of acid your stomach makes. It's used to treat conditions like heartburn, acid reflux, and stomach ulcers, especially in children. It works by blocking tiny pumps in your stomach that produce acid.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these steps:

1. Take your medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Take your dose 1 hour before a meal.
3. To prepare your dose, mix the contents of the packet with water as follows:
For 2.5 mg or 5 mg packets, use 1 teaspoon (5 mL) of water.
For 10 mg, 20 mg, or 40 mg packets, use 1 tablespoon (15 mL) of water.
* If you need to take 2 packets, double the amount of water.
4. Stir the mixture into the water, then let it sit for 2 to 3 minutes.
5. Mix well and drink the entire dose within 30 minutes of preparing it.
6. Discard any unused portion of the dose within 30 minutes of mixing.
7. Rinse your cup with more water and drink it to ensure you get the full dose.

Continuing Your Medication

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

Using a Feeding Tube

If you have a feeding tube, your medication can be given through the tube. Follow these steps:

1. For 2.5 mg or 5 mg packets, add 5 mL of water to a syringe, then add the packet contents.
2. For 10 mg, 20 mg, or 40 mg packets, add 15 mL of water to a syringe, then add the packet contents.
3. Replace the plunger and shake the syringe.
4. Let the mixture sit for 2 to 3 minutes, then shake it again.
5. Give the medication through the feeding tube.
6. After administering the medication, refill the syringe with the same amount of water used, shake, and flush the feeding tube.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

1. Store it at room temperature in a dry place, away from the bathroom.
2. Keep all medications in a safe place, out of the reach of children and pets.
3. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so.
4. Check with your pharmacist for guidance on the best way to dispose of your medication. You may also be able to participate in a drug take-back program in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, usually once a day, at least one hour before a meal.
  • For the powder for suspension, mix the contents of the packet with water as directed and administer immediately. Do not chew or crush the granules.
  • Avoid foods and drinks that trigger your symptoms (e.g., spicy foods, fatty foods, caffeine, alcohol, carbonated beverages).
  • Eat smaller, more frequent meals.
  • Avoid lying down for at least 3 hours after eating.
  • Elevate the head of your bed if you experience nighttime reflux.
  • Maintain a healthy weight.
  • Avoid smoking.

Dosing & Administration

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Adult Dosing

Standard Dose: Not typically used for adult standard dosing; adult dosing usually starts at 20mg or 40mg once daily for most indications. 5mg is primarily pediatric.

Condition-Specific Dosing:

Gastroesophageal Reflux Disease (GERD): Not applicable for 5mg strength in adults.
Erosive Esophagitis (EE): Not applicable for 5mg strength in adults.
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Pediatric Dosing

Neonatal: Not established for neonates.
Infant: GERD/Erosive Esophagitis: 1 month to <1 year (weight-based): 2.5 mg or 5 mg once daily. For 3-5 kg: 2.5 mg once daily. For >5-7.5 kg: 5 mg once daily. For >7.5-12 kg: 10 mg once daily. (Note: 5mg is available for this range).
Child: GERD/Erosive Esophagitis: 1 to 11 years (weight-based): 10 mg or 20 mg once daily. For 12-20 kg: 10 mg once daily. For >20 kg: 20 mg once daily. (Note: 5mg may be used for titration or specific lower weight ranges, but 10mg/20mg are more common starting points).
Adolescent: GERD/Erosive Esophagitis: 12 to 17 years: 20 mg or 40 mg once daily. (Note: 5mg is generally too low for this age group).
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: No dosage adjustment necessary.
Dialysis: No dosage adjustment necessary; esomeprazole is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No dosage adjustment necessary (Child-Pugh A).
Moderate: No dosage adjustment necessary (Child-Pugh B).
Severe: Consider dose reduction for patients with severe hepatic impairment (Child-Pugh C). Maximum daily dose of 20 mg for adults. For pediatric patients, dose adjustment should be considered based on clinical response and tolerability.

Pharmacology

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Mechanism of Action

Esomeprazole is a proton pump inhibitor (PPI) 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 regardless of the stimulus.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 64% after a single 40 mg dose, increasing to 89% after repeated once-daily dosing. For 20 mg, it's 50% and 68% respectively.
Tmax: 1.5 hours (oral powder for suspension).
FoodEffect: Food delays and decreases the absorption of esomeprazole. It should be taken at least one hour before a meal.

Distribution:

Vd: Approximately 0.22 L/kg.
ProteinBinding: Approximately 97% bound to plasma proteins.
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1-1.5 hours.
Clearance: Not readily quantifiable due to non-linear kinetics.
ExcretionRoute: Mainly renal (approximately 80% as metabolites) and fecal (approximately 20% as metabolites).
Unchanged: <1% in urine.
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Pharmacodynamics

OnsetOfAction: Within 1 hour.
PeakEffect: Acid suppression peaks within 2-4 hours.
DurationOfAction: Up to 24 hours, despite short plasma half-life, due to irreversible binding to the proton pump.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Severe diarrhea (possibly caused by Clostridioides 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 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 if they bother you or persist, 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain or cramping
  • Diarrhea that is watery or bloody (may be a sign of C. difficile infection)
  • Unexplained weight loss
  • Difficulty or pain when swallowing
  • Vomiting blood or material that looks like coffee grounds
  • Black, tarry stools
  • New or worsening heartburn after treatment
  • Signs of low magnesium (dizziness, confusion, fast or irregular heart rate, tremors, muscle cramps or weakness, seizures)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
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Before Using This Medicine

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 symptoms such as 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 modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

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. This medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and lab personnel that you are taking it.

There is a potential increased risk of fractures in the hip, spine, and wrist in individuals with osteoporosis (weak bones), particularly 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, 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) can lead to rare cases of low magnesium levels, which may cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your condition. Additionally, long-term treatment (usually more than 3 years) with this type of medication 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 and tingling in the arms and legs, and contact your doctor immediately if you experience any of these symptoms.

This medication has been linked to 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 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, plan to become pregnant, or are breastfeeding, consult your doctor to weigh the benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Limited experience with overdose. Symptoms may include drowsiness, confusion, blurred vision, fast heartbeat, nausea, sweating, flushing, headache, dry mouth.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Esomeprazole is highly protein-bound and not readily dialyzable.

Drug Interactions

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Contraindicated Interactions

  • Nelfinavir (co-administration with PPIs is contraindicated due to significant reduction in nelfinavir exposure)
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Major Interactions

  • Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
  • Atazanavir (reduced absorption due to increased gastric pH)
  • Rilpivirine (reduced absorption due to increased gastric pH)
  • Methotrexate (increased methotrexate levels, especially with high-dose methotrexate)
  • Warfarin (increased INR/bleeding risk, monitor closely)
  • Tacrolimus (increased tacrolimus levels)
  • Digoxin (increased digoxin levels, especially in elderly or renally impaired patients)
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Moderate Interactions

  • Iron salts (reduced absorption)
  • Ketoconazole, Itraconazole, Posaconazole (reduced absorption)
  • Erlotinib (reduced absorption)
  • Mycophenolate mofetil (reduced exposure of mycophenolic acid)
  • Citalopram (increased citalopram exposure)
  • Diazepam (reduced clearance of diazepam)
  • Cilostazol (increased cilostazol exposure)
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Minor Interactions

  • Sucralfate (delays absorption of esomeprazole, administer at least 30 minutes apart)

Monitoring

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Baseline Monitoring

Baseline symptoms of GERD/Erosive Esophagitis

Rationale: To assess initial severity and track treatment efficacy.

Timing: Prior to initiation of therapy.

Magnesium levels

Rationale: Long-term PPI use (typically >3 months) can cause hypomagnesemia.

Timing: Consider for patients expected to be on long-term therapy or with risk factors for hypomagnesemia.

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Routine Monitoring

Symptom resolution/improvement

Frequency: Periodically, as clinically indicated (e.g., at follow-up visits).

Target: Reduction or elimination of symptoms.

Action Threshold: Persistent or worsening symptoms may require dose adjustment, further investigation, or alternative therapy.

Magnesium levels

Frequency: Periodically (e.g., every 3-6 months) for patients on long-term therapy (>3 months) or with risk factors.

Target: Normal serum magnesium levels (1.7-2.2 mg/dL).

Action Threshold: Hypomagnesemia (<1.7 mg/dL) requires supplementation and/or discontinuation of PPI if possible.

Vitamin B12 levels

Frequency: Consider for patients on very long-term therapy (>3 years) or with risk factors for B12 deficiency.

Target: Normal serum B12 levels.

Action Threshold: Deficiency requires supplementation.

Bone mineral density (BMD)

Frequency: Consider for patients on very long-term therapy (>1 year) at high risk for osteoporosis.

Target: Maintain healthy BMD.

Action Threshold: Significant bone loss may require intervention or alternative therapy.

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Symptom Monitoring

  • Persistent or worsening heartburn
  • Dysphagia (difficulty swallowing)
  • Odynophagia (painful swallowing)
  • Weight loss (unexplained)
  • Anemia
  • Black, tarry stools (melena)
  • Vomiting blood (hematemesis)
  • Severe abdominal pain
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of hypomagnesemia (tetany, arrhythmias, seizures)

Special Patient Groups

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Pregnancy

Esomeprazole is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Generally considered safe for use during pregnancy when clinically indicated.

Trimester-Specific Risks:

First Trimester: Low risk based on available data.
Second Trimester: Low risk based on available data.
Third Trimester: Low risk based on available data.
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Lactation

Esomeprazole is excreted into human milk. However, the amount is very small, and adverse effects on the breastfed infant are not expected. The American Academy of Pediatrics considers omeprazole (a closely related drug) to be compatible with breastfeeding. Lactation risk is L2 (safer).

Infant Risk: Low risk of adverse effects to the infant.
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Pediatric Use

Esomeprazole powder for oral suspension is specifically formulated and approved for pediatric use, including infants as young as 1 month of age, for the treatment of GERD and erosive esophagitis. Dosing is weight-based and age-specific. Long-term safety data in children is limited; use the lowest effective dose for the shortest duration possible.

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Geriatric Use

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, and may have multiple comorbidities or polypharmacy, requiring careful monitoring.

Clinical Information

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Clinical Pearls

  • Esomeprazole is the S-isomer of omeprazole, often marketed as a 'next-generation' PPI due to potentially more consistent metabolism and acid suppression.
  • The 5mg strength is particularly useful for precise dosing in infants and young children.
  • Administer the powder for suspension at least one hour before a meal for optimal absorption and efficacy.
  • For patients unable to swallow capsules, the powder for suspension provides a suitable alternative.
  • Long-term PPI use (especially >1 year) has been associated with increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Use the lowest effective dose for the shortest duration required.
  • PPIs can mask symptoms of gastric malignancy; consider endoscopy for patients with persistent or recurrent symptoms despite therapy, especially those with alarm symptoms.
  • Avoid concomitant use with clopidogrel due to potential reduction in clopidogrel's antiplatelet effect, particularly in patients at high risk for cardiovascular events.
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Alternative Therapies

  • H2-receptor antagonists (e.g., Famotidine, Ranitidine - though Ranitidine is largely withdrawn)
  • Antacids (e.g., Tums, Maalox)
  • Prokinetics (e.g., Metoclopramide - for specific motility disorders)
  • Lifestyle modifications (dietary changes, weight loss, elevating head of bed)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200+ per 30 packets (5mg)
Generic Available: Yes
Insurance Coverage: Often Tier 2 or Tier 3 for brand, Tier 1 for generic. Coverage varies by insurance plan.
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General Drug Facts

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 provides crucial information about its use. 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, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred. This information will help healthcare professionals provide you with the most effective treatment.