Nexium 2.5mg DR Pwdr Pkt For Sus-30

Manufacturer ASTRAZENECA LP 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
Antiulcer agent
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Pharmacologic Class
Proton pump inhibitor (PPI)
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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 called a 'proton pump inhibitor' (PPI). It works by reducing the amount of acid your stomach makes. This helps to heal acid-related damage to the esophagus (the tube connecting your mouth to your stomach) and relieve symptoms like heartburn.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose 1 hour before a meal. To prepare your dose, mix the contents of the packet with water as follows:

For 2.5 mg or 5 mg packets, mix with 1 teaspoon (5 mL) of water.
For 10 mg, 20 mg, or 40 mg packets, mix with 1 tablespoon (15 mL) of water.
If you need to take 2 packets, use double the amount of water.

Stir the mixture into the water, then let it sit for 2 to 3 minutes. Mix well and drink the entire dose within 30 minutes of preparing it. Discard any unused portion after 30 minutes. Rinse your cup with more water and drink the rinse water to ensure you get the full dose.

Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well. If you have a feeding tube, your healthcare provider can administer the medication through the tube. To do so:

For 2.5 mg or 5 mg packets, add 5 mL of water to a syringe, then add the packet contents. Replace the plunger, shake well, and let sit for 2 to 3 minutes.
For 10 mg, 20 mg, or 40 mg packets, add 15 mL of water to a syringe, then add the packet contents. Replace the plunger, shake well, and let sit for 2 to 3 minutes.
Shake the syringe again and administer the medication through the feeding tube. After administration, refill the syringe with the same amount of water used, shake, and flush the feeding tube.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of the reach of children and pets. 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. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missing a Dose

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

  • Take this medicine exactly as prescribed, usually once daily, at least 1 hour before a meal.
  • For powder for suspension, mix the contents of the packet with water as directed and take immediately. Do not chew or crush the granules.
  • Avoid trigger foods that worsen acid reflux (e.g., fatty foods, spicy foods, caffeine, chocolate, peppermint, citrus).
  • Eat smaller, more frequent meals.
  • Avoid lying down for at least 3 hours after eating.
  • Elevate the head of your bed.
  • Avoid smoking and excessive alcohol consumption.
  • Maintain a healthy weight.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg or 40 mg once daily, 30-60 minutes before a meal
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

GERD/Erosive Esophagitis Healing: 20 mg or 40 mg once daily for 4-8 weeks
GERD Symptomatic Relief: 20 mg once daily for 4 weeks
Maintenance of Healing of Erosive Esophagitis: 20 mg once daily
H. pylori Eradication: 40 mg once daily for 10 days (in combination with amoxicillin and clarithromycin)
NSAID-Associated Gastric Ulcer Risk Reduction: 20 mg once daily for up to 6 months
Zollinger-Ellison Syndrome: Initial 40 mg twice daily, adjust based on response (up to 240 mg/day)
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Pediatric Dosing

Neonatal: Not established
Infant: 1 month to <1 year: 2.5 mg or 5 mg once daily for GERD (based on weight)
Child: 1-11 years: 10 mg or 20 mg once daily for GERD/Erosive Esophagitis (based on weight and indication); 12-17 years: 20 mg or 40 mg once daily for GERD/Erosive Esophagitis
Adolescent: 12-17 years: 20 mg or 40 mg once daily for GERD/Erosive Esophagitis
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; Esomeprazole is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed (Child-Pugh A)
Moderate: Consider dose reduction to 20 mg once daily for erosive esophagitis (Child-Pugh B)
Severe: Consider dose reduction to 20 mg once daily for erosive esophagitis (Child-Pugh C)

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% (single dose), increasing to 89% with repeated once-daily dosing
Tmax: 1.5 hours
FoodEffect: Food decreases the rate and extent of absorption. Administer at least 1 hour before a meal.

Distribution:

Vd: 0.22 L/kg
ProteinBinding: Approximately 97%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1-1.5 hours
Clearance: Not available
ExcretionRoute: Urine (80%), Feces (20%)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: Within 2-4 days of repeated dosing
DurationOfAction: Up to 24 hours (acid suppression)

Safety & Warnings

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Side Effects

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 immediately or seek emergency 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
Symptoms of a severe form of diarrhea called 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

Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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 or persistent diarrhea (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 joint pain
  • Muscle spasms, tremors, or irregular heartbeat (signs of low magnesium)
  • Any new or unusual rash, especially with joint pain
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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.
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 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 your safety while taking this medication. Never start, stop, or adjust 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 may lead to 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.

Patients with osteoporosis (weak bones) 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 the drug in high doses, 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, discuss your individual risks with your doctor.

Prolonged use of this medication (typically more than 3 months) may lead to rare but potentially serious side effects, including low magnesium levels. Most cases occur after at least 1 year of treatment, and low magnesium levels can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Long-term treatment with this medication (usually more than 3 years) has been associated with rare cases of low vitamin B-12 levels. Be aware of the symptoms of vitamin B-12 deficiency, which may 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.

This medication has been linked to the development or worsening of lupus, an autoimmune disease. If you have a history of 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 or questions, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to inform your doctor, as this medication may pose risks to you and your baby. Your doctor will help you weigh the benefits and risks of treatment and make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Limited experience with overdose. Symptoms may include drowsiness, disorientation, tachycardia, nausea, sweating, headache, blurred vision, and abdominal pain.

What to Do:

Call 911 or your local poison control center (1-800-222-1222 in the US) immediately. Treatment is symptomatic and supportive. Esomeprazole is highly protein-bound and not readily dialyzable.

Drug Interactions

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Major Interactions

  • Nelfinavir (decreased nelfinavir exposure)
  • Atazanavir (decreased atazanavir exposure)
  • Rilpivirine (decreased rilpivirine exposure)
  • Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
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Moderate Interactions

  • Methotrexate (increased methotrexate levels)
  • Warfarin (increased INR/bleeding risk)
  • Diazepam (decreased diazepam clearance)
  • Citalopram (increased citalopram exposure)
  • Digoxin (increased digoxin absorption)
  • Tacrolimus (increased tacrolimus levels)
  • Iron salts (decreased iron absorption)
  • Ketoconazole, Itraconazole, Erlotinib (decreased absorption of drugs requiring acidic gastric pH)
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Minor Interactions

  • St. John's Wort (potential decrease in esomeprazole exposure)
  • Rifampin (potential decrease in esomeprazole exposure)

Monitoring

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Baseline Monitoring

Baseline symptoms of GERD/acid-related conditions

Rationale: To establish a starting point for treatment efficacy assessment.

Timing: Before initiating therapy

Magnesium levels

Rationale: PPIs can cause hypomagnesemia, especially with prolonged use or concomitant diuretics.

Timing: Consider for patients on long-term therapy or with risk factors

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Routine Monitoring

Symptom resolution/control

Frequency: Periodically, as clinically indicated (e.g., 4-8 weeks for initial treatment, then as needed for maintenance)

Target: Significant reduction or elimination of symptoms

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

Magnesium levels

Frequency: Annually for long-term users, or more frequently if symptomatic or on diuretics

Target: Normal range (1.7-2.2 mg/dL)

Action Threshold: Levels below normal may require supplementation or discontinuation of PPI.

Bone mineral density (BMD)

Frequency: Consider for patients at high risk for osteoporosis on long-term therapy

Target: Maintain healthy BMD

Action Threshold: Significant decline may warrant intervention or alternative therapy.

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Symptom Monitoring

  • Persistent or worsening heartburn
  • Difficulty swallowing (dysphagia)
  • Painful swallowing (odynophagia)
  • Unexplained weight loss
  • Vomiting blood or 'coffee-ground' vomit
  • Black, tarry stools (melena)
  • New or worsening abdominal pain
  • Muscle cramps, weakness, tremors (signs of hypomagnesemia)
  • Diarrhea (especially severe or persistent, may indicate C. difficile infection)

Special Patient Groups

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Pregnancy

Generally considered low risk. Studies in animals have not shown harm to the fetus, and human data are reassuring. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, no increased risk of major congenital malformations observed in human studies.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Esomeprazole is excreted into human milk in small amounts. The amount ingested by the infant is low, and adverse effects are not expected. Generally considered compatible with breastfeeding.

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

Approved for GERD and erosive esophagitis in infants (1 month and older), children, and adolescents. Dosing is weight-based for younger children. Long-term safety data in pediatric populations are limited, and the lowest effective dose for the shortest duration should be used.

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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 C. difficile infection.

Clinical Information

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Clinical Pearls

  • PPIs should be used at the lowest effective dose for the shortest duration required to treat the condition.
  • Long-term PPI use (typically >1 year) has been associated with increased risks of bone fractures, C. difficile infection, hypomagnesemia, and possibly kidney disease.
  • Consider tapering PPIs for patients on long-term therapy who no longer have a clear indication, to avoid rebound acid hypersecretion.
  • Advise patients to take Esomeprazole at least 1 hour before the first meal of the day for optimal absorption and efficacy.
  • For patients on clopidogrel, consider alternative acid suppression if possible, or monitor for cardiovascular events, due to the potential for reduced clopidogrel efficacy.
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Alternative Therapies

  • Other Proton Pump Inhibitors (e.g., Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
  • H2-receptor antagonists (H2RAs) (e.g., Famotidine, Ranitidine [historical], Cimetidine)
  • Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
  • Prokinetics (e.g., Metoclopramide - for specific motility disorders)
  • Sucralfate (for ulcer protection)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$100+ per 30 packets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic, Tier 2 or 3 for brand
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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, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred, to help healthcare professionals provide the best possible care.