Esomeprazole 5mg DR Pwdr Pkt Susp

Manufacturer CIPLA USA 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
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Pharmacologic Class
Gastric Acid Secretion Inhibitor
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Pregnancy Category
Not available
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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 (GERD), and stomach ulcers. The 5mg powder packet is often used for children or people who have trouble swallowing pills.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose 1 hour before a meal.

Preparing Your Dose

For 2.5 mg or 5 mg packets, mix the contents with 1 teaspoon (5 mL) of water.
For 10 mg, 20 mg, or 40 mg packets, mix the contents 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 it to ensure you get the full dose.

Using a Feeding Tube

If you have a feeding tube, you can still take this medication. Follow these steps:
For 2.5 mg or 5 mg packets, add 5 mL of water to a syringe, then add the packet contents.
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 and shake the syringe.
Let it sit for 2 to 3 minutes, then shake again and administer the dose through the feeding tube.
After giving the medication, refill the syringe with the same amount of water used, shake, and flush the feeding tube.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe place, 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.
Check with your pharmacist for guidance on the best way to dispose of medications. 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's close to the time for your next dose, skip the missed dose and resume 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 packet: Empty the contents into a small amount of water (e.g., 1 tablespoon or 15 mL) in a small cup. Stir well and drink immediately. Do not chew or crush the granules. If any granules remain, add more water, stir, and drink.
  • Avoid trigger foods that worsen acid reflux (e.g., spicy foods, fatty 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 if you experience nighttime reflux.
  • Avoid smoking and excessive alcohol consumption.

Dosing & Administration

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Adult Dosing

Standard Dose: Not a standard adult dose for most indications; typically 20mg or 40mg once daily.

Condition-Specific Dosing:

GERD (non-erosive): 20mg once daily for 4-8 weeks
Erosive Esophagitis: 20mg or 40mg once daily for 4-8 weeks
Zollinger-Ellison Syndrome: Initial 40mg twice daily, adjust based on acid output
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Pediatric Dosing

Neonatal: Not established (approved for 1 month and older)
Infant: 1 month to <1 year: 2.5mg or 5mg once daily for up to 6 weeks for GERD/erosive esophagitis.
Child: 1 to 11 years: 5mg, 10mg, or 20mg once daily depending on weight and indication (e.g., 5mg for 5-10kg, 10mg for 10-20kg, 10-20mg for >20kg for GERD/erosive esophagitis).
Adolescent: 12 to 17 years: Typically 20mg or 40mg once daily for GERD/erosive esophagitis. 5mg is not a standard dose for this age group unless for specific maintenance or step-down.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment needed.
Moderate: No dose adjustment needed.
Severe: No dose adjustment needed.
Dialysis: Not removed by hemodialysis; no specific adjustment needed.

Hepatic Impairment:

Mild: No dose adjustment needed (Child-Pugh A).
Moderate: No dose adjustment needed (Child-Pugh B).
Severe: Max 20mg once daily (Child-Pugh C).
Confidence: High

Pharmacology

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Mechanism of Action

Esomeprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme system (the proton pump) located on the secretory surface of the gastric parietal cells. This inhibits the final step in gastric acid production, leading to a profound and long-lasting reduction in gastric acid secretion.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 64% after a single 40mg dose, increasing to approximately 89% after repeated once-daily dosing.
Tmax: 1.5 hours (range 1.0-2.5 hours) for oral suspension.
FoodEffect: Food decreases the rate and extent of absorption. Should be taken at least one hour before a meal.

Distribution:

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

Elimination:

HalfLife: Approximately 1-1.5 hours.
Clearance: Not readily available as a specific rate, but primarily hepatic metabolism.
ExcretionRoute: Approximately 80% via urine and 20% via feces.
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 1 hour.
PeakEffect: Full acid suppression achieved within 3-5 days of continuous dosing.
DurationOfAction: Greater than 24 hours due to irreversible binding to the proton pump.

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 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
Diarrhea associated with Clostridioides difficile (C. diff), 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 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 unusual symptoms, contact your doctor or seek medical attention:

Headache
Stomach pain or diarrhea
Constipation
Gas
Dry mouth
Upset stomach

This list is not exhaustive. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (may be a sign of C. difficile infection)
  • Unexplained muscle cramps, spasms, or weakness
  • Seizures
  • Dizziness or lightheadedness
  • Irregular heartbeat
  • Unusual fatigue or weakness
  • Numbness or tingling in hands or feet
  • Pale skin, shortness of breath, or easy bruising (signs of vitamin B12 deficiency)
  • Dark urine, yellowing of skin or eyes (signs of liver problems, rare)
  • New or worsening joint pain
  • Rash, especially on sun-exposed areas (may indicate lupus erythematosus)
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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 certain health issues, including:
+ 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 (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.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and lab 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 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 alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, discuss your risks with your doctor and take necessary precautions.

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 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) may cause low vitamin B-12 levels. Be aware of the symptoms of vitamin B-12 deficiency, 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.

Taking this medication for more than 1 year may increase the risk of 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, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Confusion
  • Blurred vision
  • Tachycardia (fast heart rate)
  • Nausea
  • Sweating
  • Headache
  • Dry mouth

What to Do:

If you suspect an overdose, contact a poison control center immediately. In the U.S., you can call 1-800-222-1222. Seek emergency medical attention if symptoms are severe.

Drug Interactions

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Contraindicated Interactions

  • Nelfinavir
  • Atazanavir
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Major Interactions

  • Clopidogrel (reduced antiplatelet effect)
  • Methotrexate (increased methotrexate levels)
  • Warfarin (increased INR)
  • Tacrolimus (increased tacrolimus levels)
  • Digoxin (increased digoxin levels)
  • Iron salts (reduced absorption)
  • Erlotinib (reduced absorption)
  • Dasatinib (reduced absorption)
  • Nilotinib (reduced absorption)
  • Mycophenolate mofetil (reduced exposure)
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Moderate Interactions

  • Citalopram (increased citalopram exposure)
  • Diazepam (decreased clearance)
  • Cilostazol (increased cilostazol exposure)
  • Phenytoin (increased phenytoin levels)
  • Ketoconazole (reduced absorption)
  • Itraconazole (reduced absorption)
  • Voriconazole (increased esomeprazole exposure)
  • Rifampin (decreased esomeprazole exposure)
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Minor Interactions

  • No specific minor interactions commonly highlighted beyond those affecting pH-dependent absorption.

Monitoring

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Baseline Monitoring

Symptom assessment (e.g., heartburn, regurgitation)

Rationale: To establish baseline severity and track treatment efficacy.

Timing: Prior to initiation of therapy.

Liver function tests (LFTs)

Rationale: Although not routinely required, consider if hepatic impairment is suspected or for severe impairment.

Timing: Prior to initiation if indicated.

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Routine Monitoring

Symptom resolution/control

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, alternative therapy, or further diagnostic workup.

Serum Magnesium levels

Frequency: Periodically (e.g., every 3-6 months) for patients on long-term therapy (β‰₯3 months) or those taking other drugs that can cause hypomagnesemia (e.g., diuretics).

Target: 0.75-1.25 mmol/L (1.8-3.0 mg/dL)

Action Threshold: Levels below normal range; consider supplementation or discontinuation of PPI.

Bone Mineral Density (BMD)

Frequency: Consider for patients at risk of osteoporosis on long-term, high-dose therapy.

Target: T-score > -2.5

Action Threshold: Significant bone loss or fracture; consider calcium/vitamin D supplementation or alternative therapy.

Vitamin B12 levels

Frequency: Consider for patients on long-term therapy (e.g., >2-3 years) or those with risk factors for deficiency.

Target: 200-900 pg/mL

Action Threshold: Levels below normal range; consider supplementation.

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Symptom Monitoring

  • Persistent or worsening heartburn
  • Regurgitation
  • Dysphagia (difficulty swallowing)
  • Abdominal pain
  • Diarrhea (especially severe or persistent, suggestive of C. difficile infection)
  • Muscle cramps or spasms
  • Tremors
  • Seizures
  • Irregular heartbeat (signs of hypomagnesemia)
  • Unusual fatigue or weakness
  • Pale skin, shortness of breath (signs of B12 deficiency)
  • Dark urine, yellowing of skin/eyes (signs of liver issues, though rare)

Special Patient Groups

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Pregnancy

Esomeprazole was previously classified as Pregnancy Category B. Current data from observational studies and meta-analyses suggest that esomeprazole use during pregnancy is not associated with an increased risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

Trimester-Specific Risks:

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

Esomeprazole is excreted into human milk. The amount is generally low, and adverse effects in breastfed infants are not expected. However, caution is advised, and the infant should be monitored for any potential adverse effects (e.g., diarrhea, drowsiness). Consider the developmental and health benefits of breastfeeding 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.

Infant Risk: L3 (Moderately safe; caution advised).
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Pediatric Use

Approved for use in infants 1 month of age and older for the treatment of GERD and erosive esophagitis. Dosing is weight-based and specific to age groups. Long-term safety and efficacy beyond 6-8 weeks have not been fully established in all pediatric age groups. The 5mg powder for suspension is particularly useful for this population.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients may be at increased risk for certain adverse effects associated with long-term PPI use, including C. difficile infection, bone fractures, and vitamin B12 deficiency. Monitor closely for these potential complications.

Clinical Information

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Clinical Pearls

  • Esomeprazole powder for oral suspension contains delayed-release granules. It must be mixed with water and consumed immediately. Do NOT chew or crush the granules, as this will destroy the enteric coating and reduce efficacy.
  • Administer at least 60 minutes before a meal for optimal absorption and acid suppression.
  • Long-term use (typically >1 year) of PPIs like esomeprazole has been associated with an increased risk of C. difficile-associated diarrhea, hypomagnesemia, bone fractures (hip, wrist, spine), and vitamin B12 deficiency. Periodically assess the need for continued therapy.
  • Rebound acid hypersecretion can occur upon discontinuation of PPIs. Consider tapering the dose gradually, especially after prolonged use, to minimize symptoms.
  • Inform patients about potential drug interactions, especially with clopidogrel, warfarin, and certain antiretrovirals.
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Alternative Therapies

  • H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (if available), Cimetidine, Nizatidine.
  • Antacids (e.g., aluminum hydroxide/magnesium hydroxide, calcium carbonate).
  • Prokinetics (e.g., Metoclopramide, for specific motility disorders).
  • Sucralfate (for ulcer protection).
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Cost & Coverage

Average Cost: Varies widely per packet
Generic Available: Yes
Insurance Coverage: Generic esomeprazole is typically covered as a Tier 1 or Tier 2 medication on most formularies. Brand-name Nexium may be Tier 3 or higher.
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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 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 contact 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.