Esomeprazole Pwdr 40mg DR For Susp

Manufacturer CIPLA 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
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 reduces the amount of acid your stomach makes. It's used to treat conditions like heartburn, acid reflux, and stomach ulcers. 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, 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.
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.

Special Instructions for Feeding Tubes

If you have a feeding tube, your medication can be given to you 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 it, 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.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However:

1. If it's close to the time for your next dose, skip the missed dose and go back to your regular schedule.
2. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take this medication exactly as prescribed, usually once daily, at least one hour before a meal.
  • Do not crush, chew, or split the delayed-release capsules or granules. The powder for suspension should be mixed with water as directed and taken immediately.
  • Avoid foods and drinks that trigger your symptoms (e.g., spicy foods, fatty foods, caffeine, alcohol, citrus, chocolate).
  • 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.
  • Quit smoking, as it can worsen acid reflux.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For Erosive Esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks. For GERD: 20 mg once daily for 4 weeks. For H. pylori eradication: 40 mg once daily for 10 days (as part of triple therapy). For Zollinger-Ellison Syndrome: Initial 40 mg twice daily, adjust based on response.
Dose Range: 20 - 240 mg

Condition-Specific Dosing:

Erosive Esophagitis: 20 mg or 40 mg once daily for 4 to 8 weeks. Maintenance: 20 mg once daily.
GERD (symptomatic): 20 mg once daily for 4 weeks.
H. pylori Eradication: 40 mg once daily for 10 days (in combination with amoxicillin and clarithromycin).
Zollinger-Ellison Syndrome: Initial 40 mg twice daily, dose adjusted based on acid output (up to 240 mg/day).
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Pediatric Dosing

Neonatal: Not established
Infant: 1 month to <1 year (GERD): 2.5 mg or 5 mg once daily depending on weight.
Child: 1 to 11 years (GERD/Erosive Esophagitis): 10 mg or 20 mg once daily depending on weight and indication.
Adolescent: 12 to 17 years (GERD/Erosive Esophagitis): 20 mg or 40 mg once daily.
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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; not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: No dosage adjustment necessary.
Severe: For patients with severe hepatic impairment (Child-Pugh Class C), a maximum dose of 20 mg once daily should not be exceeded.

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.
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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 one hour before a meal.

Distribution:

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

Elimination:

HalfLife: Approximately 1-1.5 hours
Clearance: Not readily available, but rapid hepatic metabolism.
ExcretionRoute: Approximately 80% via urine (as metabolites), 20% via feces (as metabolites).
Unchanged: <1% (urine)
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: Within 2-5 days of daily dosing (for maximal acid suppression)
DurationOfAction: Up to 24 hours (due to irreversible binding to proton pump)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

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 right away:

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
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Change in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
Symptoms of 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
+ Signs 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

Most people experience few or no side effects when taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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, 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 persistent diarrhea, especially if watery or bloody (could be a sign of C. difficile infection).
  • Unexplained weight loss, difficulty swallowing, or vomiting blood/material that looks like coffee grounds (could indicate a more serious condition).
  • New or worsening muscle cramps, spasms, tremors, or an irregular heartbeat (signs of low magnesium).
  • Any signs of an allergic reaction, such as rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing. Seek immediate medical attention.
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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 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, discuss your individual risks with your doctor.

Prolonged use of this medication (typically more than 3 months) may lead to low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels. Furthermore, long-term treatment with this medication (usually more than 3 years) may cause low vitamin B-12 levels. Be aware of the signs of vitamin B-12 deficiency, 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.

In rare cases, this medication has been associated with the development or worsening of lupus. 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 your 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.

Long-term use of this medication (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. Finally, if you are pregnant, planning to become pregnant, or 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, and other gastrointestinal disturbances.

What to Do:

There is no specific antidote. Treatment should be symptomatic and supportive. Contact a poison control center immediately (e.g., call 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Rilpivirine (decreased rilpivirine exposure)
  • Nelfinavir (decreased nelfinavir exposure)
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Major Interactions

  • Clopidogrel (decreased antiplatelet effect)
  • Atazanavir (decreased atazanavir exposure)
  • Methotrexate (increased methotrexate levels, potential toxicity)
  • Digoxin (increased digoxin levels)
  • Tacrolimus (increased tacrolimus levels)
  • Warfarin (increased INR/bleeding risk)
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Moderate Interactions

  • Iron salts (decreased absorption of iron)
  • Ketoconazole, Itraconazole, Posaconazole (decreased absorption of antifungals)
  • Erlotinib (decreased erlotinib exposure)
  • Mycophenolate mofetil (decreased mycophenolic acid exposure)
  • Citalopram (increased citalopram exposure)
  • Diazepam (decreased diazepam clearance)
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Minor Interactions

  • Sucralfate (may delay absorption of esomeprazole; administer esomeprazole at least 30 minutes before sucralfate)

Monitoring

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Baseline Monitoring

Baseline symptoms of GERD/acid-related conditions

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

Timing: Prior to initiation of therapy.

Liver function tests (LFTs)

Rationale: For patients with severe hepatic impairment, dose adjustment is necessary.

Timing: Prior to initiation in patients with suspected or known severe hepatic impairment.

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Routine Monitoring

Symptom resolution/improvement

Frequency: Regularly throughout treatment, especially during initial weeks.

Target: Significant reduction or elimination of symptoms.

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.

Serum Magnesium levels

Frequency: Periodically (e.g., every 3-6 months) for patients on long-term therapy (â‰Ĩ3 months) or with concomitant diuretics/digoxin.

Target: Within normal limits (1.7-2.2 mg/dL).

Action Threshold: Hypomagnesemia (e.g., <1.7 mg/dL) requires supplementation and/or discontinuation of PPI.

Vitamin B12 levels

Frequency: Consider periodically for patients on long-term therapy (e.g., >1 year).

Target: Within normal limits.

Action Threshold: Deficiency requires supplementation.

Bone mineral density (BMD)

Frequency: Consider baseline and periodically for patients at risk for osteoporosis on long-term therapy (e.g., >1 year).

Target: Maintain healthy BMD.

Action Threshold: Significant decrease in BMD may require intervention or alternative therapy.

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Symptom Monitoring

  • Persistent or worsening heartburn
  • Dysphagia (difficulty swallowing)
  • Odynophagia (painful swallowing)
  • Unexplained weight loss
  • Anemia
  • Gastrointestinal bleeding (black, tarry stools or vomiting blood)
  • New or worsening diarrhea (especially watery or bloody stools, fever, abdominal cramps - C. difficile infection)
  • Muscle cramps, weakness, tremors, irregular heart beat (signs of hypomagnesemia)

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. It is generally considered safe for use during pregnancy when clearly needed, especially for severe GERD or erosive esophagitis.

Trimester-Specific Risks:

First Trimester: Generally considered low risk based on available data.
Second Trimester: Generally considered low risk.
Third Trimester: Generally considered low risk.
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Lactation

Esomeprazole is excreted into human milk in small amounts. The American Academy of Pediatrics considers omeprazole (the racemic mixture of which esomeprazole is the S-isomer) to be compatible with breastfeeding. The risk of adverse effects in breastfed infants appears to be low. Use with caution and monitor the infant for any adverse effects.

Infant Risk: Low risk (L2)
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Pediatric Use

Approved for the treatment of GERD and erosive esophagitis in pediatric patients aged 1 month to 17 years. Dosing is weight-based for younger children. Long-term safety data in pediatric populations are limited, and risks such as bone fracture and hypomagnesemia should be considered with prolonged use.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is required based solely on age. However, elderly patients may be more susceptible to long-term adverse effects such as bone fractures, C. difficile infection, and hypomagnesemia, and should be monitored accordingly.

Clinical Information

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Clinical Pearls

  • Esomeprazole is the S-isomer of omeprazole and may offer slightly improved bioavailability and acid suppression compared to omeprazole in some individuals, though clinical significance is often debated.
  • Instruct patients to take the powder for suspension at least one hour before a meal for optimal absorption and efficacy.
  • Long-term use (typically >1 year) of PPIs like esomeprazole has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, hypomagnesemia, and vitamin B12 deficiency. Periodically assess the need for continued therapy.
  • For patients with difficulty swallowing pills, the powder for suspension formulation is a suitable option. Ensure proper mixing instructions are followed.
  • PPIs can mask symptoms of gastric malignancy; consider endoscopy in patients with persistent or recurrent symptoms despite therapy, especially those with alarm symptoms (e.g., dysphagia, weight loss, GI bleeding).
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Alternative Therapies

  • Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
  • H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (withdrawn in some regions), Cimetidine, Nizatidine
  • Antacids (for symptomatic relief)
  • Prokinetics (e.g., metoclopramide, for motility disorders, not primary acid suppression)
  • Surgery (e.g., Nissen fundoplication for severe, refractory GERD)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and dosage form (e.g., $10-$50 for 30-day supply of generic 40mg powder for suspension) per 30 doses
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations); Tier 3 or higher (for brand-name Nexium)
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General Drug Facts

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, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever your prescription is refilled. 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. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.