Esomeprazole Pwdr 20mg DR For Susp
Overview
What is this medicine?
How to Use This Medicine
To ensure you get the most out of your medication, follow these steps:
1. Follow Your Doctor's Orders: Take this medication exactly as directed by your doctor. Read all the information provided with your medication and follow the instructions carefully.
2. Timing and Preparation: Take your medication 1 hour before a meal. To prepare, 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.
3. Mixing and Waiting: Stir the mixture into the water, then let it sit for 2 to 3 minutes. After waiting, mix again and drink the entire dose within 30 minutes.
4. Disposal and Cleaning: Throw away any unused mixture within 30 minutes of preparation. Rinse your cup with more water and drink to ensure you get the full dose.
5. Continuing Your Medication: Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Special Instructions for Feeding Tubes
If you have a feeding tube, follow these steps to administer your medication:
1. Preparing the Mixture: Add water to a syringe, then add the packet contents as follows:
For 2.5 mg or 5 mg packets, add 5 mL of water to the syringe.
* For 10 mg, 20 mg, or 40 mg packets, add 15 mL of water to the syringe.
2. Shaking and Waiting: Replace the plunger, shake the syringe, and let it sit for 2 to 3 minutes. Shake again before administering the medication through the feeding tube.
3. Flushing the Tube: After administering the medication, refill the syringe with the same amount of water used, shake, and flush the feeding tube to ensure it is clear.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
1. Storage: Store your medication at room temperature in a dry place, away from bathrooms.
2. Keeping it Safe: Keep all medications out of the reach of children and pets.
3. Disposal: Throw away unused or expired medications. 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 disposing of medications, and consider participating 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, if it is 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 extra doses.
Lifestyle & Tips
- Take this medicine at least one hour before a meal, preferably in the morning.
- Do not crush or chew the delayed-release granules. Mix the powder with water as directed and swallow immediately.
- Avoid foods and drinks that trigger your acid reflux 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.
- Maintain a healthy weight.
- Quit smoking, as smoking can worsen acid reflux.
Available Forms & Alternatives
Available Strengths:
- Esomeprazole Magnesium 20mg DR Caps
- Esomeprazole Magnesium 40mg DR Caps
- Esomeprazole Magnesium 40mg DR Caps
- Esomeprazole Magnesium 20mg DR Caps
- Esomeprazole Pwdr 10mg DR For Susp
- Esomeprazole Pwdr 20mg DR For Susp
- Esomeprazole Pwdr 40mg DR For Susp
- Esomeprazole Sod 40mg Inj, 1 Vial
- Esomeprazole Mag 20mg DR Caps (otc)
- Esomeprazole Mag 20mg DR Caps (otc)
- Esomeprazole Mag 20mg DR Caps (otc)
- Esomeprazole 2.5mg DR Pwdr Pkt Susp
- Esomeprazole 5mg DR Pwdr Pkt Susp
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes or confusion
+ Muscle pain, cramps, or spasms
+ Weakness, shakiness, or balance changes
+ Abnormal heartbeat or seizures
+ Loss of appetite or severe nausea and vomiting
Signs of kidney problems, such as:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant 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 that may 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, or 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 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 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (may indicate C. difficile infection)
- Unusual tiredness or weakness
- Muscle cramps or spasms, tremors (signs of low magnesium)
- Dizziness, lightheadedness, or irregular heartbeat
- New or worsening joint pain or rash (may indicate lupus-like syndrome)
- Any signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Difficulty or pain when swallowing, especially if new or worsening
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools
- Unexplained weight loss
Before Using This Medicine
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.
Precautions & Cautions
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory 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.
Long-term use of this medication (typically more than 3 months) may lead to rare but potentially serious side effects. One such effect is low magnesium levels, which can occur after 1 year of treatment and may cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.
Additionally, long-term treatment with this medication (usually more than 3 years) may cause 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 or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor immediately.
This medication has been associated with the development or worsening of lupus, an autoimmune disease. 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, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Prolonged use of this medication (more than 1 year) may increase the risk of stomach growths called fundic gland polyps. If you have concerns or questions, 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.
Overdose Information
Overdose Symptoms:
- Limited experience with overdose. Symptoms may include drowsiness, disorientation, tachycardia, nausea, sweating, flushing, headache, dry mouth, and other gastrointestinal disturbances.
What to Do:
There is no specific antidote. Treatment should be symptomatic and supportive. Esomeprazole is extensively protein bound and not readily dialyzable. Call 911 or Poison Control (1-800-222-1222) immediately.
Drug Interactions
Contraindicated Interactions
- Rilpivirine-containing products (due to significant reduction in rilpivirine exposure)
Major Interactions
- Clopidogrel (reduced antiplatelet effect)
- Atazanavir (reduced atazanavir exposure)
- Nelfinavir (reduced nelfinavir exposure)
- Methotrexate (increased methotrexate levels)
- Tacrolimus (increased tacrolimus levels)
- Warfarin (increased INR/bleeding risk, especially with CYP2C19 poor metabolizers)
Moderate Interactions
- Diazepam (increased diazepam exposure)
- Citalopram (increased citalopram exposure)
- Phenytoin (increased phenytoin exposure)
- Digoxin (increased digoxin exposure)
- Iron salts (reduced iron absorption)
- Ketoconazole, Itraconazole, Erlotinib (reduced absorption of pH-dependent drugs)
- Mycophenolate mofetil (reduced mycophenolic acid exposure)
- St. John's Wort (reduced esomeprazole exposure)
Minor Interactions
- Sucralfate (may delay absorption of esomeprazole; administer at least 30 minutes apart)
Monitoring
Baseline Monitoring
Rationale: To assess initial severity and guide treatment goals.
Timing: Prior to initiation of therapy
Routine Monitoring
Frequency: Periodically, as clinically indicated (e.g., at 4-8 week follow-up)
Target: Reduction or elimination of acid-related symptoms
Action Threshold: Persistent or worsening symptoms may require dose adjustment, further diagnostic workup, or alternative therapy.
Frequency: Periodically, especially with long-term use (âĨ3 months) or concomitant diuretics/digoxin
Target: Within normal limits (1.7-2.2 mg/dL)
Action Threshold: Hypomagnesemia (<1.7 mg/dL) may require magnesium supplementation or discontinuation of esomeprazole.
Frequency: Consider for patients on long-term therapy (e.g., >2-3 years)
Target: Within normal limits
Action Threshold: Deficiency may require B12 supplementation.
Frequency: Consider for patients at risk for osteoporosis on long-term, high-dose therapy
Target: Maintain healthy BMD
Action Threshold: Significant decline may warrant evaluation and intervention.
Symptom Monitoring
- Persistent heartburn
- Regurgitation
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Unexplained weight loss
- Anemia
- Black, tarry stools (melena)
- Vomiting blood (hematemesis)
- New or worsening abdominal pain
- Muscle cramps or weakness (signs of hypomagnesemia)
Special Patient Groups
Pregnancy
Generally considered low risk. Studies in pregnant women have not shown an increased risk of major birth defects or miscarriage. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
Lactation
Low levels of esomeprazole are excreted into breast milk. Generally considered compatible with breastfeeding, but monitor the infant for any adverse effects (e.g., diarrhea).
Pediatric Use
Approved for GERD and erosive esophagitis in pediatric patients aged 1 year and older, with specific dosing based on age and weight. Safety and efficacy not established in infants younger than 1 month.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary based solely on age, but consider potential for polypharmacy and comorbidities.
Clinical Information
Clinical Pearls
- Esomeprazole is the S-isomer of omeprazole, often marketed as a 'next-generation' PPI due to potentially more consistent acid suppression, though clinical superiority over other PPIs is often debated.
- Administer the powder for suspension by mixing with water and swallowing immediately. Do not chew or crush the granules.
- Long-term use (typically >1 year) of PPIs has been associated with increased risks of C. difficile infection, hypomagnesemia, vitamin B12 deficiency, and bone fractures (especially hip, wrist, or spine).
- Patients on long-term PPI therapy should be periodically assessed for the lowest effective dose and potential for discontinuation.
- Consider drug interactions, especially with clopidogrel, methotrexate, and pH-dependent medications.
Alternative Therapies
- Other Proton Pump Inhibitors (PPIs): Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
- Histamine H2-receptor antagonists (H2RAs): Famotidine, Cimetidine
- Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
- Prokinetics (e.g., metoclopramide - for specific motility disorders)
- Surgery (e.g., Nissen fundoplication for severe GERD)
Cost & Coverage
General Drug Facts
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. If you have any questions or concerns about this medication, don't hesitate to 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 medication taken, the quantity, and the time it occurred.