Esomeprazole Pwdr 40mg 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. 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.
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.
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
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.
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.
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
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.
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
Contraindicated Interactions
- Rilpivirine (decreased rilpivirine exposure)
- Nelfinavir (decreased nelfinavir exposure)
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)
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)
Minor Interactions
- Sucralfate (may delay absorption of esomeprazole; administer esomeprazole at least 30 minutes before sucralfate)
Monitoring
Baseline Monitoring
Rationale: To establish a starting point for assessing treatment efficacy.
Timing: Prior to initiation of therapy.
Rationale: For patients with severe hepatic impairment, dose adjustment is necessary.
Timing: Prior to initiation in patients with suspected or known severe hepatic impairment.
Routine Monitoring
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.
Frequency: Periodically (e.g., every 3-6 months) for patients on long-term therapy (âĨ3 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.
Frequency: Consider periodically for patients on long-term therapy (e.g., >1 year).
Target: Within normal limits.
Action Threshold: Deficiency requires supplementation.
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.
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
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:
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.
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.
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
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).
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)