Nexium 20mg/24h Clear Mini Caps OTC
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.
Drug Class
Proton Pump Inhibitor (PPI)
Pharmacologic Class
Gastric Acid Secretion Inhibitor
Pregnancy Category
Category B
FDA Approved
Mar 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nexium 24HR is a medicine called a proton pump inhibitor (PPI) that helps reduce the amount of acid produced in your stomach. It's used to treat frequent heartburn that occurs 2 or more days a week. It works by turning off the 'pumps' in your stomach that make acid, providing 24-hour relief from heartburn.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at least 1 hour before meals with a full glass of water.
Swallow the medication whole; do not chew or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Special Instructions for Taking Your Medication
If you have difficulty swallowing the medication whole, you may sprinkle the contents on applesauce. To do this:
Use cool or room temperature applesauce; do not use warm applesauce.
Sprinkle the medication on the applesauce and swallow the mixture immediately without chewing.
Do not mix the medication with any other liquids or foods.
Take your dose right away after mixing; do not store the mixture for future use.
Instructions for Those with Feeding Tubes
If you have a feeding tube, you can make a liquid form of the medication. To do this:
Empty the contents of the capsule into a 60 mL syringe with 50 mL of water.
Replace the plunger and shake the mixture for 15 seconds.
Flush your feeding tube before and after taking the medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place.
Do not store it in a bathroom.
Keep the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and go back to your normal schedule.
Do not take two doses at the same time or take extra doses.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at least 1 hour before meals with a full glass of water.
Swallow the medication whole; do not chew or crush it.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel well.
Special Instructions for Taking Your Medication
If you have difficulty swallowing the medication whole, you may sprinkle the contents on applesauce. To do this:
Use cool or room temperature applesauce; do not use warm applesauce.
Sprinkle the medication on the applesauce and swallow the mixture immediately without chewing.
Do not mix the medication with any other liquids or foods.
Take your dose right away after mixing; do not store the mixture for future use.
Instructions for Those with Feeding Tubes
If you have a feeding tube, you can make a liquid form of the medication. To do this:
Empty the contents of the capsule into a 60 mL syringe with 50 mL of water.
Replace the plunger and shake the mixture for 15 seconds.
Flush your feeding tube before and after taking the medication.
Storing and Disposing of Your Medication
To keep your medication safe and effective:
Store it at room temperature in a dry place.
Do not store it in a bathroom.
Keep the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and go back to your normal schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take one capsule daily before breakfast for 14 days.
- Do not chew or crush the capsule. If you have trouble swallowing, you can open the capsule and mix the contents with a tablespoon of applesauce, then swallow immediately.
- Avoid trigger foods and drinks that worsen heartburn (e.g., spicy foods, fatty foods, caffeine, alcohol, citrus, chocolate, peppermint).
- Eat smaller, more frequent meals.
- Avoid eating within 2-3 hours of bedtime.
- Elevate the head of your bed.
- Maintain a healthy weight.
- Avoid smoking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg orally once daily for 14 days
Dose Range:
20 - 20 mg
Condition-Specific Dosing:
frequentHeartburn (OTC):
20 mg orally once daily for 14 days. Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.
Pediatric Dosing
Neonatal:
Not established for OTC use (prescription formulations may be used under medical supervision)
Infant:
Not established for OTC use (prescription formulations may be used under medical supervision)
Child:
Not established for OTC use (prescription formulations may be used under medical supervision)
Adolescent:
Not established for OTC use (OTC formulation is for adults 18 years and older)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not significantly removed by hemodialysis
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Use with caution; consult a doctor before use (for OTC, generally not recommended without medical supervision for severe hepatic impairment)
Pharmacology
Mechanism of Action
Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) 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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 64% (first dose), increasing to approximately 89% with repeated once-daily dosing
Tmax:
1.5 hours
FoodEffect:
Food delays and decreases the absorption of esomeprazole, but does not significantly affect its overall bioavailability or efficacy. It is recommended to take at least 1 hour before a meal.
Distribution:
Vd:
0.22-0.35 L/kg
ProteinBinding:
Approximately 97% (primarily to plasma proteins)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1 to 1.5 hours
Clearance:
Not available
ExcretionRoute:
Mainly renal (approximately 80% as metabolites), remainder via feces
Unchanged:
Less than 1% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
Within 2-5 days of continuous dosing
DurationOfAction:
Up to 24 hours (acid suppression)
Safety & Warnings
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
+ 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
+ Changes in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
A severe form of diarrhea called C. diff-associated diarrhea (CDAD), 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 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience 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, and you may experience other side effects not mentioned here. 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.
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
+ 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
+ Changes in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Severe dizziness or fainting
Bone pain
Significant weight loss
A severe form of diarrhea called C. diff-associated diarrhea (CDAD), 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 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
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience 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, and you may experience other side effects not mentioned here. 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:
- Heartburn that worsens or does not improve after 14 days of treatment.
- Heartburn that returns within 4 months after completing a 14-day course.
- Difficulty or pain swallowing food.
- Vomiting blood or material that looks like coffee grounds.
- Bloody or black, tarry stools.
- Unexplained weight loss.
- Chest pain with lightheadedness, sweating, or shortness of breath (seek immediate medical attention as this may be a heart attack).
- New or unusual joint pain or a skin rash, especially on sun-exposed areas (may be a sign of a rare lupus-like condition).
- Muscle cramps, spasms, or weakness; dizziness; abnormal heartbeat (may be signs of low magnesium).
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 allergic reaction you experienced, including any symptoms that occurred.
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 that is associated 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting 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 allergic reaction you experienced, including any symptoms that occurred.
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 that is associated 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
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 it is crucial 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, for more than a year, or if you 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, exercise caution and discuss your risks with your doctor.
Prolonged use of this medication (typically more than 3 months) may lead to rare cases of low magnesium levels, often occurring after 1 year of treatment. This condition may cause other electrolyte problems, and 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 low vitamin B-12 levels, including shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms and legs. If you experience any of these symptoms, contact your doctor immediately.
This medication has been linked to the development of lupus, as well as the exacerbation of existing 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, 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, discuss them with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.
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, for more than a year, or if you 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, exercise caution and discuss your risks with your doctor.
Prolonged use of this medication (typically more than 3 months) may lead to rare cases of low magnesium levels, often occurring after 1 year of treatment. This condition may cause other electrolyte problems, and 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 low vitamin B-12 levels, including shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms and legs. If you experience any of these symptoms, contact your doctor immediately.
This medication has been linked to the development of lupus, as well as the exacerbation of existing 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, 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, discuss them with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of overdose are generally mild and non-specific, including drowsiness, confusion, blurred vision, tachycardia, nausea, vomiting, sweating, flushing, headache, dry mouth.
What to Do:
In case of overdose, call a Poison Control Center immediately (1-800-222-1222) or seek emergency medical attention. Treatment is symptomatic and supportive.
Drug Interactions
Contraindicated Interactions
- Nelfinavir
- Atazanavir
- Rilpivirine
Major Interactions
- Clopidogrel (reduced antiplatelet effect)
- Methotrexate (increased methotrexate levels)
- Erlotinib (reduced erlotinib levels)
- Dasatinib (reduced dasatinib levels)
- Nilotinib (reduced nilotinib levels)
- Mycophenolate mofetil (reduced mycophenolic acid exposure)
Moderate Interactions
- Warfarin (increased INR/bleeding risk)
- Tacrolimus (increased tacrolimus levels)
- Digoxin (increased digoxin levels)
- Iron salts (reduced absorption of iron)
- Ketoconazole (reduced absorption of ketoconazole)
- Itraconazole (reduced absorption of itraconazole)
- Diazepam (decreased clearance of diazepam)
- Citalopram (increased citalopram levels)
- Phenytoin (increased phenytoin levels)
- Cilostazol (increased cilostazol levels)
- Voriconazole (increased esomeprazole levels)
- St. John's Wort (decreased esomeprazole levels)
Minor Interactions
- Sucralfate (may delay absorption of esomeprazole, take at least 30 minutes apart)
Monitoring
Baseline Monitoring
Symptom assessment (frequency and severity of heartburn)
Rationale: To establish baseline and determine appropriateness of OTC use.
Timing: Prior to initiation of therapy
Routine Monitoring
Heartburn symptom relief
Frequency: Daily during 14-day course
Target: Significant reduction or elimination of heartburn
Action Threshold: If symptoms persist or worsen after 14 days, or return within 4 months, consult a doctor.
Adverse effects (e.g., headache, diarrhea, nausea)
Frequency: Daily during 14-day course
Target: Absence or mild, tolerable side effects
Action Threshold: If severe or persistent side effects occur, discontinue use and consult a doctor.
Symptom Monitoring
- Persistent heartburn despite treatment
- Worsening heartburn
- Difficulty or pain swallowing
- Vomiting blood or coffee-ground like material
- Bloody or black, tarry stools
- Unexplained weight loss
- Chest pain with lightheadedness, sweating, or shortness of breath (may indicate a serious heart condition)
- New or worsening joint pain, rash (possible lupus-like syndrome)
- Muscle spasms, tremors, irregular heartbeat (possible hypomagnesemia)
Special Patient Groups
Pregnancy
Esomeprazole is generally considered safe for use during pregnancy when clinically indicated. Studies in animals have not shown harm to the fetus, and human data from observational studies have not shown an increased risk of major birth defects or miscarriage.
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.
Lactation
Esomeprazole is present in human milk. However, the amount is very low, and adverse effects on the breastfed infant are not expected. It is generally considered compatible with breastfeeding.
Infant Risk:
Low risk (L2 - Safer drug)
Pediatric Use
Nexium 24HR OTC is not for use in children under 18 years of age. Prescription formulations of esomeprazole are approved for use in certain pediatric conditions under medical supervision.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to certain adverse effects (e.g., bone fractures, C. difficile infection, hypomagnesemia) with long-term use. Use with caution and monitor for side effects.
Clinical Information
Clinical Pearls
- Nexium 24HR is intended for a 14-day course of treatment for frequent heartburn. It is not for immediate relief of occasional heartburn.
- Patients should not take more than one 14-day course every 4 months unless directed by a doctor.
- Long-term use of PPIs (beyond 14 days or repeated courses) should only be done under medical supervision due to potential risks like C. difficile infection, bone fractures, hypomagnesemia, and kidney problems.
- Advise patients to take the capsule at least 1 hour before their first meal of the day for optimal absorption.
- If symptoms persist or recur frequently after stopping the 14-day course, patients should consult a healthcare provider to rule out more serious conditions.
Alternative Therapies
- Other Proton Pump Inhibitors (e.g., Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
- H2 Receptor Blockers (e.g., Famotidine, Ranitidine [if available], Cimetidine)
- Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
- Alginates (e.g., Gaviscon)
Cost & Coverage
Average Cost:
$15 - $30 per 14 capsules (20mg)
Generic Available:
Yes
Insurance Coverage:
Generally not covered by standard health insurance plans as it is an OTC product. May be eligible for FSA/HSA reimbursement.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe and effective use. It is important to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult 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. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information about its safe and effective use. It is important to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to consult 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. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.