Omeprazole 20mg/sod Bicar 1100mg CP
It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat heartburn.It is used to treat GI (gastrointestinal) ulcers.It is used to treat or prevent ulcers of the esophagus.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Proton Pump Inhibitor; Antacid
Pharmacologic Class
Gastric Acid Secretion Inhibitor; Antacid
Pregnancy Category
C
FDA Approved
Oct 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine combines two ingredients: omeprazole, which reduces the amount of acid your stomach makes, and sodium bicarbonate, which helps neutralize stomach acid and also helps the omeprazole work better. It's used to treat conditions like heartburn, acid reflux (GERD), and ulcers by lowering stomach acid.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication at least 1 hour before a meal.
Drink water only with your medication; avoid taking it with other beverages.
Swallow the capsule whole; do not chew, break, or crush it.
Do not open the capsules.
If you need to take antacids, consult your doctor first to ensure safe use with your medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. If your dosage is increased, do not attempt to make up the higher dose by taking two capsules of a lower dose, as this can lead to excessive sodium bicarbonate intake.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light.
Keep it in a dry place, avoiding storage in bathrooms.
Ensure the lid is tightly closed when not in use.
Keep all medications in a safe location, 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication at least 1 hour before a meal.
Drink water only with your medication; avoid taking it with other beverages.
Swallow the capsule whole; do not chew, break, or crush it.
Do not open the capsules.
If you need to take antacids, consult your doctor first to ensure safe use with your medication.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. If your dosage is increased, do not attempt to make up the higher dose by taking two capsules of a lower dose, as this can lead to excessive sodium bicarbonate intake.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light.
Keep it in a dry place, avoiding storage in bathrooms.
Ensure the lid is tightly closed when not in use.
Keep all medications in a safe location, 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's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take this medication on an empty stomach, at least 1 hour before your first meal of the day, with a glass of water.
- Do not crush, chew, or open the capsule. Swallow it whole.
- 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.
- If taking for long periods, discuss with your doctor about calcium and vitamin D supplementation for bone health, and magnesium levels.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
20 mg omeprazole/1100 mg sodium bicarbonate orally once daily, at least 1 hour before a meal.
Dose Range:
20 - 40 mg
Condition-Specific Dosing:
GERD:
20 mg/1100 mg once daily for up to 4-8 weeks.
Erosive Esophagitis:
20 mg/1100 mg once daily for 4-8 weeks; maintenance 20 mg/1100 mg once daily.
Duodenal Ulcer:
20 mg/1100 mg once daily for 4 weeks.
Gastric Ulcer:
40 mg/1100 mg once daily for 4-8 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (sodium bicarbonate load concerns)
Child:
Not established (sodium bicarbonate load concerns); Omeprazole alone is used.
Adolescent:
Limited data; generally not recommended due to sodium bicarbonate component unless specifically indicated and monitored.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for omeprazole. Use with caution due to sodium bicarbonate in patients with severe renal impairment or those on sodium-restricted diets.
Moderate:
No adjustment needed for omeprazole. Use with caution due to sodium bicarbonate in patients with severe renal impairment or those on sodium-restricted diets.
Severe:
No adjustment needed for omeprazole. Use with caution; monitor for metabolic alkalosis and fluid overload due to sodium bicarbonate.
Dialysis:
No adjustment needed for omeprazole. Use with caution; monitor for metabolic alkalosis and fluid overload due to sodium bicarbonate. Avoid if possible.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Consider dose reduction for omeprazole (e.g., 20 mg once daily maximum). Monitor for adverse effects.
Pharmacology
Mechanism of Action
Omeprazole is a proton pump inhibitor (PPI) that irreversibly blocks the H+/K+-ATPase enzyme system (the proton pump) in the gastric parietal cells, thereby inhibiting the final step in gastric acid production. Sodium bicarbonate is an antacid that neutralizes existing gastric acid and also protects omeprazole from acid degradation in the stomach, allowing for its absorption.
Pharmacokinetics
Absorption:
Bioavailability:
Omeprazole: Approximately 30-40% (increases with repeated dosing). Sodium Bicarbonate: Rapidly absorbed.
Tmax:
Omeprazole: 0.5-3.5 hours (with sodium bicarbonate). Sodium Bicarbonate: Rapid.
FoodEffect:
Should be taken on an empty stomach, at least 1 hour before a meal, with water. Food significantly decreases omeprazole absorption.
Distribution:
Vd:
Omeprazole: 0.3 L/kg
ProteinBinding:
Omeprazole: Approximately 95% (primarily to albumin and alpha-1-acid glycoprotein). Sodium Bicarbonate: Not protein bound.
CnssPenetration:
Omeprazole: Limited
Elimination:
HalfLife:
Omeprazole: Approximately 0.5-1 hour (terminal half-life is longer due to irreversible binding). Sodium Bicarbonate: Variable, depends on renal function and acid-base status.
Clearance:
Omeprazole: Approximately 500-600 mL/min
ExcretionRoute:
Omeprazole: Primarily renal (80%) as metabolites, fecal (20%). Sodium Bicarbonate: Renal (excreted as bicarbonate or converted to CO2 and water).
Unchanged:
Omeprazole: <0.1% in urine. Sodium Bicarbonate: Variable, depending on body's acid-base balance.
Pharmacodynamics
OnsetOfAction:
Omeprazole: Within 1 hour (acid suppression). Sodium Bicarbonate: Immediate (antacid effect).
PeakEffect:
Omeprazole: 2 hours (acid suppression). Sodium Bicarbonate: Minutes.
DurationOfAction:
Omeprazole: Up to 72 hours (acid suppression, due to irreversible binding). Sodium Bicarbonate: Short (1-3 hours).
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:
Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Blood Pressure Changes: Severe headache or dizziness, fainting, or changes in vision.
Neurological Symptoms: Confusion, shakiness, dizziness or fainting, twitching, or abnormal sensations such as burning, numbness, or tingling.
Other Symptoms: Bone pain, fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Swelling or Weight Gain: Sudden or unexplained swelling or weight gain.
Additional Warnings:
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
Long-term treatment (more than 3 years) with this medication may lead to low vitamin B-12 levels. If you experience shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs, contact your doctor.
This medication may cause or worsen lupus. If you have lupus, inform your doctor. If you experience a rash on the cheeks or other body parts, changes in skin color, sun sensitivity, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs, seek medical attention.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. If you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands, seek immediate medical help.
Common Side Effects:
Headache
Stomach pain or diarrhea
Gas
Upset stomach or vomiting
If these side effects or any others bother you or do not go away, contact your doctor. Not all side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects:
You can 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:
Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Pancreatitis: Severe stomach pain, severe back pain, or severe upset stomach or vomiting.
Liver Problems: Dark urine, fatigue, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Blood Pressure Changes: Severe headache or dizziness, fainting, or changes in vision.
Neurological Symptoms: Confusion, shakiness, dizziness or fainting, twitching, or abnormal sensations such as burning, numbness, or tingling.
Other Symptoms: Bone pain, fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Swelling or Weight Gain: Sudden or unexplained swelling or weight gain.
Additional Warnings:
This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience stomach pain or cramps, watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
Long-term treatment (more than 3 years) with this medication may lead to low vitamin B-12 levels. If you experience shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs, contact your doctor.
This medication may cause or worsen lupus. If you have lupus, inform your doctor. If you experience a rash on the cheeks or other body parts, changes in skin color, sun sensitivity, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs, seek medical attention.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur. If you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands, seek immediate medical help.
Common Side Effects:
Headache
Stomach pain or diarrhea
Gas
Upset stomach or vomiting
If these side effects or any others bother you or do not go away, contact your doctor. Not all side effects are listed here. If you have questions or concerns about side effects, consult your doctor.
Reporting Side Effects:
You can 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 cramping
- Black, tarry stools or blood in vomit (signs of bleeding ulcer)
- Difficulty or pain when swallowing
- Unexplained weight loss
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
- Signs of kidney problems (change in urine amount, swelling in feet/ankles)
- Signs of low magnesium (muscle spasms, tremors, irregular heartbeat, seizures)
- Severe diarrhea that is watery or bloody (may be a sign of C. difficile infection)
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 and its symptoms.
Certain health conditions, including:
+ Bartter's syndrome
+ Low calcium or potassium levels
+ Acid-base problems in the blood
Symptoms that may indicate a serious health issue, such as:
+ 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
A history of kidney problems caused by this medication or similar drugs
Current use of certain medications, including:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
+ Note: This is not an exhaustive list of interacting medications
To ensure safe treatment, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems
Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 and its symptoms.
Certain health conditions, including:
+ Bartter's syndrome
+ Low calcium or potassium levels
+ Acid-base problems in the blood
Symptoms that may indicate a serious health issue, such as:
+ 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
A history of kidney problems caused by this medication or similar drugs
Current use of certain medications, including:
+ Atazanavir
+ Clopidogrel
+ Methotrexate
+ Nelfinavir
+ Rifampin
+ Rilpivirine
+ St. John's wort
+ Warfarin
+ Note: This is not an exhaustive list of interacting medications
To ensure safe treatment, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems
Do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effect of this drug may not be apparent for a few days. Be sure to follow your doctor's instructions regarding the duration of treatment, as taking this medication for longer than prescribed can have adverse effects.
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. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.
If you have diabetes, you will need to closely monitor your blood sugar levels, as this medication may increase the risk of elevated blood sugar. Additionally, this medication may increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). 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, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor. Certain medications, including those used to treat seizures, may also increase the risk of osteoporosis.
Prolonged use of this medication (typically more than 3 months, often after 1 year of treatment) may lead to low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels and overall health.
In rare cases, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be life-threatening. If you have any questions or concerns, discuss them with your doctor. Long-term use of this medication (more than 1 year) may also increase the risk of developing stomach growths called fundic gland polyps. If you have questions, consult with your doctor.
Individuals of Asian descent may be more susceptible to side effects from this medication, so caution is advised. 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.
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. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.
If you have diabetes, you will need to closely monitor your blood sugar levels, as this medication may increase the risk of elevated blood sugar. Additionally, this medication may increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). 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, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor. Certain medications, including those used to treat seizures, may also increase the risk of osteoporosis.
Prolonged use of this medication (typically more than 3 months, often after 1 year of treatment) may lead to low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your magnesium levels and overall health.
In rare cases, this medication has been associated with severe pancreas, liver, and white blood cell problems, which can be life-threatening. If you have any questions or concerns, discuss them with your doctor. Long-term use of this medication (more than 1 year) may also increase the risk of developing stomach growths called fundic gland polyps. If you have questions, consult with your doctor.
Individuals of Asian descent may be more susceptible to side effects from this medication, so caution is advised. 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:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Dizziness
- Headache
- Blurred vision
- Metabolic alkalosis (confusion, muscle twitching, irregular heart rhythm)
- Hypernatremia (excess sodium)
What to Do:
If you suspect an overdose, contact a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Rilpivirine (decreased absorption due to increased gastric pH)
- Nelfinavir (decreased absorption due to increased gastric pH)
Major Interactions
- Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition by omeprazole)
- Methotrexate (increased methotrexate levels, especially high-dose, due to reduced renal elimination)
- Tacrolimus (increased tacrolimus levels)
- Digoxin (increased digoxin levels due to increased gastric pH)
- Iron salts (decreased absorption due to increased gastric pH)
- Ketoconazole, Itraconazole, Posaconazole (decreased absorption due to increased gastric pH)
- Mycophenolate Mofetil (reduced exposure of mycophenolic acid)
Moderate Interactions
- Warfarin (increased INR/bleeding risk)
- Phenytoin (increased phenytoin levels)
- Diazepam (increased diazepam levels)
- Cilostazol (increased cilostazol levels)
- Voriconazole (increased omeprazole levels)
- Erlotinib (decreased erlotinib absorption)
- Dasatinib, Nilotinib (decreased absorption)
- Atazanavir (decreased absorption)
- Sucralfate (may reduce omeprazole absorption; separate administration by 30 minutes)
- Drugs requiring acidic gastric pH for absorption (e.g., some tyrosine kinase inhibitors)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Electrolytes (Sodium, Potassium, Bicarbonate)
Rationale: To assess baseline electrolyte status, especially given sodium bicarbonate component and potential for metabolic alkalosis.
Timing: Prior to initiation of therapy.
Renal Function (BUN, Creatinine)
Rationale: To assess baseline renal function, as sodium bicarbonate requires renal excretion and can exacerbate fluid/electrolyte issues in impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Electrolytes (Sodium, Potassium, Bicarbonate)
Frequency: Periodically, especially with prolonged use, renal impairment, or concomitant diuretics.
Target: Within normal limits.
Action Threshold: Significant deviations (e.g., hypernatremia, hypokalemia, metabolic alkalosis) require intervention.
Magnesium
Frequency: Periodically, especially with prolonged use (âĨ3 months) or concomitant diuretics.
Target: Within normal limits.
Action Threshold: Hypomagnesemia requires supplementation and consideration of PPI discontinuation.
Bone Mineral Density
Frequency: Consider for long-term use (âĨ1 year) in patients at risk for osteoporosis.
Target: Maintain healthy bone density.
Action Threshold: Significant bone loss may require alternative therapy or bone-protective measures.
Symptoms of GERD/Ulcer Healing
Frequency: Regularly throughout therapy.
Target: Resolution or significant improvement of symptoms.
Action Threshold: Persistent or worsening symptoms may indicate need for further investigation or therapy adjustment.
Symptom Monitoring
- Persistent or worsening heartburn
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Unexplained weight loss
- Black, tarry stools (melena)
- Vomiting blood (hematemesis)
- Severe abdominal pain
- Signs of electrolyte imbalance (e.g., muscle weakness, cramps, confusion, irregular heartbeat, excessive thirst, dry mouth)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Omeprazole is generally considered low risk, but sodium bicarbonate can cause fluid and electrolyte imbalances. Category C.
Trimester-Specific Risks:
First Trimester:
Limited data, but omeprazole generally not associated with increased risk of major birth defects. Sodium bicarbonate can cause electrolyte shifts.
Second Trimester:
Generally considered safe for omeprazole. Sodium bicarbonate should be used cautiously.
Third Trimester:
Sodium bicarbonate can cause fluid retention and metabolic alkalosis, which may be more problematic in late pregnancy. Omeprazole generally considered safe.
Lactation
Omeprazole is excreted in human milk. Sodium bicarbonate is also excreted. Caution should be exercised when administered to a nursing mother. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
L3 (Moderate risk). Potential for infant exposure to omeprazole and sodium bicarbonate. Monitor for adverse effects like diarrhea or electrolyte imbalance in the infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. The sodium bicarbonate component makes it less suitable for routine pediatric use compared to omeprazole alone, especially in infants and young children, due to the risk of sodium overload and metabolic alkalosis.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for bone fractures, C. difficile infection, and hypomagnesemia with long-term PPI use. Monitor renal function and electrolytes closely due to sodium bicarbonate component.
Clinical Information
Clinical Pearls
- This combination product is designed to provide rapid acid neutralization (from sodium bicarbonate) and sustained acid suppression (from omeprazole). The sodium bicarbonate also protects the acid-labile omeprazole from degradation in the stomach.
- Always take on an empty stomach, at least 1 hour before a meal, with water. Do not take with food as it significantly reduces omeprazole absorption.
- Do not crush, chew, or open the capsule. It must be swallowed whole.
- Not intended for immediate relief of heartburn, although the sodium bicarbonate component provides some rapid antacid effect. The full acid-suppressing effect of omeprazole takes a few days.
- Long-term use (over 1 year) of PPIs has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Discuss these risks with patients.
- Patients should be advised to report any signs of electrolyte imbalance (e.g., muscle cramps, weakness, irregular heartbeat) or severe, persistent diarrhea.
Alternative Therapies
- Other Proton Pump Inhibitors (e.g., Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
- H2 Receptor Antagonists (e.g., Famotidine, Ranitidine (historical), Cimetidine)
- Antacids (e.g., Calcium Carbonate, Aluminum Hydroxide/Magnesium Hydroxide)
- Prokinetics (e.g., Metoclopramide, for motility disorders)
- Lifestyle and dietary modifications
- Surgical interventions (e.g., Nissen fundoplication for severe GERD)
Cost & Coverage
Average Cost:
$50 - $300 per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand, depending on plan)
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 safe and effective treatment, 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 about its use. It is vital to 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 for clarification.
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, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information about its use. It is vital to 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 for clarification.
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, including the name of the medication taken, the amount consumed, and the time it occurred.