Protonix 40mg Granule For Susp 30pk
It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat syndromes caused by lots of stomach acid.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiulcer agent
Pharmacologic Class
Proton pump inhibitor (PPI)
Pregnancy Category
Category B
FDA Approved
Feb 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Protonix (pantoprazole) is a medication called a 'proton pump inhibitor' (PPI). It works by reducing the amount of acid produced in your stomach. This helps to heal damage to your esophagus (the tube connecting your mouth to your stomach) caused by stomach acid, and relieves symptoms like heartburn and difficulty swallowing.
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 to you and follow the instructions closely. Take your dose 30 minutes before a meal. To prepare your dose, mix the granules with 1 teaspoon of applesauce or 1 teaspoon (5 mL) of apple juice. Do not mix the granules with any other foods or liquids. Take the dose within 10 minutes of mixing, and be sure not to chew or crush the granules.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs 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 take extra doses.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your dose 30 minutes before a meal. To prepare your dose, mix the granules with 1 teaspoon of applesauce or 1 teaspoon (5 mL) of apple juice. Do not mix the granules with any other foods or liquids. Take the dose within 10 minutes of mixing, and be sure not to chew or crush the granules.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well. If you have a feeding tube, you can still use this medication. Follow the instructions provided by your healthcare provider, and be sure to flush the feeding tube after administering the medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of any unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs 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 take extra doses.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once daily before a meal (e.g., 30-60 minutes before breakfast).
- For granules: Do NOT chew or crush the granules. Mix the contents of the packet with applesauce or apple juice as directed by your pharmacist or doctor. Do not mix with water or other liquids.
- Avoid trigger foods that worsen acid reflux (e.g., spicy foods, fatty foods, caffeine, chocolate, peppermint, citrus).
- Eat smaller, more frequent meals.
- Avoid lying down within 3 hours after eating.
- Elevate the head of your bed by 6-8 inches.
- Avoid smoking and excessive alcohol consumption.
- Maintain a healthy weight.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Erosive Esophagitis (EE) associated with GERD: 40 mg once daily for up to 8 weeks. Maintenance of healing of EE: 40 mg once daily. Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome): Initial 40 mg twice daily, adjust based on patient response.
Dose Range:
20 - 240 mg
Condition-Specific Dosing:
Zollinger-Ellison Syndrome:
Initial 40 mg twice daily; doses up to 240 mg/day have been used.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Erosive Esophagitis (EE) associated with GERD (5 years and older, weighing 15 kg or more): 15 to less than 40 kg: 20 mg once daily for up to 8 weeks. 40 kg or greater: 40 mg once daily for up to 8 weeks.
Adolescent:
Erosive Esophagitis (EE) associated with GERD (5 years and older, weighing 15 kg or more): 15 to less than 40 kg: 20 mg once daily for up to 8 weeks. 40 kg or greater: 40 mg once daily for up to 8 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; pantoprazole is not significantly removed by hemodialysis.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Consider dose reduction (e.g., 20 mg/day) in patients with severe hepatic impairment (Child-Pugh C). Maximum daily dose of 20 mg is recommended.
Pharmacology
Mechanism of Action
Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme (the 'proton pump') in the secretory canaliculi of gastric parietal cells. This binding inhibits the final step in gastric acid secretion, leading to a profound and long-lasting reduction in gastric acid production.
Pharmacokinetics
Absorption:
Bioavailability:
77%
Tmax:
2.5 hours
FoodEffect:
Food may delay absorption (Tmax) but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
11-23.6 L
ProteinBinding:
98%
CnssPenetration:
Limited
Elimination:
HalfLife:
1 hour
Clearance:
Not available
ExcretionRoute:
Renal (71%), Fecal (18%)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within 2.5 hours
PeakEffect:
Within 2.5 hours (for acid suppression)
DurationOfAction:
>24 hours (due to irreversible binding to the proton pump)
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 when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Bone pain
Fever
Lupus or worsening of existing lupus, characterized by:
+ Rash on the cheeks or other body parts
+ Change in skin color
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Severe diarrhea (C diff-associated diarrhea or CDAD), marked by:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs
+ Signs such as 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; or swollen glands
Low vitamin B-12 levels, which may occur with long-term treatment (more than 3 years), characterized by:
+ Shortness of breath
+ Dizziness
+ Abnormal heartbeat
+ Muscle weakness
+ Pale skin
+ Tiredness
+ Mood changes
+ Numbness or tingling in the arms or legs
Other Possible Side Effects
Most people do not experience side effects or only have mild side effects. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Stomach pain or diarrhea
Upset stomach or vomiting
Gas
Joint pain
* Signs of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Bone pain
Fever
Lupus or worsening of existing lupus, characterized by:
+ Rash on the cheeks or other body parts
+ Change in skin color
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Severe diarrhea (C diff-associated diarrhea or CDAD), marked by:
+ Stomach pain or cramps
+ Very loose or watery stools
+ Bloody stools
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs
+ Signs such as 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; or swollen glands
Low vitamin B-12 levels, which may occur with long-term treatment (more than 3 years), characterized by:
+ Shortness of breath
+ Dizziness
+ Abnormal heartbeat
+ Muscle weakness
+ Pale skin
+ Tiredness
+ Mood changes
+ Numbness or tingling in the arms or legs
Other Possible Side Effects
Most people do not experience side effects or only have mild side effects. However, if you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Stomach pain or diarrhea
Upset stomach or vomiting
Gas
Joint pain
* Signs of a common cold
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 (especially watery or bloody stools, with fever and abdominal cramps, which could indicate C. difficile infection)
- Unexplained weight loss
- Difficulty or pain swallowing
- Vomiting blood or material that looks like coffee grounds
- Black, tarry stools
- New or worsening joint pain
- Muscle spasms, tremors, or irregular heartbeat (signs of low magnesium)
- Unusual fatigue, pale skin, tingling or numbness in hands/feet (signs of vitamin B12 deficiency)
- Rash, especially on sun-exposed areas, with joint pain (possible lupus-like syndrome)
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, Methotrexate, Nelfinavir, Rilpivirine, or Warfarin. Please note that this list is not exhaustive, and it is crucial to disclose all medications you are taking.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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, Methotrexate, Nelfinavir, Rilpivirine, or Warfarin. Please note that this list is not exhaustive, and it is crucial to disclose all medications you are taking.
To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have
This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.
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.
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 experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or vomit that resembles coffee grounds. These symptoms may indicate a more severe health issue.
Prolonged use of this medication, particularly in high doses or for more than a year, may increase the risk of fractures in the hip, spine, and wrist, especially in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.
Long-term use of this medication (at least 3 months, often after 1 year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your condition.
Taking this medication for more than 1 year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, consult your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both 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 experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or vomit that resembles coffee grounds. These symptoms may indicate a more severe health issue.
Prolonged use of this medication, particularly in high doses or for more than a year, may increase the risk of fractures in the hip, spine, and wrist, especially in individuals with osteoporosis (weak bones). This risk may be higher if you are over 50 years old. If you have risk factors for osteoporosis, such as alcohol consumption, smoking, steroid use, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.
Long-term use of this medication (at least 3 months, often after 1 year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte problems. Your doctor may recommend regular blood tests to monitor your condition.
Taking this medication for more than 1 year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, consult your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose are known. Limited experience with high doses (up to 240 mg/day) showed no severe adverse reactions. Symptoms may include drowsiness, confusion, blurred vision, tachycardia, nausea, vomiting, headache, dry mouth.
What to Do:
There is no specific antidote. Treatment should be symptomatic and supportive. Pantoprazole is not significantly removed by hemodialysis. In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Rilpivirine (due to significant reduction in rilpivirine absorption)
Major Interactions
- Atazanavir (reduced absorption, risk of virologic failure)
- Nelfinavir (reduced absorption, risk of virologic failure)
- Methotrexate (increased and prolonged methotrexate levels, especially with high-dose methotrexate)
- Clopidogrel (potential for reduced antiplatelet effect, though less pronounced than with omeprazole/esomeprazole, still monitor)
Moderate Interactions
- Iron salts (reduced absorption of iron)
- Ketoconazole (reduced absorption)
- Itraconazole (reduced absorption)
- Erlotinib (reduced absorption)
- Mycophenolate mofetil (reduced exposure of mycophenolic acid)
- Warfarin (monitor INR, potential for increased INR)
Minor Interactions
- Digoxin (potential for slightly increased digoxin levels)
Monitoring
Baseline Monitoring
Baseline symptoms of GERD/EE
Rationale: To establish a starting point for assessing treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Symptom resolution/improvement
Frequency: Regularly throughout treatment (e.g., weekly for initial 8 weeks, then as needed)
Target: Significant reduction or elimination of heartburn, regurgitation, dysphagia
Action Threshold: Lack of improvement after 4-8 weeks may warrant further diagnostic workup or alternative therapy.
Serum Magnesium (Mg)
Frequency: Periodically, especially with prolonged use (>3 months), concomitant diuretics, or other drugs causing hypomagnesemia
Target: Normal range (1.7-2.2 mg/dL)
Action Threshold: Levels below normal range; consider supplementation or discontinuation of PPI if severe and symptomatic.
Vitamin B12 levels
Frequency: Periodically, especially with prolonged use (>3 years)
Target: Normal range
Action Threshold: Levels below normal range; consider supplementation.
Bone Mineral Density (BMD)
Frequency: Consider baseline and periodic monitoring with prolonged use (>1 year), especially in patients at risk for osteoporosis
Target: Maintain healthy BMD
Action Threshold: Significant decrease in BMD or new fractures; consider calcium/vitamin D supplementation or alternative therapy.
Symptom Monitoring
- Persistent or worsening heartburn
- Regurgitation
- Dysphagia (difficulty swallowing)
- Odynophagia (painful swallowing)
- Unexplained weight loss
- Anemia
- Black, tarry stools (melena)
- Vomiting blood (hematemesis)
- Muscle cramps, weakness, tremors, irregular heartbeats (signs of hypomagnesemia)
- Unusual fatigue, pale skin, tingling/numbness (signs of B12 deficiency)
Special Patient Groups
Pregnancy
Pantoprazole is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but use only if benefits outweigh potential risks.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk.
Lactation
Pantoprazole is excreted in human milk. The amount of pantoprazole in breast milk is low, and the potential for adverse effects on the breastfed infant is considered low. However, caution should be exercised when pantoprazole is administered to a nursing mother. The Lactation Risk Category is L3 (Moderately Safe).
Infant Risk:
Low risk of adverse effects, but monitor infant for any signs of gastrointestinal upset (e.g., diarrhea, vomiting).
Pediatric Use
Approved for the short-term treatment (up to 8 weeks) of erosive esophagitis associated with GERD in children 5 years of age and older. Dosing is weight-based. Safety and effectiveness in children younger than 5 years have not been established. Long-term use in pediatric patients is not recommended.
Geriatric Use
No overall differences in safety or effectiveness were observed between geriatric and younger patients. However, due to the increased prevalence of comorbidities and polypharmacy in the elderly, caution is advised. Long-term use in the elderly may be associated with increased risks of bone fractures, C. difficile infection, and hypomagnesemia.
Clinical Information
Clinical Pearls
- Pantoprazole granules are designed for patients who cannot swallow tablets, such as pediatric patients or those with dysphagia. Ensure proper mixing and administration (applesauce or apple juice, not water).
- PPIs should be used at the lowest effective dose for the shortest duration necessary to treat the condition, especially for long-term use, due to potential risks like C. difficile infection, hypomagnesemia, vitamin B12 deficiency, and bone fractures.
- For patients on long-term PPI therapy, consider periodic monitoring of magnesium and vitamin B12 levels, and bone mineral density, especially if risk factors are present.
- Rebound acid hypersecretion can occur upon abrupt discontinuation of PPIs after prolonged use; consider gradual tapering if appropriate.
- Take pantoprazole 30-60 minutes before the first meal of the day for optimal acid suppression.
Alternative Therapies
- Other Proton Pump Inhibitors (PPIs): Omeprazole (Prilosec), Esomeprazole (Nexium), Lansoprazole (Prevacid), Dexlansoprazole (Dexilant), Rabeprazole (Aciphex)
- H2 Receptor Blockers (H2RAs): Famotidine (Pepcid), Cimetidine (Tagamet), Nizatidine (Axid)
- Antacids (e.g., Tums, Maalox, Mylanta) for immediate symptom relief
- Prokinetics (e.g., Metoclopramide) for motility issues (less common for GERD alone)
- Sucralfate (Carafate) for mucosal protection
Cost & Coverage
Average Cost:
$200 - $400 per 30 packets (40mg)
Generic Available:
Yes
Insurance Coverage:
Most insurance plans cover generic pantoprazole, often as a Tier 1 or Tier 2 medication. Brand-name Protonix may require prior authorization or be placed in a higher tier.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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, which provides crucial information for patients. 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. When reporting the overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.