Pantoprazole 40mg Tablets

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme (the 'proton pump') located on the secretory surface of the parietal cells in the stomach. This binding inhibits the final step in gastric acid production, leading to a profound and long-lasting reduction in gastric acid secretion.

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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of electrolyte problems: mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance changes, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Bone pain.
Fever.
Lupus or worsening lupus symptoms (if you already have lupus): rash on the cheeks or other body parts, skin color changes, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs. Inform your doctor if you have lupus.
Severe diarrhea (C diff-associated diarrhea, or CDAD): stomach pain or cramps, very loose or watery stools, or bloody stools. Do not attempt to treat diarrhea without consulting your doctor.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can be life-threatening. Seek medical help immediately 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.
Low vitamin B-12 levels (rarely occurs with long-term treatment, typically longer than 3 years): shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.

Other Possible Side Effects

Most people do not experience severe side effects, and some may have only minor or no side effects at all. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Dizziness or headache.
Stomach pain or diarrhea.
Nausea and vomiting.
Gas.
Joint pain.
* Common cold symptoms.

This list is not exhaustive. If you have 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.

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.
If you are currently taking any of the following medications: Atazanavir, methotrexate, nelfinavir, rilpivirine, or warfarin. Note that this list is not exhaustive, and you should discuss all your medications with your doctor.

To ensure your safety, it is crucial 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 existing health problems

This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 underlying 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, typically after 1 year of treatment) may lead to rare cases of low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your condition.

Taking this medication for more than a 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.

• Rilpivirine-containing products (due to significant reduction in rilpivirine exposure)
• Atazanavir (due to significant reduction in atazanavir exposure)

• Clopidogrel (reduced antiplatelet effect of clopidogrel)
• Methotrexate (increased and prolonged serum levels of methotrexate and/or its metabolite, potentially leading to toxicity)
• Nelfinavir (reduced nelfinavir exposure)

• Warfarin (increased INR and prothrombin time)
• Tacrolimus (increased tacrolimus levels)
• Digoxin (increased digoxin levels)
• Iron salts (reduced absorption of iron)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Drugs dependent on gastric pH for absorption (e.g., ketoconazole, itraconazole, posaconazole, erlotinib)

• Cyanocobalamin (Vitamin B12) (long-term use may lead to malabsorption)
• Magnesium (long-term use may lead to hypomagnesemia)
• Calcium salts (long-term use may lead to reduced absorption and increased risk of fracture)

• Resolution of heartburn
• Resolution of regurgitation
• Resolution of dyspepsia
• Improvement in swallowing difficulties
• Monitoring for signs of C. difficile-associated diarrhea (CDAD) (e.g., persistent diarrhea, abdominal pain, fever)
• Monitoring for signs of acute interstitial nephritis (e.g., fever, rash, nausea, malaise, oliguria)
• Monitoring for signs of lupus erythematosus (e.g., arthralgia, rash on sun-exposed skin)

Generally considered low risk. Animal studies have not shown evidence of harm to the fetus. Human data are limited but do not suggest an increased risk of major birth defects or adverse maternal/fetal outcomes.

Pantoprazole is present in human milk in very low concentrations. The amount ingested by the infant is small and unlikely to cause adverse effects. Considered L2 (Safer) by LactMed.

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.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may be at increased risk for certain adverse effects associated with long-term PPI use, such as bone fractures and C. difficile infection. No dose adjustment is generally needed based on age alone.

• Pantoprazole is a delayed-release formulation and should be swallowed whole. Do not crush, chew, or split the tablet.
• For optimal acid suppression, take Pantoprazole approximately 30-60 minutes before the first meal of the day.
• PPIs are not for immediate relief of heartburn; they work over time to reduce acid production.
• Long-term use (especially >1 year) of PPIs has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, hypomagnesemia, and vitamin B12 deficiency.
• Consider the lowest effective dose for the shortest duration necessary.
• If discontinuing long-term PPI therapy, consider a gradual taper to avoid rebound acid hypersecretion.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Blockers (e.g., Famotidine, Cimetidine, Nizatidine)
• Antacids (for symptomatic relief)
• Prokinetics (e.g., Metoclopramide, for motility issues, but with more side effects)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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 you receive a refill of this medication. If you have any questions or concerns about this medication, 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 details about the medication taken, the quantity, and the time it occurred.