Pantoprazole 20mg Tablets

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme (the 'proton pump') on the secretory surface of the parietal cells in the stomach. This 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 signs or symptoms, contact your doctor or seek medical attention immediately:

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, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Bone Pain: Severe or persistent bone pain.
Fever: High fever or chills.
Lupus: If you have lupus, this medication may worsen your condition. Watch for signs like a rash on the cheeks or other body parts, changes in skin color, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
C. difficile-Associated Diarrhea (CDAD): Severe diarrhea, stomach pain or cramps, very loose or watery stools, or bloody stools. Do not 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 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.
Vitamin B-12 Deficiency: If you have been taking this medication for an extended period (more than 3 years), you may be at risk for low vitamin B-12 levels. Watch for signs like 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, but some may occur. 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 is not an exhaustive list of possible side effects. If you have concerns or questions, 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 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 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 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 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 also 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.

• Atazanavir
• Nelfinavir
• Rilpivirine
• Methotrexate (high-dose)

• Clopidogrel
• Warfarin
• Digoxin
• Iron salts
• Vitamin B12
• Mycophenolate mofetil
• Tacrolimus
• Erlotinib
• Dasatinib
• Nilotinib
• Posaconazole
• Ketoconazole
• Itraconazole

• Sucralfate (administer at least 30 minutes apart)

• Persistent heartburn
• Regurgitation
• Dysphagia
• Abdominal pain
• Diarrhea
• Headache
• Nausea
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, arrhythmias, seizures)
• Signs of vitamin B12 deficiency (e.g., fatigue, numbness, tingling)

Generally considered low risk. Animal studies have shown no evidence of harm to the fetus. Human data are limited but do not suggest an increased risk of major birth defects or miscarriage. Use only if clearly needed.

Pantoprazole is present in human milk. The amount is small, and adverse effects on the breastfed infant are not expected. Considered compatible with breastfeeding by most experts (Lactation Risk Category L2).

Approved for short-term treatment of erosive esophagitis associated with GERD in children 1 year of age and older. Dosing is weight-based. Long-term safety and efficacy in pediatric patients are not fully established.

No dosage adjustment is generally necessary based on age alone. However, elderly patients may be more susceptible to adverse effects such as bone fractures and C. difficile infection with long-term use. Monitor for these risks.

• Pantoprazole is a delayed-release formulation; it must be swallowed whole and not crushed or chewed.
• For patients who cannot swallow tablets, an oral suspension or IV formulation is available.
• Long-term PPI use (especially >1 year) has been associated with increased risk of bone fractures (hip, wrist, spine), hypomagnesemia, and C. difficile-associated diarrhea.
• Consider lowest effective dose and shortest duration of therapy, especially for non-erosive GERD.
• Rebound acid hypersecretion can occur upon discontinuation, especially after prolonged use. Tapering the dose may be considered for patients on long-term therapy.
• PPIs may interfere with the antiplatelet effect of clopidogrel; consider alternative antiplatelet therapy or PPI if clinically appropriate, though the clinical significance of this interaction is debated.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Rabeprazole, Dexlansoprazole)
• H2 Receptor Blockers (e.g., Famotidine, Ranitidine (withdrawn), Cimetidine, Nizatidine)
• Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
• Prokinetics (e.g., Metoclopramide - for specific indications)
• Lifestyle modifications

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. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.