Protonix 20mg Tablets

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme (proton pump) on the secretory surface of the gastric parietal cells. This inhibits the final step in gastric acid production, leading to a profound and long-lasting decrease 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 immediately or seek emergency medical attention:

Allergic reactions: 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.
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.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Bone pain: Severe or persistent pain in the bones.
Fever: Elevated body temperature.
Lupus: If you have a history of lupus, inform your doctor. Be aware of signs like a 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.
C. diff-associated diarrhea (CDAD): Severe diarrhea that may be bloody or watery. If you experience stomach pain, cramps, or loose stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor first.
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help right away if you notice 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: 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. Contact your doctor if you experience shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.

Other Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or if they persist or bother you, contact your doctor:

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 change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.

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 symptoms such as throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer (including black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit), contact your doctor immediately, as these may be indicative of 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, seizure medication, 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 rarely lead to low magnesium levels, which can cause other electrolyte imbalances. Your doctor may recommend regular blood tests to monitor your condition. Additionally, taking this drug 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, planning to become pregnant, or 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 (due to significant reduction in rilpivirine absorption)

• Atazanavir (reduced absorption, risk of virologic failure)
• Nelfinavir (reduced absorption, risk of virologic failure)
• Dasatinib (reduced absorption)
• Erlotinib (reduced absorption)
• Ketoconazole (reduced absorption)
• Itraconazole (reduced absorption)
• Posaconazole (reduced absorption)
• Mycophenolate Mofetil (reduced exposure of mycophenolic acid)
• Methotrexate (increased methotrexate levels, potential toxicity, especially with high-dose methotrexate)

• Warfarin (potential for increased INR/PT, monitor closely)
• Clopidogrel (potential for reduced antiplatelet effect, though clinical significance debated and often considered less significant than with omeprazole)
• Digoxin (increased digoxin levels)
• Iron salts (reduced absorption)
• Cyanocobalamin (Vitamin B12) (reduced absorption with long-term use)
• Tacrolimus (increased tacrolimus levels)
• Dabigatran (increased dabigatran exposure)
• Phenytoin (increased phenytoin levels)

• Calcium carbonate (reduced absorption)
• Magnesium supplements (reduced absorption)

• Persistent or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Unexplained weight loss
• Vomiting blood or 'coffee-ground' vomit
• Black, tarry stools (melena)
• Chest pain
• New or worsening muscle cramps, spasms, or weakness (signs of hypomagnesemia)
• Dizziness or lightheadedness
• Unusual fatigue or pallor (signs of B12 deficiency)

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. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.

Pantoprazole is excreted into human milk. The amount is small, and adverse effects on the breastfed infant are not expected. However, caution should be exercised when pantoprazole is administered to a nursing mother. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.

Approved for short-term treatment of erosive esophagitis in children 5 years and older. Safety and effectiveness have not been established in children younger than 5 years of age. Dosing is weight-based for younger children.

No overall differences in safety or effectiveness were observed between elderly and younger patients. No dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to long-term adverse effects such as bone fractures and C. difficile infection.

• Pantoprazole is generally well-tolerated. The most common side effects are headache, diarrhea, nausea, and abdominal pain.
• For optimal efficacy, pantoprazole should be taken 30-60 minutes before the first meal of the day.
• Long-term use (over 1 year) of PPIs, including pantoprazole, has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Periodically assess the need for continued therapy.
• Patients on long-term PPI therapy should be monitored for Vitamin B12 deficiency.
• While some PPIs have significant interactions with clopidogrel, pantoprazole is considered to have a lower potential for interaction compared to omeprazole, due to its less potent inhibition of CYP2C19.
• Protonix is the brand name for pantoprazole. Generic versions are widely available and typically much less expensive.

• Other Proton Pump Inhibitors (PPIs): Omeprazole (Prilosec), Esomeprazole (Nexium), Lansoprazole (Prevacid), Rabeprazole (Aciphex), Dexlansoprazole (Dexilant)
• H2 Receptor Antagonists (H2RAs): Famotidine (Pepcid), Ranitidine (Zantac - largely withdrawn), Cimetidine (Tagamet), Nizatidine (Axid)
• Antacids (e.g., Tums, Maalox, Mylanta)
• Sucralfate (Carafate)
• Prokinetics (e.g., Metoclopramide - for specific motility issues)

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 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.