Protonix 40mg Tablets

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme system (the 'proton pump') located on the secretory surface of the 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.

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 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 (rarely occurring with long-term treatment, typically longer 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 experience no side effects or only mild ones. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or persist:

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, 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 is not an exhaustive list of interacting medications.

To ensure your safety, it is crucial to disclose all of your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins

Additionally, inform your doctor about any 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.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify the safety of taking this medication with all of your other medications and health problems to minimize potential interactions and ensure your well-being.

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 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.

• Rilpivirine (due to significant reduction in rilpivirine exposure)
• Nelfinavir (due to significant reduction in nelfinavir exposure)

• Atazanavir (decreased absorption, significantly reduced efficacy)
• Methotrexate (increased and prolonged serum levels of methotrexate and/or its metabolite, especially with high-dose methotrexate)
• Erlotinib (decreased erlotinib exposure)

• Clopidogrel (potential reduction in antiplatelet effect, clinical significance debated)
• Iron salts (decreased absorption of iron)
• Ketoconazole, Itraconazole, Posaconazole (decreased absorption due to increased gastric pH)
• Mycophenolate Mofetil (decreased mycophenolic acid exposure)
• Warfarin (increased INR and prothrombin time, increased risk of bleeding)
• Tacrolimus (increased tacrolimus levels)

• Digoxin (potential for increased digoxin absorption)
• Diazepam (prolonged elimination half-life of diazepam)

• Persistent or worsening GERD symptoms
• Signs of hypomagnesemia (e.g., tetany, arrhythmias, seizures, muscle cramps)
• Signs of Clostridium difficile-associated diarrhea (e.g., severe, persistent diarrhea, abdominal pain, fever)
• New or worsening bone pain or fractures
• Unexplained weight loss
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Gastrointestinal bleeding (e.g., black/tarry stools, vomiting blood)
• New or unusual skin rash (possible subacute cutaneous lupus erythematosus)

Pantoprazole was previously classified as Pregnancy Category B. Available data from observational studies on pantoprazole use in pregnant women are insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use only if clearly needed.

Pantoprazole is excreted in human milk at low levels. The risk of adverse effects on the breastfed infant appears to be low. Consider the benefits of breastfeeding, the mother's clinical need for pantoprazole, and any potential adverse effects on the breastfed infant.

Approved for the short-term treatment of erosive esophagitis associated with GERD in children 5 years of age and older. Safety and effectiveness have not been established in children younger than 5 years of age.

No overall differences in safety or effectiveness were observed between geriatric and younger patients. However, increased sensitivity of some older individuals cannot be ruled out. Long-term use in the elderly may be associated with an increased risk of bone fractures and C. difficile infection.

• Instruct patients to take pantoprazole 30-60 minutes before the first meal of the day for optimal acid suppression.
• Emphasize that delayed-release tablets should be swallowed whole and not crushed, chewed, or split.
• Counsel patients on potential long-term risks, including increased risk of bone fractures (especially with high doses or >1 year use), vitamin B12 deficiency (with >3 years use), and C. difficile infection.
• Monitor magnesium levels periodically in patients on long-term therapy or those taking concomitant diuretics.
• Be aware of potential drug interactions, particularly with pH-dependent drugs (e.g., certain antifungals, HIV antivirals) and drugs metabolized by CYP2C19 (e.g., clopidogrel, warfarin).

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, Rabeprazole
• H2-receptor antagonists (H2RAs): Famotidine, Cimetidine
• Antacids
• Prokinetics (e.g., metoclopramide, for specific motility disorders)
• Sucralfate

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it occurred.