Protonix 40mg Inj, 1 Vial

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 gastric parietal cells. This action 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 Attention Immediately

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 help right away:

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 lupus symptoms, including:
+ 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
Irritation or swelling at the injection site
Severe diarrhea (C. diff-associated diarrhea), characterized 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

While many people may not experience side effects or may only have mild side effects, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

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, 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.

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. This precaution is vital to prevent 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 coffee ground-like vomit. 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, 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, typically 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 a year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, consult your doctor. You may need to take zinc supplements while taking this medication; discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Clopidogrel (reduced antiplatelet effect)
• Atazanavir (reduced absorption and efficacy)
• Nelfinavir (reduced absorption and efficacy)
• Rilpivirine (reduced absorption and efficacy)
• Methotrexate (increased and prolonged serum levels of methotrexate and/or its metabolite)

• Iron salts (reduced absorption)
• Vitamin B12 (reduced absorption with long-term use)
• Mycophenolate mofetil (reduced exposure of mycophenolic acid)
• Digoxin (increased absorption)
• Warfarin (potential for increased INR and prothrombin time)

• Resolution of heartburn and other GERD symptoms
• Abdominal pain
• Diarrhea (especially persistent or severe, suggestive of C. difficile infection)
• Headache
• Nausea/Vomiting
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, arrhythmias)
• Signs of allergic reaction (e.g., rash, itching, swelling)

Pantoprazole is classified as Pregnancy Category B. Studies in animals 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.

Pantoprazole is excreted in human milk at low levels. The amount ingested by the infant is considered low and unlikely to cause adverse effects. Generally considered compatible with breastfeeding, but monitor the infant for any signs of adverse effects (e.g., diarrhea).

Pantoprazole IV is approved for use in children aged 5 years and older for erosive esophagitis. Safety and effectiveness in children younger than 5 years have not been established. Dosing is weight-based for younger children.

No specific dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to adverse effects (e.g., bone fractures, C. difficile infection, hypomagnesemia) and may have more comorbidities and polypharmacy, increasing the risk of drug interactions. Monitor closely.

• Pantoprazole IV is typically used for patients who cannot take oral medication, such as those with severe dysphagia, NPO status, or acute GI bleeding.
• Switch to oral pantoprazole as soon as the patient is able to tolerate oral intake.
• Long-term use of PPIs (especially >1 year) has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, hypomagnesemia, and vitamin B12 deficiency.
• Administer IV pantoprazole as an infusion over at least 2 minutes (for 40 mg) or 15 minutes (for 80 mg) or as a continuous infusion for ZES.
• Do not administer with other medications in the same IV line or mix with other solutions unless compatibility is confirmed.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, Rabeprazole)
• H2-receptor antagonists (e.g., Famotidine, Ranitidine [oral/IV])
• Antacids (for symptomatic relief)
• Sucralfate (for ulcer treatment)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is essential to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.