Pantoprazole Sod 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 inhibition of acid production.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when 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:
+ Unable to pass urine
+ Change in how much urine is passed
+ Blood in the urine
+ Sudden weight gain
Bone pain
Fever
Lupus or worsening lupus symptoms (if you have a history of lupus), 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 (do not attempt to treat diarrhea without consulting your doctor)
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which may affect body organs and can be life-threatening
+ Signs include:
- 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
- Swollen glands
Low vitamin B-12 levels (rarely occurs 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 do not experience severe side effects, and some may only have minor side effects. 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 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 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 modify 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 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, 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.

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.

• Nelfinavir (decreased nelfinavir exposure)
• Atazanavir (decreased atazanavir exposure)
• Rilpivirine (decreased rilpivirine exposure)

• Clopidogrel (potential reduction in clopidogrel's active metabolite, clinical significance debated but generally avoid co-administration)
• Methotrexate (increased methotrexate levels, especially high-dose)
• Warfarin (increased INR/PT, monitor closely)
• Iron salts (decreased absorption due to increased gastric pH)
• Ketoconazole, Itraconazole, Posaconazole (decreased absorption due to increased gastric pH)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Digoxin (potential increased absorption)
• Tacrolimus (potential increased tacrolimus levels)

• Persistent or worsening heartburn/regurgitation (indicating inadequate acid suppression or alternative diagnosis)
• Severe or persistent diarrhea (may indicate C. difficile infection)
• Muscle cramps, weakness, tremors, tetany, arrhythmias (symptoms of hypomagnesemia)
• Unexplained fatigue, pallor, numbness/tingling (symptoms of Vitamin B12 deficiency)
• New or worsening bone pain, fractures (long-term risk)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Generally considered low risk. Animal studies have shown some evidence of harm at high doses, but human data are reassuring. Use only if clearly needed.

Pantoprazole is excreted into human milk. However, the amount is small, and adverse effects on the breastfed infant are not expected. Generally considered compatible with breastfeeding.

Safety and effectiveness of Pantoprazole IV have not been established in pediatric patients under 18 years of age. Use in this population is generally not recommended unless specifically indicated for severe conditions under expert guidance.

No overall differences in safety or effectiveness were observed between geriatric and younger patients. No dose adjustment is generally needed based solely on age. However, elderly patients may be more susceptible to long-term adverse effects like bone fractures and hypomagnesemia.

• Pantoprazole IV is indicated for short-term treatment (7-10 days) of GERD with erosive esophagitis in patients unable to take oral pantoprazole. Patients should be transitioned to oral therapy as soon as clinically appropriate.
• For pathological hypersecretory conditions, the IV formulation can be used for longer periods, with dosing titrated to acid output.
• Administer pantoprazole IV over at least 2 minutes (for 40 mg dose) or 15 minutes (for 80 mg dose) via IV push or infusion. Do not administer intramuscularly.
• The reconstituted solution should be clear and colorless to slightly yellowish. Do not use if particulate matter or discoloration is present.
• Pantoprazole IV is compatible with normal saline, D5W, and Lactated Ringer's solution. Do not mix with other drugs or diluents.
• Long-term PPI use (especially >1 year) has been associated with increased risk of C. difficile infection, bone fractures (hip, wrist, spine), hypomagnesemia, and Vitamin B12 deficiency. Monitor patients on prolonged therapy for these risks.

• Other IV Proton Pump Inhibitors (e.g., Esomeprazole IV, Lansoprazole IV)
• H2-receptor antagonists (e.g., Famotidine IV, Ranitidine IV - if available)
• Antacids (for symptomatic relief, not for healing)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion or exposure. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities offer drug take-back programs, which can be a safe and convenient way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, which provides important information about its safe and effective use. Carefully read the Medication Guide when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult 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.