Pantoprazole 40mg Granules 30 Pack

Pantoprazole is a proton pump inhibitor (PPI) that irreversibly binds to the H+/K+-ATPase enzyme (the 'proton pump') in the secretory canaliculi of 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 immediate medical attention:

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
Severe diarrhea (C diff-associated diarrhea or CDAD), 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
- Swollen glands
Low vitamin B-12 levels (rarely occurring with long-term treatment, typically longer than 3 years), which may cause:
+ 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 have only minor or no side effects at all. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor or seek medical help:

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 potential 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 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 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. 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 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 a history of 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 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.

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.

• Nelfinavir
• Atazanavir
• Rilpivirine

• Methotrexate (increased methotrexate levels, especially high-dose)
• Warfarin (increased INR and prothrombin time)
• Clopidogrel (reduced antiplatelet effect, clinical significance debated)
• Erlotinib (decreased erlotinib exposure)
• Dasatinib (decreased dasatinib exposure)
• Nilotinib (decreased nilotinib exposure)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Iron salts (decreased absorption)
• Ketoconazole (decreased absorption)
• Itraconazole (decreased absorption)
• Posaconazole (decreased absorption)
• Tacrolimus (increased tacrolimus levels)
• Digoxin (increased digoxin levels, rare)

• Not available

• Persistent or worsening heartburn
• Regurgitation
• Dysphagia
• Unexplained weight loss
• Recurrent vomiting
• Black, tarry stools (melena)
• Coffee-ground emesis
• Symptoms of hypomagnesemia (e.g., muscle cramps, spasms, arrhythmias, seizures)
• Symptoms of C. difficile-associated diarrhea (e.g., severe, persistent diarrhea, abdominal pain, fever)

Pantoprazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of fetal toxicity at high doses, but human data are limited.

Pantoprazole is excreted in human milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother and the potential adverse effects on the breastfed infant. Consider alternative PPIs with less excretion into milk or shorter half-lives if possible.

Approved for short-term treatment of erosive esophagitis associated with GERD in pediatric patients 1 year of age and older. Dosing is weight-based. Safety and effectiveness in pediatric patients younger than 1 year of age have not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients. No dose adjustment is generally necessary based on age alone, but consider potential for polypharmacy and increased risk of long-term adverse effects (e.g., bone fractures, C. diff, hypomagnesemia).

• Pantoprazole granules are designed for patients who have difficulty swallowing tablets, particularly pediatric patients. They must be mixed with applesauce or apple juice and swallowed immediately.
• PPIs like pantoprazole are most effective when taken 30-60 minutes before the first meal of the day, as this allows the drug to be absorbed and transported to the parietal cells when they are actively secreting acid.
• Long-term use (over 1 year) of PPIs has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, hypomagnesemia, and Vitamin B12 deficiency. Periodically assess the need for continued therapy.
• Pantoprazole is not for immediate relief of heartburn; it may take several days for full effect.
• Patients on concomitant warfarin should have their INR monitored closely when initiating or discontinuing pantoprazole.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Rabeprazole, Dexlansoprazole
• H2-receptor antagonists (H2RAs): Famotidine, Ranitidine (if available), Cimetidine, Nizatidine
• Antacids (for symptomatic relief)
• Prokinetics (e.g., metoclopramide, for motility disorders)
• Sucralfate (for ulcer protection)

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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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. Be prepared to provide detailed information about the incident, including the substance taken, the amount, and the time it occurred.