PANVISTA

Description

PANVISTA Tablet: Essential Information

Generic Name: Pantoprazole Sodium Sesquihydrate Manufacturer: Elder Pharmaceuticals. Availability: Available in Nepal.

PANVISTA Tablet is a proton pump inhibitor (PPI). It works by significantly reducing the amount of acid your stomach produces. It achieves this by blocking a key enzyme (H+/K+ ATPase) in the stomach’s parietal cells, effectively inhibiting both the normal, baseline acid secretion and acid produced in response to stimuli.

What is PANVISTA Used For? (Indications)

PANVISTA Tablet is prescribed to treat various conditions caused by excessive stomach acid:

• Peptic Ulcer Disease: This includes ulcers in the stomach (gastric ulcers) and the first part of the small intestine (duodenal ulcers).
• H. pylori Infection: It’s used as part of a multi-drug regimen to eradicate this bacterium, which can cause ulcers.
• Gastro-oesophageal Reflux Disease (GERD): A chronic condition where stomach acid flows back into the esophagus, causing symptoms like heartburn and potentially leading to esophageal damage.
• Zollinger-Ellison Syndrome: A rare and severe condition where the stomach produces abnormally high amounts of acid.
• Oesophagitis: Inflammation of the esophagus, often a result of acid reflux.
• Acid-related Dyspepsia: General indigestion symptoms linked to stomach acid.
• NSAID-associated Ulceration: Ulcers that develop due to the use of non-steroidal anti-inflammatory drugs.
• Ulcers resistant to H2 receptor antagonists: For ulcers that haven’t healed with other types of acid-reducing medications.
• Gastrointestinal (GI) bleeding from stress: To help prevent or manage bleeding in the digestive tract that can occur due to severe stress.
• Prophylaxis for acid aspiration syndrome: Used to prevent stomach acid from being inhaled into the lungs during the induction of anesthesia for surgical procedures.

How to Take PANVISTA (Dosage & Administration)

PANVISTA can be taken orally as a tablet or administered intravenously (IV) when oral intake isn’t feasible.

Adult Dosing

• Erosive Esophagitis Associated With GERD:
  • Treatment: Take 40 mg by mouth (PO) once daily for 8-16 weeks.
  • Maintenance: To prevent recurrence, take 40 mg PO once daily.
  • Alternatively, IV: 40 mg intravenously (IV) once daily for 7-10 days.
• Short-term Treatment of GERD (when oral therapy is not possible or appropriate):
  • Administer 40 mg as an IV infusion over 15 minutes, once daily for 7-10 days. Switch to oral therapy as soon as the patient is able to swallow.
• Zollinger-Ellison Syndrome:
  • Oral: 40 mg PO once daily. In some cases, doses up to 240 mg/day have been administered.
  • IV: 80 mg as an IV infusion every 8-12 hours for up to 7 days. Switch to oral therapy once the patient can swallow.
• Peptic Ulcer Disease:
  • Duodenal Ulcer: 40 mg PO once daily for 2-4 weeks.
  • Gastric Ulcer: 40 mg PO once daily for 4-8 weeks.

Special Populations:

• Elderly Patients: No dosage adjustment is typically needed.
• Hepatic Impairment (Liver Issues): The maximum dose is 20 mg/day or 40 mg on alternate days.
• Renal Impairment (Kidney Issues): No dosage adjustment is needed.

Child Dosing (for Erosive Esophagitis Associated With GERD)

• Children <5 years: The safety and effectiveness of PANVISTA in this age group have not been established.
• Children >5 years:
  • Weighing 15 kg to <40 kg: 20 mg PO once daily for up to 8 weeks.
  • Weighing 40 kg or greater: 40 mg PO once daily for up to 8 weeks.

How to Administer the Tablet

• Controlled-release tablets: These should be taken on an empty stomach, ideally 1 hour before meals. Swallow the tablet whole; do not chew or crush it.
• Normal release tablets: Can be taken with or without food.

IV Preparation and Administration

• For GERD with a history of erosive esophagitis (15-minute infusion): Reconstitute the vial with 10 mL of Normal Saline (NS). Then, further dilute this solution with 100 mL of D5W (Dextrose 5% in Water), NS, or LR (Lactated Ringer’s) to achieve a final concentration of 0.4 mg/mL.
• For Zollinger-Ellison Syndrome:
  • 15-minute infusion: Reconstitute each vial with 10 mL NS. Combine 2 vials and further dilute with 80 mL of D5W, NS, or LR to a total volume of 100 mL (final concentration 0.8 mg/mL).
  • 2-minute injection: Reconstitute with 10 mL NS to a final concentration of 4 mg/mL.

IV Administration Rates:

• Infuse over 15 minutes.
• The infusion rate should not exceed 3 mg/min (7 mL/min) for GERD.
• The infusion rate should not exceed 6 mg/min (7 mL/min) for pathologic hypersecretory conditions.

Important Considerations

When Not to Use (Contraindications)

Do not use PANVISTA Tablet if you are taking:

• Rilpivirine
• Atazanavir
• Nelfinavir

It is also contraindicated if you are breastfeeding.

Precautions

• Your doctor should rule out gastric malignancy (stomach cancer) before you start PANVISTA.
• If you are receiving IV therapy and are prone to zinc deficiency, your doctor might consider providing zinc supplementation.
• If you are pregnant, discuss this with your doctor before using this medication.

Monitoring Parameters

• Your doctor will monitor your magnesium levels before you start PANVISTA and periodically during prolonged use, as PPIs can affect magnesium levels.

Pregnancy and Lactation

• Lactation: It’s not known whether pantoprazole is excreted into breast milk. Therefore, its use is not recommended for breastfeeding mothers.

Potential Drug Interactions

PANVISTA can interact with various other medications. Always inform your doctor or pharmacist about all prescription, over-the-counter, and herbal products you are currently taking.

• Increased Risk:
  • Digoxin: Increased risk of cardiotoxic effects.
  • Diuretics: Increased risk of hypomagnesaemia (low magnesium levels).
  • Warfarin: May increase INR and prothrombin time, potentially raising the risk of bleeding.
  • Methotrexate and Saquinavir: May increase their serum concentrations.
• Decreased Absorption or Bioavailability:
  • Sucralfate: Can lead to delayed absorption and decreased bioavailability of PANVISTA.
  • Ketoconazole, Itraconazole: Decreased absorption of these antifungal medications.
• Potentially Fatal Interactions:
  • May significantly decrease the serum levels and pharmacological effects of rilpivirine, atazanavir, and nelfinavir. This is why co-administration is contraindicated.

Possible Side Effects (Adverse Effects)

Most side effects of Pantoprazole Sodium Sesquihydrate (the active ingredient in PANVISTA) are generally mild to moderate:

• Common (occurring in 1-10% of patients):
  • Headache (>4%)
  • Abdominal pain (4%)
  • Diarrhea (4%)
  • Chest pain (4%)
  • Pruritus (itching) (4%)
  • Rash (4%)
  • Vomiting (>4%)
  • Facial edema (<4%)
  • Generalized edema (<2%)
  • Constipation (<4%)
  • Flatulence (<4%)
  • Hyperglycemia (1%)
  • Nausea (1%)
  • Photosensitivity (<2%)

Less common, but potentially serious side effects (frequency not defined) include:

• Angioedema (severe swelling under the skin)
• Atrophic gastritis (chronic inflammation of the stomach lining)
• Anterior ischemic optic neuropathy (a condition affecting vision)
• Hepatocellular damage leading to hepatic failure (severe liver damage)
• Interstitial nephritis (inflammation of the kidneys)
• Pancreatitis (inflammation of the pancreas)
• Pancytopenia (a reduction in all types of blood cells)
• Rhabdomyolysis (breakdown of muscle tissue)
• Risk of anaphylaxis (a severe, life-threatening allergic reaction)
• Stevens-Johnson syndrome (a severe skin reaction)
• Fatal toxic epidermal necrolysis (a very severe, life-threatening skin condition)
• Erythema multiforme (a type of skin rash)

Important Note: This information about PANVISTA Tablet is provided for general knowledge and informational purposes only. It is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or treatment.