PAN IV

Description

PAN IV Injection (Pantoprazole Sodium Sesquihydrate)

Overview: PAN IV Injection, containing Pantoprazole Sodium Sesquihydrate, is a proton pump inhibitor (PPI) designed for intravenous administration. It effectively reduces gastric acid secretion by inhibiting the H+/K+ ATPase enzyme system in the stomach’s parietal cells. This action blocks the final step of acid production, thereby suppressing both basal and stimulated acid output. It is used for various acid-related gastrointestinal conditions, especially when oral administration is not feasible.

Indications for Use

PAN IV Injection is used for the treatment and management of:

• Peptic Ulcer Disease (PUD), including duodenal and gastric ulcers.
• H. pylori infection (as part of an eradication regimen, often followed by oral therapy).
• Gastro-Oesophageal Reflux Disease (GERD), particularly erosive oesophagitis, or when oral therapy is inappropriate or not possible.
• Zollinger-Ellison Syndrome and other pathological hypersecretory conditions.
• Oesophagitis.
• Acid-related Dyspepsia.
• NSAID-associated ulceration (for treatment).
• Ulcers resistant to H2 receptor antagonists.
• Prophylaxis for Gastrointestinal (GI) bleeding from stress.
• Prophylaxis for acid aspiration syndrome during induction of anesthesia.

Dosage Information

Adults (Intravenous – IV):

• Erosive Esophagitis Associated With GERD:
  • 40 mg IV once daily for 7-10 days; switch to oral therapy (40 mg PO once daily for 8-16 weeks for treatment, or 40 mg PO once daily for maintenance) once the patient is able to swallow.
• Short-term Treatment of GERD (when oral therapy is inappropriate or not possible):
  • 40 mg IV infusion over 15 minutes once daily for 7-10 days; switch to oral once the patient is able to swallow.
• Zollinger-Ellison Syndrome:
  • 80 mg IV infusion every 8-12 hours for up to 7 days; switch to oral (40 mg PO once daily, up to 240 mg/day) once the patient is able to swallow.

Adults (Oral – for reference, typically used after IV therapy):

• 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.

Elderly:

• No dosage adjustment is typically needed.

Hepatic Impairment:

• Maximum dose for severe hepatic impairment: 20 mg/day or 40 mg on alternate days.

Pediatric Dosage (Oral – for reference, typically used after IV therapy if indicated)

• Erosive Esophagitis Associated With GERD:
  • <5 years: Safety and efficacy have not been established.
  • >5 years:
    • 15 kg to <40 kg: 20 mg PO once daily for up to 8 weeks.
    • 40 kg or greater: 40 mg PO once daily for up to 8 weeks.

Renal Impairment

• No dosage adjustment is typically needed.

Administration

IV Preparation:

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

IV Administration:

• For GERD: Infuse over 15 minutes, at a rate no more than 3 mg/min (7 mL/min).
• For pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome): Infuse over 15 minutes, at a rate no more than 6 mg/min (7 mL/min).
• Note: Oral forms (controlled-release and normal release tablets) are mentioned for switching from IV or general administration, to be taken on an empty stomach 1 hour before meals (controlled-release, swallowed whole) or with/without food (normal release).

Contraindications

PAN IV Injection is contraindicated with concomitant use of:

• Rilpivirine
• Atazanavir
• Nelfinavir
• It is also contraindicated during lactation.

Precautions

• Gastric malignancy should be ruled out before initiating treatment, as symptom improvement might mask an underlying serious condition.
• Consider zinc supplementation during IV therapy in patients who are prone to zinc deficiency.
• Pregnancy: Use with caution; consult a healthcare professional.
• Monitoring Parameters: Monitor magnesium levels prior to initiation of therapy and periodically during prolonged use.
• Lactation: It is not known whether pantoprazole is distributed into breast milk; therefore, its use is generally not recommended during breastfeeding.

Interactions

• Increased risk of digoxin-induced cardiotoxic effects.
• Increased risk of hypomagnesaemia with concomitant use of diuretics.
• May increase INR (International Normalized Ratio) and prothrombin time in patients on warfarin.
• May increase serum concentration of methotrexate and saquinavir.
• Delayed absorption and decreased bioavailability when oral forms are taken with sucralfate; separate administration times.
• Decreased absorption of oral ketoconazole and itraconazole.
• Potentially Fatal: May significantly decrease serum levels and pharmacological effects of rilpivirine, atazanavir, and nelfinavir, leading to loss of antiviral efficacy.

Adverse Effects

Common (1-10%):

• Headache (>4%)
• Abdominal pain (4%)
• Facial edema (<4%)
• Generalized edema (<2%)
• Chest pain (4%)
• Diarrhea (4%)
• Constipation (<4%)
• Pruritus (4%)
• Rash (4%)
• Flatulence (<4%)
• Hyperglycemia (1%)
• Nausea (1%)
• Vomiting (>4%)
• Photosensitivity (<2%)

Frequency Not Defined (Serious/Rare):

• Angioedema
• Atrophic gastritis
• Anterior ischemic optic neuropathy
• Hepatocellular damage leading to hepatic failure
• Interstitial nephritis
• Pancreatitis
• Pancytopenia
• Rhabdomyolysis
• Risk of anaphylaxis
• Stevens-Johnson syndrome
• Fatal toxic epidermal necrolysis
• Erythema multiforme

Mechanism of Action

Pantoprazole is a substituted benzimidazole, classified as a proton pump inhibitor (PPI). Its therapeutic action involves irreversibly binding to and inhibiting the H+/K+ ATPase enzyme system (commonly known as the proton pump) within the gastric parietal cells. By blocking this final step of acid secretion, pantoprazole effectively suppresses both basal (resting) and stimulated acid production in the stomach.

Important Note: This information regarding PAN IV Injection is sourced from the Farmaco Nepal drug index and is intended for general informational purposes only. It should not be used for self-diagnosis, medical advice, or treatment, and does not substitute for the professional judgment of a qualified healthcare provider. Always consult with a doctor or pharmacist for personalized medical advice regarding your condition and treatment.