Pantoprazole Sodium Powder

Pantoprazole Sodium Powder Detailed Description

1. General Overview:
Pantoprazole sodium is a proton pump inhibitor (PPI) used to reduce the amount of acid produced in the stomach. The powder form is typically used for intravenous (IV) administration when oral administration is not possible or appropriate (e.g., in hospitalized patients with severe gastroesophageal reflux or gastrointestinal bleeding).

2. Composition and Formulation:

• Active Ingredient: Pantoprazole sodium (usually in the form of pantoprazole sodium sesquihydrate)

• Dosage: Commonly available in 40 mg per vial of pantoprazole sodium (equivalent to 40 mg of pantoprazole base)

• Physical Form: A white to off-white lyophilized powder in a sterile vial

• Reconstitution: Must be reconstituted with sterile 0.9% sodium chloride injection before administration

3. Mechanism of Action:

Pantoprazole is a proton pump inhibitor (PPI) that blocks the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. This is the final step in acid production, leading to a significant and prolonged reduction in gastric acid secretion.

4. Indications:

• Gastroesophageal reflux disease (GERD)

• Zollinger-Ellison syndrome and other pathological hypersecretory conditions

• Erosive esophagitis

• Peptic ulcer disease, especially when IV administration is needed

• Prevention of stress ulcers in critically ill patients

5. Preparation and Administration:

• Reconstitution: The 40 mg vial is usually reconstituted with 10 mL of 0.9% Sodium Chloride Injection

• Further Dilution (for IV infusion): The solution can be further diluted into 100 mL of 0.9% sodium chloride or 5% dextrose solution for a 15-minute infusion

• IV Push: Can also be administered over 2 minutes without further dilution

6. Pharmacokinetics:

• Bioavailability: 100% for IV; oral form is around 77%

• Onset of Action: Within 15-30 minutes

• Peak Plasma Concentration: 2.5 hours (IV)

• Half-life: About 1 hour

• Excretion: Primarily via urine and feces as metabolites

7. Side Effects:

• Common: Headache, diarrhea, nausea, abdominal pain

• Serious but rare: Hypomagnesemia, Clostridium difficile infection, bone fractures (with long-term use), allergic reactions

• Injection-site reactions (e.g., thrombophlebitis)

8. Storage and Stability:

• Store the dry powder at controlled room temperature (2025C)

• Once reconstituted, the solution should be used immediately, though some formulations allow storage for up to 12 hours at room temperature or 24 hours refrigerated

9. Contraindications:

• Known hypersensitivity to pantoprazole or other PPIs

10. Drug Interactions:

• May interfere with drugs that require acidic pH for absorption, such as ketoconazole, ataza navir

• May increase levels of warfarin, methotrexate, and other medications