PANTOPRAZOLE SODIUM DELAYED-RELEASE

Electrolyte / Mineral

Brand names: Pantoprazole sodium delayed-release

Oral

Mechanism of Action

12.1 Mechanism of Action Pantoprazole is a PPI that suppresses the final step in gastric acid production by covalently binding to the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. The binding to the (H + , K + )-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested (20 mg to 120 mg).

Indications

including Zollinger-Ellison (ZE) Syndrome.

Contraindications

• anaphylactic shock
• angioedema
• bronchospasm
• acute tubulointerstitial nephritis
• and urticaria [see Warnings and Precautions (5.2)

FDA Warnings

5 WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic response does not preclude presence of gastric malignancy
2 ) Clostridium difficile- Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile -associated diarrhea
3 ) Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine
8 ) Fundic Gland Polyps: Risk increases with long-term use, especially beyond one year

Known Side Effects

10 documented side effects by frequency

Fatigue

1-10%

Nausea

1-10%

Diarrhea

1-10%

Shortness of Breath

1-10%

Drug Not Working

1-10%

Headache

1-10%

Vomiting

1-10%

Joint Pain

0.1-1%

Weakness

0.1-1%

Dizziness

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral