Pantoprazole Sodium (4 brand names, 5 dosage forms, 3 routes)
Available dosage forms: FOR SUSPENSION, DELAYED RELEASE, TABLET, DELAYED RELEASE, POWDER, INJECTABLE, SOLUTION.
Routes of administration: ORAL, INTRAVENOUS, INJECTION.
Brand Names
- PANTOPRAZOLE SODIUM
- PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
- PROTONIX
- PROTONIX IV
Related Health Topics
Indications and Usage
Pantoprazole sodium delayed-release tablets are indicated for:
Contraindications
• Pantoprazole sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to any component of the formulation or any substituted benzimidazole. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6)]. • Proton pump inhibitors (PPIs), including pantoprazole sodium delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7)].
Adverse Reactions
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2)] • Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.3 )] • Bone Fracture [see Warnings and Precautions ( 5.4)] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7 )] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.10 )]
Drug Interactions
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 4: Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with pantoprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drugs. • There are other antiretroviral drugs which do not result in clinically relevant interactions with pantoprazole. Intervention: Rilpivirine-containing products: Concomitant use with pantoprazole sodium is contraindicated [see Contraindications ( 4)] . See prescribing information. Atazanavir: See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with pantoprazole sodium. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals: See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including pantoprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing informat
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).
Overdosage
Experience in patients taking very high doses of pantoprazole sodium (greater than 240 mg) is limited. Spontaneous post-marketing reports of overdose are generally within the known safety profile of pantoprazole sodium. Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive. Single oral doses of pantoprazole at 709 mg/kg, 798 mg/kg, and 887 mg/kg were lethal to mice, rats, and dogs, respectively. The symptoms of acute toxicity were hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor. If overexposure to pantoprazole sodium occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.