Brand names: Pantoprazole Sodium
Route: Intravenous
Contraindications
4 CONTRAINDICATIONS • Pantoprazole sodium in 0.9% sodium chloride injection is contraindicated in patients with known hypersensitivity reactions including anaphylaxis to 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 , 5.4 ), Adverse Reactions (6) ] . • Proton pump inhibitors (PPIs), including pantoprazole sodium in 0.9% sodium chloride injection, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions (7) ] . • Patients with a known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4) • Patients receiving rilpivirine-containing products. ( 4 , 7 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole. In animal reproduction studies, no evidence of adverse development outcomes was observed with pantoprazole. Reproduction studies have been performed in rats at intravenous doses up to 20 mg/kg/day (4 times the recommended human dose) and rabbits at intravenous doses up to 15 mg/kg/day (6 times the recommended human dose) with administration of pantoprazole during organogenesis in pregnant animals and have revealed no evidence of harm to the fetus due to pantoprazole in this study (see Data) . A pre-and post-natal development toxicity study in rats with additional endpoints to evaluate the effect on bone development was performed with pantoprazole sodium. Oral pantoprazole doses of 5, 15, and 30 mg/kg/day (approximately 1, 3, and 6 times the human dose of 40 mg/day) were administered to pregnant females from gestation day (GD) 6 through lactation day (LD) 21. Changes in bone morphology were observed in pups exposed to pantoprazole in utero and through milk during the period of lactation as well as by oral dosing from postnatal day (PND) 4 through PND 21 [see Use in Specific Populations (8.4) ] . There were no drug-related findings in maternal animals . Advise pregnant women of the potential risk of fetal harm. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and pantoprazole use. Methodological limitations of thes
15 interactions on record
Concomitant use with pantoprazole sodium in 0.9% sodium chloride injection is contraindicated. Decreased exposure of rilpivirine may reduce antiviral effect.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
Decreased exposure of atazanavir when used concomitantly with pantoprazole may reduce antiviral effect and promote development of drug resistance.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
Concomitant use of pantoprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations, possibly leading to methotrexate toxicities.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
• 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. Nelfinavir : Avoid concomitant use with pantoprazole sodium in 0.9% sodium chloride injection See prescribing information for nelfinavir.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
Increased exposure of saquinavir when used concomitantly with pantoprazole may increase toxicity of the antiretroviral drug.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
Increased INR and prothrombin time in patients receiving pantoprazole and warfarin concomitantly, which may lead to abnormal bleeding and death.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
Caution must be exercised in the administration of Sodium Chloride Injection to patients receiving corticosteroids due to potential interaction.
Source: NLP:0.9% sodium chloride
Caution must be exercised in the administration of Sodium Chloride Injection to patients receiving corticotropin due to potential interaction.
Source: NLP:0.9% sodium chloride
Concomitant administration of pantoprazole and clopidogrel had no clinically important effect on exposure to active metabolite or platelet inhibition.
Source: NLP:pantoprazole sodium in 0.9% sodium chloride
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Pantoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride
7 DRUG INTERACTIONS Table 2 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with pantoprazole sodium injection and instructions for preventing or managing them. Clinically Relevant Interactions Affecting Drugs Co-Administered with Pantoprazole Sodium in 0.9% Sodium Chloride Injection and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. • 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.
Source: FDA drug label - pantoprazole sodium in 0.9% sodium chloride