pantoprazole (Rx)

Brand and Other Names:Protonix
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

oral suspension

  • 40mg/packet

powder for injection

  • 40mg/vial

tablet, delayed-release

  • 20mg
  • 40mg
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Erosive Esophagitis Associated With GERD

Treatment: 40 mg PO qDay for 8-16 weeks

Maintenance of healing: 40 mg PO qDay

Alternatively, 40 mg IV qDay for 7-10 days

Short-term Treatment of GERD

Oral therapy inappropriate or not possible: 40 mg IV infusion over 15 minutes qDay for 7-10 days; switch to PO once patient able to swallow

Zollinger-Ellison Syndrome

40 mg PO qDay; up to 240 mg/day administered in some patients

80 mg IV infusion q8-12hr up to 7 days; switch to PO once patient able to swallow

Peptic Ulcer Disease (Off-label)

Duodenal ulcer: 40 mg PO qDay for 2 weeks

Gastric ulcer: 40 mg PO qDay for 4 weeks

Dosage Forms & Strengths

oral suspension

  • 40mg/packet

tablet, delayed-release

  • 20mg
  • 40mg
more...

Erosive Esophagitis Associated With GERD

<5 years

  • Safety and efficacy not established

>5 years

  • 15 kg to <40 kg: 20 mg PO qDay for up to 8 weeks
  • 40 kg or greater: 40 mg PO qDay for up to 8 weeks
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Interactions

Interaction Checker

and pantoprazole

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            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

            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

            Postmarketing Reports

            Asthenia, fatigue, malaise

            Hepatocellular damage leading to jaundice and hepatic failure

            Anaphylaxis (including anaphylactic shock)

            Agranulocytosis, pancytopenia

            Taste disorders (ageusia, dysgeusia)

            Investigations: Weight changes

            Hyponatremia, hypomagnesemia

            Rhabdomyolysis, bone fracture

            Hallucination, confusion, insomnia, somnolence

            Interstitial nephritis

            Severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (some fatal), as well as angioedema (Quincke edema)

            Cutaneous and systemic lupus erythematosus

            Cyanocobalamin (vitamin B-12) deficiency

            Clostridium difficile-associated diarrhea

            Fundic gland polyps

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            Warnings

            Contraindications

            Hypersensitivity to pantoprazole or other proton pump inhibitors (PPIs)

            Concomitant administration with rilpivirine containing products

            Cautions

            PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

            Severe hepatic impairment

            Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations

            Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 year), high-dose therapy

            Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

            PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

            Therapy increases risk of Salmonella, Campylobacter, and other infections

            Hypomagnesemia may occur with prolonged use (>1 year); adverse effects may result, including tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels, and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically

            Infusion related reactions including thrombophlebitis and hypersensitivity reported

            Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin

            Acute interstitial nephritis reported in patients taking proton pump inhibitors

            Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI

            Risk of salmonella and campylobacter infections increased with use of proton pump inhibitors

            May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered oncomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy therapy with high dose methotrexate administration

            PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; advise pregnant women of the potential risk of fetal harm; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus

            Lactation

            Pantoprazole and metabolites are excreted in milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium; clinical relevance of this finding not known; many drugs excreted in human milk have potential for serious adverse reactions in nursing infants; based on potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account benefit of drug to mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            PPI; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in blockage of acid secretion

            Absorption

            Bioavailability: 77% (PO; neither food nor antacid alters bioavailability)

            Onset (PO PUD): 24 hr (initial response)

            Duration (PO at steady state): 7 days (PUD)

            Peak plasma time: 2.8 hr (PO); at end of infusion (IV)

            Distribution

            Protein bound: 98%

            Vd: 11-24 L

            Metabolism

            Metabolized extensively by hepatic P450 enzyme CYP2C19; second pathway through CYP3A4

            Slow metabolizers (3% of Caucasians and African Americans) are deficient in CPY2C19 enzyme system; plasma concentration can increase by 5-fold or more in comparison with that found in persons who have the enzyme

            Metabolites: Desmethylpantoprazole sulfate conjugate (activity unknown)

            Elimination

            Half-life: 1 hr; increased to 3.5-10 hr with CYP2C19 deficiency

            Dialyzable: No

            Renal clearance: 0.1 L/hr/kg

            Total body clearance: 7.6-14 L/hr

            Excretion: Urine (71%); feces (18%)

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            Administration

            Oral Administration

            Switch IV patients to PO as soon as able to take tablets

            Tablet should not be chewed or crushed

            Administer before meals

            IV Incompatibilities

            Y-site: Midazolam, zinc solutions

            IV Preparation

            GERD with a history of erosive esophagitis

            • 15-min infusion: Reconstitute with 10 mL NS, THEN further dilute with 100 mL D5W, NS, or LR to final concentration of 0.4 mg/mL

            Zollinger-Ellison syndrome

            • 15-min infusion: Reconstitute each vial with 10 mL NS, THEN
            • Combine 2 vials and further dilute with 80 mL D5W, NS, or LR to total volume of 100 mL (concentration 0.8 mg/mL)
            • 2-min injection: Reconstitute with 10 mL NS to final concentration of 4 mg/mL

            IV Administration

            Do not administer other IV solution simultaneously through same line

            Use dedicated IV line or Y-site; stop Y-site administration if discoloration or precipitation

            Infuse over 15 min no more than 3 mg/min (7 mL/min) for GERD and 6 mg/min (7 mL/min) for pathologic hypersecretory conditions

            Storage

            Reconstituted solution may be stored for 2 hr at room temperature before further dilution

            Admixed solution may be stored for 12 hr at room temperature before administration

            Store intact vials at 2-8°C (36-46°F); protect from light

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.