Pantoprazole Injection

What is Pantoprazole Injection?

• Pantoprazole Injection (Protonix I.V.) is a proton pump inhibitor (PPI) used as a short-term treatment to treat gastroesophageal reflux disease in people who have had damage to their [[esophagus[[ and who are unable to take pantoprazole by mouth.
• It is also used to treat conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome.

Pantoprazole

Pantoprazole

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Pantoprazole Enantiomers Strutural Formulae

What are the uses of this medicine?

Pantoprazole Injection (Protonix I.V.) is used in adults for the following:

• Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE).
• Hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome.

How does this medicine work?

• 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).

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity reactions including anaphylaxis to the formulation or any substituted benzimidazole.
• receiving rilpivirine-containing products.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• atazanavir (Reyataz, in Evotaz), dasatinib (Sprycel), digoxin (Lanoxin), diuretics ('water pills'), erlotinib (Tarceva), iron supplements, itraconazole ( Sporanox, Tolsura), ketoconazole, methotrexate (Trexall, Xatmep), mycophenolate (Cellcept, Myfortic), nelfinavir (Viracept), nilotinib (Tasigna), saquinavir (Invirase), warfarin ( Jantoven), and rilpivirine (Edurant, in Cabenuva, Complera, Juluca, Odefsey).

Is this medicine FDA approved?

• Study of pantoprazole began in 1985, and it came into medical use in Germany in 1994.
• It is available as a generic medication.
• In 2020, it was the twentieth most commonly prescribed medication in the United States, with more than 26 million prescriptions.

How should this medicine be used?

Recommended dosage:

Dosage for Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis:

• The recommended adult dosage of PROTONIX I.V. is 40 mg given once daily by intravenous infusion for 7 to 10 days.
• Discontinue treatment with PROTONIX I.V. as soon as the patient is able to receive treatment with PROTONIX Delayed-Release Tablets or Oral Suspension.

Dosage for Pathological Hypersecretion Including Zollinger-Ellison Syndrome:

• The recommended adult dosage of PROTONIX I.V. is 80 mg intravenously every 12 hours.
• The frequency of dosing can be adjusted to individual patient needs based on acid output measurements.
• Daily doses higher than 240 mg or administered for more than 6 days have not been studied.

Administration:

• Pantoprazole injection comes as a powder to be mixed with liquid and given intravenously by a doctor or nurse in a medical facility.
• For the treatment of GERD, pantoprazole injection is usually given once a day for 7 to 10 days.
• For the treatment of conditions where the stomach produces too much acid, pantoprazole injection is usually given every 8 to 12 hours.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 40 mg pantoprazole freeze-dried powder in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• PROTONIX I.V.

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.

Less coomon, but serious side effects may include:

• Injection Site Reactions
• Potential for Exacerbation of Zinc Deficiency
• Acute Tubulointerstitial Nephritis
• Clostridium difficile-Associated Diarrhea
• Bone Fracture
• Severe Cutaneous Adverse Reactions
• Cutaneous and Systemic Lupus Erythematosus
• Hepatic Effects
• Hypomagnesemia and Mineral Metabolism
• Fundic Gland Polyps

What special precautions should I follow?

• In adults, symptomatic response to therapy with PROTONIX I.V. does not preclude the presence of gastric malignancy.
• Thrombophlebitis is associated with the administration of intravenous pantoprazole.
• PROTONIX I.V. contains edetate disodium (the salt form of EDTA), a chelator of metal ions including zinc. Therefore, zinc supplementation should be considered in patients treated with PROTONIX I.V. who are prone to zinc deficiency.
• Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Discontinue PROTONIX I.V. and evaluate patients with suspected acute TIN.
• PPI therapy like PROTONIX I.V. may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Severe cutaneous adverse reactions, including erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs. Discontinue PROTONIX I.V at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
• Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including pantoprazole sodium. Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving PROTONIX I.V., discontinue the drug and refer the patient to the appropriate specialist for evaluation.
• Mild, transient transaminase elevations have been observed in clinical studies.
• Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, and in most cases after a year of therapy. Consider monitoring magnesium and calcium levels prior to initiation of PROTONIX I.V. and periodically while on treatment in patients with a preexisting risk of hypocalcemia (e.g., hypoparathyroidism). Supplement with magnesium and/or calcium as necessary.
• PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Use the shortest duration of PPI therapy appropriate to the condition being treated.
• Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.
• Pantoprazole sodium may produce false-positive urine screen for THC (tetrahydrocannabinol).
• Concomitant use of PPIs with methotrexate may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Pantoprazole is not removed by hemodialysis.
• In case of overdose, treatment should be symptomatic and supportive.

Can this medicine be used in pregnancy?

• Available data from published observational studies did not demonstrate an association of major malformations or other adverse pregnancy outcomes with pantoprazole.

Can this medicine be used in children?

• The safety and effectiveness of PROTONIX I.V. have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PANTOPRAZOLE SODIUM

Inactive ingredients:

• EDETATE DISODIUM
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Dist. by:

• Wyeth Pharmaceuticals LLC
• A subsidiary of Pfizer Inc
• Philadelphia, PA

What should I know about storage and disposal of this medication?

• Store PROTONIX I.V. at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

The antiulcer agents in clinical use

Proton Pump Inhibitors

• Dexlansoprazole
• Esomeprazole
• Lansoprazole
• Omeprazole
• Pantoprazole
• Rabeprazole

Selective Histamine Type 2 Receptor Antagonists or H2 Blockers

• Cimetidine
• Famotidine
• Nizatidine
• Ranitidine

• Dailymed label info on Pantoprazole Injection
• FDA Pantoprazole Injection

Pantoprazole Injection Resources
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