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Details for: PANTOPRAZOLE SODIUM FOR INJECTION

Company: JAMP PHARMA CORPORATION

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02515857PANTOPRAZOLE SODIUM FOR INJECTIONPANTOPRAZOLE (PANTOPRAZOLE SODIUM)40 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Pantoprazole Sodium for Injection is used to treat stomach acid-related problems such as:

  • Reflux esophagitis. This is a severe form of heartburn
  • Pathological hypersecretory conditions (e.g. Zollinger-Ellison syndrome). These are conditions in which the stomach produces too much acid.
  • Pantoprazole Sodium for Injection is administered:

    • mainly in hospitals.
    • when you cannot take oral medicines.
    • for short-term use (up to 7 days).
    What it does

    Pantoprazole Sodium for Injection is a proton pump inhibitor. It reduces the amount of acid your stomach makes. By reducing the acid Pantoprazole Sodium for Injection reduces the symptoms (e.g. heartburn).

    When it should not be used
    • You are allergic to any of its ingredients (see What are the ingredients in Pantoprazole Sodium for Injection?).
    • You are taking rilpivirine
    What the medicinal ingredient is

    Medicinal ingredient: pantoprazole sodium sesquihydrate.

    What the non-medicinal ingredients are

    Non-medicinal ingredients: Edetate disodium and sodium hydroxide to adjust pH.

    What dosage form it comes in
  • Powder for solution. 40 mg pantoprazole (as pantoprazole sodium sesquihydrate) per vial.
  • Your healthcare professional may switch you to a pantoprazole delayed-release tablet as soon as you can start taking oral medicines again.

    Warnings and precautions

    To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Pantoprazole Sodium for Injection. Talk about any health conditions or problems you may have, including if you:

    • are taking other medications (see The following may interact with Pantoprazole Sodium for Injection).
    • are pregnant or plan to become pregnant.
    • are breastfeeding or plan to breast feed. Pantoprazole has been found in human breast milk. Talk with your doctor.
    • suffer these effects:
      • severe or persistent diarrhea
      • repeated vomiting.
      • vomiting blood.
      • dark stools.
      • tiredness(anemia).
      • difficulty in swallowing.
    • have low magnesium in the body, which may cause symptoms such as:
      • rapid heartbeat
      • dizziness, seizures.
      • muscle cramping, twitches or spasms.
    • are due to have a specific blood test (Chromogranin A).

    Other warnings you should know about:

    You will use the lowest dose and shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

    Depending on your condition, your doctor may tell you to use this type of medicine (proton pump inhibitors) for a longer period.

    Using proton pump inhibitors for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.

    Long term use of proton pump inhibitors may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor.

    Interactions with this medication

    Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

    The following may interact with Pantoprazole Sodium for Injection: Warfarin, atazanavir, nelfinavir,saquinavir/ritonavir, methotrexate.

    Proper use of this medication

    How to take Pantoprazole Sodium for Injection:

    Your doctor or nurse will administer Pantoprazole Sodium for Injection.

    Usual Dose:

    Your doctor will decide the dose of Pantoprazole Sodium for Injection for your condition.

    The recommended doses are:

    Condition Adult Dose How Often
    Reflux Esophagitis. 40 mg Once daily
    HypersecretoryConditions. This includes Zollinger-Ellison Syndrome. 80 mg Every 12 hours

    Overdose:

    If you think you, or a person you are caring for, have taken too much Pantoprazole Sodium for Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

    Missed Dose

    Contact your healthcare professional if you feel your doctor or nurse has missed a dose.

    Side effects and what to do about them

    What are possible side effects from using Pantoprazole Sodium for Injection?

    Like all medication, Pantoprazole Sodium for Injection may cause side effects. Side effects have generally been mild and did not last a long time. These are not all the possible side effects you may feel when taking Pantoprazole Sodium for Injection.

    The most common side effects are:

    • headache.
    • diarrhea.
    • nausea/vomiting.
    • general stomach discomfort.

    Less often the following can occur:

    • swelling or bruising at the injection site
    • itchiness
    • rash

    Tell your doctor right away if you have any of these symptoms:

    • new or worsening joint pain
    • rash on your cheeks or arms that gets worse in the sun

    Your symptoms may get worse after stopping your medication. This may occur as your stomach may increase the production of acid.

    Serious side effects and what to do about them
    Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
    RARE
    Disturbances in vision. Most cases reported are not serious.    
    ISOLATED CASES
    Liver damage. Symptoms include a yellow tinge to the skin and eyes.    
    Serious skin reactions. Symptoms include widespread rash, itching, or hives. Peeling of the skin, blisters on the skin, mouth, nose, eyes and genitals are other symptoms.    
    Muscle wasting    
    Clostridium difficile colitis. Symptoms include severe (watery or bloody) diarrhea, fever, and abdominal pain or tenderness.    

    How to store

    The healthcare professional will store the product appropriately (15°C to 30°C, protected from light). The reconstituted (ready-to-use) solution or further diluted solution for intravenous infusion must be used within 6 hours of initial puncture of the stopper. Keep out of reach and sight of children.

    Reporting side effects

    You can report any suspected side effects associated with the use of health products to Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

    More information

    If you want more information about Pantoprazole Sodium for Injection:

    • Talk to your healthcare professional
    • Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug-product-database.html); or by calling 1-866-399-9091.

    This leaflet was prepared by JAMP Pharma Corporation

    1310, rue Nobel

    Boucherville, Québec

    J4B 5H3

    Last revised: 13 May, 2021

    Date modified: