Patient Medication Information: uses, side effects, how to take - Pantoprazole Sodium for Injection (Sandoz Canada)
What is PANTOPRAZOLE SODIUM FOR INJECTION used for?
Pantoprazole Sodium for Injection is used in adults to treat:
- Reflux esophagitis. Inflammation caused by acid moving up from the stomach to the throat (esophagus). This is a severe form of heartburn.
- Pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome: These are conditions in which the stomach produces too much acid.
PANTOPRAZOLE SODIUM FOR INJECTION is given:
- mainly in hospitals
- when you cannot take oral medicines
- for short-term use (up to 7 days)
How does PANTOPRAZOLE SODIUM FOR INJECTION work?
PANTOPRAZOLE SODIUM FOR INJECTION is a proton pump inhibitor (PPI). It helps reduce the amount of acid made in your stomach.
What are the ingredients in PANTOPRAZOLE SODIUM FOR INJECTION?
Medicinal ingredients: pantoprazole sodium.
Non-medicinal ingredients: none.
PANTOPRAZOLE SODIUM FOR INJECTION comes in the following dosage forms:
Powder for injection. 40 mg pantoprazole (as pantoprazole sodium) per vial.
Do not use PANTOPRAZOLE SODIUM FOR INJECTION if:
- you are allergic to pantoprazole, substituted benzimidazoles, or any of the other ingredients in PANTOPRAZOLE SODIUM FOR INJECTION.
- you are taking rilpivirine (a medicine used to treat HIV).
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:
- have had allergic reactions to any other drugs.
- have had had severe skin rash, peeling or blistering after taking a drug like pantoprazole.
- have or think you have a gastric ulcer (sore on the lining of the stomach).
- have or had fractures related to low bone density (osteoporosis).
- have liver problems.
- have kidney problems.
- have or have had problems with the amount of zinc in your blood. Your healthcare professional may supplement your treatment with zinc supplements.
are pregnant or plan to become pregnant.
- are breastfeeding or plan to breast feed. Pantoprazole has been found in human breast milk.
- are taking medication that may cause low magnesium levels in your blood (hypomagnesemia) such as digoxin.
- are taking atazanavir, nelfinavir, saquinavir, and ritonavir (medicines used against retroviruses).
Other warnings you should know about:
Taking PPIs such as PANTOPRAZOLE SODIUM FOR INJECTION can cause the following:
- Bone Fractures: Treatment with PPIs for long periods may increase your risk of broken bones of the hip, wrist or spine. Talk to your healthcare professional about these risks.
- Low magnesium: Taking PPIs for more than three months can cause hypomagnesemia (low magnesium levels in your blood). This can lead to muscle cramps, spasms, tremors, arrhythmias (abnormal heart rhythms), and seizures. Your healthcare professional will monitor your magnesium levels and may decide to discontinue your treatment with PPIs.
- Vitamin B12 absorption: PPIs may affect vitamin B12 absorption from your diet. This may cause a shortage of vitamin B12 in your body. Talk to your healthcare professional about this risk.
- Cancer: Treatment with PPIs for long periods can cause cancer in the stomach, liver and thyroid. Your healthcare professional will monitor you for signs and symptoms of cancer.
- Gastrointestinal problems: Treatment with PPIs may increase the amount of bacteria in the gastrointestinal tract. This can increase your risk of gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile. Your healthcare professional will assess your health before and during treatment with Pantoprazole for Injection.
- Immune problems: Subacute Cutaneous Lupus Erythematosus (SCLE) has been reported with the use of PPIs. This is a disease that causes non-scarring skin rashes or cuts that worsens with sunlight exposure. If you notice any lesions, especially in sun-exposed areas of the skin, tell your healthcare professional right away.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Monitoring and Laboratory Tests:
- Your healthcare professional will monitor your health before and during treatment. This will tell your healthcare professional how PANTOPRAZOLE SODIUM FOR INJECTION is affecting you.
- PANTOPRAZOLE SODIUM FOR INJECTION can cause abnormal blood test results (e.g., chromogranin A). Your healthcare professional may stop treatment with Pantoprazole for Injection before performing specific blood tests.
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:
- medicines used to treat fungal infections such as ketoconazole, itraconazole, and posaconazole.
- medicines used to prevent blood clotting such as warfarin.
- medicines used to treat HIV such as atazanavir, nelfinavir, saquinavir and ritonavir.
- medicines used to treat cancer such as methotrexate and erlotinib.
How to take PANTOPRAZOLE SODIUM FOR INJECTION:
- Your healthcare professional will prepare and give you Pantoprazole for Injection.
- Your healthcare professional may switch you to pantoprazole sodium tablets. This may occur as soon as you can start taking oral medicines again.
Usual dose:
Your doctor will decide the dose and length of your treatment with PANTOPRAZOLE SODIUM FOR INJECTION.
The recommended doses are:
| Condition | Adult Dose | How Often |
|---|---|---|
| Reflux Esophagitis | 40 mg | Once daily |
| Hypersecretory Conditions including 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, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
Contact your healthcare professional if you feel your doctor or nurse has missed a dose.
What are possible side effects from using PANTOPRAZOLE SODIUM FOR INJECTION?
Like all medicines, 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.
Side effects include:
- headache.
- diarrhea.
- nausea/vomiting.
- general stomach discomfort.
- swelling or bruising at the injection site.
- itchiness.
- rash.
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
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash (exanthema), severe itching of the skin (pruritus), swelling of the face, lips, tongue or throat. | ✓ | ||
| RARE | |||
| Eye problems: disturbances in vision. blurred vision, loss of vision in eye, increased sensitivity of the eyes to light, eye pain or redness, swelling and itching of the eyelids, decreased sharpness of vision, eye irritation, or blocked eye veins. | ✓ | ||
| VERY RARE | |||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, or unusual tiredness. | ✓ | ||
| Severe skin reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, yellow skin or eyes, shortness of breath, dry couth, chest pain or | ✓ | ||
| discomfort, feeling thirsty, urinating less often, less urine. | |||
| Muscle wasting | ✓ | ||
| Clostridium difficile colitis (bowel inflammation): severe or persistent diarrhea, abdominal pain or tenderness, nausea and vomiting, fever. | ✓ | ||
| UNKNOWN | |||
| Severe Cutaneous Adverse Reactions (SCAR) (Severe Skin Reactions): Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet). You may also experience fever, chills, body aches, shortness of breath, or enlarged lymph nodes. | ✓ | ||
| Microscopic colitis (inflammation of the gut): chronic watery diarrhea, abdominal pain, cramps or bloating, weight loss, nausea, uncontrollable bowel movement, signs of dehydration such as extreme thirst, less frequent urination, dark-coloured urine, fatigue, dizziness, confusion. | ✓ | ||
| The symptoms of microscopic colitis can come and go frequently. If you have watery diarrhea that lasts more than a few days, contact your doctor. | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
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.
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 Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-
- products/drug-products/drug-product-database.html); the manufacturer’s website http://www.sandoz.ca, or by calling 1-800-361-3062.