Consumer Information for: AZITHROMYCIN FOR INJECTION
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AZITHROMYCIN FOR INJECTION is an antibiotic medicine to treat the following types of mild to moderate
infections by certain microorganisms in adults: genitourinary infections and pneumonia.
Antibacterial drugs like AZITHROMYCIN FOR INJECTION treat only bacterial infections. They do not treat
viral infections such as the common cold. Although you may feel better early in treatment, AZITHROMYCIN
FOR INJECTION should be taken exactly as directed. Misuse or overuse of AZITHROMYCIN FOR
INJECTION could lead to the growth of bacteria that will not be killed by AZITHROMYCIN FOR INJECTION
(resistance). This means that AZITHROMYCIN FOR INJECTION may not work for you in the future. Do not
share your medicine.
What it does
AZITHROMYCIN FOR INJECTION helps stop the growth of the bacteria that cause infection. It gets into infected tissue where it is released slowly over time so the medicine keeps fighting bacteria for many days after the last dose is taken. This is why AZITHROMYCIN FOR INJECTION may be taken for as short a time as one day.
When it should not be used
Do not use AZITHROMYCIN FOR INJECTION if you:
- have a history of liver problems when you have used azithromycin.
- are hypersensitive (allergic) to azithromycin, or any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of AZITHROMYCIN FOR INJECTION (see What are the ingredients in AZITHROMYCIN FOR INJECTION?).
What the medicinal ingredient is
Azithromycin monohydrate
What the non-medicinal ingredients are
Anhydrous citric acid; sodium hydroxide for pH adjustment
What dosage form it comes in
Azithromycin for injection*, 500 mg/vial which delivers 500 mg/5 mL when reconstituted as directed. (*as azithromycin monohydrate).
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AZITHROMYCIN FOR INJECTION. Talk about any health conditions or problems you may have, including if you:
- have a known prolonged heart cycle (interval) (QT prolongation)
- are currently taking medication known to prolong QT interval (prolong your heart cycle) such as antiarrhythmics (drugs to regulate your heart beat such as class IA: quinidine, procainamide and class III; dofetilide, amiodarone, sotalol); antipsychotic agents; antidepressants; and fluoroquinolones (a class of antibiotics)
- have a history of life-threatening irregular heart beat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heart beat or cardiac insufficiency (your heart has a hard time pumping blood to your body)
- are pregnant or think you are pregnant,
- are breast feeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if AZITHROMYCIN FOR INJECTION could affect your baby. Discuss with your doctor.
- have ever had any liver or kidney problems
- have a weak immune system
- have ever had an allergic reaction to any medicines, including antibiotics such as erythromycin
- have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness).
If you develop diarrhea during or after treatment with AZITHROMYCIN FOR INJECTION, tell your doctor at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.
Your healthcare professional will ensure that AZITHROMYCIN FOR INJECTION is administered for the full number of days prescribed. If AZITHROMYCIN FOR INJECTION is stopped too soon, your infection could come back. The next infection may be worse and be more difficult to treat.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with AZITHROMYCIN FOR INJECTION:
- Warfarin (or other anticoagulant medicine);
- Cyclosporin (used to suppress the immune system to prevent and treat rejection in organ or bone marrow
- transplants);
- Digoxin (used for treatment of heart problems);
- Nelfinavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with AZITHROMYCIN FOR INJECTION.
Proper use of this medication
How to take AZITHROMYCIN FOR INJECTION;
AZITHROMYCIN FOR INJECTION will always be prepared and given to you by a doctor or a healthcare
professional.
AZITHROMYCIN FOR INJECTION must be reconstituted and diluted as directed, and administered as an
intravenous infusion over at least 60 minutes.
Overdose
Side effects and what to do about them
These are not all the possible side effects you may feel when taking AZITHROMYCIN FOR INJECTION. If you
experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Diarrhea/loose stools
- Stomach pain
- Nausea and vomiting
- Headache
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| Vaginitis (inflammation of the vagina): change in colour, odor or amount of discharge, itching or irritation, pain during intercourse, painful urination, light vaginal bleeding or spotting | ✔ | ||
| Injection site reaction: pain, redness and/or swelling at the injection site | ✔ | ||
| Uncommon | |||
| Abnormal heart rhythm: feel your heart beating in your chest, abnormal heartbeat, dizziness or feeling faint | ✔ | ||
| Severe allergic reaction: trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters | ✔ | ||
| Liver disorder: abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine | ✔ | ||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
The healthcare professional will store the product under appropriate conditions.
Keep out of reach and sight of children.
Reporting side effects
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/medeffectcanada/adverse-reaction-reporting.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 AZITHROMYCIN 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; or by calling 1-844-596-9526
- This document can be found at: www.sterimaxinc.ca
Last revised: August 13, 2019
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