Patient Medication Information: uses, side effects, how to take - Azithromycin for Injection, USP (Strides Pharma Canada)
What is AZITHROMYCIN FOR INJECTION used for?
AZITHROMYCIN FOR INJECTION is an antibiotic medicine used 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.
How does AZITHROMYCIN FOR INJECTION work?
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.
What are the ingredients in AZITHROMYCIN FOR INJECTION?
Medicinal ingredients: Azithromycin monohydrate
Non-medicinal ingredients: Anhydrous citric acid; sodium hydroxide for pH adjustment
AZITHROMYCIN FOR INJECTION comes in the following dosage forms:
Azithromycin for injection*, 500 mg/vial which delivers 500 mg/5 ml when reconstituted as directed (*as azithromycin monohydrate).
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?).
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 breastfeeding or planning to breastfeed. Azithromycin is 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).
Other warnings you should know about:
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.
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);
- Colchicine (used for treatment of gout);
- 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.
Some medicines may affect how well AZITHROMYCIN FOR INJECTION works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on AZITHROMYCIN FOR INJECTION.
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:
| If you think you have been given too much AZITHROMYCIN FOR INJECTION, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
What are possible side effects from using AZITHROMYCIN FOR INJECTION?
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
Serious side effects and what to do about them
| Symptom/effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
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.
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/health-
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. |
Storage:
The healthcare professional will store the product under appropriate conditions.
Keep out of reach and sight of children.
If you want more information about AZITHROMYCIN FOR INJECTION, USP:
- 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/drug-products/drug-product-database.html; or by calling Strides Pharma Canada Inc at 1-888-318-0234
1565, Boul. Lionel-Boulet, Varennes, QC J3X 1P7
Revised on: July 30, 2021