Patient Medication Information: uses, side effects, how to take - Azithromycin for Injection (Teva Canada)
ABOUT THIS MEDICATION
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.
What it does:
AZITHROMYCIN FOR INJECTION 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.
Antibiotics work only on infections caused by bacteria. They do not kill viruses. No antibiotic, including AZITHROMYCIN FOR INJECTION, can treat viral infections such as the common cold and the flu.
When it should not be used:
- If you have a history of cholestatic jaundice/hepatitis (liver problems) associated with prior use of azithromycin.
- If you are hypersensitive (allergic) to azithromycin or any macrolide or ketolide antibiotic (including erythromycin), or any other ingredient of AZITHROMYCIN FOR INJECTION (see What the nonmedicinal ingredients are).
What the medicinal ingredient is:
Azithromycin hydrogen citrate
What the nonmedicinal ingredients are:
Citric acid and sodium hydroxide for pH adjustment
What dosage forms it comes in:
AZITHROMYCIN FOR INJECTION, 500 mg/vial or 500 mg/5 mL when reconstituted.
WARNINGS AND PRECAUTIONS
Before you use AZITHROMYCIN FOR INJECTION talk to your doctor or pharmacist 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;
- have a history of heart problems such as bradycardia (slow heart rate), cardiac arrhythmia (irregular heart beat) or cardiac insufficiency (your heart has a hard time pumping blood to your body);
- are taking any prescription medicines or any over the counter medicines you can buy without a prescription, including natural/herbal remedies or antacids (see Interactions With This Medication);
are pregnant or think you are pregnant;
- are breastfeeding 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 ever had an allergic reaction to azithromycin or any of the ingredients of AZITHROMYCIN FOR INJECTION (see What the nonmedicinal ingredients are).
- have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness).
If you develop diarrhea during or after treatment, 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.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with AZITHROMYCIN FOR INJECTION include:
- warfarin (or other anticoagulant medicine);
- cyclosporine (used in suppressing of the immune system to prevent and treat the rejection in organs or bone marrow transplants);
- digoxin (used for treatment of cardiac impairment);
- 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.
PROPER USE OF THIS MEDICATION
AZITHROMYCIN FOR INJECTION will always be prepared and given to you by a doctor or healthcare professional.
AZITHROMYCIN FOR INJECTION must be reconstituted and diluted as directed, and administered as an intravenous infusion over at least 60 minutes.
Overdose:
| In case of drug overdose, contact a healthcare professional, hospital emergency department or regional Poison Control Centre, even if there are no symptoms. |
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with most drugs, AZITHROMYCIN FOR INJECTION can cause some side effects.
The most common side effects are diarrhea/loose stools, stomach pain, nausea and vomiting.
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking AZITHROMYCIN FOR INJECTION and contact your healthcare professional immediately.
Allergic reactions to AZITHROMYCIN FOR INJECTION are rare, but these reactions can be very serious if not treated right away by a doctor. Symptoms of a severe allergic reaction may include trouble breathing, swelling of the face, mouth, throat, neck or severe skin rash or blisters. If you think you might be having an allergic reaction to AZITHROMYCIN FOR INJECTION, discontinue the drug and call your doctor right away.
If you develop symptoms of hepatitis (liver inflammation) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc., stop taking the medicine immediately and call the doctor or nurse.
If you develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen, contact your doctor. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelids, blurred or double vision, difficulty chewing and swallowing, or trouble breathing.
Please tell your doctor right away if you feel your heart beating in your chest or if you have an abnormal heartbeat or get dizzy or faint when taking AZITHROMYCIN FOR INJECTION.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||||||
| Only if severe | In all cases | ||||||||
| Common | |||||||||
| Diarrhea/loose stools | √ | ||||||||
| Nausea | √ | ||||||||
| Stomach pain | √ | ||||||||
| Headache | √ | ||||||||
| Vomiting | √ | ||||||||
| Vaginitis | √ | ||||||||
| Uncommon | |||||||||
| Abnormal heart rhythm | √ | ||||||||
| Severe allergic reaction (such as trouble breathing, swelling of the face, mouth, throat or neck, severe skin rash or blisters) | √ | ||||||||
| Liver disorder (symptoms include abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine) | √ | ||||||||
| Uncommon | |||||||||
| Myasthenia gravis (muscle weakness, drooping eyelids, vision changes, difficulty chewing and swallowing, trouble breathing) | √ | ||||||||
This is not a complete list of side effects. For any unexpected effects while taking AZITHROMYCIN FOR INJECTION, contact your doctor or pharmacist.
HOW TO STORE IT
Dry powder: Store at controlled room temperature (15-30°C).
Diluted solution: Stable for 24 hours at or below 30°C, or for 7 days if stored under refrigeration (5°C). For single-use only. Discard any unused portion after use.
Keep AZITHROMYCIN FOR INJECTION and all medicines out of the reach of children.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
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
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at:
1-800-268-4127 ext. 1255005 (English)
or 1-877-777-9117 (French)
or druginfo@tevacanada.com
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9