Zithromax Injection - Consumer Medicine Information
|Condition:||Babesiosis, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bartonellosis, Bronchitis, Cervicitis, Chancroid, Chlamydia Infection, Cystic Fibrosis, COPD, Acute, Granuloma Inguinale, Gonococcal Infection, Uncomplicated, Legionella Pneumonia, Lyme Disease, Erythema Chronicum Migrans, Mycoplasma Pneumonia, Mycobacterium avium-intracellulare, Treatment, Mycobacterium avium-intracellulare, Prophylaxis, Nongonococcal Urethritis, Otitis Media, Pelvic Inflammatory Disease, Pertussis, Pertussis Prophylaxis, Pneumonia, Sinusitis, Skin and Structure Infection, Skin or Soft Tissue Infection, STD Prophylaxis, Typhoid Fever, Toxoplasmosis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||azithromycin dihydrate, anhydrous citric acid, sodium hydroxide (198.5 mg) for pH adjustment|
Azithromycin for injection,
(as azithromycin dihydrate)
About This Medication
What the Medication is Used For
ZITHROMAX 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
ZITHROMAX 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 ZITHROMAX, 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 ZITHROMAX (see What the nonmedicinal ingredients are).
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
Anhydrous citric acid; sodium hydroxide (198.5 mg) for pH adjustment
What Dosage Forms It Comes In
Azithromycin for injection*, 500 mg/vial or 500 mg/5 ml when reconstituted (* as azithromycin dihydrate)
Warnings and Precautions
BEFORE you use ZITHROMAX talk to your doctor or pharmacist if you:
- you have a known prolonged heart cycle (interval) (QT prolongation)
- you 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)
- you have a history of life-threatening irregular heart beat
- you have constantly low levels of potassium or magnesium
- you have a history for 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 ZITHROMAX 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 ZITHROMAX injection for IV (See “What the non medicinal 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 Zithromax is administered for the full number of days prescribed. If ZITHROMAX 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 ZITHROMAX include:
- Warfarin (or other anticoagulant medicine);
- Cyclosporin (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 ZITHROMAX.
Some medicines may affect how well ZITHROMAX works. Check with your doctor before starting any new prescription or over-the- counter medicines, including natural/herbal remedies or antacids, while on ZITHROMAX.
Proper Use of This Medication
ZITHROMAX Injection for IV will always be prepared and given to you by a doctor or a healthcare professional.
ZITHROMAX Injection for IV must be reconstituted and diluted as directed, and administered as an intravenous infusion over at least 60 minutes.
|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, ZITHROMAX 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 ZITHROMAX and contact your healthcare professional immediately.
Allergic reactions to ZITHROMAX 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 ZITHROMAX, 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 eyelid, 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 ZITHROMAX.
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|
|Uncommon||Abnormal heart rhythm||✓|
|Severe allergic reaction such as trouble breathing, swelling of the face, mouth, throat, 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 eyelid, vision changes, difficulty chewing and swallowing, trouble breathing)||✓|
This is not a complete list of side effects. For any unexpected effects while taking ZITHROMAX, contact your doctor or pharmacist.
How to Store It
The healthcare professional will store the product under appropriate conditions.
Keep ZITHROMAX and all medicines out of the reach of Children
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.