Zmax SR - Consumer Medicine Information
|Condition:||Babesiosis, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bartonellosis, Bronchitis, Bronchitis, Chronic (COPD), Cervicitis, Chancroid, Chlamydia Infection, Chronic Bronchitis (COPD), 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, Pharyngitis, Pneumonia, Sinusitis, Sinusitis, Acute (Sinusitis), Skin and Structure Infection, Skin or Soft Tissue Infection, STD Prophylaxis, Typhoid Fever, Toxoplasmosis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection|
|Ingredients:||azithromycin dihydrate, artificial cherry flavour and artificial banana flavour, colloidal silicon dioxide, glyceryl behenate, hydroxypropylcellulose, magnesium hydroxide, poloxamer, sucrose, sodium phosphate tribasic anhydrous, titanium dioxide, xanthan gum|
Azithromycin sustained-release granules for oral suspension
(as azithromycin dihydrate)
About This Medication
What the Medication is Used For
Zmax SR is an antibiotic for the treatment of the following mild to moderate infections by certain microorganisms:
- Exacerbations of chronic bronchitis
- Community acquired pneumonia
This medication is indicated for adult patients (including elderly > 65 years of age).Your doctor will decide on whether Zmax SR is the most appropriate antibacterial for you.
What It Does
Zmax SR belongs to a group of antibacterials known as macrolides. These medicinal products are used for the treatment of a large range of bacterial infections. Zmax SR stops the growth of the bacteria, which cause the infection. Zmax SR only works against bacteria. It does not work against viruses, like the common cold or flu.
Not all respiratory infections require the use of antibacterials. Unnecessary use of antibacterials induces the emergence of resistant bacteria in the community. In case of a respiratory infection, always consult your doctor regarding the need for an antibacterial.
When It Should not be Used
- If you have a history of cholestatic jaundice/hepatis (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 Zmax SR (see What the nonmedicinal ingredients are).
What the Medicinal Ingredient Is
Azithromycin sustained release granules for oral suspension (as azithromycin dihydrate).
What the Nonmedicinal Ingredients Are
Zmax SR sustained-release granules for oral suspension contains: Artificial cherry flavour and artificial banana flavour, colloidal silicon dioxide, glyceryl behenate, hydroxypropylcellulose, magnesium hydroxide, poloxamer, sucrose, sodium phosphate tribasic anhydrous, titanium dioxide, xanthan gum.
What Dosage Forms It Comes In
- Sustained-release granules for oral suspension, 2g azithromycin/bottle (as azithromycin dihydrate).
Warnings and Precautions
BEFORE you use Zmax SR talk to your doctor or pharmacist if:
- 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)
- you have liver problems
- you have kidney problems;
- you are pregnant, or might be pregnant. It is not known if Zmax SR could harm your baby
- you have any other medical problems
- you have myasthenia gravis (a chronic autoimmune neuromuscular disease which cause muscle weakness)
- you are immunocompromised
- you are taking any other medications including those obtained without a prescription, including natural/herbal remedies or antacids
- you have diabetes, or rare hereditary problems of fructose intolerance, glucose/galactose malabsorption or sucrase-isomaltase insufficiency, as this product contains sucrose.
- you are breastfeeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if Zmax could affect your baby. Discuss with your doctor.
Zmax SR is not recommended for use in children below the age of 18
If you develop diarrhea during or after your treatment, tell your doctor at once. Do not take any medicine to treat your diarrhea without first checking with your doctor.
This antibacterial fights certain bacteria, but it does not work for all bacteria or for infections caused by fungi (funguses).
Zmax SR needs time to work, so you may not feel better right away. If your symptoms do not get better in a few days, call your doctor.
Interactions With This Medication
Drugs that may interact with Zmax SR 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 Zmax.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Proper Use of This Medication
Usual Adult Dose
Always take Zmax SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Zmax SR allows you to complete treatment with a single dose, therefore this medicine should be taken once as a single dose. Zmax SR should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal).
Use the prepared suspension within 12 hours after reconstitution. Drink the entire contents of the bottle as a single dose.
|In case of drug overdosage, contact a healthcare professional (e.g. doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.|
Vomiting After Dosing
If you vomit (throw up) within 30 minutes of taking Zmax SR, call your health care professional (doctor, pharmacist or nurse) right away to see if more medicine is needed.
Side Effects and What to Do About Them
As with most drugs, Zmax SR can cause some side effects.
The most common side effects are diarrhea/loose stools, stomach pain, nausea, headache, 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 Zmax SR and contact your healthcare professional immediately. Diarrhea can occur as late as two months after you take an antibacterial such as Zmax SR.
Allergic reactions to Zmax SR 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 Zmax SR, call your doctor right away. If you cannot reach your doctor, go to the nearest hospital emergency room. These symptoms could go away and then come back.
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 have an abnormal heart beat, or get dizzy or faint when taking Zmax SR.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with |
your doctor or
|Stop taking |
|In all |
|Uncommon||Abnormal heart rhythm||✓|
|Severe allergic reaction with symptoms such as trouble breathing, swelling of the face, mouth, thoat, 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 Zmax SR, contact your doctor or pharmacist.
How to Store It
Before reconstitution, store Zmax SR at 15-30°C. Keep container tightly closed.
After reconstitution, store suspension at 25oC; excursions permitted to 15-30oC. Do not refrigerate or freeze. Reconstituted suspension should be consumed in a single dose and within 12 hours of reconstitution.
Drink the entire contents of the bottle as a single dose.
Do not take Zmax SR after the expiry date shown on the package. Always keep Zmax SR out of reach and sight of children.
The Zmax SR suspension is white or off-white, do not use Zmax SR if you notice discoloration of the suspension.
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:
or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.