Zithromax Oral Suspension - Consumer Medicine Information
|Condition:||Babesiosis, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bartonellosis, Bronchitis, Cervicitis, Chancroid, Chlamydia Infection, Cystic Fibrosis, COPD, Acute, Ear Infection, outer (Otitis Externa), 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, Skin and Structure Infection, Skin or Soft Tissue Infection, STD Prophylaxis, Typhoid Fever, Toxoplasmosis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection|
|Ingredients:||azithromycin dihydrate, sucrose (3.86 g per 100 mg/5 mL and 3.87 g per 200 mg/5 mL); sodium phosphate (8.76 mg per 100 mg/5 mL and 17.50 mg per 200 mg/5 mL), tribasic hydroxypropyl cellulose; xanthan gum; FD&C Red #40 and artificial flavours|
Azithromycin for oral suspension USP
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 children: ear infections, pneumonia, and throat infections and in adults who have difficulty swallowing tablets, for various conditions.
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. This is why ZITHROMAX may be taken for as short a time as one day.
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 thenonmedicinal ingredients are).
What the Medicinal Ingredient Is:
What the Nonmedicinal Ingredients Are
The non-medicinal ingredients include: sucrose (3.86 g per 100 mg/5 mL and 3.87 g per 200 mg/5 mL); sodium phosphate (8.76 mg per 100 mg/5 mL and 17.50 mg per 200 mg/5 mL), tribasic hydroxypropyl cellulose; xanthan gum; FD&C Red #40 and artificial flavours.
What Dosage Forms It Comes In
Oral suspension – azithromycin 300, 600, 900 mg/bottle, or 100 mg/5 ml, 200 mg/5 ml when reconstituted (as azithromycin dihydrate)
Warnings and Precautions
BEFORE you use ZITHROMAX talk to your doctor or pharmacist if you or your child:
- 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 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)
- is 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)
- have diabetes or hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency, as this product contains sucrose.
- is pregnant or thinks they are pregnant,
- is breastfeeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if ZITHROMAX could affect a baby. Discuss with your doctor.
- has ever had any liver or kidney problems
- has a weak immune system
- has myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
- is allergic to any medicines including antibiotics such as erythromycin
- is allergic to azithromycin or any of the ingredients of ZITHROMAX suspension. (See “What the non medicinal ingredients are” )
If your child develops diarrhea during or after treatment, tell your child’s doctor at once. Do not use any medicine to treat your child’s diarrhea without first checking with your child’s doctor. Although ZITHROMAX's dosing is short and you may be able to give all the medicine to your child more easily, you should not expect ZITHROMAX to work faster than other antibiotics which are dosed for up to 10 days.
Your child's doctor or nurse can advise you when your child should begin feeling better.
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
Your child's doctor will decide the total amount of ZITHROMAX to give to your child, depending on your child's weight and on the specific infection your child has. In addition to deciding the total amount of ZITHROMAX to give to your child, the doctor will tell you to give all the medicine to your child in 1 day or to divide it over 3 days or over 5 days.
ZITHROMAX should be taken once- a-day and may be given with or without food. Shake the bottle well just before you give a dose.
Use the dosing device that comes with ZITHROMAX to carefully measure the dose. Do not use a household teaspoon as it is not accurate enough.
Give ZITHROMAX for the full number of days prescribed by the doctor, even if your child feels better before finishing all the medicine as prescribed.
For Ear Infections
For ear infections, your child's doctor will tell you to give ZITHROMAX to your child in one of the following ways:
- the total amount as 1 dose on 1 day or
- once-a-day for 3 days or
- once-a-day for 5 days, with a double dose on the first day.
Whether given all on 1 day, or divided over 3 days or over 5 days, the total amount of ZITHROMAX you give to your child should be the same.
For pneumonia, your child's doctor will tell you to give ZITHROMAX to your child once-a-day for 5 days, with a double dose on the first day.
For Throat Infections (Pharyngitis/Tonsillitis)
For throat infections, your child's doctor will tell you to give ZITHROMAX to your child in the following way: once-a-day for 5 days. When ZITHROMAX is given for 5 days for throat infections, you do not need to give a double dose on the first day (as you would with ear infections).
If your child vomits within 30 minutes after the 1-day treatment for an ear infection, it is recommended that you call your pharmacist or child’s doctor because your child may need to receive the same dose of medicine again.
If you have questions about how to give ZITHROMAX to your child, please ask your child's doctor, nurse or pharmacist.
Instructions for Use of the Dosing Devices
Use only the dosing device provided to measure the correct amount of suspension.
|1. To open, push down on the bottle cap while twisting the cap counter clockwise. Remove cap from bottle.|
|2. Push plastic stopper into bottle top (if pharmacist has not done so).|
|3. Pull back on syringe handle to prescribed dose.|
|4. Insert syringe into bottle top.|
|5. Push down on syringe handle to allow air into bottle.|
|6. Turn bottle upside down and pull back syringe handle, drawing prescribed dose of medicine into syring.e.|
|7. Remove syringe from bottle. Give medicine by mouth by slowly pushing on syringe handle.. Remember to put the cap back on the medicine bottle.|
Instructions for Use of the Dosing Cup
If you receive the dosing cup with ZITHROMAX oral suspension shake the bottle well before using. Rinse the cup with water after each daily dose. After your child has taken ZITHROMAX for the correct number of days, throw out the cup, cap, and bottle.
|1. To open, push down on the bottle cap while twisting the cap counter clockwise. Remove cap from bottle.|
|2. A label on the bottle shows how much medicine your child must take.|
|3. Pour medicine into the cup provided. The cup may need to be filled more than once. Depending on your child’s dose, there might be some medicine left in the bottle.|
|4. Give dose to child. Make sure child drinks all of the medicine for the number of days instructed by the doctor or pharmacist. Remember to put the cap back on the medicine bottle.|
Do not save any medicine for future use.
|In case of drug overdose, contact a healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptoms.|
If you forget to give your child a dose, call your pharmacist or child’s doctor. Do not double dose.
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 your child experiences symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, your child may have Clostridium difficile colitis (bowel inflammation). If this occurs, your child should stop taking ZITHROMAX and contact your child’s healthcare professional immediately.
Allergic reactions to ZITHROMAX are rare, but these reactions can be very serious if not treated right away by a doctor. If you think your child might be having an allergic reaction to ZITHROMAX, call your child’s doctor right away. If you cannot reach your child’s doctor, go to the nearest hospital emergency room. Symptoms of a severe allergic reaction may include trouble breathing; swelling of the face, mouth, throat neck; or severe skin rash or blisters.
If your child develops 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 your child’s doctor or nurse.
If your child develops symptoms of myasthenia gravis or the symptoms of your child’s existing myasthenia gravis worsen, contact your child’s 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 child’s doctor right away if your child feels their heart beating in their chest or if your child has an abnormal heartbeat or gets dizzy or faints 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
ZITHROMAX can be stored in the refrigerator or kept at room temperature (between 5°-30° C). Throw away any medicine that is left over after treatment.
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.