Details for: APO-AZITHROMYCIN Z
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02415542 | APO-AZITHROMYCIN Z | AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) | 250 MG | TABLET | ORAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-AZITHROMYCIN Z is an antibiotic medicine used to treat the following types of mild to moderate
infections by certain microorganisms in adults such as bronchitis, certain types of skin infections, strep throat
(pharyngitis, tonsillitis), genitourinary infections, and pneumonia.
Antibacterial drugs like APO-AZITHROMYCIN Z treat only bacterial infections. They do not treat viral
infections such as the common cold. Although you may feel better early in treatment, APO-AZITHROMYCIN Z
should be taken exactly as directed. Misuse or overuse of APO-AZITHROMYCIN Z could lead to the growth of
bacteria that will not be killed by APO-AZITHROMYCIN Z (resistance). This means that APO-AZITHROMYCIN
Z may not work for you in the future. Do not share your medicine.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of APO-AZITHROMYCIN Z
and other antibacterial drugs, APO-AZITHROMYCIN Z should be used only to treat infections that are proven or
strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available,
they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local
epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
What it does
APO-AZITHROMYCIN Z 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 APO-AZITHROMYCIN may be taken for as short a time as one day.
When it should not be used
Do not use APO-AZITHROMYCIN Z 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 APO-AZITHROMYCIN Z (see What are the ingredients in APO-AZITHROMYCIN Z?).
What the medicinal ingredient is
Azithromycin dihydrate
What the non-medicinal ingredients are
croscarmellose sodium, dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, HPMC 2910/hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin.
What dosage form it comes in
Tablets: 250 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-AZITHROMYCIN Z. 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 has been reported to be excreted in human breast milk. It is not known if APO-AZITHROMYCIN Z 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)
- have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption as this product contains lactose.
Other warnings you should know about:
You should begin to feel better within the first few days, but be sure to take APO-AZITHROMYCIN Z for the full
number of days your doctor prescribed. Although APO-AZITHROMYCIN Z’s dosing is short, you should not
expect APO-AZITHROMYCIN Z to work faster than other antibiotics which are dosed up to 10 days. If you stop
taking APO-AZITHROMYCIN Z too soon, your infection could come back. The next infection may be worse and
be more difficult to treat. If you are not able to take all the medicine, tell your doctor.
If you develop diarrhea during or after treatment with
APO-AZITHROMYCIN Z, tell your doctor at once. Do not
use any medicine to treat your diarrhea without first checking with your doctor.
Interactions with this medication
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 APO-AZITHROMYCIN Z:
- 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 problem);
- Nelfinavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with APO-AZITHROMYCIN Z.
Some medicines may affect how well APO-AZITHROMYCIN Z works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on APO-AZITHROMYCIN Z.
Proper use of this medication
How to take APO-AZITHROMYCIN Z:
Always take APO-AZITHROMYCIN Z as the doctor has prescribed for you, depending on the specific condition
you have.
APO-AZITHROMYCIN Z can be taken with or without food.
Usual Dose
If your doctor prescribes APO-AZITHROMYCIN Z 250 mg tablets for 3 days for treatment of bronchitis:
Days 1 through 3: Take two tablets each day
If your doctor prescribes the 5 day APO-AZITHROMYCIN Z 250 mg tablets for 5 days for treatment of respiratory tract infections or certain types of skin infections:
Day 1: Take 2 tablets once.
Day 2 through 5: Take 1 tablet daily.
If your doctor prescribes APO-AZITHROMYCIN Z 250 mg tablets for 1 day for treatment of genital ulcers or non-gonococcal urethritis and cervicitis:
Days 1: Take four tablets once
If your doctor prescribes APO-AZITHROMYCIN Z 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Days 1: Take eight tablets once
Overdose
If you think you have taken too much APO-AZITHROMYCIN Z, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you forget to take a dose, call your pharmacist or doctor. Do not double dose
Side effects and what to do about them
These are not all the possible side effects you may feel when taking APO-AZITHROMYCIN Z. 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
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| COMMON | |||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| 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.
How to store
Store APO-AZITHROMYCIN Z at controlled room temperature (between 15ºC to 30ºC).
Keep out of reach and sight of children.
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/healthcanada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html)for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
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
- 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 (www.healthcanada.gc.ca); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: January 4, 2019