Details for: PRO-AZITHROMYCINE
Company: PRO DOC LIMITEE
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02310600 | PRO-AZITHROMYCINE | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) | 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
PRO-AZITHROMYCINE 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, disseminated
mycobacterium avium complex (MAC) disease in people with HIV, and pneumonia.
Antibacterial drugs like PRO-AZITHROMYCINE treat only bacterial infections. They do not
treat viral infections such as the common cold. Although you may feel better early in treatment,
PRO-AZITHROMYCINE should be taken exactly as directed. Misuse or overuse of PROAZITHROMYCINE could lead to the growth of bacteria that will not be killed by
PRO-AZITHROMYCINE (resistance). This means that PRO-AZITHROMYCINE may not work
for you in the future. Do not share your medicine.
What it does
PRO-AZITHROMYCINE 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 PRO-AZITHROMYCINE may be taken for as short a time as one day.
When it should not be used
Do not use PRO-AZITHROMYCINE 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 PRO-AZITHROMYCINE (see What are the ingredients in PRO-AZITHROMYCINE).
What the medicinal ingredient is
Azithromycin dihydrate
What the non-medicinal ingredients are
250 mg tablets: Croscarmellose sodium D&C Red No. 27, FD∓C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hydroxypropylmethyl Cellulose, Lactose, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide
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 PRO-AZITHROMYCINE. 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 breast feeding or planning to breastfeed. Azithromycin is excreted in human breast milk. It is not known if PRO-AZITHROMYCINE 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 glucosegalactose 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
PRO-AZITHROMYCINE for the full number of days your doctor prescribed. Although
PRO-AZITHROMYCINE dosing is short, you should not expect PRO-AZITHROMYCINE to
work faster than other antibiotics which are dosed up to 10 days. If you stop taking
PRO-AZITHROMYCINE 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 PRO-AZITHROMYCINE, tell your doctor
at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs,
vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with PRO-AZITHROMYCINE:
- 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);
- Colchicine (used for treatment of gout);
- Nelfinavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with PRO-AZITHROMYCINE.
Proper use of this medication
How to take PRO-AZITHROMYCINE:
Always take PRO-AZITHROMYCINE as the doctor has prescribed for you, depending on the
specific condition you have.
PRO-AZITHROMYCINE can be taken with or without food.
Usual Dose
If your doctor prescribes PRO-AZITHROMYCINE 250 mg tablets for 3 days for treatment of bronchitis:
-
Days 1 through 3: Take two tablets each day.
-
Day 1: Take 2 tablets once.
Day 2 through 5: Take 1 tablet daily.
-
Days 1: Take four tablets once.
-
Days 1: Take eight tablets once.
Overdose
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 ZITHROMAX. 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 with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist 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 PRO-AZITHROMYCINE at controlled temperature between 15°C and 30°C
Keep PRO-AZITHROMYCINE and all medicines out of the reach and sight of children.
Reporting 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 three 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
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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.
More information
If you want more information about PRO-AZITHROMYCINE:
- 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by contacting Pro Doc Ltée at 1-800-361-8559, www.prodoc.qc.ca or info@prodoc.qc.ca.
This leaflet was prepared by Pro Doc Ltée.
Last Revised: May 28, 2019