Details for: AZITHROMYCIN
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02330881 | AZITHROMYCIN | 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
AZITHROMYCIN 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 AZITHROMYCIN treat only bacterial infections. They do not treat viral
infections such as the common cold. Although you may feel better early in treatment,
AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of AZITHROMYCIN
could lead to the growth of bacteria that will not be killed by AZITHROMYCIN (resistance).
This means that AZITHROMYCIN may not work for you in the future. Do not share your
medicine.
What it does
AZITHROMYCIN 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 AZITHROMYCIN may be taken for as short a time as one day
When it should not be used
- 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 AZITHROMYCIN (see “What are the ingredients in AZITHROMYCIN?”).
What the medicinal ingredient is
Azithromycin Dihydrate (250 mg);
What the non-medicinal ingredients are
Cellulose microcrystalline, colloidal anhydrous silica, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, sodium lauryl sulfate, sodium starch glycolate 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 AZITHROMYCIN. 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 heartbeat 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 heartbeat
- 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 AZITHROMYCIN 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.
You should begin to feel better within the first few days, but be sure to take AZITHROMYCIN for the full number of days your doctor prescribed. Although AZITHROMYCIN’s dosing is short, you should not expect AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking AZITHROMYCIN 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 AZITHROMYCIN, 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
- 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 AZITHROMYCIN. Some medicines may affect how well AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on AZITHROMYCIN.
Proper use of this medication
Always take AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
AZITHROMYCIN can be taken with or without food
Usual Dose
If your doctor prescribes AZITHROMYCIN 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 AZITHROMYCIN. 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 AZITHROMYCIN at controlled room temperature (between 15°C-30ºC).
Keep out of 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
- 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://www.canada.ca/en/health-canada.html); the manufacturer’s website www.sanis.com or by contacting Sanis Health Inc. at:
1-866-236-4076
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: March 5, 2019