Consumer Information for: AG-AZITHROMYCIN
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
AG-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, disseminated mycobacterium avium complex (MAC) disease in people with HIV, and pneumonia.
Antibacterial drugs like AG-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, AG- AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of AG- AZITHROMYCIN could lead to the growth of bacteria that will not be killed by AG- AZITHROMYCIN (resistance). This means that AG-AZITHROMYCIN may not work for you in the future. Do not share your medicine.
What it does
AG-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 AG-AZITHROMYCIN may be taken for as short a time as one day.
When it should not be used
Do not use AG-AZITHROMYCIN 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 AG-AZITHROMYCIN (see What are the ingredients in AG-AZITHROMYCIN?).
What the medicinal ingredient is
Azithromycin dihydrate
What the non-medicinal ingredients are
AG-AZITHROMYCIN Tablets 250 mg contain azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: Dibasic calcium phosphate, hypromellose, microcrystalline cellulose, Pregelatinized starch, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, titanium dioxide, triacetin and D&C Red #30 Aluminum lake.
AG-AZITHROMYCIN Tablets 600 mg contain azithromycin dihydrate equivalent to 600 mg azithromycin and the following inactive ingredients: Dibasic calcium phosphate, hypromellose, microcrystalline cellulose, Pregelatinized starch, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, titanium dioxide and triacetin.
What dosage form it comes in
AG-AZITHROMYCIN comes in the following dosage forms:
Tablets: 250 mg, 600 mg
Warnings and precautions
Serious Warnings and Precautions
Read this carefully before you start taking AG-AZITHROMYCIN and each time you get a refill. This leaflet is a summary and will not tell you everything about this drug. Talk to your healthcare professional about your medical condition and treatment and ask if there is any new information about AG-AZITHROMYCIN.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-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 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 is excreted in human breast milk. It is not known if AG-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 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 AG-AZITHROMYCIN for the full number of days your doctor prescribed. Although AG-AZITHROMYCIN’s dosing is short, you should not expect AG-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking AG-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 AG-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
The following may interact with AG-AZITHROMYCIN:
- 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 AG-AZITHROMYCIN.
Some medicines may affect how well AG-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on AG-AZITHROMYCIN.
Proper use of this medication
Always take AG-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
AG-AZITHROMYCIN can be taken with or without food.
Usual Dose
Usual adult dose:
If your doctor prescribes AG-AZITHROMYCIN 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 AG-AZITHROMYCIN 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 AG-AZITHROMYCIN 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 AG-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Days 1: Take eight tablets once.
If your doctor prescribes AG-AZITHROMYCIN 600 mg tablets for prevention of Mycobacterium avium complex (MAC) disease:
Take two tablets once weekly.
Overdose
If you think you have taken too much AG-AZITHROMYCIN, 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 AG-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 Symptom / effect | ✔ | ||
| 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 | ✔ | ||
How to store
Store AG-AZITHROMYCIN at controlled room temperature (between 15-30°C).
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 3 ways:
- Report online at 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 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at 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 AG-AZITHROMYCIN:
- Talk to your doctor or pharmacist.
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website ***
This leaflet was prepared by Angita Pharma Inc.
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Last Revised: August 31, 2020
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