Patient Medication Information: uses, side effects, how to take - NRA-Azithromycin
What is NRA-AZITHROMYCIN used for?
NRA-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 NRA-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, NRA-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of NRA-AZITHROMYCIN could lead to the growth of bacteria that will not be killed by NRA-AZITHROMYCIN (resistance). This means that NRA-AZITHROMYCIN may not work for you in the future. Do not share your medicine.
How does NRA-AZITHROMYCIN work?
NRA-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 NRA-AZITHROMYCIN may be taken for as short a time as one day.
What are the ingredients in NRA-AZITHROMYCIN?
Medicinal ingredients: Azithromycin dihydrate
Non-medicinal ingredients:
NRA-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.
NRA-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.
NRA-AZITHROMYCIN comes in the following dosage forms:
Tablets: 250 mg, 600 mg
Do not use NRA-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 NRA-AZITHROMYCIN (see What are the ingredients in NRA-AZITHROMYCIN?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NRA-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 NRA-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 NRA-AZITHROMYCIN for the full number of days your doctor prescribed. Although NRA-AZITHROMYCIN’s dosing is short, you should not expect NRA-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking NRA-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 NRA-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.
The following may interact with NRA-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 NRA-AZITHROMYCIN.
Some medicines may affect how well NRA-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on NRA-AZITHROMYCIN.
How to take NRA-AZITHROMYCIN:
Always take NRA-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
NRA-AZITHROMYCIN can be taken with or without food.
Usual adult dose:
If your doctor prescribes NRA-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 NRA-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 NRA-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 NRA-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Days 1: Take eight tablets once.
If your doctor prescribes NRA-AZITHROMYCIN 600 mg tablets for prevention of Mycobacterium avium complex (MAC) disease:
Take two tablets once weekly.
Overdose:
Missed Dose:
If you forget to take a dose, call your pharmacist or doctor. Do not double dose.
What are possible side effects from using NRA-AZITHROMYCIN?
These are not all the possible side effects you may feel when taking NRA-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
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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 | √ | ||
If you think you have taken too much NRA-AZITHROMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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.
Storage:
Store NRA-AZITHROMYCIN at controlled room temperature (between 15-30ºC). Keep out of reach and sight of children.
If you want more information about NRA-AZITHROMYCIN:
- 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 Nora Pharma Inc. at 1-888-270-9874.
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/health-canada/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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Nora Pharma Inc.
40 rue Prince-Arthur, Suite 310 Saint-Lambert, Québec, J4P 1X2
Date of revision: February 3, 2022