Details for: TEVA-AZITHROMYCIN
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02267845 | TEVA-AZITHROMYCIN | 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
TEVA-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 TEVA-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common
cold. Although you may feel better early in treatment, TEVA-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse
of TEVA-AZITHROMYCIN could lead to the growth of bacteria that will not be killed by TEVA-AZITHROMYCIN (resistance). This
means that TEVA-AZITHROMYCIN may not work for you in the future. Do not share your medicine.
What it does
TEVA-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 TEVAAZITHROMYCIN may be taken for as short a time as one day.
When it should not be used
Do not use TEVA-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 TEVA-AZITHROMYCIN (see What are the ingredients in TEVA-AZITHROMYCIN?).
What the medicinal ingredient is
Medicinal ingredient: Azithromycin (as azithromycin monohydrate hemiethanolate)
What the non-medicinal ingredients are
Nonmedicinal ingredients: Butylated hydroxytoluene powder, calcium phosphate (dibasic) anhydrous, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized corn starch, propyl gallate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate, D&C Red #27, FD&C Blue #2, FD&C Red #40, FD&C Yellow #6.
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 use TEVA-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 TEVAAZITHROMYCIN 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)
Other warnings you should know about:
You should begin to feel better within the first few days, but be sure to take TEVA-AZITHROMYCIN for the full number of days your
doctor prescribed. Although TEVA-AZITHROMYCIN’s dosing is short, you should not expect TEVA-AZITHROMYCIN to work
faster than other antibiotics which are dosed up to 10 days. If you stop taking TEVA-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 TEVA-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 TEVA-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 problems);
- 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 TEVA-AZITHROMYCIN.
Some medicines may affect how well TEVA-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on TEVA-AZITHROMYCIN.
Proper use of this medication
How to take TEVA-AZITHROMYCIN:
Always take TEVA-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
Usual adult dose:
TEVA-AZITHROMYCIN can be taken with or without food.
If your doctor prescribes TEVA-AZITHROMYCIN 250 mg tablets for 3 days for treatment of bronchitis:
Days 1 through 3: Take two tablets each day.
If your doctor prescribes TEVA-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 TEVA-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 TEVA-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
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 TEVA-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 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 TEVA-AZITHROMYCIN between 15-30°C.
Keep TEVA-AZITHROMYCIN and all medicines out of the 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/health-canada/services/drugs-healthproducts/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
If you want more information about TEVA-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); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com .
This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9
Last Revised: August 2, 2019