Details for: RIVA-AZITHROMYCIN
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02275309 | RIVA-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
RIVA-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 drags like RIVA-AZITHROMYCIN treat only bacterial infections. They do not
treat viral infections such as the common cold. Although you may feel better early in treatment,
RIVA-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of RIVA-AZITHROMYCIN
could lead to the
growth of bacteria that will not be killed by RIVA-AZITHROMYCIN (resistance). This means that
RIVA-AZITHROMYCIN
may not work for
you in the future. Do not share your medicine.
What it does
RIVA-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 RIVA-AZITHROMYCIN may be taken for as short a time as one day.
When it should not be used
Do not use RIVA-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 RIVA-AZITHROMYCIN (see What are the ingredients in RIVA-AZITHROMYCIN?).
What the medicinal ingredient is
Azithromycin dihydrate
What the non-medicinal ingredients are
RIVA-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 aluminium lake.
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 RIVA-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)
- 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 heartbeat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heartbeat 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 RIVA-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.
Other warnings you should know about
You should begin to feel better within the first few days, but be sure to take RIVA-AZITHROMYCIN for
the full
number of days your doctor prescribed. Although RIVA-AZITHROMYCIN dosing is short, you should not
expect
RIVA-AZITHROMYCIN to
work faster than other antibiotics which are dosed up to 10 days. If you stop taking RIVA-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 RIVA-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 RIVA-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);
- Nelfmavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with RIVA-AZITHROMYCIN.
Some medicines may affect how well RIVA-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on RIVA-AZITHROMYCIN.
Proper use of this medication
Always take RIVA-AZITHROMYCIN as the doctor has prescribed for you, depending on the
specific condition you have.
RIVA-AZITHROMYCIN can be taken with or without food.
Usual adult dose
If your doctor prescribes RIVA-AZITHROMYCIN 250 mg tablets for 3 days for treatment of bronchitis:
Days 1 through 3: Take two tablets each day.
If your doctor prescribes RIVA-AZITHROMYCIN 250 mg tablets for 5 days for treatment of
respiratory tract infections or certain types of skin infections:
Day 1: Take two tablets once.
Days 2 through 5: Take one tablet daily.
If your doctor prescribes RIVA-AZITHROMYCIN 250 mg tablets for 1 day for treatment of
genital ulcers or non-gonococcal urethritis and cervicitis:
Day 1: Take four tablets once.
If your doctor prescribes RIVA-AZITHROMYCIN 250 mg tablets for 1 day for treatment of
gonococcal urethritis and cervicitis:
Day 1: Take eight tablets once.
Overdose
If you think you have taken too much RIVA-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 RIVA-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 RIVA-AZITHROMYCIN at controlled room temperature (between 15-30°C).
Keep out of reach and sight of children.
Reporting side effects
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
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.
More information
If you want more information about RIVA-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) www.labriva.com, or by calling 1-800-363-7988.
This leaflet was prepared by:
Laboratoire Riva Inc.
660 Boul. Industriel,
Blainville, Quebec
J7C 3V4
www.labriva.com
Last Revised: August 21, 2020