Consumer Information for: DOM-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

Azithromycin Tablets, USP

Dom-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 Dom-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Dom-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of Dom-AZITHROMYCIN could lead to the growth of bacteria that will not be killed by Dom-AZITHROMYCIN (resistance). This means that Dom-AZITHROMYCIN may not work for you in the future. Do not share your medicine.

Azithromycin for Oral Suspension, House Standard

Dom-AZITHROMYCIN is an antibiotic medicine used to treat the following types of mild to moderate infections by certain microorganisms in children: ear infections, pneumonia, and throat infections and in adults who have difficulty swallowing tablets, for various conditions.

Antibacterial drugs like Dom-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Dom-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of Dom-AZITHROMYCIN could lead to the growth of bacteria that will not be killed by Dom-AZITHROMYCIN (resistance). This means that Dom-AZITHROMYCIN may not work for you in the future. Do not share your medicine.

What it does

Azithromycin Tablets, USP

Dom-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 Dom-AZITHROMYCIN may be taken for as short a time as one day.

Azithromycin for Oral Suspension, House Standard

Dom-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 Dom-AZITHROMYCIN may be taken for as short a time as one day.

When it should not be used

Azithromycin Tablets, USP

  • 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 Dom-AZITHROMYCIN (see What are the ingredients in Dom-AZITHROMYCIN).

Azithromycin for Oral Suspension, House Standard

  • 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 Dom-AZITHROMYCIN (see What are the ingredients in Dom-AZITHROMYCIN?).
What the medicinal ingredient is

Azithromycin Tablets, USP

Azithromycin dihydrate

Azithromycin for Oral Suspension, House Standard

Azithromycin Dihydrate

What the non-medicinal ingredients are

Azithromycin Tablets, USP

250 mg tablets: Croscarmellose sodium D&C Red No. 27, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hydroxypropylmethyl Cellulose, Lactose, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide.

600 mg tablets: Croscarmellose sodium D&C Red No. 27, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hydroxypropylmethyl Cellulose, Croscarmellose Sodium D&C Red No. 27, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hydroxypropylmethyl Cellulose, Lactose, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide, Lactose, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide.

Azithromycin for Oral Suspension, House Standard

Artificial Cherry Flavor, Carboxyvinyl Polymer, Colloidal Silicon Dioxide, FD&C Red No. 40, Polyethylene Glycol, Sodium Chloride, Sodium Citrate Dihydrate, Sodium Lauryl Sulfate and Sucrose.

What dosage form it comes in

Azithromycin Tablets, USP

Tablets: 250 mg and 600 mg.

Azithromycin for Oral Suspension, House Standard

Powder for Oral Suspension: 100 mg/5 mL and 200 mg/ 5 mL.

Warnings and precautions

Azithromycin Tablets, USP

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dom-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 breast feeding or planning to breastfeed. Azithromycin is excreted in human breast milk. It is not known if Dom-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 Dom-AZITHROMYCIN for the full number of days your doctor prescribed. Although Dom-AZITHROMYCIN dosing is short, you should not expect Dom-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking Dom-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 Dom-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.

Azithromycin for Oral Suspension, House Standard

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Dom-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)
  • have diabetes or hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency, as this product contains sucrose
  • 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 Dom-AZITHROMYCIN could affect a baby. Discuss with your doctor
  • have ever had any liver or kidney problems
  • have a weak immune system
  • have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
  • are allergic to any medicines including antibiotics such as erythromycin
Other warnings you should know about:
If your child develops diarrhea during or after treatment with Dom-AZITHROMYCIN, tell your child’s doctor at once. Do not use any medicine to treat your child’s diarrhea without first checking with your child’s doctor.

Your child should begin to feel better within the first few days, but be sure to give for the full number of days your child’s doctor prescribed. Although Dom-AZITHROMYCIN’s dosing is short, and you may be able to give all the medicine to your child more easily, you should not expect Dom-AZITHROMYCIN to work faster than other antibiotics which are dosed for up to 10 days. If you stop giving Dom-AZITHROMYCIN to your child too soon, their infection could come back. The next infection may be worse and be more difficult to treat. If you are not able to give all the medicine to your child, tell your child’s doctor.

If your baby develops projectile vomiting or irritability during feeding, during or after treatment with Dom-AZITHROMYCIN, contact your baby’s doctor at once.

Your child's doctor or nurse can advise you when your child should begin feeling better.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

Azithromycin Tablets, USP

  • 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 Dom-AZITHROMYCIN.
Some medicines may affect how well Dom-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on Dom-AZITHROMYCIN.

Azithromycin for Oral Suspension, House Standard

  • 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 Dom-AZITHROMYCIN.
Some medicines may affect how well Dom-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on Dom-AZITHROMYCIN.
Proper use of this medication
Azithromycin Tablets, USP
Azithromycin for Oral Suspension, House Standard

Azithromycin Tablets, USP

How to take Dom-AZITHROMYCIN

Always take Dom-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.

Dom-AZITHROMYCIN can be taken with or without food.

Usual adult dose

If your doctor prescribes Dom-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 Dom-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 Dom-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 Dom-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Days 1: Take eight tablets once.

If your doctor prescribes Dom-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 Dom-AZITHROMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Center 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.

Azithromycin for Oral Suspension, House Standard

How to take Dom-AZITHROMYCIN

Your child's doctor will decide the total amount of Dom-AZITHROMYCIN to give to your child, depending on your child's weight and on the specific infection your child has. In addition to deciding the total amount of Dom-AZITHROMYCIN to give to your child, the doctor will tell you to give all the medicine to your child in 1 day or to divide it over 3 days or over 5 days.

AZITHROMYCIN should be taken once-a-day and may be given with or without food. Shake the bottle well just before you give a dose.

Use the dosing device that comes with Dom-AZITHROMYCIN to carefully measure the dose. Do not use a household teaspoon as it is not accurate enough.

Give Dom-AZITHROMYCIN for the full number of days prescribed by the doctor, even if your child feels better before finishing all the medicine as prescribed.

Usual dose

For Ear Infections
For ear infections, your child's doctor will tell you to give Dom-AZITHROMYCIN to your child in one of the following ways:

  • the total amount as 1 dose on 1 day or
  • once-a-day for 3 days or
  • once-a-day for 5 days, with a double dose on the first day.

Whether given all on 1 day, or divided over 3 days or over 5 days, the total amount of DomAZITHROMYCIN you give to your child should be the same.

For Pneumonia
For pneumonia, your child's doctor will tell you to give Dom-AZITHROMYCIN to your child once-a-day for 5 days, with a double dose on the first day.

For Throat Infections
For throat infections, your child's doctor will tell you to give Dom-AZITHROMYCIN to your child in the following way: once-a-day for 5 days. When Dom-AZITHROMYCIN is given for 5 days for throat infections, you do not need to give a double dose on the first day (as you would with ear infections).

If your child vomits within 30 minutes after the 1-day treatment for an ear infection, it is recommended that you call your pharmacist or child’s doctor because your child may need to receive the same dose of medicine again.

If you have questions about how to give Dom-AZITHROMYCIN to your child, please ask your child's doctor, nurse or pharmacist.

Instructions for Use of the Dosing Devices

Use only the dosing device provided to measure the correct amount of suspension.

Instructions for Use of the Oral Syringe for Oral Suspension:

  1. Shake well before each use. To open, push down the bottle cap while twisting the cap counter clockwise. Remove cap from bottle.
  2. Insert syringe into bottle top.
  3. Pull back syringe handle, drawing prescribed dose of medicine into syringe.
  4. Remove syringe from bottle. Give medicine by mouth by slowly pushing on syringe handle. Remember to put the cap back on the medicine bottle

Do not save any medicine for future use.

Overdose

If you think you have taken too much Dom-AZITHROMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Missed Dose

If you forget to give your child a dose, call your pharmacist or child’s doctor. Do not double dose.

Side effects and what to do about them

Azithromycin Tablets, USP

These are not all the possible side effects you may feel when taking ZITHROMAX. 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 Only if severe Talk to your healthcare professional Un 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.

Azithromycin for Oral Suspension, House Standard

These are not all the possible side effects you may feel when taking Dom-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 Only if severe Talk to your healthcare professional Un 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

Azithromycin Tablets, USP

Store Dom-AZITHROMYCIN at controlled temperature between 15°C and 30°C

Keep Dom-AZITHROMYCIN and all medicines out of the reach and sight of children.

Azithromycin for Oral Suspension, House Standard

Dry powder: Store between 15°C and 30°C

Reconstituted suspension: Store refrigerated at 4°C or at room temperature between 15°C and 30C. Discard unused portion after 10 days.

Keep Dom-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:

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
  • 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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website, or by calling 1-888-550-6060.

This leaflet was prepared by Dominion Pharmacal.

Last Revised: November 29, 2018