Apo-Azithromycin (Apotex, Capsule): Uses, Side Effects and Dosage

What is APO-AZITHROMYCIN used for?

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

How does APO-AZITHROMYCIN work?

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

What are the ingredients in APO-AZITHROMYCIN?

Medicinal ingredients: Azithromycin

Non-medicinal ingredients: Lactose, stearic acid, croscarmellose sodium and colloidal silicon dioxide. The capsule shells contain gelatin, sodium lauryl sulfate, silicon dioxide, FD&C red #40 and titanium dioxide. The edible black printing ink contains shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, black iron oxide, FD&C blue #1, FD&C blue #2, D&C yellow #10 and FD&C red #40.

APO-AZITHROMYCIN comes in the following dosage forms:

Capsules: 250 mg

Do not use APO-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 APO-AZITHROMYCIN (see What are the ingredients in APO-AZITHROMYCIN?).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-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 APO-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 APO-AZITHROMYCIN for the full number of days your doctor prescribed. Although APO-AZITHROMYCIN’s dosing is short, you should not expect APO-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking APO-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 APO-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 APO-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 APO-AZITHROMYCIN.

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

How to take APO-AZITHROMYCIN:

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

APO-AZITHROMYCIN should be taken at least 1 hour before or 2 hours after food..

Usual adult dose:

If your doctor prescribes APO-AZITHROMYCIN 250 mg capsules for 3 days for treatment of bronchitis:

Days 1 through 3: Take two capsules each day.

If your doctor prescribes the 5 day APO-AZITHROMYCIN 250 mg capsules for 5 days for treatment of respiratory tract infections or certain types of skin infections:

Day 1: Take 2 capsules once.

Day 2 through 5: Take 1 capsule daily.

If your doctor prescribes APO-AZITHROMYCIN 250 mg capsules for 1 day for treatment of genital ulcers or non-gonococcal urethritis and cervicitis:

Days 1: Take four capsules once.

If your doctor prescribes APO-AZITHROMYCIN 250 mg capules for 1 day for treatment of gonococcal urethritis and cervicitis:

Days 1: Take eight capsules once.

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 APO-AZITHROMYCIN?

These are not all the possible side effects you may feel when taking APO-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

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.

Reporting Side Effects

Storage:

Store at controlled room temperature (15°C to 30°C). Keep bottles tightly closed.

Keep out of reach and sight of children.

If you want more information about APO-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). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last revised: November 23, 2020