Azithromycin (Dominion Pharmacal): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

AZITHROMYCIN is an antibiotic medicine 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.

What it does:

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

Antibiotics work only on infections caused by bacteria. They do not kill viruses. No antibiotic, including

AZITHROMYCIN, can treat viral infections such as the common cold and the flu.

When it should not be used:

• If you have a history of cholestatic jaundice/hepatitis

  (liver problems) associated with prior use of azithromycin.

• If you are hypersensitive (allergic) to azithromycin, or

  any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of

  AZITHROMYCIN (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

Azithromycin dihydrate.

What the nonmedicinal ingredients are:

The non-medicinal ingredients include: sucrose (3.86 g per 100 mg/5 mL and 3.87 g per 200 mg/5 mL); sodium phosphate (8.76 mg per 100 mg/5 mL and 17.50 mg per 200 mg/5 mL), tribasic hydroxypropyl cellulose; xanthan gum; FD&C Red #40 and artificial flavours.

What dosage forms it comes in:

Oral suspension – azithromycin 300, 600, 900 mg/bottle, or 100 mg/5 ml, 200 mg/5 ml when reconstituted (as azithromycin dihydrate)

WARNINGS AND PRECAUTIONS

BEFORE you use AZITHROMYCIN talk to your doctor or pharmacist if your child:

• you have a known prolonged heart cycle (interval) (QT prolongation)
• you 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)
• you have a history of life-threatening irregular heart beat
• you have constantly low levels of potassium or magnesium

• you have a history for heart problems such as bradycardia

  (slow heart rate), cardiac arrhythmia ( irregular heart beat) or cardiac insufficiency (your heart has a hard time pumping blood to your body)

• is taking any prescription medicines or any over the counter medicines you can buy without a prescription, including natural/herbal remedies or antacids (See Interactions With This Medication)
• have diabetes or hereditary problems of fructose intolerance, glucose-galactose malabsorption or saccharase-isomaltase deficiency, as this product contains sucrose.

• is pregnant or thinks they are pregnant,

• is breast feeding. Azithromycin has been reported to be excreted in human breast milk. It is not known if AZITHROMYCIN could affect a baby. Discuss with your doctor.
• has ever had any liver or kidney problems
• has a weak immune system
• has myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
• is allergic to any medicines including antibiotics such as erythromycin

• is allergic to azithromycin or any of the ingredients of

  AZITHROMYCIN suspension. (See “What the non medicinal ingredients are”)

If your child develops diarrhea during or after treatment, 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. Although AZITHROMYCIN's dosing is short and you may be able to give all the medicine to your child more easily, you should not expect AZITHROMYCIN to work faster than other antibiotics which are dosed for up to 10 days.

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

INTERACTION WITH THIS MEDICATION

Drugs that may interact with AZITHROMYCIN include:

• Warfarin (or other anticoagulant medicine);

• Cyclosporin (used in suppressing of the immune system

  to prevent and treat the rejection in organs or bone marrow transplants);

• Digoxin (used for treatment of cardiac impairment);
• Nelfinavir (used for treatment of HIV infections);

• Ergotamine and ergot derivatives (used for migraine

  treatment). Ergotamine and ergot derivatives should not be used with AZITHROMYCIN.

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

AZITHROMYCIN.

PROPER USE OF THIS MEDICATION

Your child's doctor will decide the total amount of 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 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 an oral syringe to carefully measure the dose. Do not use a household teaspoon as it is not accurate enough.

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

For Ear Infections

For ear infections, your child's doctor will tell you to give 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 AZITHROMYCIN you give to your child should be the same.

For Pneumonia

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

For Throat Infections (Pharyngitis/Tonsillitis)

For throat infections, your child's doctor will tell you to give AZITHROMYCIN to your child in the following way: once-a-day for 5 days. When 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 AZITHROMYCIN to your child, please ask your child's doctor, nurse or pharmacist.

Instructions for Use with a Syringe:

1. 1. To open, push down on the bottle cap while twisting the cap counter clockwise. Remove cap from bottle.
2. 2. Insert syringe into bottle top and pull back syringe handle, drawing prescribed dose of medicine into syringe.
3. 3. 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

In case of drug overdose, contact a health professional, hospital emergency department or regional poison control center, 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

As with most drugs, AZITHROMYCIN can cause some side effects.

The most common side effects are diarrhea/loose stools, stomach pain, nausea, and vomiting.

If your child experiences symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, your child may have Clostridium difficile colitis (bowel inflammation). If this occurs, your child should stop taking AZITHROMYCIN and contact your child’s healthcare professional immediately.

Allergic reactions to AZITHROMYCIN are rare, but these reactions can be very serious if not treated right away by a doctor. If you think your child might be having an allergic reaction to AZITHROMYCIN, call your child’s doctor right away. If you cannot reach your child’s doctor, go to the nearest hospital emergency room. Symptoms of a severe allergic reaction may include trouble breathing; swelling of the face, mouth and neck; or severe skin rash or blisters.

If your child develops symptoms of hepatitis (liver inflammation) such as abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine etc., stop taking the medicine immediately and call your child’s doctor or nurse.

If your child develops symptoms of myasthenia gravis or the symptoms of your child’s existing myasthenia gravis worsen, contact your child’s doctor. These symptoms could include muscle weakness that gets worse with activity and gets better with rest, drooping eyelid, blurred or double vision, difficulty chewing and swallowing, or trouble breathing.

Please tell your child’s doctor right away if your child feels their heart beating in their chest or if your child has an abnormal heartbeat or gets dizzy or faints when taking AZITHROMYCIN.

Common Diarrhea/loose stools ✓

Nausea ✓

Stomach pain ✓

Headache ✓

Vomiting ✓

This is not a complete list of side effects. For any unexpected effects while taking AZITHROMYCIN, contact your doctor or pharmacist.

HOW TO STORE IT

AZITHROMYCIN can be stored in the refrigerator or kept at room temperature (between 5°-30°C). Throw away any medicine that is left over after treatment.

Keep AZITHROMYCIN and all medicines out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Dominion Pharmacal at 1-888-550-6060.

Dominion Pharmacal

Montréal, Canada

H4P 2T4

Last revised: December 17, 2013