Azithromycin (4513347 Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

AZITHROMYCIN is an antibiotic medicine taken once a day to treat the following types of infections in adults: bronchitis, certain types of skin infections, strep throat (pharyngitis, tonsillitis), and pneumonia.

Can Antibiotics Cure A Cold or Flu?

No. 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.

What it does:

AZITHROMYCIN helps to stop the growth of the bacteria that cause infection. It gets into infected tissue where it is released slowly over time. The medicine fights the infection for several days after the last dose is taken.

When it should not be used:

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

What the medicinal ingredient is:

azithromycin monohydrate.

What the important nonmedicinal ingredients are:

:

dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, sodium lauryl sulphate, magnesium stearate, Titanium dioxide, Talc, Lecithin (Soya), and Xanthum gum.

The 250 mg tablets also contain: Ponceau 4R Aluminum Lake,

Carmoisine (Azorubine) Aluminum Lake, and Quinoline Yellow Lake.

What dosage forms it comes in:

AZITHROMYCIN is available in 2 strengths, mainly: tablets 250 mg and 600 mg

WARNINGS AND PRECAUTIONS

Only your doctor can decide if AZITHROMYCIN is right for you. Before you start AZITHROMYCIN, be sure to tell the doctor if you:

• are taking any prescription medicines, including theophylline or warfarin
• are taking any over the counter medicines you can buy without a prescription, including natural/herbal remedies or antacids

• are pregnant, think you are pregnant, or are breast feeding - have ever had any liver or kidney problems - have any other medical problems

• have ever had an allergic reaction to any medicines, including antibiotics such as erythromycin - have ever had an allergic reaction to azithromycin or any of the ingredients of AZITHROMYCIN (see ABOUT THIS MEDICATION)

INTERACTIONS WITH THIS MEDICATION

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

AZITHROMYCIN can be taken with or without food.

Usual dose:

250 mg AZITHROMYCIN for 5 days

Day 1: Take 2 tablets once

Days 2-5: Take 1 tablet daily

600 mg AZITHROMYCIN

The recommended dose of AZITHROMYCIN for the prevention of disseminated Mycobacterium avium complex (MAC) disease is 1200 mg (two 600 mg tablets) taken once weekly.

You should begin to feel better better within the first few days, but be sure to take AZITHROMYCIN for the full number of days your doctor prescribed. If you stop taking AZITHROMYCIN too soon, your infection could come back. The next infection may be worse

Overdose:

In case of accidental overdose, call your doctor right away or go to the nearest emergency room.

Missed Dose:

If a dose of this medication is missed, it should be taken as soon as possible. This will help to keep a constant amount of medication in the blood. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, AZITHROMYCIN may cause some side effects that are usually mild to moderate and go away after the medicine is stopped. The most common ones are:

• nausea
• diarrhea
• stomach pain
• vomiting

As with other antibiotics, if you develop diarrhea that becomes severe and watery or does not go away, stop taking the medicine and call your doctor. This could be a sign of a serious medical problem.

Allergic reactions to AZITHROMYCIN are rare, but these reactions can be very serious if not treated right away by a doctor.

If you think you might be having an allergic reaction to AZITHROMYCIN, stop taking the medicine and call your doctor right away. If you cannot reach your 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; severe skin rash or blisters.

AZITHROMYCIN may cause other less common side effects besides those listed here. If you have any unexpected side effects while taking AZITHROMYCIN, contact your doctor, nurse or pharmacist.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

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

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

Store AZITHROMYCIN at controlled room temperature (between 15-30 °C).

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345

toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, 4513347 Canada Inc., at: 306.270.2975.

4513347 Canada Inc. 109-2002 Quebec Ave, Saskatoon, SK

S7K 1W4

Last revised: January 25, 2010