Riva Azithromycin: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RIVA-AZITHROMYCIN is an antibiotic medicine 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.

This medication is indicated for adult patients. Your doctor will decide on whether RIVA-AZITHROMYCIN is the most appropriate antibacterial for you.

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. The medicine fights the infection for several days after the last dose is taken.

Antibiotics work only on infections caused by bacteria. They do not kill viruses. No antibiotic, including RIVA-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 macrolid or ketolide antibiotic (including erythromycin) or any other ingredient RIVA-AZITHROMYCIN (see What the nonmedicinal ingredients are).

What the medicinal ingredient is:

Azithromycin Monohydrate.

What the important nonmedicinal ingredients are:

The following inactive ingredients are common to all tablet strengths:

Dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, sodium lauryl sulphate, magnesium

stearate, Titanium dioxide, Talc, Lecithin (Soya), Polyvinyl Alcohol (Partially Hydrolyzed) 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:

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

WARNINGS AND PRECAUTIONS

Before you use RIVA-AZITHROMYCIN talk to your doctor or pharmacist if you:

• are 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),
• 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),

• are pregnant or think you are pregnant,

• are breastfeeding or planning to breastfeed.

  Azithromycin has been reported to be 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 ever had an allergic reaction to azithromycin or any of the ingredients of RIVA-AZITHROMYCIN,
• 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.

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, tell your doctor at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with RIVA-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 a heart problem);
• Nelfinavir (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

Usual adult dose:

RIVA-AZITHROMYCIN can be taken with or without food.

• If your doctor prescribes RIVA-AZITHROMYCIN 250

  mg tablets for 3 days:

  Days 1 through 3: Take two tablets each day.

OR

• If your doctor prescribes RIVA-AZITHROMYCIN 250

  mg tablets for 5 days:

  Day 1: Take 2 tablets once.

  Day 2 through 5: Take 1 tablet daily.

OR

• If your doctor prescribes RIVA-AZITHROMYCIN 600

  mg tablets:

The recommended dose of RIVA-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 within the first few days, but be sure to take RIVA-AZITHROMYCIN for the full number of days your doctor prescribed. Although RIVA-AZITHROMYCIN’s

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.

Overdose:

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

As with most drugs, RIVA-AZITHROMYCIN may cause some side effects.

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

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

Allergic reactions to RIVA-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 RIVA-AZITHROMYCIN, 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, throat, neck; or severe skin rash or blisters.

If you develop 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 the doctor or nurse.

If you develop symptoms of myasthenia gravis or the symptoms of your existing myasthenia gravis worsen, contact your 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 doctor right away if you feel your heart beating in your chest or if you have an abnormal heartbeat or get dizzy or faint when taking RIVA-AZITHROMYCIN.

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

HOW TO STORE IT

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

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

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™ 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 found by contacting the sponsor, Laboratoire Riva Inc., at: 1-800-363-7988.

Laboratoire Riva Inc.

660 Industriel Blvd.

Blainville, Quebec, Canada

J7C 3V4

Last revised: March 17, 2015