PMS-Azithromycin (Pharmascience, 100 mg, 200 mg): Uses, Side Effects and Dosage

What is pms-AZITHROMYCIN used for?

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

How does pms-AZITHROMYCIN work?

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

What are the ingredients in pms-AZITHROMYCIN?

Medicinal ingredients: Azithromycin dihydrate.

Non-medicinal ingredients: 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.

pms-AZITHROMYCIN comes in the following dosage forms:

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

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-AZITHROMYCIN. Talk about any health conditions or problems you may have, includint 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 breast feeding or planning to breast feed. Azithromycin has been reported to be excreted in human breast milk. It is not known if pms-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 pms-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 pms-AZITHROMYCIN for the full number of days your child’s doctor prescribed. Although pms-AZITHROMYCIN's dosing is short and you may be able to give all the medicine to your child more easily, you should not expect pms-AZITHROMYCIN to work faster than other antibiotics which are dosed for up to 10 days. If you stop giving pms-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 pms-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.

The following may interact with pms-AZITHROMYCIN:

• Warfarin (or other anticoagulant medicine);
• Cyclosporin (used to suppress of the immune system to prevent and treat rejection in organ or bone marrow transplants);
• Digoxin (used for treatment of heart problems);
• Nelfinavir (used for treatment of HIV infections);
• Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with pms-AZITHROMYCIN.

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

How to take pms-AZITHROMYCIN:

Your child's doctor will decide the total amount of pms-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 pms-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.

pms-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 pms-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 pms-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 pms-AZITHROMYCIN you give to your child should be the same.

For Pneumonia

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

Instructions for Use with a Syringe:

Do not save any medicine for future use.

Overdose:

Missed Dose:

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

What are possible side effects from using pms-AZITHROMYCIN?

These are not all the possible side effects you may feel when taking pms-AZITHROMYCIN. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Diarrhea/loose stool
• 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.

Storage:

pms-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 out of the reach and sight of children.

If you want more information about pms-AZITHROMYCIN:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Information by visiting the Health Canada website (www.healthcanada.gc.ca); or by contacting Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montréal, Canada

H4P 2T4

www.pharmascience.com

Last revised: October 5, 2016