GD Azithromycin Tablets - Consumer Medicine Information
|Condition:||Babesiosis, Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis), Bacterial Infection, Bartonellosis, Bronchitis, Cervicitis, Chancroid, Chlamydia Infection, Cystic Fibrosis, COPD, Acute, Granuloma Inguinale, Gonococcal Infection, Uncomplicated, Legionella Pneumonia, Lyme Disease, Erythema Chronicum Migrans, Mycoplasma Pneumonia, Mycobacterium avium-intracellulare, Treatment, Mycobacterium avium-intracellulare, Prophylaxis, Nongonococcal Urethritis, Otitis Media, Pelvic Inflammatory Disease, Pertussis, Pertussis Prophylaxis, Pharyngitis, Pneumonia, Sinusitis, Skin and Structure Infection, Skin or Soft Tissue Infection, STD Prophylaxis, Typhoid Fever, Toxoplasmosis, Tonsillitis/Pharyngitis, Upper Respiratory Tract Infection|
|Ingredients:||azithromycin dihydrate, pregelatinized starch (27 mg), anhydrous calcium phosphate dibasic, sodium croscarmellose (9 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake; anhydrous calcium phosphate dibasic, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose, titanium dioxide, triacetin|
Azithromycin tablets 250 and 600 mg (as azithromycin dihydrate)
About This Medication
What the Medication is Used For
GD-AZITHROMYCIN is an antibiotic medicine to treat the following types of mild to moderate infections by certainmicroorganisms 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 GD-AZITHROMYCIN is the most appropriate antibacterial for you.
What It Does
GD-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 GD-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 GD-AZITHROMYCIN (see What the nonmedicinal ingredients are).
What the Medicinal Ingredient Is
What the Nonmedicinal Ingredients Are
GD-AZITHROMYCIN Tablets 250 mg contain azithromycin dihydrate equivalent to 250 mg azithromycin and the following inactive ingredients: pregelatinized starch (27 mg), anhydrous calcium phosphate dibasic, sodium croscarmellose (9 mg), magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake.
GD-AZITHROMYCIN Tablets 600 mg contain azithromycin dihydrate equivalent to 600 mg azithromycin and the following inactive ingredients: anhydrous calcium phosphate dibasic, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulphate, hydroxypropyl methylcellulose, lactose, titanium dioxide and triacetin.
What Dosage Forms It Comes In
Warnings and Precautions
BEFORE you use GD-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 WithThis 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 breast feeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if GD-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 GD-AZITHROMYCIN tablets
- 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 GD-AZITHROMYCIN for the full number of days your doctor prescribed. Although GD-AZITHROMYCIN’s dosing is short, you should not expect GD-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking GD-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 GD-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 GD-AZITHROMYCIN.
Some medicines may affect how well GD-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the -counter medicines, including natural/herbal remedies or antacids, while on GD-AZITHROMYCIN.
Proper Use of This Medication
Usual Adult Dose
GD-AZITHROMYCIN can be taken with or without food.
If your doctor prescribes the 3 day GD-AZITHROMYCIN TRI-PAK 500 mg tablets for treatment of bronchitis:
Days 1 through 3: Take 1 tablet each day.
If your doctor prescribes GD-AZITHROMYCIN 250 mg tablets for 3 days for treatment of bronchitis:
Days 1 through 3: Take two tablets each day.
If your doctor prescribes the 5 day GD-AZITHROMYCIN Z-PAK 250 mg tablets for 5 days for treatment of respiratory tract infections or certain types of skin infections:
Day 1: Take 2 tablets once.
Day 2 through 5: Take 1 tablet daily.
Always take GD-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
|In case of drug overdose, contact a healthcare professional, hospital emergency department or regional poison control centre, even if there are no symptoms.|
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, GD-AZITHROMYCIN can 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 GD-AZITHROMYCIN and contact your healthcare professional immediately.
Allergic reactions to GD-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 GD-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 GD-AZITHROMYCIN.
Serious Side Effects, how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your
|Uncommon||Abnormal heart rhythm||✓|
|Severe allergic reaction (such as trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters)||✓|
|Liver disorder (symptoms include abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine)||✓|
|Uncommon||Myasthenia gravis (muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing)||✓|
This is not a complete list of side effects. For any unexpected effects while taking GD-AZITHROMYCIN, contact your doctor or pharmacist.
How to Store It
Store GD-AZITHROMYCIN at controlled room temperature (between 15-30ºC).
Keep GD-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
Postal Locator 0701D
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.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting the sponsor, GenMed, a division of Pfizer Canada Inc., at: