Patient Medication Information: uses, side effects, how to take - PMS-Azithromycin (Pharmascience, 250 mg, 600 mg)
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 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.
Antibacterial drugs like pms-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold.
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 ingredient: Azithromycin dihydrate
Non-medicinal ingredients:
250 mg tablets: Croscarmellose Sodium, D&C Red No. 27, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hypromellose, Lactose Anhydrous, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide.
600 mg tablets: Croscarmellose Sodium , Hypromellose, Lactose Anhydrous, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Talc and Titanium Dioxide.
pms-AZITHROMYCIN comes in the following dosage forms:
Tablets: 250 mg and 600 mg.
Do not use pms-AZITHROMYCIN if:
- you have a history of liver problems when you have used azithromycin.
- you 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, including 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 heartbeat 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 heartbeat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heartbeat 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 is excreted in human breast milk. It is not known if pms-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 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.
Other warnings you should know about:
If you develop diarrhea during or after treatment with pms-AZITHROMYCIN, tell your doctor at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.
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 the immune system to prevent and treat rejection in organ or bone marrow transplants);
- Digoxin (used for treatment of heart problem);
- Colchicine (used for treatment of gout);
- 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:
- 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 the future.
- Do not share your medicine.
pms-AZITHROMYCIN can be taken with or without food.
Usual adult dose:
If your doctor prescribes pms-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 pms-AZITHROMYCIN 250 mg tablets for 5 days for treatment of respiratory tract infections or certain types of skin infections:
Day 1: Take 2 tablets once.
Days 2 through 5: Take 1 tablet daily.
If your doctor prescribes pms-AZITHROMYCIN 250 mg tablets for 1 day for treatment of genital ulcers or non-gonococcal urethritis and cervicitis:
Day 1: Take four tablets once.
If your doctor prescribes pms-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Day 1: Take eight tablets once.
If your doctor prescribes pms-AZITHROMYCIN 600 mg tablets for prevention of Mycobacterium avium complex (MAC) disease:
Take two tablets once weekly.
Overdose:
| If you think you, or a person you are caring for, have taken too much pms-AZITHROMYCIN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed Dose:
If you forget to take a dose, call your pharmacist or doctor. Do not double dose.
What are possible side effects from using pms-AZITHROMYCIN?
These are not all the possible side effects you may have when taking pms-AZITHROMYCIN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Diarrhea/loose stools
- Stomach pain
- Nausea and vomiting
- Headache
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| COMMON | |||
| Clostridioides difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✓ | ||
| UNCOMMON | |||
| Abnormal heart rhythm: feel your heart beating in your chest, abnormal heartbeat, dizziness or feeling faint | ✓ | ||
| Severe allergic reaction: trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters | ✓ | ||
| Liver disorder: abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine | ✓ | ||
| Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store pms-AZITHROMYCIN at room temperature between 15°C and 30°C
Keep pms-AZITHROMYCIN and all medicines 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 the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.pharmascience.com, or by calling 1-888-550-6060.