Details for: APO-AMOXI CLAV
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243350 | APO-AMOXI CLAV | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 250 MG; 125 MG | TABLET | ORAL |
| 02243351 | APO-AMOXI CLAV | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 500 MG; 125 MG | TABLET | ORAL |
| 02245623 | APO-AMOXI CLAV | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 875 MG; 125 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Amoxicillin-containing Products - Assessing the Potential Risk of Aseptic Meningitis
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-AMOXI CLAV is an antibiotic used to treat bacterial infections.
What it does
APO-AMOXI CLAV’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
When it should not be used
- you or your child are allergic to:
- amoxicillin.
- beta-lactam antibiotics (such as penicillins and cephalosporins).
- any of the other ingredients of APO-AMOXI CLAV. See What are the ingredients in APO-AMOXI CLAV.
- you or your child have had a history of:
- jaundice (yellowing of the skin and/or eyes).
- liver disease .
- you have mononucleosis.
What the medicinal ingredient is
amoxicillin trihydrate and clavulanate potassium.
What the non-medicinal ingredients are
Cellulose, microcrystalline, Crospovidone, Sodium Starch Glycolate, Ethyl cellulose Dispersion, Colloidal Silicon Dioxide, Magnesium Stearate, Hypromellose, Polyethylene Glycol, Titanium Dioxide.
What dosage form it comes in
APO-AMOXI CLAV Tablets (amoxicillin / clavulanic acid): 250/125 mg, 500/125 mg and 875/125 mg.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-AMOXI CLAV. Talk about any health conditions or problems you may have, including if you:
- or your child have had an allergic reaction (such as a rash) when taking an antibiotic.
- start to have a skin rash while taking APO-AMOXI CLAV then:
- stop taking APO-AMOXI CLAV.
- tell your healthcare professional right away.
- have mononucleosis.
- have liver or kidney problems.
- have phenylketonuria (PKU). This is because APO-AMOXI CLAV has aspartame in it.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed:
- The amoxicillin in APO-AMOXI CLAV is passed into human breast milk. Talk about this with your healthcare professional.
- are taking a birth control pill. Birth control pills may not work as well if you take APO-AMOXI CLAV.
Other warnings you should know about:
- APO-AMOXI CLAV treats only bacterial infections, not viral infections like the common cold.
- Although you may feel better early in treatment, use APO-AMOXI CLAV exactly as directed.
- Using too much APO-AMOXI CLAV or using it in the wrong way may cause:
- more bacteria to grow
- bacteria that will not be killed (resistance).
- it not to work for you in the future (resistance).
Do not share your medicine.
Tell your healthcare professional about all the medicines you or your child are taking, including any
drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- allopurinol or probenecid (for treatment of gout)
- anticoagulants (used to prevent blood clots) such as warfarin
- mycophenolate mofetil (suppressed the immune system)
Proper use of this medication
You must use the medicine as instructed by your healthcare professional. Your healthcare professional will
decide how much medicine you or your child need each day, and how many days you should take it for.
Treatment normally lasts 7 to 10 days. Your healthcare professional may ask you to take APO-AMOXI CLAV
for 48 to 72 hours more depending on how it works for you.
It is better to take APO-AMOXI CLAV at the same time as a meal, but it still works without food.
For the oral suspension:
- shake before use.
- an accurate measuring device (like a measuring spoon) should be used to deliver the dose.
If there is anything you do not understand please ask your healthcare professional.
Usual dose
Adults:
The usual adult does is 1 APO-AMOXI CLAV 500/125 mg tablet every 12 hours or 1 APO-AMOXI CLAV
250/125 mg tablet every 8 hours. For more severe infections and infections of the lower respiratory tract, the dose
should be 1 APO-AMOXI CLAV 875/125 mg tablet every 12 hours or 1 APO-AMOXI CLAV 500/125 mg tablet
every 8 hours.
N.B. Since both the APO-AMOXI CLAV 250/125 mg and APO-AMOXI CLAV 500/125 mg tablets contain the same amount of clavulanic acid (125 mg as the potassium salt) two APO-AMOXI CLAV 250/125 mg tablets are not equivalent to one APO-AMOXI CLAV 500/125 mg tablet. Therefore, two APO-AMOXI CLAV 250/125 mg tablets should not be substituted for one APO-AMOXI CLAV 500/125 mg tablet.
Overdose
Missed Dose
If you or your child miss a dose of APO-AMOXI CLAV, take it as soon as you remember. However, if it is
almost time for the next dose, do not take the missed dose. Instead, continue with your next scheduled dose.
Do not try to make up for the missed dose by taking double the dose next time.
Side effects and what to do about them
Using APO-AMOXI CLAV may cause side effects:
- that are not all listed here. If not listed here, contact your healthcare professional. Side effects may also be explained in Warnings and Precautions.
While taking APO-AMOXI CLAV common side effects can be:
- a yeast infection of the nails, skin, mouth, vagina, stomach or urinary tract.
- nausea (feeling sick) or vomiting.
- diarrhea (loose, or watery bowel movements) in children.
While taking APO-AMOXI CLAV uncommon side effects can be indigestion and headache.
While taking APO-AMOXI CLAV, very rare side effects can be:
- jyour tongue may change colour to yellow, brown or black or look “hairy”.
- your teeth may discolour.
- to reduce or prevent discolouring, brush your teeth thoroughly.
- talk to your dentist or doctor if this does not go away.
Stop taking APO-AMOXI CLAV and contact your healthcare professional immediately if you have:
- severe diarrhea (bloody or watery) with or without fever.
- abdominal pain, tenderness.
These may be signs of Clostridium difficile colitis (bowel inflammation).
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| UNCOMMON | |||
| Allergic reactions with symptoms such as mild rash, itching or hives (itchy lumps) | ✔ | ||
| RARE | |||
| Allergic reactions with symptoms such as a skin reaction which results in itchy reddish purple patches especially on the palms of the hands or soles of the feet | ✔ | ||
| Blood problems, with symptoms such as bleeding, or bruising, more easily than usual | ✔ | ||
| VERY RARE | |||
| Allergic reactions with symptoms such as skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties, mouth ulcers, or a rash with blisters that may cause the skin to peel, flake, or bleed | ✔ | ||
| Central Nervous System problems such as convulsions (fits or seizures) | ✔ | ||
| Liver problems with symptoms such as yellowing of the skin and/or eyes, or dark coloured urine, nausea, vomiting, abdominal pain, fever or unusual tiredness | ✔ | ||
| Kidney problems with symptoms such as blood in the urine which may be associated with a rash, fever, joint pain, or a reduction in passing water (urination) | ✔ | ||
| Digestive system problems with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
How to store
Oral Suspensions:
Store powder in a dry place at room temperature (15°C to 25°C). Use the powder only if its appearance is white
to off-white.
The reconstituted APO-AMOXI CLAV oral suspension (125 mg/31.25 mg per 5 mL and 250 mg/62.5 mg per 5
mL) should be stored under refrigeration and should be used within 10 days.
The reconstituted APO-AMOXI CLAV oral suspension (400 mg/57 mg per 5 mL) should be stored under
refrigeration and should be used within 7 days.
Keep bottle tightly closed at all times.
Tablets:
Store at room temperature (15°C to 30°C), protected from light and moisture.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website ( www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: February 23, 2018