Patient Medication Information: uses, side effects, how to take - Apo-Amoxi Clav 125mg/31.25mg per 5mL
What is APO-AMOXI CLAV used for?
APO-AMOXI CLAV is an antibiotic used to treat bacterial infections.
How does APO-AMOXI CLAV work?
APO-AMOXI CLAV’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
What are the ingredients in APO-AMOXI CLAV?
Medicinal ingredients: amoxicillin trihydrate and clavulanate potassium.
Non-medicinal ingredients:
Powder for oral suspension: artificial raspberry-orange flavor, aspartame, silicon dioxide and xanthan gum.
APO-AMOXI CLAV powder for oral suspension contains aspartame, which is a source of phenylalanine. This is important if you or your child has a condition called phenylketonuria (PKU), and you must tell your healthcare professional about this condition.
APO-AMOXI CLAV comes in the following dosage forms:
Powder for Oral Suspension:
125/31.25 mg Amoxicillin/Clavulanic Acid per 5 ml
250/62.5 mg Amoxicillin/Clavulanic Acid per 5 ml
400/57 mg Amoxicillin/Clavulanic Acid per 5 ml.
Do not use if:
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) or liver disease, after taking
APO-AMOXI CLAV
- you have mononucleosis.
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.
The following may interact with APO-AMOXI CLAV:
- allopurinol or probenecid (for treatment of gout)
- anticoagulants (used to prevent blood clots) such as warfarin
- mycophenolate mofetil (suppressed the immune system)
How to take APO-AMOXI CLAV:
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:
Children:
For children aged 12 weeks (3 months) and older as directed by a healthcare professional:
| Infection | Severity | Dosing Regimen | |
Twice a day* APO-AMOXI CLAV 400 mg/57 mg per 5 mL | Three times a day APO-AMOXI CLAV 125 mg/31.25 mg per 5 mL APO-AMOXI CLAV 250 mg/62.5 mg per 5 mL | ||
| Urinary tract | Mild to moderate | 25mg per kg per day in divided doses every 12 hours | 20mg per kg per day in divided doses every 8 hours |
| Skin and Soft Tissue | Severe | 45mg per kg per day in divided doses every 12 hours | 40mg per kg per day in divided doses every 8 hours |
Lower Respiratory Tract, Sinusitis | 45mg per kg per day in divided doses every 12 hours | 40mg per kg per day in divided doses every 8 hours | |
| Otitis Media (inner ear infection)** | 40mg per kg per day in divided doses every 8 hours | ||
*The twice a day regimen is recommended as it is associated with significantly less diarrhea. **Duration of therapy studied and recommended for acute otitis media is 10 day.
Infants and children less than 12 weeks (3 months):
The recommended dose of APO-AMOXI CLAV is 30mg per kg per day in divided doses every 12 hours as directed by a healthcare professional. APO-AMOXI CLAV 125 mg/31.25 mg per 5 mL oral suspension is recommended.
The children’s dosage should not exceed that recommended for adults. Children weighing more than 38 kg should be dosed according to the adult recommendations.
Patients with kidney problems:
If you have kidney problems, your doctor may adjust your dose.
Overdose:
If you think you have taken too much APO-AMOXI CLAV, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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.
What are possible side effects from using APO-AMOXI CLAV?
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, or if they are serious they will be listed in the Serious Side Effects Table below.
While taking APO-AMOXI CLAV a very common side effect in adults can be diarrhea (loose, or watery bowel
movements).
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
- mild skin rash or itching
While taking APO-AMOXI CLAV, very rare side effects can be:
- your 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.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| RARE | |||||
| Erythema multiforme (allergic skin reaction): 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: difficulty breathing, fever, hives (itchy and red bumps on skin), itching, rash, swelling of your tongue or throat | ✓ | ||||
Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe life-threatening reaction): flu-like symptoms with fever, rash, swelling of the face or glands | ✓ | ||||
| Vasculitis (blood vessel inflammation): red or purple raised spots on the skin, fatigue, fever, numbness or weakness | ✓ | ||||
Severe skin reactions: (Steven-Johnson syndrome and toxic epidermal necrolysis) blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals; or more severely, blisters and peeling skin on a lot of the body; body aches or fever (bullous exfoliative dermatitis) red itchy scaly rash with blisters and bumps under the skin (exanthemous pustulosis) widespread red skin rash with small blisters containing pus | ✓ | ||||
| Central Nervous System | |||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
| Only if severe | In all cases | |||
(fits or seizures) problems such as convulsions (aseptic meningitis) inflammation of the protective membrane surrounding the brain | ✓ | |||
| 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) | ✓ | |||
| Clostridium difficile colitis (bowel inflammation): with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✓ | |||
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.
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 (https://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.
Storage:
Powder for 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.
If you want more information about APO-AMOXI CLAV:
- 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 (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp). Find the Patient Medication Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.