Patient Medication Information: uses, side effects, how to take - Apo-Amoxi Clav 250mg/62.5mg per 5mL
Serious Warnings and Precautions
Hypersensitivity: Serious allergic reactions including death and severe skin adverse reactions have been reported in patients taking antibiotics, including amoxicillin, one of APO-AMOXI CLAV medicinal ingredients. See ‘Serious side effects and what to do about them’ Table.
What is APO-AMOXI CLAV used for?
APO-AMOXI CLAV is an antibiotic used to treat bacterial infections.
Antibacterial drugs like APO-AMOXI CLAV treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, APO-AMOXI CLAV should be taken exactly as directed. Misuse or overuse of APO-AMOXI CLAV could lead to the growth of bacteria that will not be killed by APO-AMOXI CLAV (resistance). This means that APO-AMOXI CLAV may not work for you in the future. Do not share your medicine.
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 (as trihydrate) and clavulanic acid (as 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: 250/62.5 mg and 400/57 mg of amoxicillin/clavulanic acid per 5 mL (when reconstituted with purified water).
Do not use APO-AMOXI CLAV 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:
- 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.
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 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).
- Methotrexate (used to treat conditions such as cancer and severe psoriasis)
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 250 mg/62.5 mg per 5 mL | ||
| Urinary tract | Mild to moderate | 25 mg per kg per day in divided doses every 12 hours | 20 mg per kg per day in divided doses every 8 hours |
| Skin and Soft Tissue | Severe | 45 mg per kg per day in divided doses every 12 hours | 40 mg per kg per day in divided doses every 8 hours |
| Lower Respiratory Tract, Sinusitis | 45 mg per kg per day in divided doses every 12 hours | 40 mg per kg per day in divided doses every 8 hours | |
Otitis Media (inner ear infection)** | 40 mg 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 days.
Infants and children less than 12 weeks (3 months):
The recommended dose of amoxicillin and clavulanate potassium for oral suspension is 30 mg per kg per day in divided doses every 12 hours as directed by a healthcare professional. The use of other formulations of amoxicillin and clavulanate potassium, 125/31.25 mg per 5 mL oral suspension is recommended for this age group.
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, or a person you are caring for, have taken too much APO-AMOXI CLAV, contact a 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?
These are not all the possible side effects you may have when taking APO-AMOXI CLAV. If you experience any side effects not listed here, tell your healthcare professional.
- very common side effect in adults can be diarrhea (loose, or watery bowel movements)
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
uncommon side effects can be:
- Indigestion and headache
- Mild skin rash or itching
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
APO-AMOXI CLAV can cause abnormal urine tests (for glucose) results or blood test (for pregnancy) results. If you are getting blood or urine tests done, let the healthcare professional know that you are taking APO-AMOXI CLAV.
| 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 | |||
| Blood problems, with symptoms such as bleeding, or bruising, more easily than usual | |||
| 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 | |||
| VERY RARE | |||
| Allergic reactions: difficulty breathing, fever, hives (itchy and red bumps on skin), itching, rash, swelling of your tongue or throat | |||
Central Nervous System (fits or seizures) problems such as convulsions (aseptic meningitis) inflammation of the protective membrane surrounding the brain | |||
| Clostridium difficile colitis (bowel inflammation): with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | |||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe life-threatening reaction): flu-like symptoms with fever, rash, swelling of the face or glands | |||
| 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) | |||
| 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 | |||
| Severe skin reactions: | |||
| 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 | ||
(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 | |||
| Vasculitis (blood vessel inflammation): red or purple raised spots on the skin, fatigue, fever, numbness or weakness | |||
| UNKNOWN FREQUENCY | |||
Cardiovascular Kounis syndrome: chest pain which can be a sign of a potentially serious allergic reaction | |||
| Drug-induced enterocolitis syndrome: repetitive vomiting (1 to 4 hours after taking APO-AMOXI CLAV), stomach pain, abnormal drowsiness, diarrhea and low blood pressure. These can be a sign of a serious allergic reaction | |||
| Linear IgA disease: rash with blisters arranged in a circle with central crusting or like a string of pearls | |||
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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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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 (250 mg/62.5 mg per 5 mL) should be stored under refrigeration and should be used within 10 days. Dispose of any unused suspension 10 days after it is first made up.
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. Dispose of any unused suspension 7 days after it is first made up.
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://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.