Patient Medication Information: uses, side effects, how to take - Clavulin 125 F Oral Sus
Serious warnings and precautions box
Hypersensitivity: Serious allergic reactions including death and severe skin adverse reactions have been reported in patients taking antibiotics, including amoxicillin, one of CLAVULIN’s medicinal ingredients. See the Serious side effects and what to do about them table below for more information on this and other serious side effects.
What CLAVULIN is used for:
CLAVULIN is an antibiotic used to treat bacterial infections in children less than 18 years of age.
Antibacterial drugs like CLAVULIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, CLAVULIN should be taken exactly as directed. Misuse or overuse of CLAVULIN could lead to the growth of bacteria that will not be killed by CLAVULIN (resistance). This means that CLAVULIN may not work for you in the future. Do not share your medicine.
How CLAVULIN works:
CLAVULIN’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
The ingredients in CLAVULIN are:
Medicinal ingredients: amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium)
Non-medicinal ingredients: aspartame, colloidal silica, golden syrup flavour, hydroxypropyl methylcellulose, orange flavour, raspberry flavour, silicon dioxide, succinic acid, xanthan gum.
CLAVULIN powder for oral suspension contains aspartame, which is a source of phenylalanine. This is important if your child has a condition called phenylketonuria (PKU), and you must tell your healthcare professional about this condition.
CLAVULIN comes in the following dosage form:
Powder for Oral Suspension: 125 mg / 31.25 mg, 200 mg / 28.5 mg, 250 mg / 62.5 mg and 400 mg / 57 mg of amoxicillin / clavulanic acid per 5 mL (when reconstituted with purified water).
Do not use CLAVULIN if:
your child is allergic to:
- amoxicillin
- beta-lactam antibiotics (such as penicillins and cephalosporins)
- any of the other ingredients of CLAVULIN (see The ingredients in CLAVULIN are)
your child has a history of:
- jaundice (yellowing of the skin and/or eyes) or liver disease, after taking CLAVULIN
- your child has mononucleosis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take CLAVULIN. Talk about any health conditions or problems you may have, including if your child:
- has had an allergic reaction (such as a rash) when taking an antibiotic.
starts to have a skin rash while taking CLAVULIN then:
- stop taking CLAVULIN.
- tell your healthcare professional right away.
- has liver or kidney problems.
- has phenylketonuria (PKU). This is because CLAVULIN has aspartame in it.
is pregnant or planning to become pregnant.
is breastfeeding or planning to breastfeed:
- The amoxicillin in CLAVULIN is passed into human breast milk. Talk about this with your healthcare professional.
- is taking a birth control pill. Birth control pills may not work as well if you take CLAVULIN.
Tell your healthcare professional about all the medicines your child takes, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with CLAVULIN:
- 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 CLAVULIN:
- Your child must use the medicine as instructed by their healthcare professional. Your child’s healthcare professional will decide how much medicine your child needs each day, and how many days they should take it for. If you have any questions, talk to your child’s healthcare professional.
- Treatment normally lasts 7 to 10 days. Your healthcare professional may ask your child to take CLAVULIN for 48 to 72 hours more depending on how it works for them.
It is better to take CLAVULIN at the same time as a meal, but it still works without food.
- Shake the bottle before use.
- An accurate measuring device (like a measuring spoon) should be used to deliver the dose.
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* CLAVULIN -200 CLAVULIN -400 | Three times a day CLAVULIN -125F CLAVULIN -250F | ||
| 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 CLAVULIN is 30 mg per kg per day in divided doses every 12 hours as directed by a healthcare professional. CLAVULIN -125F 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 adult recommendations.
Patients with kidney problems:
If your child has kidney problems, your healthcare professional may adjust their dose.
Overdose:
If you think you, or a person you are caring for, have taken too much CLAVULIN, 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 your child misses a dose of CLAVULIN, have them 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 their next scheduled dose. Do not try to make up for the missed dose by taking double the dose next time.
Possible side effects from using CLAVULIN:
These are not all the possible side effects your child may have when taking CLAVULIN. If your child experiences any side effects not listed here, tell your healthcare professional.
Side effects may include:
- diarrhea
- nausea, vomiting
- indigestion
- tongue discolouration (yellow, brown, black or “hairy” looking)
- teeth discolouration (brush teeth thoroughly to help prevent discolouration)
- yeast infection of the nails, skin, mouth, vagina, stomach or urinary tract
- mild skin rash or itching
- headache
CLAVULIN can cause abnormal urine tests (for glucose) results or blood test (for pregnancy) results. If your child is getting blood or urine tests done, let the healthcare professional know that they are taking CLAVULIN.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Rare | |||
| Blood problems: 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 | ✓ | ||
| Aseptic meningitis (inflammation of the protective membrane surrounding the brain): confusion, fever, nausea, fatigue, sudden headache or stiffness of your neck, sensitivity to light, vomiting | ✓ | ||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✓ | ||
| Convulsions: seizures, spasms, shaking or fits | ✓ | ||
| 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: blood in the urine which may be associated with a rash, fever, joint pain, passing less urine | ✓ | ||
| Liver problems: yellowing of the skin and/or eyes, or dark coloured urine, nausea, vomiting, abdominal pain, fever or unusual tiredness | ✓ | ||
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 | ✓ | ||
| Vasculitis (blood vessel inflammation): red or purple raised spots on the skin, fatigue, fever, numbness or weakness | ✓ | ||
| Unknown | |||
| Drug-induced enterocolitis syndrome: repetitive vomiting (1 to 4 hours after taking CLAVULIN), stomach pain, abnormal drowsiness, diarrhea and low blood pressure. These can be a sign of a serious allergic reaction | ✓ | ||
| Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) (condition where your white blood cells attack your organs and other blood cells): fever, enlarged liver and spleen, swollen lymph nodes, skin rashes, problems related to nerves, such as shaking or tremor, confusional state, yellowing of the skin and eyes, breathing problems, stomach ache, vomiting, diarrhea, headache, trouble walking, feeling weak, bleeding and/or bruising more easily. This can be potentially life-threatening. | ✓ | ||
| Kounis syndrome: a mixture of symptoms and signs of an allergic reaction and heart attack or unstable angina, with chest pain, shortness of breath, faintness, nausea, vomiting, fainting, itching, skin rash, sudden, heavy sweating, unusual paleness, palpitations, low blood pressure, slow heartbeat | ✓ | ||
| Linear IgA disease: rash with blisters arranged in a circle with central crusting or like a string of pearls | ✓ | ||
| Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE): a red rash commonly seen on both sides of buttocks, upper inner thighs, armpits, and neck | ✓ | ||
If your child has a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with their 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:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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 powder in a dry place at room temperature (15°C to 25°C). Use the powder only if its colour is white to off-white.
The reconstituted CLAVULIN -125F and CLAVULIN -250F oral suspension should be stored under refrigeration (2°C to 8°C) and should be used within 10 days. Dispose of any unused suspension 10 days after it is first made up.
The reconstituted CLAVULIN -200 and CLAVULIN -400 oral suspensions should be stored under refrigeration (2°C to 8°C) 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.
Keep out of reach and sight of children.
If you want more information about CLAVULIN:
- 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 website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gsk.ca; or by calling 1-800-387-7374.
Date of Authorization: 2026-04-24
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