Details for: CLAVULIN
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01916882 | CLAVULIN 125 F ORAL SUS | CLAVULANIC ACID (CLAVULANATE POTASSIUM); AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 31.25 MG / 5 ML; 125 MG / 5 ML | POWDER FOR SUSPENSION | ORAL |
| 02238831 | CLAVULIN 200 | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 200 MG / 5 ML; 28.5 MG / 5 ML | POWDER FOR SUSPENSION | ORAL |
| 01916874 | CLAVULIN 250 F ORAL SUS | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 250 MG / 5 ML; 62.5 MG / 5 ML | POWDER FOR SUSPENSION | ORAL |
| 02238830 | CLAVULIN 400 | CLAVULANIC ACID (CLAVULANATE POTASSIUM); AMOXICILLIN (AMOXICILLIN TRIHYDRATE) | 57 MG / 5 ML; 400 MG / 5 ML | POWDER FOR SUSPENSION | ORAL |
| 01916858 | CLAVULIN 500 F TAB | AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM) | 500 MG; 125 MG | TABLET | ORAL |
| 02238829 | CLAVULIN 875 | 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
CLAVULIN is an antibiotic used to treat bacterial infections.
What it does
CLAVULIN’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
When it should not be used
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 CLAVULIN. See What are the ingredients in CLAVULIN.
- you or your child have had a history of:
- jaundice (yellowing of the skin and/or eyes) or liver disease, after taking CLAVULIN.
- you have mononucleosis.
What the medicinal ingredient is
amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium).
What the non-medicinal ingredients are
Tablets: colloidal silica, dimethicone 500, hydroxypropyl methylcellulose (methocel E5), hydroxypropyl
methylcellulose (methocel E15), magnesium stearate, microcrystalline cellulose, polyethylene Glycol 4000,
polyethylene glycol 6000, sodium starch glycollate, titanium dioxide.
Powder for oral suspension: 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 you or your child has a condition called phenylketonuria (PKU), and you must tell your
healthcare professional about this condition.
What dosage form it comes in
CLAVULIN Tablets : 500/125mg and 875/125mg of amoxicillin / clavulanic acid.
CLAVULIN Powder for Oral Suspension : 125/31.25mg, 200/28.5mg, 250/62.5mg and 400/57mg of
amoxicillin / clavulanic acid per 5mL (when reconstituted with purified water).
Warnings and precautions
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 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 CLAVULIN then:
- stop taking CLAVULIN.
- tell your healthcare professional right away.
- have mononucleosis.
- have liver or kidney problems.
- have phenylketonuria (PKU). This is because CLAVULIN has aspartame in it.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed:
- The amoxicillin in CLAVULIN 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 CLAVULIN.
- CLAVULIN treats only bacterial infections, not viral infections like the common cold.
- Although you may feel better early in treatment, use CLAVULIN exactly as directed.
- Using too much CLAVULIN 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).
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
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)
Proper use of this medication
How to take CLAVULIN:
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 CLAVULIN for 48
to 72 hours more depending on how it works for you.
It is better to take CLAVULIN 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
Usual Dose
Adults:
The usual adult does is 1 CLAVULIN 500mg tablet every 12 hours. For more severe infections and
infections of the lower respiratory tract, your healthcare professional may prescribe 1 CLAVULIN 875mg
tablet every 12 hours or 1 CLAVULIN 500mg tablet every 8 hours.
Children:
For children aged 12 weeks (3 months) and older as directed by a healthcare professional:
| Infection | Severity | Twice a day* CLAVULIN -200 CLAVULIN -400 |
Three times a day CLAVULIN -125F CLAVULIN -250F |
|---|---|---|---|
| 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 CLAVULIN is 30mg 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 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 CLAVULIN, 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 CLAVULIN, 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 CLAVULIN 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 CLAVULIN 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.
- indigestion and headache
- mild skin rash or itching
- 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.
| 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 |
|---|---|---|---|
| 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): flulike 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
(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.
How to store
Powder for Oral Suspensions:
Store powder in a dry place at room temperature (15ºC to 25ºC). 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 (4°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.
Tablets:
Store in a dry place at room temperature (15ºC to 25ºC).
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at MedEffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available at MedEffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
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 latest available Patient Medication Information by visiting the Health Canada website; the manufacturer’s website http://www.gsk.ca, or by calling 1-800-387-7374.
This leaflet was prepared by GlaxoSmithKline Inc. Mississauga, Ontario L5N 6L4
Last Revised: January 28, 2020
©2019 GSK Inc. All Rights Reserved
Trademarks are owned by or licensed to the GSK group of companies.