Patient Medication Information: uses, side effects, how to take - Ratio-Aclavulanate (Teva Canada)
ABOUT THIS MEDICATION
What the medication is used for:
ratio-ACLAVULANATE is an antibiotic which is used to treat various bacterial infections, as determined by your doctor. It contains two medicinal ingredients: one is a penicillin called amoxicillin and the other is clavulanic acid.
What it does:
ratio-ACLAVULANATE works in 2 ways. Amoxicillin interferes with bacterial cell wall growth leading to bacterial death. Clavulanic acid interferes with bacterial enzymes which destroy antibiotics allowing antibiotics to continue killing bacteria.
When it should not be used:
Do not use ratio-ACLAVULANATE:
- If you or your child currently have or have had a history of an allergy to amoxicillin or beta-lactam antibiotics (such as penicillins and cephalosporins) or any of the other ingredients of ratio-ACLAVULANATE.
- If you or your child currently have or have had a history of jaundice (yellowing of the skin and/or eyes) or liver disease while taking ratio-ACLAVULANATE.
- You have or your doctor believes you have glandular fever (mononucleosis).
What the medicinal ingredient is:
ratio-ACLAVULANATE tablets or powder for oral suspension contain the medicinal ingredients amoxicillin trihydrate and clavulanate potassium.
What the important non-medicinal ingredients are:
ratio-ACLAVULANATE tablets contain: 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 and titanium dioxide.
ratio-ACLAVULANATE powder for oral suspension contains: aspartame, colloidal silica, golden syrup dry flavour, hydroxypropyl methylcellulose, orange dry flavour 1, orange dry flavour 2, raspberry dry flavour, silicone dioxide, succinic acid and xanthan gum.
ratio-ACLAVULANATE 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 doctor about this condition.
What dosage forms it comes in:
ratio-ACLAVULANATE Tablets (amoxicillin / clavulanic acid): 500/125 mg, 875/125 mg.
ratio-ACLAVULANATE 125F and ratio-ACLAVULANATE 250F Powder for Oral Suspension (amoxicillin / clavulanic acid): 125/31.25 mg and 250/62.5 mg per 5 mL (when reconstituted with purified water).
WARNINGS AND PRECAUTIONS
BEFORE you use ratio-ACLAVULANATE talk to your doctor or pharmacist if you or your child:
- Are allergic to amoxicillin or beta-lactam antibiotics (such as penicillins and cephalosporins) or any of the other ingredients of ratio-ACLAVULANATE. If you or your child have had an allergic reaction (such as a rash) when taking an antibiotic, you should talk to your doctor before taking ratio-ACLAVULANATE.
- Develop a skin rash while taking ratio-ACLAVULANATE. Stop taking ratio-ACLAVULANATE and immediately tell your doctor.
- Have glandular fever (mononucleosis) and are prescribed ratio-ACLAVULANATE. Please talk to your doctor before taking ratio-ACLAVULANATE.
- Have liver or kidney problems.
- Suffer from a condition called phenylketonuria (PKU). This is because ratio-ACLAVULANATE 125F and ratio-ACLAVULANATE 250F contain aspartame.
Are pregnant or planning to become pregnant.
- Are breastfeeding or planning to breastfeed. Penicillins including amoxicillin are excreted in human breast milk. Discuss with your doctor.
- Are taking a contraceptive pill as ratio-ACLAVULANATE may reduce the effectiveness of the contraceptive.
INTERACTIONS WITH THIS MEDICATION
Some medicines may cause unwanted effects if they are taken at the same time as ratio-ACLAVULANATE. Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines or supplements, even those that can be bought without a prescription.
Tell your doctor especially if you or your child are taking or using any of the following medicines:
- Allopurinol or probenecid (for treatment of gout)
- Anticoagulants (used to prevent blood clots) such as warfarin.
- Mycophenolate mofetil (suppresses the immune system).
PROPER USE OF THIS MEDICATION
Adults:
The usual adult dose is 1 ratio-ACLAVULANATE 500 mg tablet every 12 hours. For more severe infections and infections of the lower respiratory tract, your doctor may prescribe 1 ratio-ACLAVULANATE 875 mg tablet every 12 hours or 1 ratio-ACLAVULANATE 500 mg tablet every 8 hours.
Children:
For children aged 12 weeks (3 months) and older as directed by a doctor:
| Infection | Severity | Dosing Regimen | |
| Twice a day* | Three times a day | ||
| 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 Track, 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.
The normal duration of treatment is 7 to 10 days. Your doctor may continue this treatment for an additional 48 to 72 hours depending on your response to ratio-ACLAVULANATE.
Infants and children less than 12 weeks (3 months):
The recommended dose of ratio-ACLAVULANATE is 30 mg per kg per day in divided doses every 12 hours as directed by a doctor.
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.
You must follow the doctor’s advice and use the medicine as instructed. Your doctor will decide how much medicine you or your child need each day, and how many days you should take it for.
It is better to take ratio-ACLAVULANATE at the same time as a meal, but ratio-ACLAVULANATE still works if given without food.
If there is anything you do not understand please ask your doctor or pharmacist.
Overdose:
| In case of drug overdose, contact a health care practitioner, 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 ratio-ACLAVULANATE, 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
The following are very rare side-effects that may happen in people taking ratio-ACLAVULANATE:
- The tongue may change colour to yellow, brown or black, and it may have a hairy appearance.
- Teeth discolouration while using ratio-ACLAVULANATE. This is less likely to happen if teeth are cleaned thoroughly, and any discolouration can usually be removed by brushing. If the discolouration does not disappear, ask your doctor or dentist for advice.
These are common side-effects that may happen in people taking ratio-ACLAVULANATE:
- A yeast infection of the nails, skin, mouth, vagina, stomach, urinary tract (mucocutaneous candidiasis)
- Nausea (feeling sick) and vomiting (being sick) in adults and children
- Diarrhea (loose, or watery bowel movements) in children
These are uncommon side-effects that may happen in people taking ratio-ACLAVULANATE:
- Ingestion
- Headache
If you experience symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness, you may have Clostridium difficile colitis (bowel inflammation). If this occurs, stop taking ratio-ACLAVULANATE and contact your healthcare professional immediately.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
|---|---|---|---|
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Uncommon | |||
| Allergic reactions with symptoms such as mild rash, itching or hives (itchy lumps) | X | ||
| 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. | X | ||
| Blood problems with symptoms such as bleeding, or bruising, more easily than usual. | X | ||
| Very Rare | |||
| Allergic reactions with symptoms such as skin itching or rash, swelling of the face, lips, tongue, body or breathing difficulties, mouth | X | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
|---|---|---|---|
| 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) | X | ||
| 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 | X | ||
| 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) | X | ||
| Digestive system problems with symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | X | ||
This is not a complete list of side effects. For any unexpected effects while taking ratio-ACLAVULANATE, contact your doctor or pharmacist.
HOW TO STORE IT
Store all medicines out of the reach of children, preferably in a locked cupboard.
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 ratio-ACLAVULANATE 125F and ratio-ACLAVULANATE 250F oral suspension should be stored under refrigeration and should be used within 10 days.
Keep bottle tightly closed at all times.
Tablets:
Store in a dry place at room temperature (15°C – 25°C).
REPORTING SUSPECTED 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:
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- Report online at www.healthcanada.gc.ca/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 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/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
This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited
at: 1-800-268-4127 ext. 1255005 (English)
or druginfo@tevacanada.com
or 1-877-777-9117 (French)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9