Patient Medication Information: uses, side effects, how to take - M-Amoxi Clav
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 M-AMOXI CLAV’s medicinal ingredients. See ‘Serious side effects and what to do about them’ Table.
What is M-AMOXI CLAV used for?
M-AMOXI CLAV is an antibiotic used to treat bacterial infections.
Antibacterial drugs like M-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, M-AMOXI CLAV should be taken exactly as directed. Misuse or overuse of M-AMOXI CLAV could lead to the growth of bacteria that will not be killed by M-AMOXI CLAV (resistance). This means that M-AMOXI CLAV may not work for you in the future. Do not share your medicine.
How does M-AMOXI CLAV work?
M-AMOXI CLAV’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
What are the ingredients in M-AMOXI CLAV?
Medicinal ingredients: amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium).
Non-medicinal ingredients: carmellose sodium, citric acid anhydrous, colloidal silica, mannitol, microcrystalline cellulose, silicon dioxide, sodium citrate anhydrous, sucralose, tutti frutti flavour, vanilla flavour and, xanthan gum.
M-AMOXI CLAV comes in the following dosage forms:
M-AMOXI CLAV Powder for Oral Suspension: 250/62.5 mg and 400/57mg of amoxicillin / clavulanic acid per 5mL (when reconstituted with purified water).
Do not use M-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 M-AMOXI CLAV (see What are the ingredients in M-AMOXI CLAV?)
You or your child have had a history of:
- Jaundice (yellowing of the skin and/or eyes) or liver disease, after taking M-AMOXI CLAV
- You have mononucleosis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take M-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 M-AMOXI CLAV then:
- stop taking M-AMOXI CLAV.
- tell your healthcare professional right away.
- Have mononucleosis.
- Have liver or kidney problems.
Are pregnant or planning to become pregnant.
Are breastfeeding or planning to breastfeed:
- The amoxicillin in M-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 M-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 M-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 M-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 M-AMOXI CLAV for 48 to 72 hours more depending on how it works for you.
It is better to take M-AMOXI CLAV at the same time as a meal, but it still works without food.
For the oral suspension:
- Shake before use.
- Please administer using the syringe provided by your pharmacist to ensure the correct dose is given.
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* 200 mg amoxicillin and 28.5 mg clavulanic Acid*** 400 mg amoxicillin and 57 mg clavulanic Acid | Three times a day 125 mg amoxicillin and 31.25 mg clavulanic acid*** 250 mg amoxicillin and 62.5 mg clavulanic acid | ||
| 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 |
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*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.
*** M-AMOXI-CLAV is only available in strengths of 250 mg amoxicillin / 62.5 mg clavulanic acid and of 400 mg amoxicillin / 57 mg clavulanic acid.
Infants and children less than 12 weeks (3 months):
The recommended dose of M-AMOXI CLAV is 30mg per kg per day in divided doses every 12 hours as directed by a healthcare professional. 125 mg amoxicillin / 31.25 mg clavulanic acid per 5 mL for oral suspension is recommended. M-AMOXI CLAV is NOT available at the strength of 125 mg amoxicillin / 31.25 mg clavulanic acid or 200 mg amoxicillin / 28.5 mg clavulanic acid.
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 M-AMOXI CLAV, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you or your child miss a dose of M-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 M-AMOXI CLAV?
These are not all the possible side effects you may have when taking M-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
M-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 M-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 | ✓ | ||
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 | ||
| 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: (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 | ✓ | ||
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 | ||
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 M-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 | ✓ | ||
| 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 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: Store at room temperature (15-30°C) in its original carton to protect from light and moisture. Use the powder only if its colour is white to off-white.
The reconstituted M-AMOXI CLAV (250 mg / 62.5 mg per 5 mL) 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 M-AMOXI CLAV (400 mg / 57 mg per 5 mL) oral suspension 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 M-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); or by contacting Mantra Pharma Inc. at medinfo@mantrapharma.ca or at 1-833-248-7326.
Mantra Pharma Inc.
1000 rue du Lux, Suite 201
Brossard, Quebec
J4Y 0E3