Patient Medication Information: uses, side effects, how to take - Jamp Amoxi Clav Suspension
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 JAMP Amoxi Clav Suspension’s medicinal ingredients. See ‘Serious side effects and what to do about them’ table.
What is JAMP Amoxi Clav Suspension used for?
JAMP Amoxi Clav Suspension is an antibiotic used to treat bacterial infections.
Antibacterial drugs like JAMP Amoxi Clav Suspension treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, JAMP Amoxi Clav Suspension should be taken exactly as directed. Misuse or overuse of JAMP Amoxi Clav Suspension could lead to the growth of bacteria that will not be killed by JAMP Amoxi Clav Suspension (resistance). This means that JAMP Amoxi Clav Suspension may not work for you in the future. Do not share your medicine.
How does JAMP Amoxi Clav Suspension work?
JAMP Amoxi Clav Suspension’s ingredients work in 2 ways. Amoxicillin causes bacterial death. Clavulanic acid helps amoxicillin kill bacteria.
What are the ingredients in JAMP Amoxi Clav Suspension?
Medicinal ingredients: amoxicillin (as trihydrate) and clavulanic acid (as clavulanate potassium)
Non-medicinal ingredients: citric acid, golden syrup flavour, hypromellose, magnesium stearate, orange flavour, raspberry flavour, silica hydrophobic colloid, silicon dioxide, sodium benzoate, sucralose and xanthan gum.
JAMP Amoxi Clav Suspension comes in the following dosage forms:
JAMP Amoxi Clav Suspension Powder for Oral Suspension: 200 / 28.5 mg, 250 / 62.5 mg and 400 / 57 mg of amoxicillin / clavulanic acid per 5 mL (when reconstituted with purified water).
Do not use JAMP Amoxi Clav Suspension if:
You or your child are allergic to:
- Amoxicillin
- Beta-lactam antibiotics (such as penicillins and cephalosporins)
- Any of the other ingredients of JAMP Amoxi Clav Suspension (see What are the ingredients in JAMP Amoxi Clav Suspension)
You or your child have a history of:
- Jaundice (yellowing of the skin and / or eyes) or liver disease, after taking JAMP Amoxi Clav Suspension
- You have mononucleosis
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JAMP Amoxi Clav Suspension. 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 JAMP Amoxi Clav Suspension then:
- stop taking JAMP Amoxi Clav Suspension.
- 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 JAMP Amoxi Clav Suspension 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 JAMP Amoxi Clav Suspension.
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 JAMP Amoxi Clav Suspension:
- 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 JAMP Amoxi Clav Suspension:
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 JAMP Amoxi Clav Suspension for 48 to 72 hours more depending on how it works for you.
It is better to take JAMP Amoxi Clav Suspension 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, 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* JAMP Amoxi Clav Suspension -200 JAMP Amoxi Clav Suspension -400 | Three times a day 125 mg amoxicillin / 31.25 mg clavulanic acid per 5 mL for oral suspension*** JAMP Amoxi Clav Suspension -250 | ||
| 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.
***JAMP Amoxi Clav Suspension is NOT available at the strength of 125 mg amoxicillin / 31.25 mg clavulanic acid.
Infants and children less than 12 weeks (3 months):
The recommended dose of JAMP Amoxi Clav Suspension is 30 mg 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. JAMP Amoxi Clav Suspension is NOT available at the strength of 125 mg amoxicillin / 31.25 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 JAMP Amoxi Clav Suspension, 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 JAMP Amoxi Clav Suspension, 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 JAMP Amoxi Clav Suspension?
These are not all the possible side effects you may have when taking JAMP Amoxi Clav Suspension. 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
JAMP Amoxi Clav Suspension 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 JAMP Amoxi Clav Suspension.
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 | ✓ | ||
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 | ||
| 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 | ✓ | ||
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 | ||
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 (exanthematous 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 JAMP Amoxi Clav Suspension), 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 | ✓ | ||
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 | |
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. |
|---|
Storage:
Store powder in a dry place at room temperature, 15-25°C. Use the powder only if its colour is white to off-white.
The reconstituted JAMP Amoxi Clav Suspension-250 oral suspension should be stored under refrigeration (2-8°C) and should be used within 10 days. Dispose of any unused suspension 10 days after it is first made up.
The reconstituted JAMP Amoxi Clav Suspension -200 and JAMP Amoxi Clav Suspension -400 oral suspensions should be stored under refrigeration (2-8°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 JAMP Amoxi Clav Suspension:
- 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 calling 1-866-399-9091.
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada