Patient Medication Information: uses, side effects, how to take - Amoxicillin Sodium and Potassium Clavulanate for Injection
What is Amoxicillin Sodium and Potassium Clavulanate for Injection used for?
Amoxicillin Sodium and Potassium Clavulanate for Injection is used to treat certain bacterial infections including infections of the:
- Nose, ear, and throat
- Respiratory tract
- Genitals and urinary tract
- Skin and soft tissue
- Bone and joints
- Abdominal organs
- Amoxicillin Sodium and Potassium Clavulanate for Injection is also used to help stop infections in patients having surgery.
How does Amoxicillin Sodium and Potassium Clavulanate for Injection work?
Amoxicillin Sodium and Potassium Clavulanate for Injection is an antibiotic. It belongs to a group of antibiotics called penicillins. Amoxicillin works by killing bacteria that cause infections. It does this by preventing them from making their cell walls. Clavulanic acid helps amoxicillin kill bacteria.
Antibacterial drugs like Amoxicillin Sodium and Potassium Clavulanate for Injection treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, Amoxicillin Sodium and Potassium Clavulanate for Injection should be taken exactly as
Serious Warnings and Precautions
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directed. Misuse or overuse of Amoxicillin Sodium and Potassium Clavulanate for Injection could lead to the growth of bacteria that will not be killed by Amoxicillin Sodium and Potassium Clavulanate for Injection (resistance). This means that Amoxicillin Sodium and Potassium Clavulanate for Injection may not work for you in the future. Do not share your medicine.
What are the ingredients in Amoxicillin Sodium and Potassium Clavulanate for Injection?
Medicinal ingredients: Amoxicillin (as amoxicillin sodium) and clavulanic acid (as clavulanate potassium)
Non-medicinal ingredients: None
Amoxicillin Sodium and Potassium Clavulanate for Injection comes in the following dosage forms:
Powder for solution: 500 mg / 100 mg, 1000 mg / 200 mg, 2000 mg / 200 mg
Container composition:
Clear 20 mL (Type II) glass vials with Bromobutyl rubber stoppers and polypropylene-aluminum bordered caps. The stopper is not made with natural rubber latex.
Do not use Amoxicillin Sodium and Potassium Clavulanate for Injection if:
- you are allergic to amoxicillin or clavulanic acid or any ingredients in this drug , including the components of the container (see What are the ingredients in Amoxicillin Sodium and Potassium Clavulanate for Injection?).
you are allergic to beta-lactam antibiotics such as medications from the following:
- penicillins
- carbapenems
- monobactams
- cephalosporins
- you have a previous history of amoxicillin/ clavulanic acid associated jaundice (yellowing of the skin and/or eyes) and / or liver disease.
- you have a disease called mononucleosis.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Amoxicillin Sodium and Potassium Clavulanate for Injection. Talk about any health conditions or problems you may have, including if you:
have allergies to:
- other antibiotics, in particular penicillins and cephalosporines. If you are allergic to any of these antibiotics you may be allergic to Amoxicillin Sodium and Potassium Clavulanate for Injection.
- any other drugs or any other substances such as foods, preservatives or dyes.
have any medical conditions, especially:
- kidney problems
- liver problems
- controlled potassium intake
- mononucleosis (glandular fever)
are pregnant or intend to become pregnant.
- are breast-feeding or plan to breast-feed.
Other warnings you should know about:
- Clostridium difficile colitis (bowel inflammation): If you develop severe diarrhea (very loose or watery stool), tell your healthcare professional right away. Do this even if it occurs several weeks after you stopped taking Amoxicillin Sodium and Potassium Clavulanate for Injection. Diarrhea may mean that you have a serious condition affecting your bowel (colitis). You may need urgent medical care. Do not try to treat loose stools without first checking with your healthcare professional (see the Serious side effects and what to do about them table below).
Allergic reactions: If you develop the following while receiving Amoxicillin Sodium and Potassium Clavulanate for Injection:
- itching with swelling
- skin rash
- difficulty breathing
Tell your healthcare professional immediately.
Driving and using machinery: Amoxicillin Sodium and Potassium Clavulanate for Injection can have side effects that make you unable to drive. Before driving a vehicle or using machinery wait to see how you feel after taking Amoxicillin Sodium and Potassium Clavulanate for Injection.
- Laboratory tests: If you have to have any blood or urine tests, tell your healthcare professional you are being given Amoxicillin Sodium and Potassium Clavulanate for Injection. It may affect the results of some blood and urine tests.
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 Amoxicillin Sodium and Potassium Clavulanate for Injection:
- medicines to treat gout and stone formations (including allopurinol and probenecid).
- medicines to suppress the immune system (including methotrexate, used to treat cancer and severe psoriasis, and mycophenolate mofetil).
- medicines used for birth control (contraceptive pills). You may need to use extra birth control methods such as condoms.
- medicines to prevent blood clots (including warfarin).
Avoid drinking alcohol during treatment and several days after treatment.
How to take Amoxicillin Sodium and Potassium Clavulanate for Injection:
Your healthcare professional will give you Amoxicillin Sodium and Potassium Clavulanate for Injection by:
- Intravenous injection (shot into the vein or by drip tube)
- Intravenous infusion (injected slowly into a vein)
Usual dose:
Your healthcare professional will decide how much, how often and how long you will receive Amoxicillin Sodium and Potassium Clavulanate for Injection. This will be based on the severity and type of infection and your body weight.
Overdose:
| If you think you, or a person you are caring for, have taken too much Amoxicillin Sodium and Potassium Clavulanate for Injection, 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:
The injection will be given to you by your healthcare professional. They will monitor your response and condition to decide what treatment is needed. If you miss an appointment, call your doctor or nurse for instructions.
What are possible side effects from using Amoxicillin Sodium and Potassium Clavulanate for Injection?
These are not all the possible side effects you may have when taking Amoxicillin Sodium and Potassium Clavulanate for Injection. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Headache
- Nausea
- Vomiting
- Diarrhea
- Indigestion
- Dizziness
- Itching
- Hives
- Soreness of the mouth or tongue
- Yeast infections (thrush) of the mouth, scalp, skin, and nails.
During treatment, you may also have side effects of abnormal blood test results including:
- low number of white blood cells
- low number of cells involved in blood clotting
- blood takes longer to clot
- high level of enzymes related to the liver
- crystals in urine
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 | |||
| Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | X | ||
| Thrombophlebitis (blood clot of the vein): swelling and redness along a vein, tender to the touch | X | ||
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 | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blister or crust in the center; possibly swollen lips, mild itching or burning | X | ||
Severe Cutaneous Adverse Reactions (SCAR) (severe skin reactions that may also affect other organs):
| X | ||
| NOT KNOWN | |||
| Anaphylaxis (allergic reaction): wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy rash (hives) or fainting | X | ||
| Kounis syndrome (heart problems caused by an allergic reaction): symptoms of anaphylaxis (see above), chest pain, chest pressure or discomfort, heart palpitations, nausea or vomiting, sweating, shortness of breath, fatigue, clammy skin, feeling anxious or faint, disorientation, upset stomach | X | ||
Drug-induced enterocolitis syndrome: repetitive vomiting (1 | X | ||
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 | ||
to 4 hours after taking Amoxicillin Sodium and Potassium Clavulanate for Injection), 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 | X | ||
| Hypersensitivity vasculitis (Inflammation of the blood vessels): rash, red spots, hives, and blisters on the lower part of the body | X | ||
| Convulsions | X | ||
| Aseptic meningitis (inflammation of the brain lining): fever, headache, body aches, vomiting, fatigue | X | ||
| Antibiotic-associated colitis (inflammation of the colon): severe diarrhea, passing of blood with stool, fatigue, fever | X | ||
| Liver problems: fatigue, fever, body ache, dark urine or pale stools, difficulty to urinate, yellowing of the skin and/or eyes | X | ||
| Stevens-Johnson syndrome (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | X | ||
| Toxic Epidermal Necrolysis (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | X | ||
| Bullous Exfoliative | X | ||
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 | ||
| Dermatitis: widespread red skin rash with small pus-containing blisters | |||
| Acute Generalised Exanthemous Pustulosis (AGEP): a red, scaly rash with bumps under the skin and blisters | X | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect more than one or more organs): fever, severe rash, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinate less often, less urine | X | ||
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:
Amoxicillin Sodium and Potassium Clavulanate for Injection should be stored at room temperature between 15°C to 30°C.
It should be used within 15 minutes after reconstitution.
Keep out of reach and sight of children.
If you want more information about Amoxicillin Sodium and Potassium Clavulanate for Injection:
- 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; the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.