Details for: ERFA-AMIKACIN
Company: ERFA CANADA 2012 INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02489147 | ERFA-AMIKACIN | AMIKACIN (AMIKACIN SULFATE) | 250 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02489147 | ERFA-AMIKACIN | AMIKACIN (AMIKACIN SULFATE) | 250 MG / ML | SOLUTION | INTRAVENOUS |
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
ERFA-AMIKACIN™ is used to treat certain serious bacterial infections:
- of the nose, throat, chest and lungs (respiratorytract)
- in the blood
- of the joints and bones
- of the kidneys and urinary bladder (urinarytract)
- of the lining of the abdomen (peritoneum)
- of the soft tissues
Antibacterial drugs like ERFA-AMIKACIN™ treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, ERFA-AMIKACIN™ should be used exactly as directed. Misuse or overuse of ERFA-AMIKACIN™ could lead to the growth of bacteria that will not be killed by ERFA-AMIKACIN™ (resistance). This means that ERFA-AMIKACIN™ may not work for you in the future.
What it does
ERFA-AMIKACIN™ is an antibiotic. It works by killing or slowing the growth of certain types of bacteria that cause the infection.
When it should not be used
Do not use ERFA-AMIKACIN™ if you:
- you are allergic to amikacin or any other ingredients in the drug (See What are the ingredients in ERFA-AMIKACIN™)
- you are sensitive or allergic to other aminoglycosides
What the medicinal ingredient is
Amikacin as amikacin sulfate
What the non-medicinal ingredients are
sodium metabisulfite, sodium citrate dihydrate, sulfuric acid to adjust pH and water for injection.
What dosage form it comes in
ERFA-AMIKACIN™ is a sterile aqueous solution containing 250 mg/mL of amikacin as amikacin sulfate.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ERFA-AMIKACIN™. Talk about any health conditions or problems you may have, including if you:
- have been or are being treated with other aminoglycosides.
- have drug allergies.
- have kidney problems.
- have hearing or balance problems.
- have myasthenia gravis (a muscle condition) or Parkinson’s disease.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
- have asthma.
- have sulfite sensitivity.
Other warnings you should know about:
- ERFA-AMIKACIN™ and other similar aminoglycosides have been known to cause hearing and balance problems (ototoxicity) and kidney problems (nephrotoxicity). Your doctor will observe you carefully for warning signs of these events after giving you ERFA-AMIKACIN™.
- Your doctor may monitor the level of amikacin sulfate in your blood through blood tests, especially if you are taking, or have taken in the recent past, certain medications that can interact with ERFA-AMIKACIN™.
- The safety for treatment periods which are longer than 14 days has not been established.
- ERFA-AMIKACIN™, like many antibiotics, can cause Clostridium difficile colitis (bowel inflammation caused by a bacterial infection). 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 ERFA-AMIKACIN™ and contact your doctor rightaway.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with ERFA-AMIKACIN™:
- Other antibiotics such as other aminoglycosides (e.g. gentamicin, neomycin, streptomycin, tobramycin), cephalosporins, clindamycin, imipenem, polymixin B, bacitracin, cephaloridine, colistin, paromomycin, penicillin and vancomycin.
- Amphotericin B, a medicine used to treat severe fungal infections.
- Anti-cancer drugs, such as cisplatin.
- Potent diuretics, such as ethacrynic acid, furosemide and mannitol.
- Neuromuscular blocking agents (muscle relaxants such as tubocurarine, succinylcholine and decamethonium)
- Anesthetic agents such as those used during surgery.
- Any drug that may cause kidney or hearingproblems.
Proper use of this medication
ERFA-AMIKACIN™ will be given to you by a healthcare professional either as an injection into a muscle or injection into a vein at a hospital or clinical setting.
Usual Dose
Your doctor will decide the dose that is right for you based on your age, weight and other factors. If you have kidney problems, your doctor may adjust the dosage schedule to suit you.
The usual dose of ERFA-AMIKACIN™ is 7.5 mg/kg of body weight, given every 12 hours, for a total daily dose of 15 mg/kg of body weight, over a period of up to 10 days.
Overdose
If you think you have been given too much ERFA-AMIKACIN, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose
ERFA-AMIKACIN™ is administered by a healthcare professional. If you think you have missed a dose talk to your healthcare professional.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking ERFA-AMIKACIN™. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- rash
- nausea, vomiting
- allergic reaction, such as hives
- difficulty breathing
- headache
- pain at injection site
- fever
- hypotension
- anemia
- tremor
- joint pain
| 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 |
|---|---|---|---|
| Common | |||
| Kidney Problems: blood in urine, change in frequency of urination or amount of urine, weakness, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea, vomiting, fluid retention causing swelling of the legs, ankles or feet | ✔ | ||
| Hearing Problems: trouble hearing or hearing loss with or without ringing in the ears, roaring in the ears, dizziness | ✔ | ||
| UNKNOWN FREQUENCY | |||
| Nervous System Problems: numbness, skin tingling, muscle twitching, convulsions, seizure, trouble breathing | ✔ | ||
| Serious Allergic Reaction (hypersensitivity): swelling of the face, lips, tongue or throat, trouble breathing or swallowing, itching, hives, skin rash with or without blisters or peeling | ✔ | ||
| Inner Ear Problems: loss of balance, dizziness or lightheadedness, sensation of spinning, feeling of constant movement of self or surroundings | ✔ | ||
| Clostridium difficile Colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | ✔ | ||
| Decreased Platelets: bruising, bleeding, fatigue and weakness | ✔ | ||
| Decreased White Blood Cells: infections, fatigue, fever, aches, pains and flu-like symptoms | ✔ | ||
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
ERFA-AMIKACIN™ vials should be protected from light and stored at 15°C - 30°C.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
More information
If you want more information about ERFA-AMIKACIN™:
- 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 Canadawebsite (https://www.canada.ca/en/health-canada.html); the manufacturer’s website (http://www.eci2012.net/index.php), or by calling 1-888-922-3133.
This leaflet was prepared by Erfa Canada 2012 Inc.
Date prepared: May 31, 2019