Details for: AMIKACIN SULFATE INJECTION
Company: OMEGA LABORATORIES LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02486717 | AMIKACIN SULFATE INJECTION | AMIKACIN (AMIKACIN SULFATE) | 250 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02486717 | AMIKACIN SULFATE INJECTION | 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
Amikacin Sulfate Injection 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
What it does
Amikacin Sulfate Injection 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 Amikacin Sulfate Injection if you:
- you are allergic to amikacin or any other ingredients in the drug (See What arethe ingredients in Amikacin Sulfate Injection)
- 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
Amikacin Sulfate Injection 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 Amikacin Sulfate Injection. 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’sdisease.
- are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
- have asthma.
- have sulfite sensitivity.
- Amikacin Sulfate Injection 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 Amikacin Sulfate Injection.
- 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 caninteract with Amikacin Sulfate Injection.
- The safety for treatment periods which are longer than 14 days has not been established.
- Amikacin Sulfate Injection, like many antibiotics, can cause Clostridium difficile colitis (bowel inflammation caused by a bacterial infection). If you experience symptoms such assevere 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 Amikacin Sulfate Injection and contact your doctor rightaway.
Interactions with this medication
The following may interact with Amikacin Sulfate Injection:
- Other antibiotics such as other aminoglycosides (e.g. gentamicin, neomycin, streptomycin, tobramycin), cephalosporins, clindamycin, imipenem, polymixin B, bacitracin,cephaloridine, colistin, paromomycin, penicillins 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 andmannitol.
- Neuromuscular blocking agents (muscle relaxants such as tubocurarine, succinylcholine and decamethonium).
- Anesthetic agents such as those used duringsurgery.
- Any drug that may cause kidney or hearingproblems
Proper use of this medication
How to take Amikacin Sulfate Injection:
Amikacin Sulfate Injection 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 Amikacin Sulfate Injection 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
Missed Dose
Amikacin Sulfate Injection 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 Amikacin Sulfate Injection.
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 with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist 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 | ✔ | ||
How to store
Amikacin Sulfate Injection vials should be protected from light and stored at 15°C - 25°C.
Discard unused portion.
Keep out of reach and sight of children
Reporting side effects
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 Amikacin Sulfate 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 Canadawebsite (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.omegalaboratory.com, or by calling1-800-363-0584.
Date prepared: March 15, 2019