Gentamicin Injection USP (Hikma Canada): Uses, Side Effects and Dosage

What is Gentamicin Injection USP used for?

Gentamicin Injection USP is used only to treat serious and life-threatening infections that are proven or strongly suspected to be caused by certain bacteria for the following:

• Bacteria in the blood.
• Lung infections.
• Urinary tract infections.
• Bone and soft tissue infections.
• Infected wounds – both surgical and through injury.
• Burns that are complicated by infection.

How does Gentamicin Injection USP work?

Gentamicin Injection USP interferes with the production of certain bacterial substances needed in the bacterial cell wall. This causes the bacteria to die.

What are the ingredients in Gentamicin Injection USP?

Medicinal ingredient: Gentamicin as gentamicin sulfate.

Non-medicinal ingredients: Methylparaben (40 mg/mL strength only), propylparaben (40 mg/mL strength only), sodium metabisulfite, sulfuric acid, sodium hydroxide and water for

Serious Warnings and Precautions

• Gentamicin Injection USP can potentially harm your kidneys. Your healthcare professional will do bloodwork to monitor your kidney function while you are taking Gentamicin Injection USP Contact your healthcare professional immediately if you notice a change in the amount or colour (dark brown) of your urine.
• Gentamicin Injection USP can potentially harm your hearing. Your hearing should be closely monitored while you are taking Gentamicin Injection USP. Contact your healthcare professional immediately if you develop hearing loss or ringing in the ears.
• Tell your healthcare professional about all the medications you are taking as some medications may also cause kidney and hearing problems or may add to the kidney or hearing problems caused by Gentamicin Injection USP.

Injection.

Gentamicin Injection USP comes in the following dosage forms:

Gentamicin Injection USP is a sterile solution containing 10 mg/mL or 40 mg per mL of gentamicin as gentamicin sulfate.

Do not use Gentamicin Injection USP if:

• you have a history of hypersensitivity or serious allergic reaction to gentamicin, other aminoglycosides, or any of the other ingredients in Gentamicin Injection USP.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Gentamicin Injection USP. Talk about any health conditions or problems you may have, including if you:

• Were treated with aminoglycosides in the past.
• Have a history of kidney problems and/or diabetes.
• Are taking a diuretic like furosemide/Lasix.
• Have a history of Clostridium difficile-associated disease (CDAD).
• Have a history of hearing problems.
• Have a history of myasthenia gravis or Parkinson’s disease.

• Are pregnant or planning to become pregnant.

• Are breastfeeding or planning to breastfeed.

Other warnings you should know about:

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 Gentamicin Injection USP and contact your healthcare professional immediately.

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 Gentamicin Injection USP:

• Other antibiotics such as aminoglycosides (e.g. amikacin, kanamycin, parmomycin, streptomycin, tobramycin), cephalosporins, clindamycin, carbenicillin, piperacillin, polymixin B, colistin and vancomycin.
• Amphotericin B, a medicine used to treat fungal infections.
• Anti-cancer drugs, such as cisplatin and carboplatin.
• Diuretics, “water pills” such as furosemide.
• Medicines used to supress the immune system, such as cyclosporine and tacrolimus.
• Zalcitabine, an HIV medication.
• Neuromuscular blocking agents used for anesthesia during surgery.
• Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine.
• Magnesium.
• Mannitol.
• Certain vaccines, such as live typhoid and BCG (Bacillus of Calmette and Guerin).
• Indomethacin, a nonsteroidal anti-inflammatory drug (NSAID) used to reduce fever and inflammation.
• Any drug that may cause kidney or hearing problems.

How to take Gentamicin Injection USP:

Gentamicin Injection USP will be given to you by your healthcare professional either as an injection into a muscle or directly into your vein. Your healthcare professional will decide on the dose that is right for you.

Usual dose:

Your healthcare professional will decide on the dose that is right for you. This will depend on your age, weight, type of infection and how well your kidneys are working.

Your healthcare professional will also tell you how long to use Gentamicin Injection USP.

Ask your healthcare professional if you have any questions about how many doses of Gentamicin Injection USP you will need or when you will receive them.

Overdose:

If you think you, or a person you are caring for, have taken too much Gentamicin Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Gentamicin Injection USP is administered by a healthcare professional. If you think you have missed a dose talk to your healthcare professional.

What are possible side effects from using Gentamicin Injection USP?

These are not all the possible side effects you may have when taking Gentamicin Injection USP. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Nausea, vomiting
• decreased appetite
• rash, itchy or red skin
• allergic reaction such as hives
• difficulty sleeping
• headache, dizziness or light-headedness
• tiredness
• swelling
• pain at injection site
• fever
• depression
• anxiety, confusion

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:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.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.

Storage:

Gentamicin Injection USP ampoules should be protected from light and stored at room temperature (15 – 30^oC).

Keep out of reach and sight of children.

If you want more information about Gentamicin Injection USP:

• 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 1-800-656-0793.

Hikma Canada Limited

Mississauga, Ontario

L5R 3P9

Last Revised: May 2, 2022