Details for: GENTAMICIN INJECTION USP
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02268531 | GENTAMICIN INJECTION USP | GENTAMICIN (GENTAMICIN SULFATE) | 10 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02268531 | GENTAMICIN INJECTION USP | GENTAMICIN (GENTAMICIN SULFATE) | 10 MG / ML | SOLUTION | INTRAVENOUS |
| 02242652 | GENTAMICIN INJECTION USP | GENTAMICIN (GENTAMICIN SULFATE) | 40 MG / ML | SOLUTION | INTRAMUSCULAR |
| 02242652 | GENTAMICIN INJECTION USP | GENTAMICIN (GENTAMICIN SULFATE) | 40 MG / ML | SOLUTION | INTRAVENOUS |
Summary Reports
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
Gentamicin Injection USP is used to treat serious bacterial infections such as:
- blood infections
- chest infections
- infections of system that carries urine out of the body (Urinary tract)
- Bone and tissue infections
- Infected wounds or burns
Antibacterial drugs like Gentamicin Injection USP treat only bacterial infections. They do not treat viral infections. Although you may feel better early in treatment, Gentamicin Injection USP should be used exactly as directed. Misuse or overuse of Gentamicin Injection USP could lead to the growth of bacteria that will not be killed by Gentamicin Injection USP (resistance). This means that Gentamicin Injection USP may not work for you in the future.
What it does
Gentamicin Injection USP is in a class of medications called aminoglycoside antibiotics. It works by preventing bacteria from growing and by killing them.
When it should not be used
- to gentamicin
- other aminoglycosides antibiotics such as amikacin, kanamycin, parmomycin, streptomycin, tobramycin
- any of the other ingredients in Gentamicin Injection USP (see What are the ingredients in Gentamicin Injection USP?)
What the medicinal ingredient is
Gentamicin Injection USP 10 mg per mL and 40 mg per mL contain: Gentamicin as gentamicin sulphate.
What the non-medicinal ingredients are
Gentamicin Injection USP 10 mg per mL and 40 mg per mL contain: disodium edetate dihydrate, sodium bisulfite, sulfuric acid, sodium hydroxide, and water for injection. Gentamicin Injection USP 40 mg per mL also contains: methylparaben and propylparaben
What dosage form it comes in
Gentamicin Injection USP comes a sterile solution (liquid) containing 10 mg per mL or 40 mg per mL of gentamicin as gentamicin sulphate.
Warnings and precautions
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:
- have a history of kidney problems and/or diabetes
- have a history of hearing problems or if you have been treated with medicines that affect hearing in the past (see “The following may interact with Gentamicin Injection USP” section)
- have problems with balance
- have a history of muscles problems such as 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:
Gentamicin Injection USP may harm your hearing or your kidneys (see “Serious Side Effects and What to do About Them” section). While you are using Gentamicin Injection USP, your healthcare professional may do bloodwork to check how your kidneys are working. Sometimes you may also take a hearing test to check if Gentamicin Injection USP is not affecting your hearing.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
- Medications that affect your kidneys or hearing such as:
- Other antibiotics;
- aminoglycosides (e.g. amikacin, kanamycin, parmomycin, streptomycin tobramycin)
- cephalosporins such as cefazolin, cefixime or cephalexin
- clindamycin
- carbenicillin, piperacillin, polymixin B, colistin
- vancomycin
- Amphotericin B, a medicine used to treat fungal infections
- Anti-cancer drugs, such as cisplatin and carboplatin
- Diuretics, “water pills” such as ethacrynic acid or furosemide
- Medicines used to supress the immune system, such as cyclosporine and tacrolimus
- Medications used to reduce fever and inflammation (nonsteroidal anti-inflammatory) such as indomethacin
- Zalcitabine, an HIV medication
- Mannitol
- Medications given during surgery to relax the muscles such as tubocurarine and succinylcholine
- Medicines used to treat myasthenia gravis such as neostigmine and pyridostigmine.
- Magnesium
Many other medications may also interact with gentamicin. Tell your healthcare professional about all the medications you are taking, even those that do not appear on this list.
Proper use of this medication
Your healthcare professional will give Gentamicin Injection USP as a shot into a muscle or as a slow drip through a needle into a large vein (infusion).
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 have been given too much Gentamicin Injection USP, contact your 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.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking Gentamicin Injection USP. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- nausea, vomiting
- decreased appetite
- weight loss
- weakness or tiredness
- increased salivation
- rash (area of itchy, red, irritated or swollen skin)
- hives (red and sometimes itchy bumps on your skin)
- headache
- pain at injection site
- join pain
- fever
| 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: dark-coloured urine, increased/decreased urination, unusual tiredness or weakness, nausea, vomiting, swelling of the arms or legs | ✔ | ||
| Hearing Problems: dizziness, hearing loss, ringing in the ears, problems with balance, sensation of spinning | ✔ | ||
| UNKNOWN FREQUENCY | |||
| Nervous System Problems: trouble walking, dizziness, numbness, skin tingling, muscle twitching, seizure (fits), 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 | ✔ | ||
Decreased of cells in the blood that help the blood clot (Platelets):
|
✔ | ||
| Decreased White Blood Cells: (usually found when your doctor orders tests) more likely to develop 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
Gentamicin Injection USP vials should be protected from light and stored at room temperature (15 – 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) 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
- 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 (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website www.sandoz.ca, or by calling 1-800-361-3062.
This leaflet was prepared by Sandoz Canada Inc.
Last Revised: August 29, 2017