Gentamicin(E) 120mg Liq IV 1.2mg/mL: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

This medication is an antibiotic that belongs to a group of medicines called aminoglycosides. It is used to treat bacterial infections such as:

• Septicemia (infection of the blood)
• Respiratory tract infections
• Urinary tract infections
• Bone, skin and soft tissue infections (including burns)

• Intra-abdominal infections (including inflammation of the

  abdominal lining)

What it does:

This medication is an antibiotic that works by helping to stop bacterial protein synthesis which prevents growth and kills the bacteria.

When it should not be used:

You should not receive this medication if:

• You are allergic to gentamicin or any other

  aminoglycoside.

• You are allergic to any of the nonmedicinal

  ingredients (see “What the important nonmedicinal ingredients are:”).

What the medicinal ingredients is:

Gentamicin (as sulfate)

What the important nonmedicinal ingredients are:

Sodium Chloride

Sodium Hydroxide or Sulfuric Acid (For pH adjustment) Water for Injection

What dosage forms it comes in:

Gentamicin(e) (Gentamicin (as sulfate) in 0.9% sodium chloride injection) 1.0 mg/mL

Gentamicin(e) (Gentamicin (as sulfate) in 0.9% sodium chloride injection) 1.2 mg/mL

Gentamicin(e) (Gentamicin (as sulfate) in 0.9% sodium chloride injection) 1.6 mg/mL

WARNINGS AND PRECAUTIONS

Gentamicin(e) can cause neuromuscular blockade (interfered muscle action) which can cause respiratory paralysis (difficulty breathing). If you develop breathing difficulties, contact your doctor immediately.

BEFORE receiving this medication tell your doctor, pharmacist or nurse if you:

• Have or have had any medical conditions, such as the following:

  • Kidney problems
  • Hearing problems
  • Neuromuscular problems (such as myasthenia gravis or Parkinson’s disease)

  • Are taking any medications (see Interactions With

    This Medication)

• Have severe liver problems
• Suffer from heart failure
• Are allergic to gentamicin, any of its nonmedicinal ingredients or any other medicines for bacterial infections

• Are pregnant or intend to become pregnant

• Are breastfeeding or plan to breast feed

INTERACTIONS WITH THIS MEDICATION

Tell your doctor, pharmacist or nurse if you are taking any other medicines, including any that you buy without a Serious Warnings and Precautions

• Aminoglycosides, including Gentamicin(e), may cause kidney problems and your doctor may monitor your kidney function (see Warnings below). Contact your doctor if you develop symptoms such as dark-coloured urine, increased or decreased urination, weakness, or dizziness.
• Aminoglycosides, including Gentamicin(e), may cause hearing problems and hearing loss (see Side Effects).
• Tell your doctor about all the medications you are taking as some other medications may also cause or add to kidney problems caused by Gentamicin(e).

prescription from your pharmacy, supermarket or health food store. Some medicines and Gentamicin(e) may interface with each other. Examples of such drugs include but are not limited to:

• Other antibiotics such as cephalosporins, clindamycin,

  piperacillin, polymixin B and vancomycin

• Amphotericin B, an anti-fungal medicine
• Anti-cancer drugs, such as cisplatin and carboplatin
• Diuretics, such as furosemide

• Immunosuppressants, such as cyclosporine and

  tacrolimus

• Zalcitabine, an HIV medication
• Neuromuscular blocking agents used for anesthesia
• Magnesium
• Mannitol
• Live typhoid vaccine
• Any drug that may cause kidney or hearing problems

The above medicines may affect the way Gentamicin(e) works or be affected by Gentamicin(e). You may need different amounts of your medicine, or you may need to take a different medicine. Your doctor will advise you about continuing to take other medicines while you are receiving Gentamicin(e).

PROPER USE OF THIS MEDICATION

Usual dose:

This medication should only be administered intravenously (with an IV). Your body weight will be used by the doctor to determine the appropriate dose.

Adult patients with normal renal function:

• For lower urinary tract infections the usual dose is 160

  mg once a day or 80 mg twice a day for 7 to 10 days. For adults weighing less than 60 kg, the single daily dose is 3 mg/kg of body weight.

• For systemic infections the usual dose is 3 mg/kg/day,

  administered in 3 equal doses for 7-10 days. Patients with life-threatening infections:

• Dosages up to 5 mg/kg/day should be administered in 3

  or 4 equally divided doses.

Patients with impaired renal function:

• Dose will be determined by your doctor after reviewing

  your serum concentrations.

Children, infants, neonates and full term/pre-term newborn babies with normal renal function:

This Baxter Gentamicin(e) product (1.0, 1.2 and 1.6 mg/ml) may not be appropriate for this sub-group and other higher concentration gentamicin injection products should be used (e.g., 10 mg/ml or 40 mg/ml) to reduce volume and infusion time in this sub-group. These directions are included for completeness.

Children:

• A dosage of 6-7.5 mg/kg/day administered in 3 equal doses (2-2.5 mg/kg) every 8 hours.

Infants and Neonates greater than 1 week of age:

• A dosage of 7.5 mg/kg/day administered in 3 equal doses (2.5 mg/kg) every 8 hours.

Pre-Term or Full-Term Newborn babies less than 1 week of age:

• A dosage of 5 mg/kg/day, administered in 2 equal doses

  (2.5 mg/kg) every 12 hours.

Overdose:

In the event of overdosage or toxic reactions, hemodialysis will aid in the removal of Gentamicin(e) from the blood.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

This medication may cause side effects. Common side effects include nausea and vomiting. Some patients using Gentamicin(e) have experienced the following: low blood counts (white blood cells and platelets), allergic reactions including anaphylaxis and toxic epidermal necrolysis (e.g., peeling and blistered skin), nerve problems including neuropathy (e.g., nerve pain), blurred vision, ear disorders including hearing loss, ringing in the ears, loss of balance and kidney failure.

Tell your doctor or nurse if you do not feel well while you are being given Gentamicin(e). Ask your doctor, pharmacist or nurse to answer any questions that you may have.

If the following occur while taking Gentamicin(e), contact your doctor immediately:

• Kidney failure with symptoms such as dark-coloured urine, increased or decreased urination, weakness, or dizziness.
• Ear disorders including ringing in the ears, hearing loss, loss of balance, dizziness, or sensation of spinning.
• Neuropathy with symptoms such as tingling, numbing, nerve pain, or change in skin sensation.
• Serious skin reactions such as toxic epidermal necrolysis (peeling and dead skin).
• Anaphylactic (allergic) reaction with symptoms such as swelling of mouth, tongue, throat, limbs, difficulty in breathing, rash, hives, itching.
• Changes in vision (blurred vision).
• Low blood cell counts (white blood cells and

platelets).

• If you suffer persistent, watery or bloody diarrhea,

  with or without cramping and fever, contact your doctor immediately as this may be signs of a serious condition.

Tell your doctor if you experience any additional side effects.

This is not a complete list of side effects. If you have any unexpected effects while taking this medication, contact your doctor, pharmacist or nurse.

HOW TO STORE IT

Store between 15°- 25°C.

Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can obtained by contacting the sponsor at: BAXTER CORPORATION at:

1-800-387-8399

Or,

http://www.baxter.ca

Last revised: August 28, 2012