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GENTAMICIN(E) is a brand name for Gentamicin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
9% sodium chloride injection) are potentially nephrotoxic therefore renal function should be assessed prior to and regularly during treatment. Adequate therapeutic peak and trough serum concentrations of gentamicin should be maintained and higher potentially toxic levels should be avoided during therapy.
Dosage adjustment is required in children and in patients with renal dysfunction (See WARNINGS AND PRECAUTIONS, Renal, Special Populations, Geriatric (≥ 65 years of age) and Pediatric (≤ 12 years of age), Monitoring and Laboratory Tests, Renal; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; ACTION AND CLINICAL PHARMACOLOGY).
Aminoglycosides including Gentamicin(e) are potentially ototoxic therefore, patients receiving Gentamicin(e) should be closely monitored for eighth cranial nerve toxicity. The ototoxicity is usually associated with high serum levels and renal insufficiency.
(See WARNINGS AND PRECAUTIONS, Ear/Nose/ Throat, Ototoxicity, Monitoring and Laboratory Tests, Audiometric Testing; ADVERSE REACTIONS). The prior/concurrent and/or sequential system or topical use of other potentially nephrotoxic/neurotoxic drugs should be avoided with Gentamicin(e) treatment (See WARNINGS AND PRECAUTIONS, Ear/Nose/Throat, Ototoxicity, Renal; DRUG INTERACTIONS, Drug-Drug Interactions).
9% sodium chloride injection) is a ready to use isotonic solution and should be used for intravenous infusion only. It must not be administered by any other route. Not all strains of these bacteria are susceptible to gentamicin. In serious or life-threatening infections known or suspected to be caused by these organisms, initial empiric combination therapy should be considered until results of susceptibility tests become available.
To reduce the risk of Gentamicin(e) toxicity, careful attention must be given to appropriate dosage. Caution should be exercised when Gentamicin(e) is prescribed to patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction.
Periodic electrolyte determinations should be performed in patients with low potassium reserves, and the possibility of hypokalemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics.
9% sodium chloride solution (9 mg/mL). Solutions containing sodium ions should be used with great care, if at all, in patients with Gentamicin(e) Product Monograph Page 6 of 41 congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Gentamicin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients should be well hydrated during treatment. Treatment with Gentamicin(e) may result in overgrowth of non susceptible or resistant organisms. If treatment failure occurs, prescribe appropriate therapy. Cardiovascular QT Interval Prolongation The effect of Gentamicin for injection on prolonged cardiac repolarisation, QT interval and increased risk of developing cardiac arrhythmia and torsades de pointes is not known.
Ear/Nose/Throat Ototoxicity In patients receiving Gentamicin(e) therapy, the function of the eighth cranial nerve (auditory and vestibular branches) should be carefully monitored as these changes may not be manifested until after completion of therapy, and are usually irreversible.
Ototoxicity manifested by loss of high frequency auditory perception usually precedes clinically detectable hearing loss, and may be detected by audiological assessment. Ototoxicity (tinnitus, roaring in the ears), including serious irreversible complete hearing loss, usually bilateral; and vestibular toxicity (nausea, vomiting, dizziness, eighth nerve disorder, nystagmus, vertigo, ataxia) have been reported, primarily in patients with renal dysfunction, or in patients receiving high doses and/or prolonged therapy.
To reduce the risk of ototoxicity, if a patient reports tinnitus or hearing loss during therapy, the physician should refer them for audiological assessment. If ototoxicity occurs in a patient receiving Gentamicin(e), stop the drug and substitute treatment with an alternative non- ototoxic agent.
If discontinuation is not possible, then the dosage should be adjusted so that trough serum concentration falls below 2 mcg/mL. Additionally, the patient must be well- hydrated to reduce the risk of ototoxicity. (See Monitoring and Laboratory Tests; Audiological Assessment).
In high risk patients, it may be necessary to consider audiological assessment before initiating the therapy. Gentamicin(e) should be used with caution with the understanding that toxic effects may be cumulative in patients with sensorineural hearing deficit, elderly, visual impairment patients, liver disease, bacteremia, high temperature, and dehydration.
In addition, some individuals have a genetic predisposition to aminoglycoside-induced ototoxicity. The prior use of other aminoglycosides and concomitant administration of diuretics, have been associated with 8th cranial nerve dysfunction and therefore use of Gentamicin(e) in patients receiving sequential/concomitant treatment with these agents should be avoided.
(See ADVERSE REACTIONS; DRUG INTERACTION, Drug-Drug Interactions; DOSAGE AND ADMINISTRATION). Gentamicin(e) Product Monograph Page 7 of 41 Gastrointestinal Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including Gentamicin for injection.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of the colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. […]