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GENTAMICIN is a brand name for Gentamicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gentamicin is indicated for the treatment of the following infections in adults and children from birth when less toxic antimicrobial agents are not effective (see sections 4.4 and 5.1) Under these conditions, Gentamicin is indicated in the treatment of the following infections: – Complicated urinary tract infection…
Verbatim from this product's MHRA label. Tap a section to expand.
4) Posology The dose depends on the severity of the clinical picture, the setting, the patient's renal function and the bacterium identified. Dosage and dosage interval should be adjusted individually in accordance with the patient's renal function, the bacterium identified and must be controlled by regular determination of the serum concentration.
The dose is expressed in terms of the patient's body weight. Dosing regimens are identical for intravenous and intramuscular use. During treatment the patient should be sufficiently hydrated. e. when results from antimicrobial susceptibility tests become available).
e. 4). The dose ranges from 3 to 6 mg/kg/day according to official recommendations, with the maximum dose of 6 mg/kg/day particularly recommended at the start of treatment, in severe infections and/or in cases where there is a risk of infection due to a bacterial strain with reduced sensitivity and with an increased minimum inhibitory concentration (MIC) for gentamicin.
Paediatric population The daily recommended dose in children and adolescents with normal renal function is 3-6mg/kg body weight per day as one (preferred) up to two single doses. 5 mg/kg body weight per day as 1 (preferred) up to 2 single doses.
The daily dose in neonates and pre-term infants (aged 0-4 weeks old) is 4-7 mg/kg body weight per day. Due to the longer half-life, new-borns are given the required daily dose in 1 single dose. Particular attention must be paid to the preparation (dilution) and amount administered.
Any error, however slight, can have a major impact on the serum concentrations obtained. There is no dose recommendation for children with impaired renal function. Elderly Patients Elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous eighth nerve impairment or borderline renal dysfunction.
Accordingly, therapy should be closely monitored by frequent determination of gentamicin serum levels, assessment of renal function and signs of ototoxicity. Patients with Renal impairment Since gentamicin is chiefly eliminated via the kidneys by glomerular filtration, the elimination rate depends on the patient’s renal function, and the recommended daily dose must therefore be adjusted to the renal function.
The following table is a guide to recommended dosage schedules:
Those adverse reactions deemed most likely to be treatment-related are listed below by organ and by frequency.
Frequencies are defined as:
Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). 4) General disorders and administration site conditions Increased body temperature Pain at the injection site 1 Generally, in these cases, other antibiotics are also involved.
2 May occur as hypersensitivity reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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General information In the absence of data, Gentamicin solution for injection/infusion is not recommended for use via inhalation. Aminoglycosides must be used within a strict prescribing framework (indications restricted to severe infections or due to resistant bacteria, administration regimens must be observed) and accompanied by appropriate surveillance.
Prescription of gentamicin must meet this objective. Risks for the development of renal and auditory toxicities increase with treatment periods of more than 5-7 days, even in healthy subjects; the risk is greater in patients with renal impairment.
Nevertheless, early toxicity can even appear with the very first doses. To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinin, creatinin clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended.
Concurrent use with Neurotoxic or nephrotoxic antibiotics Simultaneous and/or sequential systemic or topical treatment with other potentially neuro- and/or nephrotoxic agents should be avoided. Neuromuscular blockade and respiratory paralysis have been reported following administration of aminoglycosides in patients receiving non-depolarising muscle relaxants during anaesthesia.
8). Ototoxicity Damage to the vestibulocochlear nerves (eighth cranial nerve), where balance and hearing are affected, is possible. Vestibular damage is the most common ototoxic reaction. Hearing loss is initially manifested by reduced high-frequency acuity and is usually irreversible.
8). There is an increased risk of ototoxicity in patients with mitochondrial DNA mutations (particularly the nucleotide 1555 A to G substitution in the 12S rRNA gene), even if aminoglycoside serum levels are within the recommended range during treatment.
Alternative treatment options should be considered in such patients. In patients with a maternal history of relevant mutations or aminoglycoside induced deafness, alternative treatments or genetic testing prior to administration should be considered.
1. - Myasthenia gravis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Blood urea (mg/100ml) Creatinine clearance (GFR) (ml/min) Dose and frequency of administration <40 >70 80mg† 8-hourly 40 - 100 30 - 70 80mg† 12-hourly 100 - 200 10 - 30 80mg† daily >200 5 - 10 80mg† every 48 hours Twice-weekly intermittent haemodialysis <5 80mg† after dialysis † 60mg if body weight <60kg If the dose is not reduced, and/or the dosage interval not lengthened, abnormally high and possibly toxic concentrations can be reached in the blood and tissues due to accumulation.
8). For the first injection, the dosage is identical to that of patients with normal renal function, regardless of the degree of renal impairment (including all situations involving renal replacement therapy). Further injections at the same dose as the first injection should be performed, unless the single dose needs to be adjusted according to the peak assay.
Continuous renal replacement therapy in patients on dialysis, injections should be given 2 to 4 hours before the dialysis session to reduce the potential for toxicity. Adjustment of treatment should be considered by performing repeated assays to determine residual levels; gentamicin may be reinjected only when levels are below the toxicity threshold.
4). If the residual assay (generally performed 24 hours post-dose) is higher than the toxicity threshold, the assay must be repeated 24 hours later. Patients with Hepatic impairment In patients with impaired hepatic function no dose adjustment is necessary.
43 x excess weight (Excess weight = total weight - ideal weight) 1 Lorentz formula (ideal weight expressed in kg): Women = height (cm) – 100 – [height (cm) - 150] / 2 Men = height (cm) – 100 – [height (cm) – 150] / 4 Conditions for use of this formula: • age over 18 years; • height between 140 and 220 cm.
Method of administration The recommended dose and precautions for intramuscular and intravenous administration are identical. Gentamicin when given intravenously should be injected directly into a vein or into the drip set tubing over no less than three minutes.
If administered by infusion, this should be over 20 – 30 minutes and in no greater volume of fluid than 100 ml. Longer infusion times of up to 60 minutes may be used, in particular for a once daily dosing regimen. Once daily dosing should only be administered through the intravenous route.
Special clinical circumstances Therapeutic monitoring Regular serum concentration monitoring of gentamicin is recommended for all patients, […]
In patients with end-stage renal disease, on intermittent haemodialysis or chronic peritoneal dialysis, toxicity is mainly auditory, as the kidneys are no longer functional. g. Parkinson's disease). 8). 1), promotes tissue diffusion has a clinical efficacy at least identical to that obtained following administration divided into several daily injections is responsible for renal and auditory toxicities comparable to or even less than those observed with other methods of administration, decreases the risk for the emergence of resistant mutant strains.
Impaired renal function In the presence of acute or chronic pre-existing renal impairment, aminoglycosides should be used only when absolutely necessary. All possible non-nephrotoxic alternatives should be looked into. 2). Clinical signs of kidney damage are: proteinuria, cylindruria, haematuria, oliguria, increased blood concentrations of creatinine and urea.
8). Paediatric population According to the data available, renal and auditory toxicities remain rare in newborns and children. Elderly Patients Elderly patients can have impaired renal function that does not show up in routine analyses like BUN and serum creatinine.
Creatinine clearance determination is more practicable. Checking the function is particularly important in these patients. Patients with severe burns injuries Patients with severe burn injuries must be monitored extra carefully due to the altered pharmacokinetics.
Treatment with gentamicin may produce an excessive growth of drug-resistant microorganisms. If this happens, an appropriate treatment should be initiated. Diarrhoea and pseudomembranous colitis have been observed when gentamicin is combined with other antibiotics.
These diagnoses should be considered in every patient that develops diarrhoea during or immediately after treatment. Gentamicin should be discontinued if the patient suffers severe diarrhoea and/or bloody diarrhoea during treatment and an appropriate treatment should be initiated.
8). 47 mg of sodium per 2 ml vial.