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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 an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is indicated in adults and children including neonates. Gentamicin is indicated for the treatment of severe infections caused by pathogens susceptible to gentamicin. Under these conditions, gentamicin can be used for: - urinary…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose depends on the severity of the clinical picture, the setting, the patient's renal function and the type of infection. Several presentations of gentamicin are available, some of which are more suitable for high doses to be administered intravenously.
The dose is expressed in terms of the patient’s body weight. The recommended daily dose in adolescents and adults with normal renal function should preferably be given as a single dose, or else divided into 2 separate doses. A dosing frequency of more than twice daily may be adopted for some specific pathogens or some sites of infection as recommended in national and local guidance.
Once daily dosing is not recommended in cases of endocarditis, depending on the responsible pathogens. National and local guidance on treatment with gentamicin and serum level monitoring in endocarditis should be followed. Dose calculations should be based on ideal body weight.
Recommendations for dosage Posology (adults and adolescents) Recommended dose: 3 – 6 mg gentamicin / kg / day Subsequent doses should be adjusted according to serum concentration levels (see “Monitoring advice”) using local guidance or nomograms.
Dosage in impaired renal function Gentamicin is mainly excreted by glomerular filtration. Thus, the dosage for patients with impaired renal function must be adjusted accordingly. Dose adjustments in patients with renal impairment should also be based on therapeutic drug monitoring.
For patients on once daily dose regimens, a prolongation of the dose interval is generally recommended. The initial dose interval should be at least 24 hours and extended according to the degree of renal impairment and the results of serum gentamicin monitoring.
Limited data are available in patients with severe renal impairment (creatinine clearance < 30 mL / min) for once daily dose administration. Dose adjustment Nomograms are available for the calculation of dose or dose interval, which depends on the patient’s age, weight and renal function and plasma concentrations.
Local guidance should be followed where available.
If nomograms or local guidance are not available, the following may be used:
For dosage adjustment, there are two possibilities: A. Prolongation of the dosing interval while maintaining the same dose (subsequent doses identical to the initial dose). B. Reduction of the dose while maintaining the same dosing intervals (subsequent doses smaller than the initial dose).
Tabulated list of adverse reactions 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 Body temperature increased Injection site pain 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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Warnings In cases of advanced renal impairment or pre-existing inner ear deafness, gentamicin should only be used for life-threatening indications. , myasthenia gravis, Parkinson’s disease). , with perioperative administration of gentamicin).
Diabetes, auditory vestibular dysfunctions, otitis media, a history of otitis media, previous use of ototoxic medicinal products and a genetically determined high sensitivity to aminoglycoside induced ototoxicity, are other main factors which may pre-dispose the patients to toxicity.
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.
Renal and vestibulocochlear damage Impaired renal function Clinical signs of kidney damage are: proteinuria, cylindruria, haematuria, oliguria, increased blood concentrations of creatinine and urea. 8). Effects on the vestibulocochlear nerves 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). In patients with end-stage renal failure, on intermittent haemodialysis or chronic peritoneal dialysis, toxicity is mainly auditory, as the kidneys are no longer functional.
Paediatric population According to the data available, renal and auditory toxicities remain rare in newborn infants and children. Risk factors 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.
1. - Subcutaneous administration, due to the lack of efficacy and onset of necrosis at the injection site.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For patients on once daily dosing, prolonging the dose interval is preferable. For patients on multiple daily dosing, reduction of the dose is preferred. 0 less than 10 10 It must also be remembered that renal function may change during the course of treatment.
, sepsis). 85 x the above value If serum creatinine values are used for assessing renal function, these values should be taken several times, as correlation to creatinine clearance values exists only when impaired renal function remains the same.
Paediatric population The daily dose recommended in children aged 1 year and above with normal renal function, is 3 – 6 mg / kg / day as one single dose (preferred) or two divided doses. 5 mg / kg per day and should be preferably given as a single dose, or else divided into 2 separate doses.
The recommended daily dose in newborn infants is 4 – 7 mg / kg body weight per day. Due to the longer half-life, newborn infants are given the required dose as a single dose. Particular attention must be paid to the preparation (dilution) and amount administered.
Any error, however minor, can have a major impact on the serum concentrations obtained. Elderly There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous auditory/vestibular 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. If renal function is impaired, the daily recommended dose should be reduced and adjusted to renal function.
Hepatic impairment In cases of hepatic impairment, gentamicin may be prescribed, and no dosage adjustment is necessary. Dosage for haemodialysis patients Gentamicin is dialysable. A haemodialysis session lasting 4 – 5 hours or 8 – 12 hours can be expected to reduce concentrations by 50 – 60 % and 70 – 80 %, respectively.
After each dialysis session, the patient must be given individual booster doses, based on current gentamicin serum concentrations. 7 mg / kg body weight. As haemodialysis patients are usually on anticoagulant therapy, intramuscular injections must not be given in such cases, due to the risk of haematoma formation.
Obese patients Dose calculations should be based on ideal body […]
Nevertheless, early toxicity can even appear with the very first doses. Renal toxicity is independent of the peak plasma concentration obtained (Cmax). With regard to auditory and vestibular toxicities, there is no evidence of a correlation with the peak plasma concentration level obtained, even when treatment is administered as a single daily dose.
5). Diarrhoea associated with antibiotics and pseudomembranous colitis 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). Treatment with gentamicin may produce an excessive growth of drug-resistant microorganisms.
If this happens, an appropriate treatment should be initiated. Precautions To avoid adverse drug reactions, continuous monitoring of renal function (serum creatinine, creatinine clearance before, during and after administration) and checks on vestibular and cochlear function, as well as hepatic and laboratory parameters, are recommended.
2). o If possible, restrict the duration of treatment to 10 – 14 days. o Avoid a new course of aminoglycoside therapy immediately after a previous course of aminoglycoside treatment: 7 – 14-day treatment-free interval if possible. o If possible, no co-administration of other potential oto- and nephrotoxic substances.
If this cannot be avoided, particularly close monitoring of renal function is indicated. o Ensure adequate hydration and urine production. 1), o promotes tissue diffusion, o has a clinical efficacy at least identical to that obtained following administration divided into several daily injections, o is responsible for renal and auditory toxicities comparable to or even less than those observed with other methods of administration, o decreases the risk for the emergence of resistant mutant strains.
This medicinal product contains: o Sodium metabisulfite which may rarely cause severe hypersensitivity reactions and bronchospasm. o Sodium: This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium-free’.