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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 in adolescents, children and adults for the following: The treatment of systemic infections due to susceptible bacteria such as, bacteraemia, septicaemia, urinary-tract infections and severe chest infections. Consideration should be given to official local guidance on the appropriate use of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The daily recommended dose in adults with normal renal function is 3-6mg/kg body weight per day as one (preferred) up to two single doses. Serious infections In life-threatening infections the frequency of dosage may need to be increased to 6-hourly and the quantity of each dose may also be increased at the discretion of the clinician up to a total dosage of 5mg/kg in 24 hours.
In such cases it is advisable to monitor gentamicin serum levels. If renal function is not impaired, 160mg once daily may be used in some cases. Renal impairment In cases of impaired renal function a reduction in dosage frequency is recommended.
The following table is a guide to recommended dosage schedules:
Blood urea (mg/100ml) Creatinine clearance (GFR) (ml/min) Dose and frequency of administration <40 40 - 100 100 - 200 >200 Twice-weekly intermittent haemodialysis >70 30 - 70 10 - 30 5 - 10 <5 80mg† 8-hourly 80mg† 12-hourly 80mg† daily 80mg† every 48 hours 80mg† after dialysis † 60mg if body weight <60kg 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.
5mg/kg body weight per day as one (preferred) up to two single doses. The daily dose in newborns is 4-7mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in one single dose.
Method of administration:
Gentamicin is normally administered intramuscularly but may be given intravenously as a slow intravenous injection over at least 3 minutes or short infusion if required. Gentamicin should not be given as a slow infusion or mixed with other drugs before use (see Incompatibilities).
Monitoring advice:
Serum concentration monitoring of gentamicin is recommended, especially in elderly, in newborns and in patients with impaired renal function. Samples are taken at the end of a dosing interval (trough level). Trough levels should not exceed 2μg/ml administering gentamicin twice daily and 1μg/ml for a once daily dose.
Prolonged use should be avoided and whenever possible the treatment should not exceed 7 days. Caution is advised in significant obesity as gentamicin is poorly distributed into fatty tissue. The dosage calculation should be based on an estimate of lean body weight.
As with all aminoglycosides, at critical levels gentamicin exhibits toxicity. The following undesirable effects have been reported for gentamicin. g. hypomagnesaemia, hypocalcaemia and hypokalaemia) Psychiatric disorders Very rare Confusional state, hallucination and depression Nervous system disorders Common Very rare Neuromuscular blockade2 Encephalopathy, seizure Ear and labyrinth disorders Not known Irreversible hearing loss, deafness Vascular disorders Not known Purpura Gastrointestinal disorders Uncommon Nausea, vomiting, stomatitis.
Skin and subcutaneous tissue disorders Not known Steven Johnson syndrome, Toxic epidermal necrosis. Rash Renal and urinary disorders Very rare Not known Acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high-dose Nephropathy toxic 3, General disorders and administration site conditions Very rare Lethargy Investigations Uncommon Aspartate/alanine aminotransferase increased, blood bilirubin increased 1 usually in these cases other antibiotics are also involved.
2 Gentamicin can cause neuromuscular blockade which may unmask or aggravate myasthenia gravis and cause postoperative respiratory distress. 3 Nephrotoxicity may occur, resulting in a gradual reduction in creatinine clearance after several days of treatment.
This is usually reversible if the drug is withdrawn. Nephrotoxicity is more common if trough serum concentrations exceed 2 micrograms/ml and where there is pre-existing renal disease or concomitant treatment with other nephrotoxic agents.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinine, creatinine clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended.
Where renal function is impaired through disease or old age the frequency, but not the amount, of each dose should be reduced according to the degree of impairment. Gentamicin is excreted by simple glomerular filtration, and dosage frequency may be predicted by assessing serum creatinine, creatinine clearance rates or blood urea and reducing the frequency accordingly.
Volume depletion or hypotension and liver disease have been reported as additional risk factors for nephrotoxicity. In some patients with impaired renal function there has been a transient rise in blood-urea-nitrogen which has usually reverted to normal during or following cessation of therapy.
It is important to adjust the frequency of dosage according to the degree of renal function. Ototoxicity has been recorded following the use of gentamicin. Impaired hepatic function or auditory function, bacteraemia and fever have been reported to increase the risk of ototoxicity.
Groups at special risk include patients with impaired renal function, infants and possibly the elderly. Consequently, renal, auditory and vestibular functions should be monitored in these patients and serum levels determined so as to avoid peak concentrations above 10mg/l and troughs above 2mg/l when administrating Gentamicin twice daily and 1mg/l for a once daily dose.
As there is some evidence that risk of both ototoxicity and nephrotoxicity is related to the level of total exposure, duration of therapy should be the shortest possible compatible with clinical recovery. 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.
1 or to other aminoglycosides. Myasthenia gravis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4).
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.
Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown. Caution is required in Parkinsonism and other conditions characterised by muscular weakness. 2). 6). 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).