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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: Indications : gentamicin is indicated in bacteraemia, urinary tract infections, chest infections, severe neonatal infections and other serious systemic infections due to susceptible organisms, in adults and children including neonates. Please see section 5.1. Consideration should be given to official local guidance on…
Verbatim from this product's MHRA label. Tap a section to expand.
Adults:
Systemic infections: if renal function is not impaired, 3-5 mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight. Serious infections: if renal function is not impaired, 5mg/kg daily in divided doses at six or eight hourly intervals.
The total daily dose may be subsequently increased or decreased as clinically indicated. Urinary tract infections: as 'systemic infections'. Or, if renal function is not impaired, 160mg once daily may be used.
Paediatric Patients:
The daily dose recommended in children (aged 1 year and above) and adolescents with normal renal function, is 3-6 mg/kg body weight per day as 1 single dose (preferred) or up to 2 single doses. 5 mg/kg body weight per day as 1 single dose (preferred) or up to 2 single doses.
The daily dose in neonates is 4-7 mg/kg body weight per day. Due to the longer half- life, neonates are given the required daily dose in 1 single dose.
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 toxicity.
Renal impairment:
Gentamicin is excreted by simple glomerular filtration. In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. Nomograms are available for the calculation of the dose, which depends on the patient's age, weight, and renal function The following table may be useful when treating adults.
Blood Urea Creatine clearance (mg/100ml) (mmol/I) (GFR) (ml/min) Dose and frequency of administration <40 6-7 >70 80mg* 8 hourly 40-100 6-17 30-70 80mg* 12 hourly 100-200 17-34 10-30 80mg* daily >200 >34 5-10 80mg* every 48 hours Twice weekly intermittent haemodialysis <5 80mg* after dialysis *60mg if body weight <60kg.
Frequency of dosage in hours may also be approximated as serum creatine (mg%) x eight or in SI units, as serum creatine (μmol/l) divided by 11. If these dosage guides are used peak serum levels must be measured. Peak levels of gentamicin occur approximately one hour after intramuscular injectable and intravenous injectable.
The following CIOMS frequency rating is used, when applicable: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10 000 to <1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
4).
Gastrointestinal disorders:
Very common: vomiting Not known: stomatitis, nausea Hepatobiliary disorders: Not known: abnormal liver function, transaminases increased Skin and subcutaneous tissue disorders: Not known: Stevens-Johnson syndrome, toxic epidermal necrosis, rash, purpura, urticaria, pruritus Renal and urinary disorders: Very rare: acute renal failure, Fanconi-like syndrome in patients treated with a prolonged course of high dose Not known: nephrotoxicity (usually reversible) has been reported.
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.
Ototoxicity and nephrotoxicity Ototoxicity has been reported following the use of aminoglycosides, including gentamicin. 8). Important risk factors include renal impairment, high doses, prolonged duration of treatment and age (neonates/infants and possibly the elderly).
8). Serum levels are determined so as to avoid peak concentrations above 10mg/L and troughs above 1 mg/L when administering gentamicin once daily and 2mg/L when administering gentamicin twice daily. 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.
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.
1555A>G mutation, including cases where the patient’s aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered. To avoid adverse events, continuous monitoring (before, during and after treatment) of hepatic and laboratory parameters is also recommended.
6) Gentamicin should be used with care in conditions characterised by muscular weakness. 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Trough levels are measured just prior to the next injectable. Assay of peak serum levels gives confirmation of adequacy of dosage and also serves to detect levels above 10mg/l, at which the possibility of ototoxicity should be considered.
One hour concentrations of gentamicin should not exceed 10mg/l (but should reach 4mg/l), while the pre-dose trough concentration should be less than 2mg/l 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 100ml.
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. 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 2 μg/ml administering gentamicin twice daily and 1 μg/ml for a once daily dose. 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.
Superinfection Treatment with gentamicin may produce an excessive growth of drug-resistant micro-organisms. If this happens, an appropriate treatment should be initiated. 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). Severe subcutaneous adverse reactions (SCARs) Serious skin reactions including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with gentamicin treatment. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely.
Treatment should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of skin hypersensitivity. e. it is essentially sodium free. Sodium metabisulphite, one of the excipients of this medicinal product, may rarely cause severe hypersensitivity reactions and bronchospasm.