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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: For the treatment of severe infections due to bacteria susceptible to gentamicin when less toxic antimicrobial agents are not effective. Gentamicin 1 mg/ml solution for infusion should for all indications, except complicated urinary tract infections, only be used in combination with other relevant antibiotics…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage in patients with normal renal function Adults and adolescents Treatment of bacterial infections The daily dose recommended in adolescents and adults with normal renal function, is 3 – 6 mg/kg body weight per day as 1 (preferred) up to 2 single doses.
A maximum daily dose of 6 mg/kg may be needed for the treatment of serious infections and when the susceptibility of the pathogen is relatively poor. 1). Recent in vitro and in vivo studies show, that the uptake of aminoglycosides in renal cortex is limited and hence, with higher peak serum gentamicin levels (after single daily dosing) less aminoglycoside is stored in the kidneys than with conventional multiple dosing.
g. with a beta-lactam antibiotic in the normal dosage) it is also possible to administer the total daily dose as a single dose once a day. g. neutropaenia), severe renal failure, ascites, bacterial endocarditis, patients with extensive burns (more than 20% of the skin), and in pregnancy.
The duration of treatment should be limited to 7 – 10 days. A longer duration of treatment may be necessary in difficult and complicated infections. Paediatric population The daily dose in newborns is 4 – 7 mg/kg body weight per day.
Due to the longer half-life, newborns are given the required daily dose in 1 single dose. 5 mg/kg body weight per day as 1 (preferred) up to 2 single doses. The daily dose recommended in older children with normal renal function is 3 – 6 mg/kg body weight per day as 1 (preferred) up to 2 single doses.
One 80 ml bottle of Gentamicin 1 mg/ml solution for infusion contains 80 mg gentamicin. To avoid overdosing especially in children, Gentamicin 1 mg/ml solution for infusion should not be administered to children who need less than 80 mg gentamicin per dose.
Dosage in patients with renal impairment In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. 4). Dose reduction and interval prolongation are equivalently suitable solutions.
Nonetheless, it should be remembered that doses determined in the way described below are only approximate and that the same dose may lead to different concentrations in the organisms of different patients. Therefore gentamicin serum levels should be determined in the given patient, so that the dosage can then be adapted accordingly.
Under certain conditions gentamicin shows ototoxic and/or nephrotoxic effects. Renal impairment is commonly observed in patients treated with gentamicin and is usually reversible upon withdrawal of the drug. In most cases nephrotoxicity is associated with an excessively high dosage or prolonged treatment, pre-existing renal abnormalities or associated with other substances reported to be nephrotoxic.
The adverse reactions considered at least possibly related to treatment are listed below by body system organ class and absolute frequency. 4. General disorders and administration site conditions Increased body temperature Pain at injection site 1 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. uk/yellowcard.
4. Method of administration Gentamicin 1 mg/ml solution for infusion and is administered by intravenous infusion over a period of 30 – 60 minutes. Gentamicin 1 mg/ml solution for infusion is not suitable for intramuscular or slow intravenous injection.
Only for intravenous use. 1.. – Myasthenia gravis. 4 Special warnings and precautions for use In patients with advanced renal impairment or with pre-existing inner ear deafness, gentamicin should be used only if its use is considered essential by the physician.
2). Renal impairment Renal impairment such as restriction of glomerular filtration is observed in approximately 10% of patients treated with gentamicin and is usually reversible. The most important risk factors are high total dose, long duration of therapy, raised serum level (high trough level); in addition, other potential risk factors are age, hypovolaemia and shock.
Clinical signs of renal damage are: proteinuria, cylindruria, haematuria, oliguria, raised creatinine and urea concentrations in serum. In isolated cases, acute renal failure may occur. g. Parkinson’s disease). Particularly careful monitoring is mandatory.
) Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia. These patients should also be monitored very carefully.
) Effect on vestibulocochlear nerve Damage to the vestibulocochlear nerve (eighth cranial nerve), whereby both balance and hearing may be affected, is possible. Vestibular damage is the most common ototoxic reaction. Hearing loss is manifested initially by diminution of high-tone acuity and is usually irreversible.
Important risk factors are pre-existing renal impairment or a history of damage to the eighth cranial nerve; in addition, the risk increases in proportion to the level of the total and daily dose or by association with potentially ototoxic substances.
1.. – Myasthenia gravis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1) Extension of dosage interval at the normal dose: Since the gentamicin clearance is directly proportional to the creatinine clearance, the following approximate equation may be used: Normal dose interval × (normal creatinine clearance/creatinine clearance of the patient) = subsequent dose interval.
Based on a normal creatinine clearance of 100 ml/min and a creatinine clearance of 30 ml/min in the patient, the application interval with a constant dose would in this case be 26 hours (8 x 100/30 [h]). 3 6 – 12 80 mg* every 48 hours *In case patient’s weight is < 60 kg the dose should be decreased to 60 mg.
2) Reduction of dose at the normal dose interval: After the usual initial dose, dividing the normal recommended dose by the serum creatinine may be taken as a rough guide for the measurement of the reduced dose that should be administered every 8 hours.
0 mg/100 ml after an initial dose of 60 mg (1 mg/kg; 60:2). Alternatively, after the usual initial dose, subsequent doses every 8 hours may be calculated to the formula: Normal dose × creatinine clearance of the patient/normal creatinine clearance (100 ml/min) = subsequent dose.
g. sepsis). It should be emphasized that renal function may change during therapy with gentamicin. Dosage in patients undergoing haemodialysis Gentamicin is dialysable. In the case of a 4 – 5-hour haemodialysis, a 50 - 60% reduction in concentration should be expected and in the case of an 8 – 12-hour haemodialysis, a 70 - 80% reduction in concentration.
The dosage must be individually adjusted after each dialysis, based on the gentamicin serum concentration at that time. 7 mg/kg body weight. Elderly patients may require lower maintenance doses than younger adults because of impaired renal function.
In obese patients the initial dose should be based on ideal body weight plus 40% of weight excess. In patients with impaired hepatic function no dose adjustment is necessary.
Monitoring advice:
Serum concentration monitoring of gentamicin is recommended, especially in elderly, in newborns and in patients with impaired renal function. Blood samples are taken before the start of the next […]
Symptoms of ototoxic effects are: dizziness, ringing/roaring in the ears (tinnitus), vertigo and less common hearing loss. With gentamicin the vestibular mechanism may be affected if trough levels of 2 μg/ml are exceeded. This is usually reversible if observed promptly and the dose adjusted.
8) Ototoxicity 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.
Antibiotic-associated diarrhoea, 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). 6).
Once daily dosing of gentamicin in elderly patients:
There is limited experience with once daily dosing of gentamicin in elderly patients. Once daily dosing of gentamicin may not be suitable and therefore, close monitoring is warranted in these patients. Monitoring To avoid adverse events, continuous monitoring (before, during and after treatment) of renal function (serum creatinin, creatinin clearance), control of function of vestibule and cochlea as well as hepatic and laboratory parameters is recommended.
Super-infections Treatment with gentamicin may produce an excessive growth of drug-resistant microorganisms. If this happens, an appropriate treatment should be initiated. Cross-allergenicity/-resistance Cross resistance and hypersensitivity to aminoglycosides may occur.
Nephrotoxicity and ototoxicity In order to reduce the risk of nephrotoxicity and ototoxicity, the following instructions should be considered: – Regular assessment of auditory, vestibular and renal function is particularly necessary in patients with additional risk factors.
Impaired hepatic function or auditory function, bacteraemia and fever have been reported to increase the risk of ototoxicity. Volume depletion or hypotension and liver disease have been reported as additional risk factors for nephrotoxicity.
– Monitoring of renal function before, during and after treatment. – Dosage strictly according to creatinine clearance (or serum creatinine concentration). 2). – In patients with impaired renal function additionally receiving gentamicin locally (inhalation, intratracheal, instillation), the amount of gentamicin absorbed after local administration must also be taken into account for dose adjustment of systemic treatment.
– Monitoring of serum gentamicin concentrations during therapy in order to avoid that peak levels exceed 10-12 μg/ml (toxic threshold for the cochleo- vestibular system) with conventional multiple […]