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GENTAMICIN PAEDIATRIC is a brand name for Gentamicin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Gentamicin is a proven bactericisal antibiotic active against a broad spectrum of gram-positive and gram-negative pathogens including Escherichia coli, klebseilla, proteus, pseudomonas aeruginosa and antibiotic resistant strains of staph. aureus. Gentamicin is often active against strains resistant to streptomycin,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Paediatric population For paediatric use only. Gentamicin Paediatric 20mg/2ml Solution for Injection is normally administered intramuscularly but may be given intravenously if required. If intravenous administration is necessary the normal intramuscular dose should be given as a bolus injection into the tubing of the giving set or directly into the venous system over a period of two or three minutes.
Gentamicin should not be given as a slow infusion or mixed with other drugs before use. With either intramuscular or intravenous administration the following dosage applies. The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is 3-6mg/kg bodyweight per day as 1 single dose (preferred) or 2 divided doses.
5mg/kg bodyweight per day as 1 single dose (preferred) or 2 divided doses. The daily dose in neonates (aged 0 – 4 weeks old) is 4-7mg/kg bodyweight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose.
Gentamicin Paediatric Solution for Injection can be expected to give lower serum levels than those found in adults at equivalent dosage per bodyweight. In neonates, infants and children, subsequent dosage will often need to be increased to achieve therapeutic serum levels.
Peak levels should be measured about one hour after intramuscular or intravenous injection and should reach 4 micrograms/ml, but not exceed 10 micrograms/ml. Trough levels can be measured just prior to the next injection. Renal impairment In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function.
) Method of administration For intramuscular or intravenous injection. 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).
4).
The following MedDRA frequency convention has been used for the classification of frequency: 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) and not known (cannot be estimated from the available data).
Infections and infestations:
Not known: antibiotic-associated colitis, pseudomembranous colitis, Superinfection (caused by gentamicin-resistant bacteria).
Blood and lymphatic system disorders:
Not known: anaemia, blood dyscrasia. Immune system disorders Not known: hypersensitivity, anaphylaxis/anaphylactic reaction (including anaphylactic shock) Metabolism and nutrition disorders: Not known: hypomagnesaemia on prolonged therapy.
). Nervous system disorders .
Not known:
Central neurotoxicity (including convulsions, encephalopathy, lethargy, peripheral neuropathy.
Gastrointestinal disorders:
Not known: stomatitis, nausea, vomiting.
Hepatobiliary disorders:
Not known: abnormal liver function, transaminases increased Skin and subcutaneous tissue disorders Not known: rash, purpura, urticaria, pruritus, Steven Johnson syndrome, toxic epidermal necrosis 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.
Ototoxicity and nephrotoxicity 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.
Ototoxicity has been recorded following the use of gentamicin. 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. 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. 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 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.
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. Myasthenia gravis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Gentamicin in United Kingdom.
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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.
Drug-resistant microorganisms Treatment with gentamicin may produce an excessive growth of drug-resistant microorganisms. If this happens, an appropriate treatment should be initiated. Clostridium difficile infection 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 and/or bloody diarrhoea during treatment and an appropriate treatment should be initiated. 8). 6). Conditions characterized by muscular weakness Gentamicin should be used with care in conditions characterised by muscular weakness.
Obesity In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered. Gentamicin Paediatric 20mg/2ml Solution for Injection contains sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm.
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