Haemodialysis and peritoneal dialysis will aid removal from the blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.
2 years
Hypersensitivity; maysthenia gravis.
In general, gentamicin injection should not be mixed. In particular the following are incompatible in mixed solution with gentamicin injection: penicillins, cephalosporins, erythromycin, heparins, sodium bicarbonate. * Dilution in the body will obviate the danger of physical and chemical incompatibility and enable gentamicin to be given concurrently with the drugs listed above either as a bolus injection into the drip tubing, with adequate flushing, or at separate sites. In the case of carbenicillin, administration should only be at a separate site.
* Carbon Dioxide may be liberated on addition of the two solutions. Normally this will dissolve in the solution but under some circumstances small bubbles may form.
Sodium Chloride
2M Sodium Hydroxide
1M Sulphuric Acid
Water for Injections
Solution for Injection.
Clear, colourless solution.
Side-effects include vestibular damage or hearing loss, particularly after exposure to ototoxic drugs or in the presence of renal dysfunction. Nephrotoxicity (usually reversible) and occasionally acute renal failure, hypersensitivity, anaemia, blood dycrasias, purpura, stomatitis, convulsions and effects on liver function occur occasionally.
Rarely hypomagnesia on prolonged therapy and antibiotic-associated colitis have been reported.
Nausea, vomiting and rash have also been reported.
Central neurotoxicity, including encephalopathy, confusion, lethargy, mental depression and hallucinations, has been reported in association with gentamicin therapy but this is extremely rare. Peripheral neuropathy has also been reported but the frequency of occurrence of this side effect is unknown.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Not applicable
Gentamicin is an aminoglycoside antibiotic with broad-spectrum bactericidal activity. It is usually active against most strains of the following organisms: escherichia coli, klebsiella spp., Proteus spp. (indole positive and indole negative), pseudomonas aeruginosa, staphylococci, enterobacer spp., Citrobacter spp. and providencia spp.
Indications : gentamicin injection and gentamicin paediatric injection are indicated in bacteraemia, septicaemia, urinary tract infections, chest infections, severe neonatal infections and other serious systemic infections due to susceptible organisms.
Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.
Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but its most important effects is inhibition of protein synthesis at the level of the 30s ribosomal subunit.
Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 to 3 hours.
- Effective plasma concentration is 4-8μg/ml.
- The volume of distribution (VD) is 0.31kg.
- The elimination rate constant is:
1. 0.02hr-1 for anuric patients*
2. 0.30hr-1 normal
* Therefore in those with anuria care must be exercised following the initial dose, any subsequent administration being reduced in-line with plasma concentrations of gentamicin.
Paediatric patients, premature infants and neonates
Distribution
The distribution volume of gentamicin is about equivalent to the volume of extracellular water. In the newborn water makes up 70 to 75% of bodyweight, compared with 50 to 55% in adults. The extracellular water compartment is larger (40% of body weight compared with 25% of body weight in adults). Therefore, the volume of distribution of gentamicin per kg bodyweight is affected and decreases with increasing age from 0.5 to 0.7 L/kg for a premature newborn to 0.25 L/kg for an adolescent. The larger volume of distribution per kg bodyweight means that for adequate peak blood concentration a higher dose per kg bodyweight needs to be administered.
Elimination
Gentamicin is not metabolized in the body but is excreted unchanged in microbiologically active form predominantly via the kidneys. In patients with normal renal function the elimination half life is about 2 to 3 hours. In neonates elimination rate is reduced due to immature renal function.
Elimination half life averages approximately 8 hours in neonates at a gestational age of 26 to 34 weeks compared with about 6.7 hours in neonates at a gestational age of 35 to 37 weeks.
Correspondingly, clearance values increase from about 0.05 L/h in neonates at a gestational age of 27 to 0.2 L/h in neonates at a gestational age of 40 weeks.
25/06/15
Gentamicin Paediatric 20mg/2ml Solution for Injection.
Cidomycin Paediatric Injectable is supplied in vials.
PL 17780/0507
Each vial (2ml) contains Gentamicin Sulphate Ph Eur equivalent to 20mg Gentamicin base.
To avoid adverse events, continuous monitoring (before, during and after) of renal function (serum creatinin, creatinin 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.)
Gentamicin should be used with care in conditions characterised by muscular weakness.
In cases of significant obesity gentamicin serum concentrations should be closely monitored and a reduction in dose should be considered.
Not known.
Adults:
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.
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.
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 (preferred) up to 2 single doses.
The daily dose in infants after the first month of life is 4.5-7.5 mg/kg body weight per day as 1 (preferred) up to 2 single doses.
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.
Elderly:
There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous eighth nerve 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 | Dose and frequency of administration | |
| (mg/100ml) | (mmol/I) | (GFR) (ml/min) | |
| <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.
Not applicable.
10/03/2010
