Gentamicin Sulph BP - Panpharma Special Precautions

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 10 mg/l and troughs above 2 mg/l when administrating Gentamicin twice daily and 1 mg/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 have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.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.
Caution is required in Parkinsonism and other 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 (see Dosage & Administration).
Gentamicin should only be used in pregnancy if considered essential by the physician (see Use in Pregnancy & Lactation).
Effects on ability to drive and use machines: This medicine has no or negligible influence on the ability to drive and use machines.