In paediatric patients the amount of diluents used will depend on the amount of amikacin tolerated by the patient. The solution should normally be infused over a 30 to 60 minute period. Infants should receive a 1 to 2 hour infusion.
Elderly TEXT IN PARAGRAPH AMENDED
Amikacin is excreted by the renal route, renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by pseudomonas TITLE MADE BOLD AND UNDERLINED
Urinary tract infections: (other than pseudomonas infections) TITLE MADE BOLD AND UNDERLINED
Impaired renal function TITLE MADE BOLD AND UNDERLINED
Intraperitoneal use TITLE MADE BOLD AND UNDERLINED
Other routes of administration TITLE MADE BOLD AND UNDERLINED
4.4. Special warnings and special precautions for use
Paediatric use Aminoglycosides should be used with caution in premature and neonatal infants because of the renal immaturity of these patients and the resulting prolongation of serum half-life of these drugs. TEXT IN PARAGRAPH AMENDED
4.6. Pregnancy and lactation
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There are limited data on use of aminoglycosides in pregnancy. Amnioglycosides can cause foetal harm. Aminoglycosides cross the placenta and there have been reports of total, irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although adverse effects on the foetus or newborns have not been reported in pregnant women treated with other aminoglycosides, the potential for harm exists. In reproduction toxicity studies in mice and rats no effects on fertility or foetal toxicity were reported. If amikacin is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus.
It is not known whether amikacin is excreted in human milk. A decision should be made whether to discontinue breast-feeding or to discontinue therapy.
Amikacin should be administered to pregnant women and neonatal infants only when clearly needed and under medical supervision (see section 4.4).
5.2. Pharmacokinetic properties
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Data from multiple daily dose trials show that spinal fluid levels in normal infants are approximately 10 to 20% of the serum concntrations and may reach 50% in meningitis.
Intamuscular and intravenous administration
In neonates and particularly in premature babies, the renal elimination of amikacin is reduced.
In a single study in newborns (1-6 days of post natal age) grouped according to birth weights (<2000, 2000-3000 and >3000g). Amikacin was administered intramuscularly and/or intravenously at a dose of 7.5 mg/kg. Clearance in neonates >3000 g was 0.84 ml/min/kg and terminal half-life was about 7 hours. In this group, the initial volume of distribution and volume of distribution at steady state was 0.3 ml/kg and 0.5 mg/kg, respectively. In the groups with lower birth weight clearance/kg was lower and half-life longer. Repeated dosing every 12 hours in all the above groups did not demonstrate accumulation after 5 days.
