Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GENTAMICIN SULFATE
Roussel Laboratories Limited
5 Mg/Ml
Solution for Injection
1976-06-10
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cidomycin Intrathecal Injectable 5 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule (1ml) contains Gentamicin Sulphate equivalent to 5mg (5000 international units) of gentamicin. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection Sterile, clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gentamicin intrathecal injectable is indicated for the treatment of meningitis and ventriculitis due to bacteria sensitive to this anti-infective. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION The usual daily dose by the intraventricular or intrathecal route is 1mg gentamicin base. The dose can be controlled by the physician on the basis of CSF levels of drug. Duration of treatment is dependent on microbiological clearing of the CSF. If the MIC of the infecting organisms so requires, an intrathecal/ventricular dose up to 5mg daily can be given in addition to the above treatment. Gentamicin should be given intramuscularly according to the following suggested schedules : _Adults _: 2 to 4 mg/kg every 24 hours in divided doses at 8 hour intervals. _Children _- (infants over 2 weeks up to children aged 12 years): 6.0 mg/kg in three equal divided doses. _Infants up to 2 weeks_: 6.0 mg/kg/day in two equal divided doses. _Patients with renal impairment _: Frequent assays of gentamicin levels in serum and CSF should be carried out to avoid levels > 10µg/ml. creatinine clearance ml/min dose mg frequency of administration > 70 80 8 hourly 30 – 70 80 12 hourly 10 – 30 80 24 hourly 5 – 10 80 48 hourly 5 with haemodialysis 80 after dialysis IRISH MEDICINES BOARD ________________________________________________________________________________________________________________ Read the complete document