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  • Gentamicin B. Braun
    / Lapidot


    Active Ingredient
    Gentamicin (as Sulfate) 1 mg/ml, 3 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Solution for Infusion

    20 X 80 ml X 1 mg/ml

    partial basket chart 50869 7905

    Solution for Infusion

    20 X 80 ml X 3 mg/ml

    partial basket chart 50870 7906

    Solution for Infusion

    20 X 120 ml X 3 mg/ml

    partial basket chart 50871 7907

    Dosage

    Dosage in patients with normal renal function
    Adults and adolescents:
    Treatment of bacterial infections: The daily dose recommended in adolescents and adults with normal renal function, is 3 – 6 mg/kg body weight per day as 1 (preferred) up to 2 single doses. A maximum daily dose of 6 mg/kg may be needed for the treatment of serious infections and when the susceptibility of the pathogen is relatively poor.
    Gentamicin has a long-lasting post-antibiotic effect. Recent in vitro and in vivo studies show, that the intake of aminoglycosides in renal cortex is limited and hence, with higher peak serum gentamicin levels (after single daily dosing) less aminoglycoside is stored in the kidneys than with conventional multiple dosing. In the case of combination treatment (e.g. with a beta-lactam antibiotic in the normal dosage) it is also possible to administer the total daily dose as a single dose once a day.
    Due to the requirement for dose adjustments once daily dosing of gentamicin
    is not recommended for patients with weakened immunity (e.g. neutropenia), severe renal failure, ascites, bacterial endocarditis, patients with extensive burns (more than 20% of the skin), and in pregnancy.
    The duration of treatment should be limited to 7 – 10 days. A longer duration of treatment may be necessary in difficult and complicated infections.
    Paediatric patients: 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.
    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 recommended in older children with normal renal function is 3 – 6 mg/kg body weight per day as 1 (preferred) up to 2 single doses.
    One bottle of Gentamicin 1 mg/ml solution for infusion (Gentamicin 3 mg/ml solution for infusion) contains 80 mg gentamicin (240 mg gentamicin). To avoid overdosing especially in children, Gentamicin 1 mg/ml solution for infusion (Gentamicin 3 mg/ml solution for infusion) should not be administered to children who need less than 80 mg gentamicin (240 mg gentamicin) per dose.
    See prescribing information for full details.


    Indications

    For the treatment of serious infections caused by susceptible microorganisms.


    Contra-Indications

    Hypersensitivity to gentamicin or other aminoglycosides or to any of the excipients. Myasthenia gravis.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    Under certain conditions gentamicin shows ototoxic and/or nephrotoxic effects. Renal impairment is commonly observed in patients treated with gentamicin and is usually reversible upon withdrawal of the drug. In most cases nephrotoxicity is associated with an excessively high dosage or prolonged treatment, pre-existing renal abnormalities or associated with other substances reported to be nephrotoxic.
    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of gentamicin in pregnant women. Studies in animals have shown reproductive toxicity.
    Gentamicin crosses the placenta. Because of the potential risk of inner ear and renal damage to the fetus, gentamicin should not be used in pregnancy unless in case of a life-threatening indication and if no other treatment options are available.
    In case of exposition to gentamicin during pregnancy, monitoring of hearing and renal function of the newborn is recommended.
    Lactation: Gentamicin is excreted in human breast milk and was detected in low concentrations in serum of breast-fed children. A decision must be made whether to discontinue lactation or to discontinue/abstain from gentamicin therapy. Diarrhoea and fungus infection of the mucous membranes could occur in the breast-fed infant, so that nursing might have to be discontinued. The possibility of sensitisation should be borne in mind.


    Overdose

    Gentamicin has a narrow therapeutic window. In the event of accumulation (e.g. as a result of impaired renal function), renal damage and damage to the vestibulocochlear nerve may occur.
    Treatment: Discontinue medication. There is no specific antidote. Gentamicin can be removed from the blood by haemodialysis (elimination is more slowly and discontinuous with peritoneal dialysis).
    Treatment of neuromuscular blockade: In the event of neuromuscular blockade (usually caused by interactions), the administration of calcium chloride is advisable and artificial respiration if required.


    Manufacturer
    Rafa Laboratories Ltd.
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