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  • Erythrocin Lactobionate I.V
    / Biotis


    Active Ingredient
    Erythromycin 1 g/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 20 ml

    partial basket chart 28909 5483

    Dosage

    Adults, children and neonates: Severe and immunocompromised infections;
    50 mg/kg/day, preferably by continuous infusion, (equivalent to 4g per day for adults). Mild to moderate infections (oral route compromised); 25 mg/kg/day.
    Elderly: No special dosage recommendations.
    Recommended administration:
    Bolus injection (IV push) is contraindicated.
    Continuous infusion of erythromycin lactobionate is preferred due to the slower infusion rate and lower concentration of erythromycin; however, intermittent
    infusion at intervals not greater than every six hours is also effective.
    Intravenous erythromycin should be replaced by oral erythromycin as soon as
    possible.
    Preparations for administration:
    For Intermittent Infusion of 1 gram dose:
    Step 1 – add 20 ml of Water for Injections BP to the 1 g vial.
    Step 2 – add 20 ml of Step 1 solution to 200-250 ml of Sodium Chloride.
    Intravenous Infusion BP (0.9% Saline). This provides a 0.5%-0.4% solution.
    If it is decided to administer the daily dose as an intermittent infusion, then the
    erythromycin concentration should not exceed 5 mg/ml and the time of each infusion should be between 20 and 60 minutes.
    For Continuous Infusion of 1 gram dose:
    Step 1 – add 20 ml of Water for Injections BP to the 1 g vial.
    Step 2 – add 20 ml of Step 1 solution to 500-1000 ml of Sodium Chloride
    Intravenous Infusion BP (0.9% Saline). This provides a 0.2%-0.1% infusion.
    The infusion should be completed within eight hours of preparation to ensure
    potency.
    Alternative Step 2 diluents:
    Compound Sodium Lactate Injection BP (Hartmann’s Solution).
    Solutions containing glucose may also be used but sodium bicarbonate must first be added as a buffer to ensure neutrality.
    5 ml of sterile 8.4% w/v sodium bicarbonate solution will neutralise one litre of:
    Glucose Injection BP (5%), or of Sodium Chloride and Glucose Injection BP (usually 0.18% sodium chloride and 4.0% glucose).
    The stability of solutions of Erythrocin IV Lactobionate is adversely affected below pH 5.5.


    Indications

    For the treatment of bacterial infections susceptible to erythromycin and require I.V treatment.


    Contra-Indications

    Known hypersensitivity to erythromycin.
    Erythromycin is contraindicated in patients taking astemizole, terfenadine,
    cisapride or pimozide.
    Erythromycin is contraindicated with ergotamine and dihydroergotamine.
    Bolus injection (IV push) is an unacceptable route of administration.
    Erythromycin lactobionate must be administered by continuous or intermittent
    intravenous infusion only.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    Blood and lymphatic system disorders: Eosinophilia.
    Cardiac disorders: QTc interval prolongation, torsades de pointes, palpitations, and cardiac rhythm disorders including ventricular tachyarrhythmias.
    Ear and labyrinth disorders: Deafness, tinnitus
    There have been isolated reports of reversible hearing loss occurring chiefly in
    patients with renal insufficiency or taking high doses.
    Gastrointestinal disorders: The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. The following have been reported: upper abdominal discomfort, nausea, vomiting, diarrhoea, pancreatitis, anorexia, infantile hypertrophic pyloric stenosis.
    Pseudomembranous colitis has been reported rarely in association with
    erythromycin therapy.
    General disorders and administration site conditions: Chest pain, fever, malaise.
    Hepatobiliary disorders: Cholestatic hepatitis, jaundice, hepatic dysfunction, hepatomegaly, hepatic failure, hepatocellular hepatitis.
    Immune system disorders: Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.
    Investigations: Increased liver enzyme values.
    Nervous system disorders: Dizziness, isolated reports of transient central nervous system side effects including confusion, seizures and vertigo; however, a cause and effect relationship has not been established.
    Psychiatric disorders: Hallucinations
    Renal and urinary disorders: Interstitial nephritis
    Skin and subcutaneous tissue disorders: Skin eruptions, pruritus, urticaria, exanthema, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.
    Vascular disorders: Hypotension.


    Drug interactions

    Carbamazepine, cyclosporin, disopyramide, theophylline, bromocriptine, midazolam, triazolam. Coumarin anticoagulants, ergot alkaloids, digoxin. Alfentanil, lincomycin, clindamycin, terfenadine, astemizole, cisapride.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate and well-controlled studies in pregnant women. However, observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing erythromycin during early pregnancy.
    Erythromycin has been reported to cross the placental barrier in humans, but foetal plasma levels are generally low.
    Lactation: Erythromycin is excreted in breast milk, therefore, caution should be exercised when erythromycin is administered to a nursing mother.


    Overdose

    Symptoms: Hearing loss, severe nausea, vomiting and diarrhoea.
    Treatment: Gastric lavage, general supportive measures.
    Erythromycin is not removed by peritoneal dialysis or haemodialysis.


    Manufacturer
    Famar L'aigle
    Licence holder
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