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  • Vancomycin Mylan
    / Gemedix


    Active Ingredient
    Vancomycin HCl 500 mg, 1 g

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 500 mg

    partial basket chart 29145 22280

    Vial

    1 X 1 g

    partial basket chart 29144 22279

    Dosage

    Intravenous administration: Solution concentrations of no more than 5 mg/ml are recommended. In selected patients in need of fluid restriction, solution concentration up to 10 mg/ml may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusions should be given over at least 60 minutes. In adults, if doses exceeding 500 mg are used, a rate of infusion of no more than 10 mg/min is recommended. Infusion-related adverse events are related to both concentration and rate of administration of vancomycin. The duration of treatment is guided by the severity of the infection and its clinical and bacteriological progression.
    Patients with normal renal and hepatic functions:
    Adult and adolescents above 12 years of age: The recommended daily intravenous dose is 2000 mg (2g), divided into doses of 500 mg every 6 hours or 1000mg every 12 hours. For bacterial endocarditis, the generally accepted regimen is 1000 mg of vancomycin intravenously every 12 hours for 4 weeks either alone or in combination with other antibiotics (gentamicin plus rifampin, gentamicin, streptomycin). Enterococcal endocarditis is treated for 6 weeks with vancomycin in combination with an aminoglycoside – according to national recommendations.
    Children 1 month to 12 years of age: The recommended intravenous dose is 10mg/kg, every 6 hours.
    Infants and newborn: The recommended initial dose is 15 mg/kg, followed by 10 mg/kg every 12 hours during the first week of life and every 8 hours after that age and up to 1 month of age. Careful monitoring of serum concentration of vancomycin is recommended.
    Elderly patients: Lower maintenance doses may be required due to the age –related reduction in renal function.
    Obese patients: Modification of the usual daily doses may be required.
    Patients with impaired hepatic function There is no evidence that the dose has to be reduced in patients with impaired hepatic function.
    For full details see prescribing information.


    Indications

    Intravenous administration: Vancomycin hydrochloride is indicated for the treatment of severe or serious infections due to susceptible strains of methicillin – resistant (betaIactam-resistant) staphylococci. It is also indicated for administration to penicillin-allergic patients as well patients who have failed to respond to or who cannot receive other drugs including cephalosporins or penicillins and for infections due to vancomycinsusceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride is indicated for first-line therapy when methicillinresistant staphylococci are suspected but when susceptibility data become available appropriate therapy should be instituted. Vancomycin hydrochloride is effective in the treatment of staphylococcal endocarditis as well as in other infections due to staphylococci including lower respiratory tract infections septicemia skin and skin – structure infection and bone infections. Antibiotic therapy is as an adjunct to appropriate surgical measures when staphylococcal infections are purulent and localized. For endocarditis due to Streptococcus viridans or Streptococcus bovis vancomycin hydrochloride has been shown to be effective in combination with an aminoglycoside. Vancomycin hydrochloride has been shown to be effective only in combination with an aminoglycoside for endocarditis due to enterococci (e.g. Enterococcus fecalis). Vancomycin hydrochloride has been shown to be effective for the treatment of diphtheroid endocareditis. In early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis or diptheroids vancomycin hydrochloride has been administered successfully in combination with either rifampin an aminoglycoside or combined with both drugs. Bacteriologic cultures of specimens should be obtained for isolation and identification of causative organisms and determination of susceptibilities to vancomycin hydrochloride.
    Oral administration: Vancomycin hydrochloride injection may be given orally for the treatment of antibiotic-associated Pseudomembrannous colitis due to Staphylococcus enterocolitis and Clostridium difficile. Vancomycin hydrochloride is not effective orally when administered for other types of infection. Consideration should be given to official guidance on the appropriate use of antibacterial agents.


    Contra-Indications

    Vancomycin is contraindicated in patients with known hypersensitivity to this drug.


    Special Precautions

    Warnings
    Rapid bolus administration (e.g., over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest. Vancomycin should be infused in a dilute solution over a period of not less than 60 minutes to avoid rapid infusion-related reactions. Stopping the infusion usually results in a prompt cessation of these reactions.
    Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of oral vancomycin and, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. The risk is greater in patients with renal impairment. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly.
    Due to its potential ototoxicity and nephrotoxicity, vancomycin should be used with care in patients with renal insufficiency and the dose should be reduced according to the degree of renal impairment.
    The risk of toxicity is appreciably increased by high blood concentrations or prolonged therapy.
    Blood levels should be monitored and renal function tests should be performed regularly.
    Vancomycin should also be avoided in patients with previous hearing loss. If it is used in such patients, the dose should be regulated, if possible, by periodic determination of the drug level in the blood. Deafness may be preceded by tinnitus.
    The elderly are more susceptible to auditory damage. Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
    Vancomycin should be administered with caution in patients allergic to teicoplanin, since allergic cross reactions between vancomycin and teicoplanin have been reported.
    Usage in paediatrics: In premature neonates and young infants, it may be appropriate to confirm desired vancomycin serum concentrations. Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema and histamine-like flushing in children.
    Usage in the elderly: The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted.
    Precautions
    Clinically significant serum concentrations have been reported in some patients being treated for active C. difficile-induced pseudomembranous colitis after multiple oral doses of vancomycin.
    Therefore, monitoring of serum concentrations may be appropriate in these patients.
    Patients with borderline renal function and individuals over the age of 60 should be given serial tests of auditory function and of vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis and renal function tests.
    Vancomycin is very irritating to tissue, and causes injection site necrosis when injected intramuscularly; it must be infused intravenously. Injection site pain and thrombophlebitis occur in many patients receiving vancomycin and are occasionally severe.
    The frequency and severity of thrombophlebitis can be minimised by administering the drug slowly as a dilute solution (2.5 to 5.0 g/l) and by rotating the sites of infusion.
    Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis, due to C.
    difficile, developing in patients who received intravenous vancomycin.


    Side Effects

    Infusion-related events: During or soon after rapid infusion of vancomycin, patients may develop anaphylactoid reactions including hypotension, wheezing, dyspnoea, urticaria or pruritus. Rapid infusion may also cause flushing of the upper-body (‘red-neck’syndrome) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. In animal studies, hypotension and bradycardia occurred in animals given large doses of vancomycin at high concentrations and rates. Such events are infrequent if vancomycin is given by slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin was administered at a rate of 10mg/min or less.
    Rapid bolus injection may give hypotension, bradycardia, cardiogenic shock and rarely cardiac arrest.
    Nephrotoxicity: Rarely, renal failure, principally manifested by increased serum creatinine or blood urea concentrations, have been observed, especially in patients given large doses of intravenously administered vancomycin. Rare cases of interstitial nephritis have been reported. Most occurred in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When vancomycin was discontinued, azotaemia resolved in most patients.
    Ototoxicity: Hearing loss associated with intravenously administered vancomycin has been reported.
    Most of these patients had kidney dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug. Vertigo, dizziness and tinnitus have been reported rarely. Tinnitus, possibly preceding onset of deafness, may occur and should be regarded as an indication to discontinue treatment.
    Haematological: Reversible neutropenia, usually starting one week or more after onset of intravenous therapy or after a total dose of more than 25 g. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported. Reversible agranulocytosis (less than 500 granulocytes per mm3) has been reported rarely, although causality has not been established. Eosinophilia has been reported.
    Miscellaneous: Phlebitis, hypersensitivity reactions anaphylaxis, nausea, chills, drug fever, rashes (including exfoliative dermatitis) and rare cases of vasculitis. Vancomycin has been associated with the bullous eruption disorders, Stevens-Johnson syndrome, toxic epidermal necrolysis and linear IgA bullous dermatosis. If a bullous disorder is suspected, the drug should be discontinued and specialist dermatological assessment should be carried out.


    Drug interactions

    Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema, histamine-like flushing and anaphylactoid reactions.
    There have been reports that the frequency of infusion-related events increases with the concomitant administration of anaesthetic agents. Infusion-related events may be minmised by the administration of vancomycin as a 60-minute infusion prior to anaesthetic induction.
    Concurrent or sequential systemic or topical use of other potentially neurotoxic or nephrotoxic drugs, such as amphotericin B, aminoglycosides, bacitracin, polymixin B, colistin, viomycin or cisplatin, when indicated, requires careful monitoring.


    Pregnancy and Lactation

    Usage in pregnancy: Teratology studies have been performed at 5 times the human dose in rats and 3 times the human dose in rabbits, and have revealed no evidence of harm to the foetus due to vancomycin. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin hydrochloride on infants were evaluated when the drug was administered to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. Vancomycin hydrochloride was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant, whose mother received vancomycin in the third trimester,
    experienced conductive hearing loss that was not attributable to vancomycin. Because vancomycin was administered only in the second and third trimesters, it is not known whether it causes foetal harm. Vancomycin should be given in pregnancy only if clearly needed and blood levels should be monitored carefully to minimise the risk of foetal toxicity. It has been reported, however, that
    pregnant patients may require significantly increased doses of vancomycin to achieve therapeutic serum concentrations.
    Usage in nursing mothers: Vancomycin hydrochloride is excreted in human milk. Caution should be exercised when vancomycin is administered to a nursing woman. It is unlikely that a nursing infant can absorb a significant amount of vancomycin from its gastro-intestinal tract.


    Overdose

    Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed from the blood by haemodialysis or peritoneal dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit.


    Manufacturer
    MYLAN S.A.S, France
    Licence holder
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