Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

For intravenous infusion and oral use only and not for intramuscular administration.

Infusionrelated adverse events are related to both concentration and rate of administration of vancomycin.

Concentrations of no more than 5 mg/ml are recommended. In selected patients in need of fluid restriction, a concentration up to 10 mg/ml may be used; use of such higher concentrations may increase the risk of infusionrelated 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. Infusionrelated events may occur, however, at any rate or concentration.

Intravenous Infusion in Patients with Normal Renal Function

Adults: The usual intravenous dose is 500 mg every six hours or 1 g every 12 hours, in Sodium Chloride Intravenous Infusion BP or 5% Dextrose Intravenous Infusion BP. Each dose should be administered at no more than 10 mg/min. Other patient factors, such as age, obesity or pregnancy, may call for modification of the usual daily dose. The majority of patients with infections caused by organisms sensitive to the antibiotic show a therapeutic response within 48-72 hours. The total duration of therapy is determined by the type and severity of the infection and the clinical response of the patient. In staphylococcal endocarditis, treatment for three weeks or longer is recommended.

Pregnancy: It has been reported that significantly increased doses may be required to achieve therapeutic serum concentrations in pregnant patients, but see 'Warnings'.

The elderly: Dosage reduction may be necessary to a greater extent than expected because of decreasing renal function (see below). Monitor auditory function .

Neonates have a larger volume of distribution and incompletely developed renal function; therefore dosing guidelines differ from those recommended for children and adults. In neonates and young infants, the total daily dosage may be lower. An initial dose of 15mg/kg is suggested, followed by 10mg/kg every 12 hours in the first week of life and every 8 hours thereafter until one month of age. Each dose should be administered over 60 minutes. Close monitoring of serum vancomycin concentrations may be warranted in these patients. One dosing nomogram for dosing vancomycin in neonates is illustrated in the following table.

Vancomycin Dosage Guideline for Neonates

Oral Administration

The contents of vials for parenteral administration may be used.

Adults and the elderly: The usual daily dose given is 500 mg in divided doses for 7 to 10 days, although up to 2 g/day have been used in severe cases. The total daily dosage should not exceed 2 g. Each dose may be reconstituted in 30 ml water and either given to the patient to drink, or administered by nasogastric tube.

Common flavouring syrups may be added to the solution at the time of administration to improve the taste.

Capsules are also available.

Child Dosage

The usual daily dose is 40 mg/kg in three or four divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g.

Intravenous Infusion in Patients with Normal Renal Function

The usual intravenous dosage is 10 mg/kg per dose given every 6 hours (total daily dosage 40 mg/kg of body weight). Each dose should be administered over a period of at least 60 minutes.

Elderly Dosage

Contra Indications

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 infusionrelated reactions. Stopping the infusion usually results in a prompt cessation of these reactions (see 'Posology and method of administration' and 'Undesirable effects' sections).

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 histaminelike 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 (see 'Posology and method of administration').

Precautions

Clinically significant serum concentrations have been reported in some patients being treated for active C. difficileinduced 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 nonsusceptible 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.

Interactions

Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema, histaminelike flushing and anaphylactoid reactions.

There have been reports that the frequency of infusionrelated events increases with the concomitant administration of anaesthetic agents. Infusionrelated events may be minimised 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.

Adverse Reactions

Infusionrelated 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 upperbody ('redneck'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, infusionrelated 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 preexisting 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, preexisting 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, StevensJohnson 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.

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