Drug Class Description
Glycopeptides.

Generic Name
Vancomycin

Drug Description
Matrigel capsules (dark blue and peach, coded Lilly 3125) containing chromatographically purified vancomycin hydrochloride, equivalent to 125 mg vancomycin base.

Presentation
Capsules, hard.Dark blue and peach hard capsules, coded 3125

Indications
Vancomycin may be used orally for the treatment of staphylococcal enterocolitis and pseudomembranous colitis due to Clostridium difficile.Vancomycin is not significantly absorbed from the normal gastrointestinal tract and is therefore not effective by the oral route for other types of infection. Intravenous administration may be used concomitantly if required.

Adult Dosage
For oral administration.Either the Matrigel capsules or the contents of the 500 mg vial for parenteral administration may be used.Adults and the elderly: The usual daily dose is 500 mg in divided doses for 7 to 10 days, although up to 2 g/day, in three or four divided doses, have been used in severe cases. The total daily dosage should not exceed 2 g.Oral solution: The contents of the 500 mg vial for parenteral administration may be used and either given to the patient to drink, or administered by nasogastric tube. Mix thoroughly to dissolve. Common flavouring syrups may be added to the solution at the time of administration to improve the taste.This preparation is for oral use only. If parenteral vancomycin therapy is desired, use Vancocin CP Injection (Sterile Vancomycin Hydrochloride BP) and consult literature accompanying that preparation.The bitter taste of vancomycin can be avoided by the use of the Matrigel capsules. Vancomycin powder should be used when the patient is unable to swallow the capsules.

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.

Contra Indications
Hypersensitivity to vancomycin.

Special Precautions
PrecautionsClinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficileinduced pseudomembranous colitis. Therefore, monitoring of serum concentrations may be appropriate in these patients.Some patients with inflammatory disorders of the intestinal mucosa may have significant systemic absorption of vancomycin and, therefore, may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin (see package insert accompanying the intravenous preparation). 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.Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, have an underlying hearing loss, or are receiving concomitant therapy with an ototoxic agent such as an aminoglycoside. Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity.When treating patients with underlying renal dysfunction or patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed.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.

Interactions
None known.

Adverse Reactions
Since vancomycin is not usually significantly absorbed from the gastrointestinal tract, the toxicity encountered with parenteral therapy is unlikely to occur after oral administration (but see 'Precautions').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.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 and reversible agranulocytosis (granulocyte count less than 500/mm3 ) have been reported rarely.Miscellaneous: Hypersensitivity reactions, anaphylaxis, chills, drug fever, eosinophilia, hypotension, wheezing, dyspnoea, urticaria, pruritus, flushing of the upper body ("red neck" syndrome), pain, muscle spasm of the chest and back, nausea and rashes, including exfoliative dermatitis, StevensJohnson syndrome, toxic epidermal necrolysis and rare cases of vasculitis.

Manufacturer
Flynn Pharma Ltd

Drug Availability
(POM)

Updated
27 March 2009