VANCOCIN

What it is

VANCOCIN is available as capsules containing vancomycin hydrochloride equivalent to 125 mg or 250 mg of vancomycin. The 125 mg capsules are size 2, hard gelatin capsules with an opaque blue cap and opaque peach body, whilst the 250 mg capsules are size 0, hard gelatin capsules with an opaque blue cap and opaque mushroom grey body.

Approved indications

— Staphylococcal enterocolitis — Antibiotic-associated pseudomembranous colitis produced by *C. difficile*

Dosing overview

For children, the usual daily dose is 20 mg/kg orally in 4 divided doses, but doses of up to 40 mg/kg/day may be used, provided the total daily dose does not exceed 2 g.

Key safety warnings

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active *C. difficile*-induced pseudomembranous colitis. Significant systemic absorption of orally administered vancomycin has been reported in some patients with inflammatory disorders of the intestinal mucosa, and such patients may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. The risk is greater if renal impairment is present. Ototoxicity has occurred in patients receiving VANCOCIN and may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent such as an aminoglycoside, or have impaired renal clearance of vancomycin, such as in the elderly. VANCOCIN capsules should be avoided in patients with previous hearing loss unless no other appropriate therapy is available. Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Patients should be advised to inform their doctor at the first appearance of rash or any other sign of hypersensitivity, and if a SCAR is suspected, the drug should be discontinued and specialist dermatological assessment should be carried out. Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.

Contraindications

VANCOCIN is contraindicated in patients with known hypersensitivity to vancomycin or any of the excipients or other glycopeptides.

PBS listing

The 250 mg capsule (as hydrochloride) and 125 mg capsule (as hydrochloride) are each listed on the PBS with authority required restriction at ex-manufacturer prices of A$78.36 and A$39.19 respectively.

Regulatory history

VANCOCIN 125 mg and 250 mg capsules were first listed on the ARTG on 5 September 1991. VANCOCIN received its first approval on 13 August 1992.