VANORX

What it is

VANORX is a preparation containing vancomycin hydrochloride capsules for oral use in the treatment of colitis. VANORX capsules contain the active ingredient vancomycin hydrochloride equivalent to 125 mg or 250 mg of vancomycin. The formulation contains sulfites.

Approved indications

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

Dosing overview

For adults with staphylococcal enterocolitis and antibiotic-induced pseudomembranous colitis produced by C. difficile, the usual daily dosage is 250 mg six hourly for 5–10 days. However, doses of 500 mg to 2 g orally administered in 3 or 4 divided doses for 7–10 days have been used for the treatment of antibiotic-associated pseudomembranous colitis produced by C. difficile. 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, with the total daily dose not exceeding 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 patients treated with VANORX capsules may be at risk for the development of adverse reactions associated with parenteral administration of vancomycin. The risk is greater if renal impairment is present. The total systemic and renal clearances of vancomycin are reduced in the elderly, and the need for estimation of serum levels and dosage adjustment should be considered in such cases. 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. If a SCAR is suspected, the drug should be discontinued and specialist dermatological assessment should be carried out. Ototoxicity has occurred in patients receiving vancomycin 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 (for example, in the elderly). VANORX capsules should be avoided in patients with previous hearing loss unless no other appropriate therapy is available. Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered. Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cross hypersensitivity, including fatal anaphylactic shock, may occur.

Contraindications

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

Regulatory history

VANORX vancomycin hydrochloride capsules in 125 mg and 250 mg strengths were first registered on the ARTG on 3 February 2026.