ARTG Entry
VANCOR
ARTG entry for VANCOR (vancomycin), ARTG 445032 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Pharmacor
- Active ingredient: vancomycin
- Therapeutic area: Infectious Disease
What it is
VANCOR contains vancomycin hydrochloride equivalent to 125 mg or 250 mg of vancomycin. It is a capsule preparation for oral use only in the treatment of colitis.
Approved indications
— Staphylococcal enterocolitis. — Antibiotic-associated pseudomembranous colitis produced by Clostridioides difficile.
Dosing overview
For adults, the usual daily dosage for staphylococcal enterocolitis and for antibiotic induced pseudomembranous colitis produced by Clostridioides difficile is 250 mg 6 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 Clostridioides 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, and the total daily dose should not exceed 2 g.
Key safety warnings
Patients with a creatinine clearance less than 60 mL/minute and all elderly individuals should be given serial tests of auditory function and of vancomycin blood levels. Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active Clostridioides difficile-induced pseudomembranous colitis, and significant systemic absorption of orally administered vancomycin has been reported in some patients with inflammatory disorders of the intestinal mucosa. Therefore, patients treated with VANCOR capsules may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. 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. Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. VANCOR capsules should be avoided in patients with previous hearing loss unless no other appropriate therapy is available.
Contraindications
VANCOR is contraindicated in patients with known hypersensitivity to vancomycin or any of the excipients or other glycopeptides.
Regulatory history
VANCOR vancomycin hydrochloride 125 mg and 250 mg capsule blister packs were first listed on the ARTG on 3 February 2026.