Product Dossier
ZOVIRAX
Product Dossier for ZOVIRAX (aciclovir, hydrocortisone, Haleon). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Haleon
- Active ingredient: aciclovir, hydrocortisone
- Therapeutic area: Dermatology
- Related brand: XOROX
- Related brand: SOLU-CORTEF
- Related brand: ALKINDI
- Same area: DERMATANE
- Same area: NEOTIGASON
What it is
ZOVIRAX contains aciclovir 200 mg or 800 mg per tablet. The 200 mg tablets are capsule shaped, biconvex, white to off-white tablets debossed "200" on one side and "ACV" on the other side, while the 800 mg tablets are capsule shaped, biconvex, white to off-white tablets debossed "800" on one side and "ACV" on the other side.
Approved indications
— Treatment of first episode (primary or nonprimary) genital herpes and the management of recurrent episodes of genital herpes in certain patients. — Treatment of acute attacks of herpes zoster (shingles) when the duration of rash is less than 72 hours. — The management of patients with advanced symptomatic human immunodeficiency virus (HIV) disease (CD4+ counts < 150 × 10°/L).
Dosing overview
Key safety warnings
Renal insufficiency or acute renal failure has been observed in patients taking acyclovir at the recommended dosage and/or with no previous renal conditions; aciclovir is eliminated by renal clearance, therefore the dose must be reduced in patients with renal impairment. Elderly patients are likely to have reduced renal function and both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir. As aciclovir has been associated with reversible encephalopathic changes, it should be used with caution in patients with underlying neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities, and should also be used with caution in patients who have manifested neurological reactions to cytotoxic drugs or are receiving interferon or intrathecal methotrexate concomitantly. Resistant strains have been isolated in vitro and in animals following treatment with aciclovir; HSV strains resistant in vitro to aciclovir have also been isolated from both immunocompromised and immunocompetent patients receiving aciclovir for herpes simplex infections, therefore the potential for the development of resistant HSV strains in patients treated with aciclovir should be borne in mind.
Contraindications
Known hypersensitivity to aciclovir or valaciclovir.
Regulatory history
ZOVIRAX was first approved on 29 May 2024.