Product Dossier
ACICLOVIR-WGR
Product Dossier for ACICLOVIR-WGR (aciclovir, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- Active ingredient: aciclovir
- Therapeutic area: Infectious Disease
- Related brand: XOROX
- Related brand: ViruPOS
- Related brand: ARX-ACICLOVIR
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
ACICLOVIR-WGR is a medicine containing aciclovir 200 mg or 800 mg per tablet. The 200 mg tablets are capsule shaped, biconvex, white to off-white tablets, and the 800 mg tablets are also capsule shaped, biconvex, white to off-white tablets.
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 aciclovir at the recommended dosage and may be associated with renal pain. Aciclovir is eliminated by renal clearance, therefore the dose must be reduced in patients with renal impairment. 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. Attention should be given to maintaining adequate hydration in elderly patients. HSV strains resistant in vitro to aciclovir have been isolated from immunocompromised as well as 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. Aciclovir has been associated with reversible encephalopathic changes and should be used with caution in patients with underlying neurological abnormalities, significant hypoxia or serious renal, hepatic or electrolyte abnormalities. It should also be used with caution in patients who have manifested neurological reactions to cytotoxic drugs or are receiving interferon or intrathecal methotrexate concomitantly.
Contraindications
Known hypersensitivity to aciclovir or valaciclovir.
Regulatory history
ACICLOVIR-WGR was first registered on the ARTG on 29 May 2024, with two variants registered: the 200 mg tablet (ARTG 431491) and the 800 mg tablet (ARTG 431493).