Aciclovir

Registered South African indications:

• Herpes simplex keratitis

Contraindications

South African recommendations

• Known to be previously hypersensitive to aciclovir or valaciclovir

Recommendations in other jurisdictions

• Hypersensitivity to the active substance or to any of the excipients
• Hypersensitivity to valaciclovir

Cautions

• Pregnancy
• Concomitant use of contact lenses
• May impair visual ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: eyo

Dosages below include:

• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Herpes simplex virus; Varicella zoster virus

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Herpes simplex keratitis

• Opthalmic (eyo): Apply in the lower conjunctival sac, 4hrly; Treatment duration: 3 days after ulcer has healed
  (STG, Adult 2019)

South African registered indications and dosages &
Indications and dosages registered in other jurisdictions

Herpes simplex keratitis

• Opthalmic (eyo): Apply 10mm ribbon to the inside of lower conjunctival sac, 4hrly; Max: 5 applications/24hrs; Treatment duration: ≥3 days after healing

Paed. forms avail. in SA and covered in this monograph: eyo

Paed. dosages below include:

• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Herpes simplex virus; Varicella zoster virus

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Herpes simplex keratitis and conjucntivitis

• Opthalmic (eyo): Insert in the lower conjunctival sac, 4hrly; Treatment duration: 10 days
  (STG, Paed. 2022)

South African registered indications and dosages &
Indications and dosages registered in other jurisdictions

Herpes simplex keratitis

• See adult dosage

Pregnancy

• Caution
• A post-marketing aciclovir pregnancy registry has documented pregnancy outcomes in women exposed to any formulation of aciclovir. The registry findings have not shown an increase in the number of birth defects described amongst aciclovir exposed subjects compared with the general population, and any birth defects showed no uniqueness or consistent pattern to suggest a common cause
• Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, foetal abnormalities were observed but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain
• The use of aciclovir ophthalmic ointment should be considered only when the potential benefits outweigh the possibility of unknown risks

Breastfeeding

• Compatible 
• Limited human data show that the drug does pass into breast milk following systemic administration. However, the dosage received by the breastfeeding infant following maternal use of aciclovir ophthalmic ointment would be insignificant

Fertility

• There is no information on the effect of aciclovir on human female fertility
• In a study of 20 male patients with normal sperm count, oral aciclovir administered at doses of up to 1g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
  - Angioedema
  - Urticaria

Sensory Disorders

• Superficial punctate keratopathy
• Transient mild stinging of the eye
• Conjunctivitis
• Blepharitis

No significant interactions

None routine

Aciclovir is an antiviral agent which is highly active in vitro against herpes simplex virus (HSV) types I and II and varicella-zoster virus. Toxicity to mammalian host cells is low. Aciclovir is phosphorylated after entry into herpes infected cells to the active compound aciclovir triphosphate. The first step in this process is dependent on the presence of the HSV-coded thymidine kinase. Aciclovir triphosphate acts as an inhibitor of, and substrate for, the herpes-specified DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes.

Spectrum of activity: Herpes simplex virus, Varicella-zoster virus

Eye ointment (per g) 30mg

• Zovirax (GSK) originator

Also available in the following forms: Tablet, suspension, injection and cream.