Aciclovir

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Herpes simplex virus infections of the skin, lips or genitalia in the initial and recurrent situation

Contraindications

South African recommendations & Recommendations in other jurisdictions

• Known to be hypersensitive to aciclovir, valaciclovir or propylene glycol, or any of the excipients

Cautions

• Pregnancy
• Application to mucous membranes
• Treatment of genital herpes
• Contact with eyes
• Severe recurrent herpes labialis 
• Immunocompromised patients
• Treatment of ocular herpes infections

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

Dosages below include:

• 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 registered indications and dosages

Herpes simplex virus infections of the skin, lips (herpes labialis) or genitalia in the initial and recurrent situation

• Topical (cre): Apply small quantity to affected area(s), 4hrly; Max: 5 applications/24hrs; Herpes labialis: Treatment duration: ≥4 days; Genital herpes: Treatment duration: ≥5 days; If healing has not occurred: Treatment duration: Up to 10 days

Aciclovir cream should be applied to the lesions or impending lesions as soon as possible, preferably during the early stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages

Indications and dosages registered in other jurisdictions

Herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis

• Topical (cre): Apply small quantity to affected area(s), 4hrly; Max: 5 applications/24hrs (omitting the night time application); Herpes labialis: Treatment duration: ≥4 days; Genital herpes: Treatment duration: ≥5 days; If healing has not occurred: Treatment duration: Up to 10 days

Aciclovir cream should be applied to the lesions or impending lesions as soon as possible, preferably during the early stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages

In the severely immunocompromised (e.g. AIDS patients or bone marrow transplant recipients) oral aciclovir dosing should be considered. Such patients should be encouraged to consult a doctor concerning the treatment of any infection

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

Paed. dosages below include:

• 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 registered indications and dosages

Herpes simplex virus infections of the skin, lips (herpes labialis) or genitalia in the initial and recurrent situation

• See adult dosage

Indications and dosages registered in other jurisdictions

Herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis

• 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 topical aciclovir should be considered only when the potential benefits outweigh the possibility of unknown risks however the systemic exposure to aciclovir from topical application of aciclovir cream is very low

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 topical aciclovir 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 yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Skin and Subcutaneous Tissue Disorders

• Transient burning or stinging
• Mild drying or flaking of the skin
• Itching
• Erythema
• Contact dermatitis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
  - Angioedema
  - Urticaria

No information available 

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

Cream (per g) 50mg

• Acitop (Cipla)
• Activir Pump Pack (GSK)
• Adco Acyclovir Topical cream (Adcock Ingram)
• Beta-Vira Topical cream (Adcock Ingram)
• Lovire (Ranbaxy)
• Zotrin 5% (Trinity Pharma)
• Zovirax (GSK) originator

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