acyclovir topical (Rx)

>10%

Burning/stinging (30%)

1-10%

Pruritus (4%)

<1%

Dry lips (<1%)

Rash (0.3%)

Frequency Not Defined

Angioedema

Vulvitis

Contraindications

Hypersensitivity

Cautions

Not recommended for recurrent infections

Use caution in immunocompromised patients

Avoid physical contact when lesions are present

For external use only; not for use on the eye or inside mouth

Pregnancy

No available data on use in pregnant women; however, published observational studies over decades of use of acyclovir have not identified a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; systemic exposure of acyclovir following buccal administration is minimal

Animal data

• Animal reproduction studies with topical formulation not conducted; animal reproduction studies with systemic exposure of acyclovir have been conducted; refer to oral and parental acyclovir prescribing information for additional details

Lactation

There are no data on presence of drug in human milk following buccal administration; there are no data on effects of drug on breastfed infant or milk production; systemic exposure following buccal administration is minimal; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Exerts its antiviral effect on herpes simplex viruses and varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication

Helps shed herpes virus quicker and reduces pain and duration; used for management of initial episodes of herpes genitalis and in mucocutaneous herpes simplex viral infections in immunocompromised patients

Absorption

Minimal

Metabolism

In cells infected with herpes viruses, principally by intracellular phosphorylation of drug by virus-coded thymidine kinase and several cellular enzymes

Elimination

Excretion: Urine