Novirax 5% w/w (Cream)

Indications

• Treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older

Pharmacology

• Acyclovir is an antiviral drug active against herpes simplex virus
• Inhibits replication of herpes viral DNA in three ways

Dosage & Administration

• Apply five times per day for four days
• Initiate therapy early following onset of signs or symptoms of herpes labialis
• Same dosage for adolescents 12 years of age and older

Interaction

• No identified interactions resulting from topical or systemic administration of other drugs concomitantly

Contraindications

• Contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation

Side Effects

• Common adverse reactions at the site of topical application
• Minimal systemic absorption
• Adverse reactions occurred in less than 1% of patients receiving Novirax cream and placebo

Pregnancy & Lactation

• Pregnancy Category B
• Use during pregnancy only if potential benefit justifies potential risk to the fetus

Precautions & Warnings

• Apply only on the affected external aspects of the lips and face
• Not recommended for application to human mucous membranes
• Intended for cutaneous use only
• Has potential for irritation and contact
• Effect not established in immunocompromised patients

Use in Special Populations

• Safety and effectiveness in pediatric patients less than 12 years of age have not been established
• Clinical studies did not include sufficient numbers of subjects aged 65 and over
• Systemic absorption is minimal after topical administration

Therapeutic Class

• Topical Antiviral preparations

Storage Conditions

• Store at room temperature between 20°C to 25°C

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