Simplovir 5% w/w (Cream)

Indications

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

Pharmacology

• Antiviral drug active against herpes simplex virus
• Inhibitory activity against HSV types 1 and 2
• Competitive inhibition of viral DNA polymerase
• Incorporation into and termination of viral DNA chain
• Inactivation of viral DNA polymerase

Dosage & Administration

• Applied five times per day for four days
• Therapy initiated early on signs or symptoms of herpes labialis
• Same dosage for adolescents 12 years of age and older

Interaction

• Minimal systemic absorption
• Unlikely systemic drug interactions

Contraindications

• Hypersensitivity to acyclovir
• Hypersensitivity to valacyclovir
• Hypersensitivity to any component of the formulation

Side Effects

• Dry lips
• Desquamation
• Dryness of skin
• Cracked lips
• Burning skin
• Pruritus
• Flakiness of skin
• Stinging on skin

Pregnancy & Lactation

• Pregnancy Category B
• Use during pregnancy if benefit justifies risk to fetus
• Unknown excretion in breast milk
• Minimal systemic exposure

Precautions & Warnings

• To be applied only on affected external aspects of lips and face
• Not recommended for human mucous membranes
• Intended for cutaneous use only
• Not to be used in the eye or inside the mouth or nose
• Potential for irritation and contact
• Effect not established in immunocompromised patients

Use in Special Populations

• Safe usage observed in pediatric patients aged 12 to 17 years
• Safety and effectiveness not established in pediatric patients under 12 years of age
• Limited data for subjects aged 65 and over

Therapeutic Class

• Topical Antiviral preparation

Storage Conditions

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

Related Brands

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