This combination cream is indicated for the early management of recurrent herpes labialis (cold sores) to reduce the risk of ulcer formation and to accelerate healing time in both adults and children aged 6 years and above.

Acyclovir is a synthetic purine nucleoside analogue with antiviral activity against herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), demonstrated in both in vitro and in vivo studies. Its selective action is due to its high affinity for the viral enzyme thymidine kinase (TK), which converts acyclovir into acyclovir monophosphate. This is subsequently converted into diphosphate by cellular guanylate kinase and then into the active triphosphate form by other cellular enzymes. Acyclovir triphosphate inhibits viral DNA replication through three mechanisms:

• Competitive inhibition of viral DNA polymerase
• Incorporation into the viral DNA chain leading to chain termination
• Inactivation of viral DNA polymerase

Hydrocortisone is a naturally occurring glucocorticoid produced by the adrenal cortex. When applied topically, it exerts anti-inflammatory effects by reducing the inflammatory response and alleviating symptoms associated with various inflammatory conditions.

The cream should be topically applied 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms.

No specific contraindications have been identified for this combination cream.

The most commonly reported adverse reactions (<1%) include local skin effects such as dryness or peeling, burning or tingling sensation, redness (erythema), changes in skin pigmentation, and application site reactions including signs of inflammation.

Pregnancy Category B: There are no adequate and well-controlled studies of systemic Acyclovir in pregnant women, and no specific studies have been conducted with this combination in pregnancy. Systemic absorption of Acyclovir and Hydrocortisone following topical use is minimal. It is not known whether these agents are excreted in human breast milk when applied topically. As many drugs can pass into breast milk, caution is advised when this cream is used by breastfeeding women.

This cream should not be applied to the eyes, inside the mouth or nose, or on the genital area. Patients are advised to consult a healthcare provider if cold sores do not heal within 2 weeks.

The safety and effectiveness of this cream have not been established in children below 6 years of age.

Hydrocortisone and combination preparations

Store below 30°C, protected from light and moisture. Keep out of reach of children.