Acyclor Cream 5% w/w

Each gram of cream contains 50 mg of Aciclovir (equivalent to 5% w/w).
Dosage Form: Cream (Topical)

Therapeutic Indications

Topical Treatment of:

• Recurrent herpes simplex labialis (cold sores) caused by herpes simplex virus type 1 or 2.

Posology and method of administration

Posology:

• Apply a thin layer of cream to the affected area 5 times daily (approximately every 4 hours while awake) for 4 days.
• Treatment should be initiated as soon as the first symptoms of a herpes episode appear (e.g., tingling, redness, itching).

Special Populations:

• Pediatric Population: Safety and efficacy established in children ≥12 years. Not recommended for children <12 years.
• Elderly: No dose adjustment necessary.
• Renal/Hepatic Impairment: Not applicable due to minimal systemic absorption.

Method of Administration:

• For topical use only. Avoid contact with eyes and mucous membranes.
• Wash hands before and after application.

Contraindications

• Hypersensitivity to aciclovir, valaciclovir, or any of the excipients.
• Application on mucous membranes or open wounds.

Special warnings and precautions for use

• Not for ophthalmic use.
• If lesions do not improve after 10 days of treatment or worsen, seek medical advice.
• Use with caution in patients with severely impaired immune systems.
• Avoid extensive application to large areas of damaged skin.

Interaction with other medicinal products and other forms of interaction

• Due to minimal systemic absorption, no significant drug interactions are expected.

• Pregnancy: Limited data available; use only if clearly needed and benefit outweighs risk.
• Lactation: Unknown if aciclovir is excreted in breast milk following topical use; caution advised.

Effects on ability to drive and use machines

• No effect expected.

Frequency Categories (CIOMS III):

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (<1/1,000)

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Local skin reactions such as mild burning, itching, redness

Allergic dermatitis, rash

Severe hypersensitivity reactions (very rare)

• Usually mild and transient; discontinue if severe irritation occurs.

• Topical overdose is unlikely to cause systemic toxicity.
• In case of accidental ingestion, provide symptomatic treatment.

Pharmacodynamic Properties

• Aciclovir is a synthetic purine nucleoside analogue active against herpes viruses.
• It selectively inhibits viral DNA polymerase after conversion to aciclovir triphosphate in virus-infected cells, resulting in inhibition of viral DNA replication.

Pharmacokinetic Properties

• Minimal systemic absorption after topical application.
• Metabolism and elimination follow systemic aciclovir pathways if absorbed.

Special precautions for storage

• Store below 25°C.
• Do not freeze.