Aciclovir DOC 5%

Cream

Composition :

100 g of cream contain: aciclovir 5 g (equal to 50 mg in 1 g).

Excipients

Propylene glycol; tefose; labrafil; Vaseline oil; polassamer 407; sodium lauryl sulfate; purified water.

Therapeutic indications

Aciclovir cream is indicated in the treatment of Herpes simplex skin infections such as: primary or recurrent Herpes genitalis and Herpes labialis.

Contraindications

Aciclovir cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir, propylene glycol or any of the excipients. Generally contraindicated in pregnancy and lactation (see section 4.6).

Dosage

Aciclovir cream should be applied 5 times a day at approximately 4 hour intervals. Aciclovir cream should be applied to lesions or areas where they are developing as early as possible after the infection begins. It is especially important to start treatment for recurrent episodes during the prodrome phase or when lesions first appear. Treatment should continue for at least 5 days and up to a maximum of 10 if there is no healing.

Warnings and Precautions

The product is not for ophthalmic use. The application of aciclovir cream to mucous membranes such as those of the mouth, eyes or vagina is not recommended. Particular care should be taken to avoid accidental application into the eye. Animal studies indicate that the application of aciclovir cream in the vagina can cause reversible irritation. The use of the product, especially if prolonged, can give rise to sensitization phenomena, where this happens it is necessary to stop the treatment and consult the attending physician. In severely immunocompromised patients (AIDS patients or bone marrow transplant patients) administration of aciclovir in oral formulations should be considered. Such patients should be advised to consult their physician regarding the treatment of any infection. The excipient propylene glycol can cause skin irritation.

Interactions

No clinically significant interactions have been identified.

Side effects

The following convention has been used for the classification of undesirable effects in terms of frequency: very common> 1/10, common> 1/100 and <1/10, uncommon> 1 / 1,000 and <1/100, rare> 1 /10,000 and <1 / 1,000, very rare <1 / 10,000. Data from clinical trials were used to assign frequency categories to adverse reactions observed during clinical studies performed with aciclovir 3% ophthalmic ointment. Due to the nature of the adverse events observed, it is not possible to uniquely determine which events are related to drug administration and which are related to the disease itself. Data from spontaneous reporting was used as a basis for determining the frequency of those events detected by post-marketing pharmacovigilance. Skin and subcutaneous tissue disorders Uncommon: transient burning or pain, moderate dryness, skin peeling and itching. Rare: erythema, contact dermatitis after application. Where susceptibility tests were conducted, it was shown that the reactivity phenomena were related to the components of the cream rather than to acyclovir. Immune system disorders Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

Pregnancy and breastfeeding

Fertility Reversible toxic effects on spermatogenesis have been reported in rats and dogs only at systemic dosages significantly higher than therapeutic ones. Two-generation studies in mice revealed no effects of aciclovir, administered orally, on fertility. There are no data on the effects of aciclovir cream on female fertility. Aciclovir tablets have not been shown to affect sperm count, morphology and motility in humans. Pregnancy The use of aciclovir should only be considered when the potential benefits outweigh any possible unknown risks, even if the systemic exposure to aciclovir following topical application of aciclovir cream is very low. A registry on the use of aciclovir in pregnancy provided data on pregnancy outcomes in women exposed to different formulations of aciclovir after marketing. The registry results did not show an increase in the number of congenital defects among acyclovir-exposed subjects compared to the general population and all congenital defects did not show any particularities or common characteristics suggesting a single cause. In conventional, internationally accepted tests, systemic administration of aciclovir did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In an experimental test in rats, not included in the classic teratogenic tests, fetal abnormalities were observed after subcutaneous doses of aciclovir so high as to produce toxic effects in the mother. The clinical relevance of these findings is uncertain. Breastfeeding Limited data in humans indicate that the drug is found in breast milk after systemic administration. However, the dose received by an infant following the use of aciclovir cream in the mother should be insignificant.