ACICLOVIR SANDOZ 5% CREAM

ACICLOVIR SANDOZ 5% CREAM

Therapeutic indications

The product in the cream formulation is indicated in the treatment of Herpes simplex skin infections such as: primary or recurrent genital herpes and Herpes labialis.

Dosage and method of use

The cream should be applied 5 times a day at intervals of approximately 4 hours on the lesions or on the areas where they are developing as early as possible after the onset of the infection. It is particularly important to begin treatment of recurrent episodes during the prodrome phase or at the first appearance of lesions. Treatment must continue for at least 5 days and up to a maximum of 10 if recovery has not occurred.

Contraindications

Known hypersensitivity to aciclovir, valaciclovir, propylene glycol, other components of the formulation. Generally contraindicated during pregnancy and breastfeeding (see section 4.6).

Side effects

For the classification of side effects in terms of frequency the following convention was used: very common ≥1/10; common ≥1/100 to Skin and subcutaneous tissue disorders Uncommon: transient stinging or burning sensation following application of aciclovir cream, slight drying or peeling of the skin, itching. Rare: erythema. contact dermatitis after application. Where sensitivity tests have been conducted, the reactive substances have been shown to be more often the components of the cream, rather than aciclovir.Immune system disordersVery rare: immediate hypersensitivity reactions, including angioedema and urticaria.

Special warnings

It is recommended not to apply aciclovir cream on mucous membranes (such as eyes, mouth or vagina), as it can be irritating. Special care must be taken to avoid accidental introduction into the eye. Animal studies indicate that application of Aciclovir in the cream formulation to the vagina may cause reversible irritation. In severely immunocompromised patients (for example those suffering from AIDS or who have received a bone marrow transplant) oral administration of aciclovir should be considered. Such patients should be encouraged to consult a doctor regarding the treatment of any infection. The excipient propylene glycol may cause skin irritation. The use of the product, especially if prolonged, can give rise to sensitization phenomena, if this happens it is necessary to interrupt the treatment and consult the doctor. Keep out of the reach and sight of children.

Pregnancy and breastfeeding

PregnancyDuring this period the drug must be used only in cases of absolute necessity under the direct supervision of a doctor. A post-marketing pregnancy registry for aciclovir documented effects on pregnancy in women exposed to any formulation of aciclovir. The results showed no increase in the number of birth defects among those exposed to acyclovir compared to the general population, and any birth defects did not show any unique characteristics or recurring patterns that might suggest a common cause. Systemic administration of aciclovir in internationally recognized standard trials did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test performed in rats, fetal anomalies were observed, but only following the administration of subcutaneous doses so high as to cause maternal toxicity. The clinical relevance of these findings is uncertain. The use of aciclovir should be considered only if the potential benefits outweigh the possibility of unknown risks; however, systemic exposure to aciclovir due to topical application of aciclovir cream is very limited.Feeding timeSome limited human data have demonstrated that, following systemic administration, the drug passes into breast milk. However, the dosage received by an infant after the mother's use of aciclovir cream is insignificant. Caution is advised when using acyclovir during breastfeeding.

Expiration and conservation

Store at a temperature not exceeding 25°C.

Interactions with other drugs

Probenecid increases the mean half-life and the area under the plasma concentration curve of systemically administered Aciclovir. Clinical experience has not revealed interactions with other drugs.

Overdose

No side effects are expected even if the entire contents of a tube of aciclovir cream (500 mg) were taken orally given that single doses of 600 mg and daily doses of up to 3600 mg have been administered orally without any experienced side effects. Single intravenous doses up to 80 mg/kg have been administered accidentally without side effects. Aciclovir is dialysable.

Active principles

100 g of cream contains: Active ingredient: aciclovir 5.00 g.

Excipients

Purified water; propylene glycol; labrafil; Vaseline oil; polaxamer 407; sodium lauryl sulfate; tefose.