Aciclovir Dorom 5%

Cream

Composition:

100 g of 5% cream contain: active ingredient: aciclovir 5 g

Excipients

Tefose 1500; glycerol; Vaseline oil; stearic acid; methyl p – hydroxybenzoate; sodium methyl p-hydroxybenzoate; propyl p – hydroxybenzoate; purified water.

Therapeutic indications

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

Contraindications

ACICLOVIR DOROM 5% cream is contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir and to any of the excipients.

Dosage

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

Warnings and Precautions

ACICLOVIR DOROM 5% cream is not recommended for application on mucous membranes, such as in the mouth, eyes or vagina, as it can be irritating. Pay particular attention to avoid accidental introduction into the eye. In severely immunocompromised patients (e.g. AIDS or bone marrow transplant patients), oral aciclovir should be considered. These patients should be encouraged to consult a physician regarding the treatment of any infection. The use, especially if prolonged, of the product can give rise to sensitization phenomena.

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 to <1/10, uncommon ≥1 / 1000 to <1/100, rare ≥1 / 10,000 to <1 / 1,000, very rare <1 / 10,000. Clinical trial data were used to assign frequency categories to adverse reactions observed during trials with aciclovir 3% ophthalmic ointment. Given the nature of the adverse events observed, it is not possible to unequivocally determine which events were related to drug administration and which to disease. Spontaneous reporting data were used as a basis for frequency assignment to post-marketing observed events. Skin and subcutaneous tissue disorders Uncommon: transient stinging or stinging after application of aciclovir cream Mild dryness or flaking of the skin. Itching. Rare: erythema. Contact dermatitis after application. Where susceptibility tests have been conducted, the reactive substances have very often been found to be the components of the cream rather than acyclovir. Immune system disorders Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

Pregnancy and breastfeeding

Pregnancy The use of aciclovir should only be considered if the potential benefits outweigh the possibility of unknown risks, however systemic exposure to aciclovir due to topical application of ACICLOVIR DOROM 5% cream is very low. A pivotal post-marketing pregnancy study with aciclovir documented pregnancy outcomes in women exposed to any formulation of aciclovir. The conclusions of the pivotal data did not show an increase in the number of congenital anomalies in subjects exposed to aciclovir compared to the general population, and the observed congenital anomalies did not reveal characteristics of uniqueness or concordance that would suggest a possible common cause for their onset. Systemic administration of aciclovir in internationally accepted standard tests did not produce embryotoxic or teratogenic effects in rabbits, rats or mice. In a non-standard test in rats, fetal abnormalities were observed but only following subcutaneous doses so high as to induce maternal toxicity. The clinical relevance of these findings is uncertain. Breastfeeding Limited human data show that the drug passes into breast milk after systemic administration. However, the dose received by the infant after use of ACICLOVIR DOROM 5% cream by the mother is expected to be insignificant. Fertility Results from animal studies indicate that Aciclovir cream has no effect on fertility (see section 5).