Aciclovir Dorom*crema 3g 5%

NAME
ACICLOVIR DOROM 5% CREAM

PHARMACOTHERAPEUTIC CATEGORY
Topical chemotherapy drugs.

ACTIVE PRINCIPLES
100 g of 5% cream contain: acyclovir 5 g.

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

INDICATIONS
Treatment of Herpes simplex skin infections such as: primary or recurrent Herpes genitalis and Herpes labialis.

CONTRAINDICATIONS / SECONDARY EFFECT
Contraindicated in patients with known hypersensitivity to aciclovir, valaciclovir and to any of the excipients.

DOSAGE
Apply 5 times a day at approximately 4 hour intervals. Apply to lesions or areas where they are developing as early as possible after the onset of infection. It is particularly important to start treatment for recurrent episodes during the prodrome phase or at the first appearance of lesions. The treatment must continue for at least 5 days and up to a maximum of 10 if there is no healing.

STORAGE
There are no special storage precautions.

WARNINGS
It 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
For the classification of undesirable effects in terms of frequency the following convention has been used: very common> = 1/10, common> = 1/100 to <1/10, uncommon> = 1/1000 to <1 / 100, rare from> = 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 applying aciclovir cream Mild dryness or flaking of the skin. Itching. Rare: erythema Contact dermatitis after application. Where sensitivity tests have been conducted, very often the reactive substances have been found to be the components of the cream rather than acyclovir. Disorders of the immune system. Very rare: immediate hypersensitivity reactions including angioedema and urticaria.

PREGNANCY AND BREASTFEEDING
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 the drug 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. Limited human data show that the drug passes into breast milk after systemic administration. However, the dose received by the infant after the mother's use of the medicinal product should be insignificant. The results of animal studies indicate that the drug has no effect on fertility.