Priora® [Docosanol]

Pharmacological properties

the mechanism of antiviral activity of docosanol is not fully understood. in vitro studies have shown that docosanol affects the fusion of the virus and cell wall, thus inhibiting intracellular absorption and replication of the virus. as a result of in vitro studies, it was found that cells that are under the influence of docosanol resist infection by lipid-enveloping viruses of the hsv-1 type (herpes simplex virus type 1). docosanol has no effect on non-enveloping viruses.

Pharmacokinetics Under the condition of normal clinical use of the drug, docosanol cannot be measured (limit of quantitation, LOQ = 10 ng / ml) in the blood plasma of patients. Docosanol is metabolized to docosanol acid, its main metabolite. Both docosanol and docosanolic acid are endogenous components of the membranes of human cells, partially red blood cells, the brain, myelin sheaths of the nerve, lungs and kidneys.

Indications

Prior drug is indicated in the early stages (prodromal or erythema) of a recurrent herpetic infection of the lips in patients with normal immunity.

Application

For cutaneous use.

Adults and children over the age of 12 years: carefully apply a thin layer on an open surface affected by the herpes virus, 5 times a day (approximately every 3 hours during wakefulness). Do not start treatment with docosanol at the stage of an already developed bladder or ulcer. Therapy should be started as soon as possible after the onset of the first symptoms or signs of herpes (pain, burning, tingling, itching or redness). Treatment should be continued until recovery occurs, which usually ranges from 4 to 6 or a maximum of 10 days.

Elderly patients: there are no special recommendations regarding dosing.

Dosage for renal failure: there is no need for dose adjustment due to slight absorption with topical application.

Children. There is no experience in the use of the drug in children under the age of 12 years, so it is not recommended for patients of this age category.

Contraindications

Hypersensitivity to docosanol or to any other component of the drug.

Side effects

Very often (≥10), often (≥1 / 100 to 1/10), infrequently (≥1000 to 1/100), rarely (≥1 / 10,000 to 1/1000), very rarely (1/10 000) unknown (cannot be determined according to available data). Clinical trials for the treatment of recurrent herpes simplex on the lips confirm that there is no difference in the frequency or type of adverse effects in patients treated with prior cream or placebo.

Disorders from the nervous system: very often - a headache.

General disorders and reactions at the site of application: often - adverse reactions at the site of application, including dry skin, rash, and skin irritation. Edema of the face is also registered, but this adverse reaction at the site of application is a normal reaction on the face associated with herpes.

No evidence of contact sensitization or photoallergy has been obtained in safety studies.

special instructions

Avoid contact with the eyes or the skin around them. the medicine contains propylene glycol, so it can cause skin irritation. the cream is not recommended for patients with reduced immunity. treatment with docosanol should not be started at the stage of an already developed bladder or ulcer.

Use during pregnancy or lactation. Period of pregnancy. There is insufficient data regarding the use of docosanol in pregnant women. Animal studies have not shown direct or indirect harmful effects on pregnancy, embryonic / fetal development, childbirth or postnatal development.Since the systemic effect of docosanol is negligible, docosanol can be used during pregnancy.

The period of breastfeeding. Information on the use of docosanol in breast-feeding women is not available.

The effect of docosanol on breast-fed infants is not expected, since the systemic effect of docosanol on women who are breast-feeding is insignificant.

Docosanol can be used during lactation.

The ability to influence the reaction rate when driving vehicles or other mechanisms. Due to slight absorption, docosanol does not affect the ability to drive vehicles or work with other mechanisms.

Interactions

Interaction studies have not been conducted, therefore, the drug should not be used simultaneously with other local drugs on the same body area.

Overdose

Adverse reactions associated with an overdose with topical administration of the drug are unlikely due to slight absorption through the skin. in case of accidental ingestion of docosanol, the occurrence of adverse reactions is unlikely due to weak oral absorption.

Storage conditions

At a temperature not exceeding 25 ° c.