Gepon
(Registrier-Nr: P N000015/01-010911)


Instruction for medical application of
Gepon® preparation

Granted product license for Gepon in Russia

Ministry of health of the Russian Rederation

Approved by the Pharmacological Committee of the ministry of health of the Russian Federation

12 april 2001

Minutes No 6

(Registration Number: R No 000015/01-2000)

International nomenclature name - Gepon (Geponum)

Chemical name: tetradecapeptide Thr-Glu-Lys-Lys-Arg-Arg-Glu-Thr-Val-Glu-Arg-Glu-Lys-Glu.

Drug form: a lyophilizate to prepare solution for oral and topical administrations

Content: One vial or ampoule contents Gepon tertradecapeptide 1mg, or 2mg; or 10mg.

Description: a white coloured lyophilised powder, without smell, easily soluble in water and physiological solution.

Pharmacological qualities: Gepon is an immunomodulator with anti-viral activity. Immunopharmacological and anti-viral mechanisms of Gepon are as follows:

In patients infected with HIV, Gepon decreases concentration of HIV in blood cells and blood serum, at the same time activating immune reactions specific to HIV. In majority of patients infected with HIV Gepon therapy leads to the following positive changes:

Clinical effect of a 1-month course Gepon therapy is in the prevention of recurring opportunistic infections during periods of 3-6 months.

A short course of Gepon therapy (3-5 applications only) allows treating recurrent skin and mucosa infections caused by Candida fungi.

Gepon application provides anti-inflammatory effect. 1-2 days after Gepon treatment, the signs of inflammation get significantly reduced, for instance, redness, oedema, as well as discomfort, burning and itching sensations in the inflamed areas of skin and mucosa decline.

Pharmacokinetics of the preparation was not studied because it is a peptide and the protein sequence occurs naturally in humans.

Indications for application

Contraindications

The preparation cannot be administered to patients with hypersensitivity to Gepon. Also can not be used for treatment of children younger than 12 years of age.

Pregnancy and breastfeeding

There is no data covering Gepon influence on pregnant women. As in cases with other medical preparations, Gepon should not be administered during pregnancy, unless the benefits it provides to the patient are greater than a possible risk factor to the foetus. Breastfeeding mothers are not recommended to use Gepon.

Administration and dosage

The preparation is ex tempore dissolved in water or physiological solution.

Recommended dosage for adults and children over 12 is 2-10mg internally (orally) once a day, or 1-2mg as 0,02-0,04% solution for local application on skin and mucosa once a day.

Interaction with other medical preparations

Not described

Side effects

Not found