(Registrier-Nr: P N000015/01-010911)
Instruction for medical application of
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:
- Gepon induces production of alpha- and beta- interferons
- Gepon mobilises and activates macrophages
- Gepon reduces production of inflammatory cytokines (interleukins 1, 6, 8 and tumour necrosis factor)
- Gepon enhances production of antibodies towards various antigens of an infectious nature
- Gepon suppresses virus replication (encephalomyocarditis virus, herpes simplex viruses types I and II, hepatitis C virus, and others)
- Gepon increases resistance of human organism to infections caused by viruses, bacteria and fungi
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:
- increases the number of CD4+T and NK cells
- increases the functional activity of neutrophils and CD8+T cells that are crucial elements of the body defence against bacteria, viruses and fungi
- Increases production of antibodies specific to antigens of HIV, as well as to antigens of opportunistic infectious agents actual to a particular patient.
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
- for correction of weakened immune system and immunodeficiency conditions
- for therapy of HIV infection
- for increase of immunodefence against infections, for the prevention and therapy of opportunistic infections caused by bacteria, viruses or fungi
- for treatment of skin and mucosa infections caused by Candida fungi
- for prevention of skin and mucosa candidiasis as a result of antibiotics therapy
- for reduction of inflammation (redness, oedema, pain, burning and itching) of skin and mucosa, as well as dryness of mucosa
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.
- For treatment of opportunistic infections in HIV-infected patients or in cases of other immunodeficient conditions it is recommended to administer a course of daily Gepon therapy, at 10mg orally during 1-3 months.
- For prevention and treatment of skin and mucosa infections caused by Candida fungi, local administration of Gepon using irrigation of damaged areas of skin and mucosa with 0,02-0,04% Gepon solution. In total, 3-5 irrigations with 1-3 days intervals between procedures.
- When treating female patients with vulvavaginitis, urethritis or cervicitis, irrigations with 0,02-0,04% Gepon solution of vulvae, cervical and vaginal mucosa, as well as napkin applications on damaged skin areas near vaginal entrance are used.
- When treating male patients with urethritis and balanoposthitis, instillations of 0,02-0,04% Gepon solution are administered into urethra and on damaged skin. Dressing of mucosa and skin is repeated 3-5 times with 1-3 days interval between treatments.
- As preventative therapy against skin and mucosa candidiasis caused as a possible side effect during intensive antibiotic therapy, it is recommended to administer irrigations (or napkin applications) of 0,02-0,04% Gepon solution, given during antibiotics?ˆ™ course of therapy.
- To reduce intensity of inflammation of mucosa it is advised to administer irrigations of 0,02-0,04% Gepon solution, and to dress the inflamed areas with gauze napkins soaked in 0,02-0,04% Gepon solution
Interaction with other medical preparations