Proteflazid
Proteflazid: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Proteflazidum
ATX code: J05AX
Active ingredient: turfy pike grass (Herba Deschampsia caespitosa L.), ground reed grass (Herba Calamagrostis epigeios L.)
Producer: PJSC "Fitofarm" (Ukraine), PJSC "Farmak" (Ukraine), PJSC "Biolik" (Ukraine), LLC "Sperko Ukraine" (Ukraine)
Description and photo updated: 2018-23-11
Proteflazid is a direct-acting antiviral agent of plant origin.
Release form and composition
Proteflazid is released in the following forms:
- drops: dark green, with a specific odor (30 or 50 ml in a glass light-protective bottle, sealed with a dropper stopper with a first opening control, 1 bottle in a cardboard box);
- solution for topical use and oral administration: dark green in color, with a specific odor; during storage, the appearance of a gel-like structure is allowed, which collapses upon shaking (25, 30 or 50 ml in a dark glass bottle, sealed with a dropper stopper, in a cardboard box 1 bottle);
- suppositories: brown-green, torpedo-shaped (5 suppositories in a blister, in a cardboard box 1, 2 or 3 blisters).
1 ml of drops contains a liquid extract of Proteflazid in an amount of 1 ml:
- active substances: turfy pike grass (Herba Deschampsia caespitosa L.) and ground reed grass (Herba Calamagrostis epigeios L.) in a 1: 1 ratio (the inclusion of carboxylic acids is not less than 0.3 mg / ml in terms of malic acid, the inclusion of flavonoids is not less than 0.32 mg / ml in terms of rutin);
- additional component (extraction solvent): ethanol 96%.
1 ml of solution contains:
- active substances: turf pike grass - 500 mg, ground reed grass - 500 mg;
- additional component: ethanol 96%.
1 suppository contains:
- active substances: flavonoids obtained from a mixture of soddy pike and ground reed grass (1: 1 ratio) - not less than 1.8 mg;
- additional components: polyethylene glycol-400, butylhydroxyanisole (E 320), polyethylene glycol-4000, polyethylene glycol-1500.
Pharmacological properties
Pharmacodynamics
Proteflazid is an antiviral phytopreparation. Its active substances - flavonoids - are capable of inhibiting the replication of DNA and RNA-containing viruses in infected cells as a result of inhibition of such virus-specific enzymes as RNA, DNA polymerase, thymidine kinase, neuraminidase and reverse transcriptase. In the course of preclinical and clinical studies, the drug has demonstrated activity against hepatitis viruses, herpes, influenza and acute respiratory infections (ARI), HIV infection, papillomaviruses.
The phytopreparation stimulates the production of endogenous alpha and gamma interferons, increasing their level to physiologically active, which in turn enhances the body's nonspecific resistance to both bacterial and viral infections. Proteflazid protects the mucous membranes (including the vagina and cervix) by normalizing local immunity indicators (secretory immunoglobulin A, lactoferrin, C 3 complement component and lysozyme).
According to the data of clinical studies, Proteflazid in the form of drops with daily oral administration of the recommended age-specific doses in accordance with the indicated regimens of use does not have an immunotoxic effect and does not lead to hyporeactivity of the immune system - it does not suppress the production of alpha and gamma interferons, which, if necessary, allows the use of it over a long period.
The phytopreparation is characterized by antioxidant activity - it prevents free radical processes, preventing the accumulation of products of oxidative lipid degradation and contributing to the strengthening of the antioxidant status of cells. When taken orally, the agent reduces intoxication and helps the body recover after an infectious disease, and also helps to adapt to adverse environmental conditions.
Proteflazid refers to modulators of apoptosis, enhancing the effect of apoptosis-inducing factors and leading to the activation of caspase 9, ensures the elimination of cells affected by the virus, as well as the primary prevention of the appearance of chronic diseases in latent viral infections. Prevents recurrence of the disease and lengthens the period of remission.
With genital herpes, a herbal remedy in the form of suppositories prevents the development of new elements of the rash, helps to reduce the risk of dissemination and the occurrence of visceral complications, and speeds up the healing process. Against the background of vaginitis, vaginosis and inflammatory diseases of the cervix, Proteflazid promotes more efficient and rapid elimination of the pathogen and participates in the restoration of local immunity. Thanks to the action of the phytopreparation, dysbiotic disorders of the microflora of the genital tract are eliminated, the normal vaginal biotope is restored.
Pharmacokinetics
After oral administration of the drug, flavonoids are rapidly absorbed from the gastrointestinal tract (GIT). According to in vivo studies, their maximum concentrations are reached within 20 minutes after using the drops. When taken orally, the bioavailability of the drops is 80%, the half-life from blood plasma is approximately 2.3 hours. Significantly more active substances accumulate in blood cells than in blood plasma, the level of Proteflazid in them ensures its long-term effect, as well as accumulation in organs and tissues as a result of the release of blood cells from flavonoids. At the same time, the phytopreparation inhibits enzymes only in cells infected with a virus, its effect practically does not extend to other cells in which there is no pronounced activity of virus-specific enzymes.
Due to the pharmacokinetic dynamics of accumulation and release of flavonoids from the blood, the agent in the form of drops should be taken 2 times a day to achieve the required concentrations.
When the solution is taken in adults, the final half-life can be 5-9 hours, and therefore Proteflazid must be taken 3 times a day.
When applied topically, Proteflazid does not enter the systemic circulation and does not have a systemic effect. It has been proven that with vaginal administration it is possible to achieve a therapeutic concentration of the drug in the genital tissues.
Indications for use
Drops
Drops are recommended for the treatment and prevention of recurrence of diseases caused by the following pathogens:
- herpes viruses type I and II (Herpes simplex);
- herpes viruses type III, causing herpes zoster and chickenpox (Herpes zoster);
- herpes viruses type IV (Epstein-Barr virus) in acute and chronic active form;
- herpes viruses type V (cytomegalovirus).
As part of a combination therapy, Proteflazid is prescribed for the following diseases:
- bacterial, viral, fungal infections, their associations (mycoplasma, chlamydia, ureaplasma and others);
- hepatitis B and C;
- HIV infection and AIDS.
This form of phytopreparation is used for the etiotropic therapy of mild / moderate forms of cervical dysplasia (CIN1 and CIN2) caused by human papillomavirus infection (including oncogenic strains), and in the complex therapy of other forms of diseases caused by this infection (including oncogenic strains) …
Proteflazid is also indicated for the prevention and treatment of influenza and other acute respiratory viral infections (ARVI), including pandemic strains of influenza.
Solution
The solution is used to treat herpesvirus infections of the skin and mucous membranes, excited by herpes simplex viruses (Herpes simplex) types I and II, including genital herpes.
Suppositories
Suppositories are used to treat diseases of the female genital organs caused by the following microorganisms:
- human papillomaviruses (HPV), including oncogenic strains;
- Herpes simplex viruses (types I and II), cytomegalovirus, Epstein-Barr virus;
- pathogens of inflammatory lesions of mixed etiology: pathogenic fungi, viruses, bacteria, ureaplasma, chlamydia, mycoplasma (with complex therapy).
Contraindications
- peptic ulcer and 12 duodenal ulcer in the acute phase (for drops and solution);
- children's age (for solution and suppository);
- hypersensitivity to the components of Proteflazid.
The solution should be used with caution if there is a history of severe allergic reactions.
Instructions for the use of Proteflazid: method and dosage
Drops
Proteflazid drops are used orally and topically. Before use, the bottle with drops must be shaken, the agent is dosed using a dropper stopper. When using the drug orally, the required number of drops should be taken 10-15 minutes before meals, after diluting them in 1-2 tablespoons of water.
For children from birthday to 1 year, Proteflazid is prescribed 1 drop per day.
Recommended single doses for patients over 1 year old (frequency of administration - 2 times a day):
- from 1 to 2 years - 1 drop;
- from 2 to 4 years old - 2 drops;
- from 4 to 6 years old - 4 drops;
- from 6 to 9 years old - 9 drops;
- from 9 to 12 years old - 10 drops;
- 12 years and older - 12-15 drops.
The duration of use of Proteflazid depends on the indications and the severity of the course of the disease:
- cytomegalovirus disease, acute and chronic active form of the Epstein-Barr viral infection, human papillomavirus infection (in combination with topical application of drops); genital herpes, herpes zoster (Herpes zoster); herpetic eczema and herpetic vesicular dermatitis (in combination with topical use of drops); herpetic eye disease, herpetic meningitis and encephalitis (for therapy purposes): it is recommended to take it continuously for 3 months; in case of a recurrent course of the disease, on the recommendation of a doctor, courses are carried out 1–2 times a year;
- relapses of chickenpox, herpetic gingivostomatitis, pharyngotonsillitis (prevention / treatment); bacterial, viral, fungal infections and their associations (complex therapy); viral and bacterial infections that appear in people with insufficient immune system function (for prevention): should be taken within 1 month;
- viral hepatitis B and C, HIV infection and AIDS (complex treatment): it is recommended to take it without interruption for 6-12 months; in HIV-infected and AIDS patients, the course is carried out before or after antiretroviral therapy;
- influenza and other acute respiratory viral infections: with a therapeutic purpose - use, taking into account the severity of the disease, 5-14 days, for prevention - 14-28 days, ½ of the therapeutic dose; during an epidemic, the duration of use can be increased to 42 days.
The duration of the course of therapy in children is similar to that in adults.
Recommended method of administration and dosage regimen for topical use of drops (in combination with oral administration) for the treatment of the following diseases:
- herpes simplex infections of the skin and mucous membranes, papillomatosis of the skin, acute forms of herpes zoster: a solution of the drug in the form of applications is applied to the affected skin up to 3-5 times a day, the duration of the procedure should be 10-15 minutes; the solution for applications is prepared by diluting 36–38 drops of the drug (1.5 ml) in physiological (0.9%) sodium chloride solution at a dose of 10 ml; locally Proteflazid is used until signs of mucosal or skin lesions are removed, but not less than 10 days;
- papillomavirus and viral-bacterial infections of female genital organs, primary and recurrent genital herpes: vaginal tampons soaked in Proteflazid solution are injected for 30–40 minutes 2 times a day; to prepare the solution, 72–75 drops (3 ml) are required to be diluted in physiological sodium chloride solution at a dose of 20 ml; the duration of the use of vaginal tampons with the drug in the treatment of genital herpes is 10 days, in the treatment of papillomavirus and viral-bacterial infections of the female genital organs - 14 days.
Solution
Proteflazid solution is used orally and topically.
For oral administration, the solution is recommended to be applied to a sugar cube or food starch. Take the remedy 3 times a day according to the following scheme (doses are indicated for 1 dose):
- I week - 5 drops;
- II – III weeks - 10 drops;
- IV week - 8 drops.
One month after the end of therapy, if necessary, a second course is possible. The maximum permissible daily dose for oral administration is 30 drops (1015 mg, or 1.25 ml).
Outwardly, Proteflazid is used in the form of lotions or vaginal tampons. For the preparation of lotions, 36–38 drops of the phytopreparation (1.5 ml) should be dissolved in physiological solution taken at a dose of 10 ml. Gauze soaked in the prepared solution is applied to the affected area of the skin or mucous membrane up to 3 times a day.
When using vaginal tampons, it is recommended to dissolve 72–75 drops of the herbal remedy in 20 ml of saline. A gauze swab soaked in the prepared preparation is inserted into the vagina 2 times a day. If, when inserting a tampon, a burning sensation appears in the vagina, it is required to double the dose of the solvent.
Vaginal tampons and lotions continue to be used until the symptoms of skin or mucous membrane disease disappear, but not more than 14 days. The maximum daily dose for external use is 72–75 drops (3 ml).
Suppositories
Suppositories Proteflazid are administered intravaginally after the completion of hygiene procedures. Having released the suppository from the protective plastic packaging, it should be inserted deep into the vagina. After administration of the drug, it is advisable to be in the supine position for at least 3 hours and not to have sexual intercourse for 8 hours. It is necessary to start a course of therapy immediately after the end of menstruation; during menstruation, it is necessary to interrupt treatment.
Recommended dosage regimen:
- recurrent herpes infection, including the presence of cytomegalovirus infection and Epstein-Barr infection: apply 1 suppository once a day for 10 days, the course is 3 months (10 days a month);
- genital diseases caused by herpes viruses of types I and II: 1 suppository is prescribed once a day for 7-10 days, and if necessary, even more, until symptoms of the disease are relieved;
- papillomavirus and / or herpes infection in combination with fungal or bacterial lesions: use 2 times a day, 1 suppository for 14 days, course - 3 months (14 days a month).
Side effects
- digestive system (for solution and drops): vomiting, nausea, diarrhea, pain in the epigastric region; for drops - in the presence of chronic gastroduodenitis, an exacerbation of this disease is possible, the appearance of gastroesophageal reflux (with the development of these undesirable reactions, it is recommended to take the drug 1.5–2 hours after eating);
- allergic reactions: rarely - erythematous rash, itching; in patients with increased individual sensitivity - hypersensitivity reactions;
- general disorders (for solution and drops): isolated cases - general weakness, headache, transient increase in body temperature to 38 ° C on days 3-10 of drug treatment (in this case, it is not necessary to cancel Proteflazid, it is recommended to consult a doctor to exclude other possible causes of increased body temperature);
- laboratory indicators (for drops): in the treatment of viral hepatitis (in 10-15% of patients with severe cytolytic syndrome) - an increase in the activity of aminotransferases, noted 2-4 weeks after the start of the course, rarely - an increase in the level of bilirubin for 2-4 weeks (the appearance of these side effects does not require the abolition of Proteflazid);
- local reactions: burning sensation, dryness, itching.
Overdose
Overdose cases of Proteflazid have not been recorded, however, there is a possibility of side effects, when taken orally, mainly from the gastrointestinal tract. Therapy is prescribed symptomatic.
special instructions
With local application of drops in case of itching, burning sensation and dryness, it is recommended to reduce the concentration of the agent in the solution for applications.
To prevent urogenital reinfection, simultaneous therapy of the sexual partner is necessary (it is advisable to combine the intake of drops with the use of suppositories).
During the period of treatment with suppositories, it is recommended to refuse sexual intercourse.
Influence on the ability to drive vehicles and complex mechanisms
The negative effect of Proteflazid on the ability to drive vehicles and control other complex equipment was not found.
Application during pregnancy and lactation
According to the results of preclinical studies, teratogenic, embryotoxic, mutagenic, fetotoxic and carcinogenic effects of the active substances of the drug were not revealed. With the clinical use of Proteflazid in the I-III trimesters of pregnancy and during breastfeeding, the negative effect of the drug was not found. Special studies on the effect of the phytopreparation on the human fetus have not been conducted.
The use of Proteflazid during pregnancy and lactation is allowed only if the expected benefit from its use significantly exceeds the possible threat to the fetus. Treatment with the drug is carried out only on the recommendation and under the supervision of a physician.
When prescribing Proteflazid in the form of a solution during lactation, it is necessary to stop breastfeeding.
Pediatric use
According to the instructions, Proteflazid in the form of a solution and suppositories is contraindicated for use in pediatric practice. Children can use drops from birth in doses appropriate for age, taking into account the course of the disease, therapy should be carried out under the supervision of a physician.
Drug interactions
Negative manifestations caused by the interaction of the drug with other drugs / drugs have not been established.
Proteflazid in the form of drops and suppositories for the treatment of viral-bacterial and viral-fungal diseases can be used in combination with antibiotics, antifungal agents (for drops), and other antiviral drugs (for suppositories).
Analogs
Analogs of Proteflazid are: Immustat, Herpes Simplex, Detoxopyrol, Arbidol, Ingavirin, Kagocel, Armenicum, Flavosid, Ferrovir, Yodantipirin, Panavir.
Terms and conditions of storage
Store in a place out of the reach of children, protected from light, solution - at a temperature of 18-25 ° C, drops and suppositories - no higher than 25 ° C. The drug must not be frozen!
The shelf life of the solution and drops is 3 years, suppositories - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Proteflazid
According to reviews, Proteflazid is an effective drug used in the treatment of infectious diseases, which (especially in the form of drops) has a pronounced antiviral effect. Patients who took the drug respond positively to its properties as an immunomodulator, since after treatment with the drug, many of them began to get sick much less often. The reviews also indicate the effectiveness of the use of Proteflazid in the treatment of herpes infections and the prevention of recurrence of these lesions.
The disadvantages of the herbal remedy include its high cost and unpleasant taste; there are also complaints about the lack of the drug in pharmacies.
The price of Proteflazid in pharmacies
The price of Proteflazid in the form of drops is on average 2000 rubles per bottle containing 30 ml.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!