Proteflazidum^® (Solution) Instructions for Use

Marketing Authorization Holder

Novapharm, LLC (Russia)

Manufactured By

Fitofarm, PJSC (Ukraine)

ATC Code

J05 (Systemic antiviral drugs)

Dosage Form

Proteflazidum®

Solution for topical application and oral administration: bottle 25 ml, 30 ml or 50 ml with dropper cap

Dosage Form, Packaging, and Composition

Solution for topical application and oral administration in the form of a dark green liquid with a specific odor; during storage, the formation of a gel-like structure is possible, which is destroyed by shaking.

Excipients: ethanol 96% – sufficient quantity to produce 1 l.

25 ml – dark glass bottles (1) with dropper cap – cardboard packs.
30 ml – dark glass bottles (1) with dropper cap – cardboard packs.
50 ml – dark glass bottles (1) with dropper cap – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with antiviral action

Pharmacotherapeutic Group

Antiviral agent of plant origin

Pharmacological Action

Herbal preparation with antiviral action. Flavonoid glycosides contained in the wild grasses Deschampsia caespitosa L. and Calamagrostis epigeios L. are capable of suppressing virus-specific enzymes thymidine kinase and DNA polymerase in cells infected with herpes simplex viruses (Herpes simplex types 1 and 2). This leads to a reduction in the ability or complete blocking of the replication of viral proteins and, as a result, prevents the multiplication of viruses.

Proteflazidum^® stimulates the production of endogenous alpha and gamma interferons, which increases non-specific resistance to viral and bacterial infection and normalizes the immune status of the human body.

Pharmacokinetics

Absorption

When taken orally, the drug is partially absorbed in the stomach and then, mainly, in the small intestine.

Metabolism and Distribution

A small amount of flavonoids undergoes breakdown during the “first pass” through the liver (presystemic metabolism), the main part is distributed in organs and tissues, and penetrates into virus-infected cells. The drug has practically no effect on uninfected cells, where there is no increased activity of virus-specific enzymes. It causes suppression of enzymes only in infected cells.

Excretion

In adults, the final T_1/2 is 5-9 hours, which justifies the administration of the drug 3 times/day.

Indications

• Herpesvirus infections of the skin and mucous membranes caused by herpes simplex viruses (Herpes simplex types 1 and 2), including genital herpes.

ICD codes

Dosage Regimen

The drug is used orally and externally.

For oral use, drops are applied to a piece of sugar (or food starch).

For adults, the drug is used according to the scheme: 1st week – 5 drops 3 times/day; 2nd-3rd week – 10 drops 3 times/day; 4th week – 8 drops 3 times/day. One month after the last dose, the course of treatment can be repeated if necessary. The maximum daily dose for oral administration is 30 drops (1.25 ml or 1015 mg).

Externally, the drug is used in the form of vaginal tampons or lotions with the drug.

To prepare vaginal tampons with Proteflazidum^®, it is necessary to dilute 3 ml (72-75 drops) of the drug in 20 ml of saline solution. Insert a gauze tampon soaked in the prepared solution into the vagina. The procedure is repeated 2 times/day. If a burning sensation occurs in the vagina, it is necessary to double the amount of solvent.

Treatment should be continued until the signs of skin or mucous membrane lesions disappear. The maximum course of treatment is 14 days.

To prepare lotions with Proteflazidum^®, it is necessary to dilute 1.5 ml (36-38 drops) of the drug in 10 ml of saline solution. Apply gauze soaked in the solution to the affected area of the mucous membrane or skin up to 3 times/day.

The criterion for discontinuing treatment is the disappearance of signs of skin or mucous membrane lesions. The maximum course of treatment should not exceed 14 days.

The maximum daily dose for external use is 72 drops (3 ml).

Adverse Reactions

As a rule, the drug is well tolerated.

From the digestive system: nausea, vomiting, diarrhea.

Rarely: allergic reactions, irritation when applied to mucous membranes, transient increase in body temperature up to 38°C (100.4°F) on days 3-10 after the start of treatment.

The presence of these symptoms requires correction of the dose or dosage regimen of the drug.

Contraindications

• Gastric and duodenal ulcer in the acute stage;
• Childhood;
• Hypersensitivity to the components of the drug.

With caution, the drug should be prescribed to patients with a history of severe allergic reactions.

Use in Pregnancy and Lactation

The use of Proteflazidum^® during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. If the drug is prescribed during lactation, breastfeeding should be discontinued.

Pediatric Use

The drug is contraindicated in children.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

No negative effect on the ability to drive vehicles and operate mechanisms has been identified.

Overdose

Cases of overdose have not been described, but side effects, especially from the gastrointestinal tract, may occur.

Treatment: symptomatic therapy is performed.

Drug Interactions

Manifestations of interaction with other medicinal products have not been registered.

Storage Conditions

The drug should be stored in a place protected from light, out of the reach of children, at a temperature from 18°C (64.4°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.