Umifenovir, 50 mg capsules 10 pcs

Name: Umifenovir, 50 mg capsules 10 pcs
SKU: 484704
Availability: InStock

€3.52

EAN: 4680020183417 SKU: 484704 Categories: Antiviral, Medicine

Description

Antiviral drug

ATX: J.05.A.X.13 Umifenovir

Pharmacodynamics:

Antiviral agent.

Specifically suppresses in vitro influenza A and B viruses (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1) pdm09 and A(H5N1), as well as other viruses – causative agents of acute respiratory viral infections (ARI) (Coronavirus, associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus), and parainfluenza virus (Paramyxovirus).

In terms of the mechanism of antiviral action it refers to fusion inhibitors (fusion), interacts with hemagglutinin of the virus and prevents fusion of the lipid shell of the virus and cell membranes.

It has a moderate immunomodulatory effect, increases the body’s resistance to viral infections. It has interferon-inducing activity – in researches on mice interferon induction was noticed after 16 hours, and high titers of interferon were saved in blood up to 48 hours after injection. It stimulates cellular and humoral immune reactions: it increases the number of lymphocytes in blood, especially the number of T-cells (CD3), increases the number of T-helpers (CD4) without affecting the level of T-suppressors (CD8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages and increases the number of natural killer (NK-cells).

Therapeutic effectiveness in viral infections is manifested in reduction of duration and severity of the course of the disease and its main symptoms as well as in the decrease of the rate of development of complications due to viral infection and exacerbations of chronic bacterial diseases.

In treatment of influenza or acute respiratory infections in adult patients a clinical study showed that the effect of umifenovir in adult patients was most pronounced in the acute period of the disease and was manifested by a shorter time of resolution of disease symptoms, decreased severity of manifestations of the disease and shorter time of elimination of the virus.

Umifenovir therapy leads to a higher rate of resolution of disease symptoms on the third day of therapy compared to placebo. After 60 hours after the start of therapy, the resolution of all symptoms of laboratory-confirmed flu is more than 5 times greater than in the placebo group. A significant effect of umifenovir on the rate of elimination of the influenza virus has been established, which, in particular, is manifested by a decrease in the frequency of detection of RNA virus on the 4th day.

It belongs to low-toxic drugs (LD50>4 g/kg). It does not have any negative effect on the human body when administered orally in recommended doses.

Pharmacokinetics:

It is rapidly absorbed and distributed to organs and tissues. Maximum blood plasma concentration is reached in 1.2 h when administered in a dose of 50 mg, in a dose of 100 mg in 1.5 h. It is metabolized in the liver. The elimination half-life is 17-21 hours. About 40% is eliminated unchanged, mainly in bile (38.9%) and in small amount in kidney (0.12%). During the first day 90% of the administered dose is eliminated.

Indications

Prevention and treatment of influenza A and B, other acute respiratory infections in adults and children from 3 years (for dosage form of 50 mg capsules), from 6 years (for dosage form of 100 mg capsules).

The complex therapy of recurrent herpetic infection.

Prevention of postoperative infectious complications.

Active ingredient

Umifenovir

Composition

Composition per 1 capsule 50 mg:

Active ingredient: umiphenovir hydrochloride monohydrate – 51.75 mg in terms of umiphenovir hydrochloride – 50.00 mg.

Excipients: microcrystalline cellulose – 31.85 mg; potato starch – 16.50 mg; povidone-K25 – 5.50 mg; croscarmellose sodium – 2.20 mg; colloidal silica – 1.10 mg; magnesium stearate – 1.10 mg.

Capsule body composition: quinoline yellow dye – 0.7500%; sunset yellow dye – 0.0059%; titanium dioxide – 2.0000%; gelatin – up to 100%.

Capsule cap composition: quinoline yellow dye – 0.7500%; sunset yellow dye – 0.0059%; titanium dioxide – 2.0000%; gelatin – up to 100%.

How to take, the dosage

Ingestion, before meals.

Dose per day: For children 3 to 6 years old – 50 mg, 6 to 12 years old – 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg), over 12 years old and adults – 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg).

For non-specific prevention and treatment of influenza and other acute respiratory infections in children and adults:

Nonspecific prophylaxis:

During epidemics of influenza and other acute respiratory infections: children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, over 12 years and adults – 200 mg twice a week for 3 weeks.

In direct contact with patients with influenza and other acute respiratory infections: children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, older than 12 years and adults – 200 mg once a day for 10 to 14 days.

The treatment of influenza and other acute respiratory infections: children 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, older than 12 years and adults – 200 mg 4 times a day (every 6 hours) for 5 days.

In complex therapy of recurrent herpes infection: to children from 3 to 6 years old – 50 mg, from 6 to 12 years old – 100 mg, over 12 years old and adults – 200 mg 4 times daily (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

Prevention of postoperative infectious complications: to children from 3 to 6 years – 50 mg, 6 to 12 years – 100 mg, over 12 years and adults – 200 mg 2 days before surgery, then on the 2nd and 5th day after surgery.

The drug should be taken from the time of the first symptoms of influenza and other acute respiratory infections, preferably within 3 days from the beginning of the disease. If after using the drug for three days during the treatment of influenza and other acute respiratory viral infections the severity of symptoms persists, including high temperature (over 38 ° C and more), it is necessary to see a doctor to assess the feasibility of taking the drug.

The drug should only be used according to the indication, route of administration, and dosage listed in the directions.

Interaction

When administered with other medicinal products no adverse effects have been noted.

Special clinical studies to study interactions of umifenovir with other medicinal products have not been conducted.

There have been no reports of adverse interactions with antipyretics, mucolytic and local vasoconstrictors in clinical trials.

Special Instructions

The recommended regimen and duration of drug administration should be followed.

If a dose of the drug is missed, the missed dose should be taken as soon as possible and the course of the drug should be continued as started.

If after three days of using the drug in the treatment of influenza and other acute respiratory infections the symptoms of the disease persist, including high fever (38 ° C or more), you should see a doctor to assess the validity of taking the drug.

Impact on the ability to operate vehicles and machinery:

It does not show central neurotropic activity and can be used in medical practice in people of various professions, including those requiring increased attention and coordination of movements (vehicle drivers, operators, etc.

Synopsis

Solid gelatin capsules № 2. The body and cap are yellow, opaque.

Contraindications

Hypersensitivity to umifenovir or any drug component, children under 3 years of age (for dosage form 50 mg), under 6 years of age (for dosage form 100 mg), first trimester of pregnancy, breastfeeding.

With caution:

The second and third trimesters of pregnancy.

Side effects

Umifenovir is a low-toxicity drug and is usually well tolerated. Side effects are rare, usually mild to moderate and transient.

The incidence of adverse drug reactions has been defined according to the WHO classification: very rare (with an incidence of more than 1/10), frequent (with an incidence of at least 1/100 but less than 1/10), infrequent (with an incidence of at least 1/1000 but less than 1/100), rare (with an incidence of at least 1/10000 but less than 1/1000), very rare (with an incidence of less than 1/10), unknown (cannot be known from available data).

Immune system disorders: rare – allergic reactions.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Pregnancy use

Harmful effects on pregnancy, embryo and fetal development, labor and postnatal development have not been found in animal studies.

The use of the drug is contraindicated in the first trimester of pregnancy.

In the second and third trimesters of pregnancy, the drug can be used only for the treatment and prevention of influenza and when the expected benefits to the mother exceed the potential risk to the fetus. The benefit/risk ratio is determined by the treating physician.

It is not known whether umifenovir penetrates into breast milk in women during lactation. Breastfeeding should be discontinued if the drug has to be used.

Similarities

Arbidol, Arbidol Maximum, Arpeflu, Afludol

Additional information

Weight	0.010 kg
Shelf life	3 years. The expiration date should not be used.
Conditions of storage	At a temperature not exceeding 25 ° C. Store out of the reach of children.
Manufacturer	Ozon, Russia
Medication form	capsules
Brand	Ozon