Umifenovir, 50 mg capsules 20 pcs

.

Indications

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

Complex therapy of recurrent herpetic infection.

Prevention of postoperative infectious complications.

Pharmacological effect

Antiviral agent

ATC: J.05.A.X.13 Umifenovir
Pharmacodynamics:

Antiviral agent.

Specifically suppresses in vitro influenza viruses A and B (Influenzavirus A, B), including highly pathogenic subtypes A(H1N1) pdm09 and A(H5N1), as well as other viruses that cause acute respiratory viral infections (ARVI) (coronavirus associated with severe acute respiratory syndrome (SARS), rhinovirus, adenovirus, respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).

According to the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the hemagglutinin of the virus and prevents the fusion of the lipid membrane of the virus and cell membranes.

It has a moderate immunomodulatory effect and increases the body’s resistance to viral infections. It has interferon-inducing activity – in a study on mice, the induction of interferons was noted after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immune responses: increases the number of lymphocytes in the blood, especially T-cells (CD3), increases the number of T-helper cells (CD4) without affecting the level of T-suppressors (CD8), normalizes the immunoregulatory index, stimulates the phagocytic function of macrophages, etc. increases the number of natural killer (NK) cells.

Therapeutic effectiveness for viral infections is manifested in a decrease in the duration and severity of the disease and its main symptoms, as well as in a decrease in the incidence of complications associated with viral infection and exacerbations of chronic bacterial diseases.

In the treatment of influenza or ARVI in adult patients, a clinical study showed that the effect of umifenovir in adult patients is most pronounced in the acute period of the disease and is manifested by a reduction in the time for resolution of symptoms of the disease, a decrease in the severity of the manifestations of the disease and a reduction in the time for elimination of the virus.

Therapy with umifenovir leads to a higher rate of symptom relief on the third day of therapy compared to placebo. 60 hours after the start of therapy, the resolution of all symptoms of laboratory-confirmed influenza was more than 5 times higher 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 viral RNA on the 4th day.

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

Pharmacokinetics:

Quickly absorbed and distributed throughout organs and tissues. The maximum concentration in blood plasma when taken at a dose of 50 mg is achieved after 1.2 hours, at a dose of 100 mg – after 1.5 hours. Metabolized in the liver. The half-life is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%). During the first day, 90% of the administered dose is eliminated.

Special instructions

It is necessary to follow the regimen and duration of taking the drug recommended in the instructions.

If you miss taking one dose of the drug, the missed dose should be taken as early as possible and continue taking the drug according to the started regimen.

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

Impact on the ability to drive vehicles. Wed and fur.:

It does not exhibit central neurotropic activity and can be used in medical practice by people of various professions, incl. requiring increased attention and coordination of movements (transport drivers, operators, etc.

Active ingredient

Umifenovir

Composition

Composition per 1 capsule 50 mg:

Active ingredient: umifenovir hydrochloride monohydrate – 51.75 mg in terms of umifenovir 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 silicon dioxide – 1.10 mg; magnesium stearate – 1.10 mg.

Composition of the capsule body: quinoline yellow dye – 0.7500%; sunset yellow dye – 0.0059%; titanium dioxide – 2.0000%; gelatin – up to 100%.

Composition of the capsule cap: quinoline yellow dye – 0.7500%; sunset yellow dye – 0.0059%; titanium dioxide – 2.0000%; gelatin – up to 100%.

Pregnancy

In animal studies, no harmful effects on pregnancy, embryonic and fetal development, labor or postnatal development were identified.

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

In the second and third trimester of pregnancy, the drug can be used only for the treatment and prevention of influenza and if the expected benefit to the mother outweighs the potential risk to the fetus. The benefit/risk ratio is determined by the attending physician.

It is not known whether umifenovir passes into breast milk in women during lactation. If you need to use the drug, you should stop breastfeeding.

Contraindications

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

With caution:

Second and third trimesters of pregnancy.

Side Effects

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

The frequency of adverse drug reactions is determined in accordance with the WHO classification: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (with a frequency of at least 1/1000, but less than 1/100), rarely (with a frequency of at least 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000), frequency unknown (cannot be determined from available data).

Immune system disorders: rarely – allergic reactions.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

No negative effects were noted when prescribed with other medications.

No special clinical studies have been conducted to study the interactions of umifenovir with other drugs.

There was no evidence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical study.

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Should not be used after expiration date.

Manufacturer

Ozon, Russia