Umifenovir capsules 50mg, No. 20

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

Complex therapy of recurrent herpes infection.

Prevention of postoperative infectious complications.

Inside, before meals. Single dose: children from 3 to 6 years old - 50 mg, from 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).

Composition for 1 capsule 100 mg:

Active ingredient: umifenovir hydrochloride monohydrate - 103.50 mg in terms of umifenovir hydrochloride - 100.00 mg.

Excipients: microcrystalline cellulose - 63.70 mg; potato starch - 33.00 mg; povidone-K25 - 11.00 mg; croscarmellose sodium - 4.40 mg; colloidal silicon dioxide - 2.20 mg; magnesium stearate - 2.20 mg. The composition of the capsule body: titanium dioxide - 2.0000%; gelatin - up to 100%. The composition of the capsule cap: quinoline yellow dye - 0.7500%; dye sunset yellow - 0.0059%; titanium dioxide - 2.0000%; gelatin - up to 100%.

• Hypersensitivity to umifenovir or any component of the drug,

• children under 3 years of age (for a dosage form of 50 mg),

• age up to 6 years (for dosage form 100 mg),

• first trimester of pregnancy, breastfeeding.

  Carefully:

• Second and third trimesters of pregnancy. Application during pregnancy and during breastfeeding: In animal studies, no harmful effects on the course of pregnancy, the development of the embryo and fetus, labor and postnatal development have been 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 only be used to treat and prevent influenza and if the intended 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 necessary, use of the drug should stop breastfeeding.

Pharmacodynamics

Antiviral agent.

Specifically inhibits 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 (ARVI) (coronavirus (Coronavirus), associated with severe acute respiratory syndrome (SARS), rhinovirus (Rhinovirus), adenovirus (Adenovirus), respiratory syncytial virus (Pneumovirus) and parainfluenza virus (Paramyxovirus)).

According to the mechanism of antiviral action, it belongs to fusion inhibitors (fusion), 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, increases the body's resistance to viral infections. It has interferon-inducing activity - in a study on mice, the induction of interferons was noted already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral reactions of immunity: increases the number of lymphocytes in the blood, especially 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 cells (NK cells).

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

In the treatment of influenza or acute respiratory viral infections in adult patients, a clinical study has shown 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 resolution of the 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 frequency of relief of symptoms of the disease on the third day of therapy compared with placebo. 60 hours after the start of therapy, 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 was established, which, in particular, is manifested by a decrease in the frequency of detection of the RNA virus on the 4th day.

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

Pharmokinetics

It is rapidly absorbed and distributed to 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. It is metabolized in the liver. The half-life is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in a small amount by the kidneys (0.12%). During the first day, 90% of the administered dose is excreted.

Overdose

There are no data on drug overdose.

Side effects

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

Immune system disorders: rarely - allergic reactions.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Special conditions

It is necessary to observe the scheme and duration of the drug intake recommended in the instructions.

In case of missing one dose of the drug, the missed dose should be taken as early as possible and the course of taking the drug should be continued according to the started scheme.

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 a high temperature (38 ? C or more), persists, then you should consult a doctor to assess the feasibility of taking the drug.

Influence on the ability to drive vehicles and other mechanisms:

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

Drug interactions

When administered with other drugs, no negative effects were noted.

Special clinical studies devoted to the study of interactions of umifenovir with other drugs have not been conducted.

Information on the presence of an undesirable interaction with antipyretic, mucolytic and local vasoconstrictor drugs in the conditions of a clinical study was not identified.