Umifenovir capsules 100mg, 20pcs

Composition

Composition for 1 capsule of 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-K 25-11.00 mg; croscarmellose sodium-4.40 mg; colloidal silicon dioxide-2.20 mg; magnesium stearate-2.20 mg.

Capsule body composition: 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%.

Pharmacological action

Antiviral MEDIATX: J. 05. A. X. 13 Umifenovir 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 that cause acute respiratory viral infections (ARVI) (Coronavirus associated with severe acute respiratory syndrome (SARS), rhinovirus, adenovirus, respiratory syncytial virus (Pneumovirus) and the parainfluenza virus (Paramyxovirus)).

According to the mechanism of antiviral action, it belongs to fusion inhibitors (fusions), interacts with viral hemagglutinin and prevents the fusion of the lipid envelope 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 mouse study, interferon induction was observed as early as 16 hours, and high interferon titers persisted in the blood up to 48 hours after use. It 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, and stimulates the phagocytic function of macrophages. increases the number of natural killer cells (NK cells).

Therapeutic efficacy in viral infections is manifested in reducing the duration and severity of the course of the disease and its main symptoms, as well as in reducing the frequency 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 of resolution of symptoms of the disease, a decrease in the severity of disease manifestations and a reduction in the time of virus elimination.

Umifenovir therapy leads to a higher rate of relief of symptoms 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 is more than 5 times higher than in the placebo group. A significant effect of umifenovir on the rate of elimination of influenza virus was found, which, in particular, is manifested by a decrease in the frequency of detection of RNA of the virus on the 4th day.

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

Pharmacokinetics:

It is quickly absorbed and distributed to organs and tissues. The maximum concentration in blood plasma when taken at a dose of 50 mg is reached in 1.2 hours, at a dose of 100 mg – in 1.5 hours. It is metabolized in the liver. The elimination half-life is 17-21 hours. About 40% is excreted unchanged, mainly in the bile (38.9%) and in a small amount by the kidneys (0.12%). During the first day,90% of the administered dose is removed.

Indications

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

Complex therapy of recurrent herpetic infection.

Prevention of postoperative infectious complications.

Use during pregnancy and lactation

In animal studies, no harmful effects on the course of pregnancy, embryo and fetal development, labor and postnatal development were found.

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 for the treatment and prevention of influenza and if the intended benefit to the mother exceeds 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 it is necessary to use the drug, stop breastfeeding.

Contraindications

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 a dosage form of 100 mg), first trimester of pregnancy, breastfeeding. With caution:

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 identified in accordance with the who classification: very often (with a frequency greater than 1/10), often (with a frequency of at least 1/100, but less than 1/10), infrequently (speed of at least 1/1000, but less than 1/100), rarely (with a frequency of not less than 1/10000, but less than 1/1000), very rare (with a frequency of less than 1/10000), frequency unknown (cannot be installed according to the available data).

Immune system disorders: rarely-allergic reactions.

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

Interaction

When prescribed with other drugs, no negative effects were observed.

No specific clinical studies have been conducted to investigate the interactions of umifenovir with other drugs.

Data on the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in the clinical study were not revealed.

How to take, course of use and dosage

Inside, before meals.

Single dose: children from 3 to 6 years-50 mg, from 6 to 12 years-100 mg (1 capsule of 100 mg or 2 capsules of 50 mg), older than 12 years 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 viral infections in children and adults:

Non-specific prevention:

During the epidemic of influenza and other acute respiratory viral infections:  children from 3 to 6 years – 50 mg, from 6 to 12 years-100 mg, older than 12 years and adults-200 mg twice a week for 3 weeks.

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

Treatment of influenza and other acute respiratory viral infections: children from 3 to 6 years – 50 mg, from 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 the complex therapy of recurrent herpetic infection:  children from 3 to 6 years – 50 mg, from 6 to 12 years-100 mg, older than 12 years and adults-200 mg 4 times a day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

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

Taking the drug begins from the moment the first symptoms of influenza and other acute respiratory viral infections appear, preferably no later than 3 days after the onset of the disease. If after using the drug for three days in the treatment of influenza and other acute respiratory viral infections, the severity of symptoms of the disease persists, including a high temperature (more than 38 °C or more), then you should consult a doctor to assess the validity of taking the drug.

Use the drug only according to the indications, the method of use and in the doses indicated in the instructions.

Description

Solid gelatin capsules No. 2. The body is white, the lid is yellow, opaque.

Capsule contents: a mixture of powder and granules from white to white with a greenish-yellow or beige tint of color. It is allowed to seal the contents of the capsule into lumps that break up when pressed.

Special instructions

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

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

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

Influence on the ability to drive vehicles and fur. :

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

Form of production

100 mg capsules

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

After the expiration date, it should not be applied.

Active ingredient

Umifenovir

Dosage form

Capsules