Umifenovir 100 mg 40 capsules

Indications

Prevention and treatment of influenza A and B, other acute respiratory viral infections in adults and children from 6 years old (for the 100 mg capsule form).
Comprehensive therapy for recurrent herpes infection.
Prevention of postoperative infectious complications.

Section: Method of Use and Dosage

Take orally, before meals.
Single dose: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg (1 capsule of 100 mg or 2 capsules of 50 mg), over 12 years and adults - 200 mg (2 capsules of 100 mg or 4 capsules of 50 mg).
For nonspecific prevention and treatment of influenza and other acute respiratory viral infections (ARVI) in children and adults:
Nonspecific prevention:
During the influenza epidemic and other ARVI: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg, over 12 years and adults - 200 mg twice a week for 3 weeks.
Upon direct contact with patients with influenza and other ARVI: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg, over 12 years and adults - 200 mg once a day for 10-14 days.
Treatment of influenza and other ARVI: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg, over 12 years and adults - 200 mg 4 times a day (every 6 hours) for 5 days.
In combination therapy for recurrent herpes infection: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg, over 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: for children aged 3 to 6 years - 50 mg, from 6 to 12 years - 100 mg, over 12 years and adults - 200 mg 2 days before surgery, then on days 2 and 5 after surgery.
The medication should be started at the onset of the first symptoms of influenza and other ARVI, preferably no later than 3 days from the onset of the illness. If after taking the medication for three days the symptoms of the disease persist, including high fever (over 38 °C), it is necessary to consult a doctor to assess the appropriateness of taking the medication.
Use the medication only according to the indications, method of use, and dosages specified in the instructions.

Composition per 1 capsule 100 mg:
Active ingredient: umifenovir hydrochloride monohydrate - 103.50 mg calculated as umifenovir hydrochloride - 100.00 mg.
Excipients: microcrystalline cellulose - 63.70 mg; potato starch - 33.00 mg; povidone-K25 - 11.00 mg; sodium croscarmellose - 4.40 mg; colloidal silicon dioxide - 2.20 mg; magnesium stearate - 2.20 mg.
Composition of the capsule shell: 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%.

Description of the dosage form

Hard gelatin capsules No. 2. The body is white, the cap is yellow, opaque. The contents of the capsules: a mixture of powder and granules from white to white with a greenish-yellow or beige tint. Compaction of the capsule contents into lumps that disintegrate upon pressure is allowed.

Contraindications

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

With caution:

Second and third trimesters of pregnancy.

Use during pregnancy and breastfeeding:

Animal studies have not revealed harmful effects on the course of pregnancy, embryonic and fetal development, labor, and postnatal development. The use of the drug in the first trimester of pregnancy is contraindicated. In the second and third trimesters of pregnancy, the drug may be used only for the treatment and prevention of influenza and only 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 unknown whether umifenovir penetrates into breast milk in lactating women. If the drug is necessary, breastfeeding should be discontinued.

Use in children

Contraindicated in children under 3 years (for the 50 mg dosage form) and under 6 years (for the 100 mg dosage form).

Special instructions

It is necessary to follow the recommended scheme and duration of the drug intake as stated in the instructions. In case of missing a dose of the drug, the missed dose should be taken as soon as possible, and the course of the drug intake should be continued according to the established scheme. If, after using the drug for three days in the treatment of influenza and other ARVI, the severity of the disease symptoms persists, including high fever (38° C and above), it is necessary to consult a doctor to assess the justification for taking the drug.

Effect on the ability to drive vehicles and operate other mechanisms:
It does not exhibit central neurotropic activity and can be used in medical practice by individuals in various professions, including those requiring increased attention and coordination of movements (transport drivers, operators, etc.).

Section: Side Effects

Umifenovir is classified as a low-toxicity medication and is usually well tolerated. Side effects occur rarely, typically being mild or moderate in severity and transient in nature. The frequency of adverse drug reactions is defined according to the WHO classification: very common (with a frequency of more than 1/10), common (with a frequency of at least 1/100 but less than 1/10), uncommon (with a frequency of at least 1/1000 but less than 1/100), rare (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 established from the available data). Disorders of the immune system: rare - allergic reactions. If any of the side effects listed in the instructions worsen, or if you notice any other side effects not mentioned in the instructions, inform your doctor.

Overdose

There is no data on the overdose of the drug.

Interaction

When prescribed with other medications, no negative effects have been noted. Special clinical studies dedicated to the study of umifenovir interactions with other drugs have not been conducted. Information on the presence of undesirable interactions with antipyretics, mucolytics, and local vasoconstrictors in clinical research conditions has not been identified.

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 that cause 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)).
By the mechanism of antiviral action, it belongs to fusion inhibitors, interacts with the virus hemagglutinin, and prevents the fusion of the viral lipid envelope and cell membranes.
Exhibits moderate immunomodulatory effects, increasing the body's resistance to viral infections. Has interferon-inducing activity - in a study on mice, interferon induction was noted as early as 16 hours, and high levels of interferons were maintained in the blood for 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, and increases the number of natural killers (NK cells).
Therapeutic efficacy in viral infections is manifested in the reduction of the duration and severity of the disease and its main symptoms, as well as in the decrease in the frequency of complications associated with viral infection and exacerbations of chronic bacterial diseases.
In the treatment of influenza or ARVI in adult patients, clinical studies have 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 duration of symptom resolution, a decrease in the severity of disease manifestations, and a reduction in the duration of viral elimination.
Therapy with umifenovir leads to a higher frequency of symptom relief on the third day of therapy compared to placebo. After 60 hours from the start of therapy, the resolution of all symptoms of laboratory-confirmed influenza exceeds the corresponding indicator in the placebo group by more than 5 times. A significant effect of umifenovir on the rate of influenza virus elimination has been established, which, in particular, is manifested by a decrease in the frequency of RNA virus detection on the 4th day.
It is classified as a low-toxicity drug (LD50>4 g/kg). It does not have any negative impact on the human body when taken orally at recommended doses.

Section: Pharmacokinetics

Quickly absorbed and distributed to organs and tissues. The maximum concentration in plasma after taking a dose of 50 mg is reached in 1.2 hours, and in a dose of 100 mg - in 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%). Within the first day, 90% of the administered dose is excreted.

Описание

Umifenovir is an antiviral drug intended for the prevention and treatment of a number of viral etiology diseases. The capsules contain 100 mg of the active substance. The drug is effective against influenza, other respiratory viruses, as well as herpes viruses. It helps reduce the severity and duration of disease symptoms and accelerates recovery. Capsules are recommended to be taken 2 pieces three times a day for five to seven days at the first signs of illness. Price $16.15.