Product Overview
Structure
Active ingredient: Umifenovir hydrochloride monohydrate (in terms of Umifenovir hydrochloride) - 100 mg.
Excipients: potato starch - 30.14 mg, microcrystalline cellulose - 55.76 mg, colloidal silicon dioxide (aerosil) - 2.0 mg, povidone K 25 (collidone 25) - 10.1 mg, calcium stearate - 2.0 mg
Hard gelatin capsules No. 1:
Case: titanium dioxide (E 171) - 2,0000%, gelatin - up to 100%.
Cap: titanium dioxide (E 171) - 1.3333%, sunset sunset yellow (E 110) - 0.0044%, quinoline yellow (E 104) - 0.9197%, gelatin - up to 100%.
pharmachologic effect
Pharmacotherapeutic group: antiviral agent
ATX Code: J05AX13
Pharmacological properties:
Pharmacodynamics
Antiviral agent. Specifically inhibits in vitro influenza A and B viruses (Influenzavirus A, B), including the highly pathogenic subtypes A (H1N1) pdm09 and A (H5N1), as well as other viruses that cause acute respiratory viral infections (SARS), 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 (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, increases the body's resistance to viral infections. It has interferon-inducing activity - in a study on mice, interferon induction was observed after 16 hours, and high titers of interferon remained in the blood until 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-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 frequency of development 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 showed that the effect of Arbidol ® in adult patients is most pronounced in the acute period of the disease and is manifested by a reduction in the resolution of symptoms of the disease, a decrease in the severity of the manifestations of the disease, and a reduction in the elimination of the virus.
Therapy with Arbidol ® leads to a higher frequency of relief of the symptoms of the disease on the third day of therapy compared with placebo. 60 hours after the start of therapy, the resolution of all symptoms of laboratory-confirmed influenza is more than 5 times higher than that in the placebo group.
A significant effect of the drug Arbidol ® on the rate of elimination of the influenza virus was established, which, in particular, was manifested by a decrease in the frequency of detection of virus RNA on the 4th day.
Refers to low toxic drugs (LD 50 > 4 g / kg). It does not have any negative effects on the human body when administered orally in recommended doses.
Pharmacokinetics
It is rapidly absorbed and distributed to organs and tissues. The maximum plasma concentration is reached 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.Indications
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Prevention and treatment in adults and children: influenza A and B, other acute respiratory viral infections.
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Complex therapy of recurrent herpetic infection.
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Prevention of postoperative infectious complications.
- Combined therapy of acute intestinal infections of rotavirus etiology in children older than 6 years.
Pregnancy and lactation
Animal studies have not revealed harmful effects on pregnancy, the development of the embryo and fetus, labor and postnatal development. The use of the drug Arbidol ® in the first trimester of pregnancy is contraindicated.
In the second and third trimester of pregnancy, Arbidol ® can only be used for the treatment and prevention of 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 Arbidol ® passes into breast milk in women during lactation. If necessary, the use of the drug Arbidol ® should stop breastfeeding.
Contraindications
Hypersensitivity to umifenovir or any component of the drug; children under 6 years old. The first trimester of pregnancy. The period of breastfeeding.
Carefully:
The second and third trimesters of pregnancy.Side effects
Arbidol ® is a low-toxic drug and is usually well tolerated.
Side effects are rare, usually mild or moderate, and are 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 rarely (with a frequency of less than 1/10000), the frequency is unknown (cannot be established according to available data).
Disorders from the immune system: rarely - allergic reactions.
If any of the side effects indicated in the instructions are aggravated, or if you notice any other side effects not listed in the instructions, inform your doctor.
Interaction
When prescribed with other drugs, no negative effects were noted.
Special clinical studies dedicated to the study of the interactions of the drug Arbidol ® with other drugs have not been conducted.
Information about the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical trial have not been identified.How to take, course of administration and dosage
Arbidol is taken orally, before meals.
Single dose: for 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 (2 capsules of 100 mg or 4 capsules of 50 mg).
For non-specific prophylaxis:
In direct contact with patients with influenza and other acute respiratory viral infections:
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 once a day for 10-14 days.
During the epidemic of influenza and other acute respiratory viral infections, to prevent exacerbations of chronic bronchitis, relapse of herpes infection:
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 twice a week for 3 weeks.
For the prevention of SARS (in contact with the patient):
adults and children over 12 years of age are prescribed 200 mg once a day. For children from 6 to 12 years old, 100 mg once a day (before meals) for 12-14 days.
Prevention of postoperative complications:
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 2 days before surgery, then on 2 and 5 days after surgery.
For treatment:
Influenza, other acute respiratory viral infections without complications:
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 a day (every 6 hours) for 5 days.
Influenza, other acute respiratory viral infections with the development of complications (bronchitis, pneumonia, etc.):
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 a day (every 6 hours) for 5 days, then a single dose 1 time per week for 4 weeks.
Severe Acute Respiratory Syndrome (SARS):
children over 12 years old and adults - 200 mg 2 times a day for 8-10 days.
In the complex treatment of chronic bronchitis, herpes infection:
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 a day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.
Combined therapy of acute intestinal infections of rotavirus etiology in children older than 3 years:
from 3 to 6 years old - 50 mg, from 6 to 12 years old - 100 mg, older than 12 years old - 200 mg 4 times a day (every 6 hours) for 5 days.
Special instructions
It is necessary to observe the scheme recommended in the instructions and the duration of 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 begun.
If after using the drug Arbidol ® for three days during 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), remains, then you must consult a doctor to assess the validity of taking the drug.
Impact on the ability to drive vehicles and mechanisms:
It does not show central neurotropic activity and can be used in medical practice in people of various professions, including requiring increased attention and coordination of movements (drivers of transport, operators, etc.).
Release form
Capsules
