Arbidol capsules 100 mg: instructions for use


Arbidol Maximum caps 200 mg N10 (OTISI)

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 (Rhinovirus), adenovirus (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-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 (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. When treating influenza or ARVI in adult patients, a clinical study showed that the effect of the drug 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 the drug leads to a higher frequency of relief of symptoms of the disease 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 the same indicator in the placebo group. A significant effect of the drug 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 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.

Arbidol® Maximum

Antiviral agent. Specific inhibitors 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 (
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, 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-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 (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.

When treating influenza or ARVI in adult patients, a clinical study showed that the effect of the drug 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 the drug leads to a higher frequency of relief of symptoms of the disease 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 the same indicator in the placebo group.

A significant effect of the drug 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 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.

Arbidol capsules 100 mg: instructions for use


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The contents of the capsules are a mixture containing granules and powder from white to white with a greenish-yellowish or creamy tint.

  • Treatment:
    100 mg x 4 times a day, 5 days
  • Post-exposure prophylaxis:
    100 mg x 1 time / day, 10-14 days
  • Seasonal prophylaxis:
    100 mg x 2 times a week, 3 weeks

Active substance:

Umifenovir (umifenovir hydrochloride monohydrate (arbidol) in terms of umifenovir hydrochloride) – 100 mg.

  • Registration number:
    P N003610/01
  • Trade name:
    Arbidol®
  • International nonproprietary name:
    umifenovir
  • Dosage form:
    capsules

Composition per capsule

Active substance:

umifenovir hydrochloride monohydrate (in terms of umifenovir hydrochloride) – 100 mg.

Excipients: core: potato starch - 30.14 mg, microcrystalline cellulose - 55.76 mg, colloidal silicon dioxide (Aerosil) - 2.0 mg, povidone K 25 (kollidon 25) - 10.1 mg, calcium stearate - 2 .0 mg.

Hard gelatin capsules No. 1:

Body: titanium dioxide (E 171) – 2.0000%, gelatin – up to 100%.

Cap: titanium dioxide (E 171) – 1.3333%, sunset yellow dye (E 110) – 0.0044%, quinoline yellow (E 104) – 0.9197%, gelatin – up to 100%.

Description

Hard gelatin capsules No. 1. The body is white, the cap is yellow. The contents of the capsules are a mixture containing granules and powder from white to white with a greenish-yellowish or creamy tint.

Pharmacotherapeutic group: antiviral agent

ATX code: J05AX13

Pharmacological properties

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 (Rhinovirus), adenovirus (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-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 (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 the drug Arbidol® 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 manifestations of the disease and a reduction in the time for elimination of the virus. Therapy with Arbidol® leads to a higher frequency of relief of disease 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 was more than 5 times higher than 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 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 is reached 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.

Indications for use

  • Prevention and treatment in adults and children: influenza A and B, other acute respiratory viral infections.
  • Complex therapy of recurrent herpes infection.
  • Prevention of postoperative infectious complications.
  • Complex therapy of acute intestinal infections of rotavirus etiology in children over 6 years of age.

Contraindications

Hypersensitivity to umifenovir or any component of the drug; children under 6 years of age. First trimester of pregnancy. Breastfeeding period.

With caution: Second and third trimesters of pregnancy

Use during pregnancy and breastfeeding

In animal studies, no harmful effects on pregnancy, embryonic and fetal development, labor or postnatal development were identified. The use of Arbidol® in the first trimester of pregnancy is contraindicated. In the second and third trimester of pregnancy, Arbidol® 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 Arbidol® passes into breast milk in women during lactation. If it is necessary to use the drug Arbidol®, you should stop breastfeeding.

Directions for use and doses

Inside, before meals.

Single dose of the drug (depending on age):

AgeSingle dose
Children from 6 to 12 years old100 mg (1 capsule)
Children over 12 years old and adults200 mg (2 capsules)

Dosage regimen (depending on age):

IndicationDosage regimen
For children over 6 years of age and adults:
Nonspecific prevention during an epidemic of influenza and other acute respiratory viral infectionsin a single dose 2 times a week for 3 weeks
Nonspecific prophylaxis in direct contact with patients with influenza and other acute respiratory viral infectionsin a single dose 1 time per day for 10-14 days
Treatment of influenza and other acute respiratory viral infectionsin a single dose 4 times a day (every 6 hours) for 5 days
Complex therapy for recurrent herpes infectionin a single dose 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 complicationsin a single dose 2 days before surgery, then on the 2nd and 5th days after surgery
For children over 6 years of age:
Complex therapy of acute intestinal infections of rotavirus etiologyin a single dose 4 times a day (every 6 hours) for 5 days

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

The drug should be taken from the moment the first symptoms of influenza and other acute respiratory viral infections appear, preferably no later than 3 days from the onset of the disease.

If, after using the drug Arbidol® 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 must consult a doctor to assess the validity of taking the drug.

When treating influenza and ARVI, concomitant symptomatic therapy is possible, including taking antipyretic drugs, mucolytics and local vasoconstrictors.

Side effect

The drug Arbidol® 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), rare (with a frequency of at least 1/10,000, but less than 1/1000), very rare (with a frequency of less than 1/10,000), frequency unknown (cannot be determined from the 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.

Overdose Not noted.

Interaction with other drugs

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

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

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

special instructions

It is necessary to follow the regimen and duration of taking the drug recommended in the instructions. If you miss 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 Arbidol® 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 must consult a doctor to assess the validity of taking the drug.

Effect on the ability to drive vehicles and machinery 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.).

Release form

Capsules, 100 mg.

5 or 10 capsules per blister pack. 1, 2 or 4 contour packages with instructions for use in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the package.

Vacation conditions

Available without a prescription.

Marketing authorization holder/organization receiving consumer complaints

PJSC OTCPharm, Russia,

123317, Moscow, st. Testovskaya, 10

Tel.

Fax

,

305022, Russia, Kursk, st. 2nd Aggregatnaya, 1a/18, tel./fax: (4712) 34-03-13

Arbidol® (Arbidol®)

Antiviral agent. Specifically suppresses in
vitro
influenza viruses A and B
{ Influenzavirus A, B),
including highly pathogenic subtypes
A (
H1N1
) pdm 09
and
A ( H 5 N 1),
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 )).
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-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 (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 the drug Arbidol® 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 manifestations of the disease and a reduction in the time for elimination of the virus.

Therapy with Arbidol® leads to a higher frequency of relief of symptoms of the disease 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 the same indicator 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 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.

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