Arbidol^® (Tablets, Capsules, Powder) Instructions for Use

ATC Code

J05AX13 (Umifenovir)

Active Substance

Umifenovir (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Antiviral agent

Pharmacological Action

Antiviral drug. Specifically suppresses in vitro influenza A and B viruses (Influenza virus A, B), including highly pathogenic subtypes A(H1N1)pdm09 and A(H5N1), as well as other viruses causing 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 hemagglutinin of the virus and prevents the fusion of the viral lipid envelope 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 noted after 16 hours, and high interferon titers persisted 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 cells (NK-cells).

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

It belongs to low-toxicity drugs (LD₅₀ >4 g/kg). It does not have any negative impact on the human body when taken orally in recommended doses.

Pharmacokinetics

Absorption and Distribution

Rapidly absorbed and distributed to organs and tissues. C_max 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.

Metabolism and Excretion

Metabolized in the liver.

T_1/2 is 17-21 hours. About 40% is excreted unchanged, mainly with bile (38.9%) and in small amounts by the kidneys (0.12%). 90% of the administered dose is excreted within the first 24 hours.

Indications

• Prevention and treatment in adults and children: influenza A and B, other ARVI;
• Complex therapy of acute intestinal infections of rotavirus etiology in children over 3 years of age;
• Complex therapy of chronic bronchitis, pneumonia and recurrent herpetic infection;
• Prevention of postoperative infectious complications.

ICD codes

Dosage Regimen

Tablets

The drug is taken orally, before meals.

Single dose (depending on age)

Administration of the drug should be started from the moment the first symptoms of influenza and other ARVI appear, preferably no later than 3 days from the onset of the disease.

If the severity of disease symptoms, including high fever (38°C (100.4°F) and above), persists for 3 days after taking Arbidol^® during the treatment of influenza and other ARVI, the patient should consult a doctor to assess the appropriateness of taking the drug.

The drug should be used only according to the indications, method of administration and doses specified in the instructions.

Capsules

The drug is taken orally, before meals.

Single dose for adults and children over 12 years – 200 mg (1 caps.).

For non-specific prophylaxis and treatment of influenza and other ARVI

Non-specific prophylaxis of influenza and other ARVI

• For non-specific prophylaxis during an epidemic of influenza and other ARVI – 200 mg (1 caps.) 2 times a week for 3 weeks.
• upon direct contact with patients with influenza and other ARVI – 200 mg (1 caps.) 1 time/day for 10-14 days.

Treatment of influenza and other ARVI

• in uncomplicated course – 200 mg (1 caps.) 4 times/day (every 6 hours) for 5 days.
• in case of complications (bronchitis, pneumonia) – 200 mg (1 caps.) 4 times/day (every 6 hours) for 5 days, then a single dose 1 time per week for 4 weeks.

Complex therapy of acute intestinal infections of rotavirus etiology in children over 12 years

Prescribed 200 mg (1 caps.) 4 times/day (every 6 hours) for 5 days.

For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS)

For non-specific prophylaxis of SARS (upon contact with a patient) – 200 mg (1 caps.) 1 time/day for 12-14 days.

For treatment of SARS: – 200 mg (1 caps.) 2 times/day for 8-10 days.

In complex therapy of chronic bronchitis, pneumonia and herpetic infection

Prescribed 200 mg (1 caps.) 4 times/day (every 6 hours) for 5-7 days, then a single dose 2 times a week for 4 weeks.

Prevention of postoperative complications

Prescribed 200 mg (1 caps.) 2 days before surgery, then on the 2nd and 5th day after surgery.

Powder

The drug is taken orally, before meals.

Preparation of suspension

Add 30 ml (or approximately up to 2/3 of the bottle volume) of boiled and cooled to room temperature water to the bottle containing the powder. Close the bottle with a cap, turn it over and shake thoroughly until a homogeneous suspension is obtained. Add boiled and cooled water up to a volume of 100 ml (up to the mark on the bottle) and shake again. Before each use, shake the contents of the bottle thoroughly until a homogeneous suspension is obtained. Measure the single dose using the supplied measuring spoon.

Single dose (depending on age)

For non-specific prophylaxis and treatment of severe acute respiratory syndrome (SARS)

For non-specific prophylaxis of SARS (upon contact with a patient) in children from 6 years and adultschildren from 6 to 12 years – 20 ml (100 mg), children over 12 years and adults – 40 ml (200 mg) 1 time/day for 12-14 days.

For treatment of SARS in children from 12 years and adultschildren over 12 years and adults – 40 ml (200 mg) 2 times/day for 8-10 days.

Adverse Reactions

Arbidol^® belongs to low-toxicity drugs and is usually well tolerated. Side effects are rare, usually mild or moderate and transient.

The frequency of adverse drug reactions is determined according to the WHO classification: very common (>1/10), common (≥1/100, but <1/10), uncommon (≥1/1000, but <1/100), rare (≥1/10 000, but <1/1000), very rare (<1/10 000), frequency unknown (cannot be estimated from the available data).

From the immune system rare – allergic reactions.

If any of the side effects mentioned in the instructions worsen, or any other side effects not mentioned in the instructions are noted, the patient should inform the doctor.

During the treatment of influenza and ARVI, concomitant symptomatic therapy, including the use of antipyretics, mucolytics and topical decongestants, is possible.

Contraindications

• Hypersensitivity to umifenovir or any component of the drug;
• Children under 3 years of age;
• First trimester of pregnancy;
• Breastfeeding period.

Use in Pregnancy and Lactation

Animal studies have not revealed harmful effects on the course of pregnancy, embryonic and fetal development, labor and postnatal development.

The use of Arbidol^® in the first trimester of pregnancy is contraindicated.

In the second and third trimesters of pregnancy, Arbidol^® can be used only for the treatment and prevention of influenza and in cases where 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^® is excreted in breast milk in women during lactation. If it is necessary to use Arbidol^®, breastfeeding should be discontinued.

Pediatric Use

The drug is contraindicated for use in children under 3 years of age.

Special Precautions

It is necessary to follow the recommended regimen and duration of drug administration. In case of missing one dose of the drug, the missed dose should be taken as soon as possible and the course of administration should be continued according to the started regimen.

If the severity of disease symptoms, including high fever (38°C (100.4°F) and above), persists for 3 days after taking Arbidol^® during the treatment of influenza and other ARVI, it is necessary to consult a doctor to assess the appropriateness of taking the drug.

Effect on ability to drive vehicles and mechanisms

It does not exhibit central neurotropic activity and can be used in medical practice in individuals of various professions requiring increased attention and coordination of movements (including drivers, operators).

Overdose

Cases of drug overdose have not been reported.

Drug Interactions

No negative effects were noted when prescribed with other drugs.

Special clinical studies on the interaction of Arbidol^® with other drugs have not been conducted.

Information on the presence of undesirable interaction with antipyretic, mucolytic and topical decongestant drugs in clinical study conditions has not been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.