Arbidol suspension - instructions for use for children

Arbidol suspension - instructions for use for children

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A homogeneous suspension of white or white with a yellowish or creamy tint of color with a characteristic fruity odor.

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

Active substance:

Umifenovir (umifenovir hydrochloride monohydrate – 25.88 mg), (in terms of umifenovir hydrochloride – 25.00 mg).

Trade name of the drug:

Arbidol®

International nonproprietary name:

umifenovir

Dosage form:

powder for the preparation of suspension for oral administration.

Composition per 5 ml
active substance:
umifenovir (umifenovir hydrochloride monohydrate – 25.88 mg), (in terms of umifenovir hydrochloride – 25.00 mg);
excipients:
sodium chloride – 26.85 mg, maltodextrin (Kleptose Linecaps) – 750.00 mg, sucrose (sugar) – 840.42 mg, colloidal silicon dioxide (Aerosil) – 24, 60 mg, titanium dioxide – 25.00 mg, pregelatinized starch (type PA5PH) – 129.50 mg, sodium benzoate – 9.25 mg, banana flavor – 12.40 mg, cherry flavor – 6.10 mg.

Description:

granular powder of white or almost white color with a characteristic fruity odor.

Description of the prepared suspension:

a homogeneous suspension of white or white with a yellowish or creamy tint of color with a characteristic fruity odor.

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 - causative agents of acute respiratory viral infections (ARVI) (coronavirus (Сoronavirus) 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 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.

Pharmacokinetics

Quickly absorbed and distributed throughout organs and tissues. The maximum concentration in blood plasma when taking the drug at a dose of 200 mg of umifenovir is achieved after 1 hour, the volume of distribution (Vd) is 1432 l. Metabolized in the liver. The half-life averages 11 hours. About 40% is excreted unchanged, mainly in the bile (38.9%) and in small amounts in the kidneys (0.12%). During the first day, 90% of the administered dose is eliminated.

Indications for use

• prevention and treatment of influenza A and B, other acute respiratory viral infections in children over 2 years of age and adults;
• complex therapy of acute intestinal infections of rotavirus etiology in children over 2 years of age.

Contraindications

• Hypersensitivity to umifenovir or any component of the drug.
• Age up to 2 years. First trimester of pregnancy. Breast-feeding.
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully
• 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 only be used 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.

Preparation of the suspension.

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

Single dose of the drug (depending on age):

Dosage regimen (depending on age):

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 - itching, rash, angioedema, urticaria; very rarely - anaphylactic 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 marked.

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

When prescribing to patients with diabetes mellitus, as well as on a low-calorie diet, it is necessary to take into account that the suspension contains sucrose (0.8 g/5 ml or 0.06 XE/5 ml). It is necessary to follow the regimen and duration of taking the drug recommended in the instructions. If you miss taking 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 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.

When calculating the amount of suspension required for a course of administration, it is necessary to take into account the shelf life of the prepared suspension, which is 10 days. For a course of treatment indicated for nonspecific prophylaxis during an epidemic of influenza and other acute respiratory viral infections in children from 2 to 6 years old, two bottles of the drug Arbidol® will be required.

Impact on the ability to drive vehicles and machinery

It 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

Powder for the preparation of suspension for oral administration, 25 mg/5 ml. 37 g in bottles with a capacity of 125 ml (with a mark to the level of 100 ml) of dark (amber) glass. One bottle, along with instructions for use and a measuring spoon, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25 °C. Store the prepared suspension at a temperature not exceeding 8 °C (in the refrigerator). Do not freeze. Keep out of the reach of children.

Best before date

Powder for the preparation of a suspension for oral administration – 2 years. Prepared suspension – no more than 10 days. 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

Is it permissible during COVID-19?

Umifenovir is recommended for use both for the treatment of coronavirus infection and for the prevention of infection with Covid-19. As a preventive measure, the drug is ideal because it prevents the virus from entering cells, even if there has been contact with a sick person. Coronavirus can be present in the blood for up to 2 weeks or more without penetrating into cells. This explains the long incubation period (asymptomatic). For preventive purposes, it is recommended to take Arbidol for 2 weeks, which will prevent the virus from entering cells and its further reproduction.

It makes sense to prescribe the drug for the treatment of coronavirus infection, as it stops further reproduction of viruses. The medicine relieves symptoms and prevents complications. Arbidol copes well with mild forms of COVID-19.

Release form, composition

Arpetol is available in white coated tablets with a biconvex surface. Each tablet contains: umifenovir hydrochloride – 50 mg or 100 mg; as well as excipients: povidone (K 17), microcrystalline cellulose, modified corn starch (Starch 1500), magnesium stearate, colloidal anhydrous silicon dioxide, lactose monohydrate, opadry II white (polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc).

In pharmacies, arpetol is sold in blister packs of 10, 15 or 20 tablets (a cardboard pack can contain from 10 to 40 tablets).

Precautionary measures

Use in children

The use of Arpetol in children under 6 years of age may be limited due to the possible lack of ability to swallow tablets at this age. If you do not have the ability to swallow tablets, Arpetol is recommended to be used under the supervision of a physician due to the risk of tablet aspiration. This risk is associated with the immaturity of the swallowing reflex, which can occur before the age of 6 years.

Features of use in elderly patients

No dose adjustment is required when using the drug in elderly patients.

Features of use in patients with impaired liver and kidney function

The pharmacokinetics and safety of Arpetol in patients with impaired liver and kidney function have not been studied.

The drug contains lactose, so it should not be taken by patients with rare hereditary forms of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption syndrome.

Restrictions on use

The medicine is not recommended if you have an allergic reaction to umifenovir. The drug should not be prescribed to patients under 2 years of age. It is prohibited to use an antiviral agent during pregnancy in the first trimester. The drug is not recommended during lactation.

You should not take the medication if:

• Lactase deficiency;
• Malabsorption syndrome.

Take the medication carefully in the 2nd and 3rd trimesters of pregnancy.