Registration number: LP-002690 dated October 31, 2014
Trade name of the drug: Arbidol® Maximum
International non-proprietary name: Umifenovir
Dosage form: capsules
Composition per capsule:
Active ingredient : umifenovir hydrochloride monohydrate (in terms of umifenovir hydrochloride) - 207 mg (in terms of umifenovir hydrochloride) - 200 mg.
Excipients: potato starch - 45.67 mg, microcrystalline cellulose - 11.20 mg, colloidal silicon dioxide (aerosil) - 2.80 mg, povidone (collidone 25) - 7.73 mg, calcium stearate - 2.80 mg, sodium croscarmellose - 2.80 mg, the mass of the contents of the capsule - 280 mg.
Hard gelatin capsules No. 0:
The composition of the capsule shell (body and cap): titanium dioxide (E 171) - 1.92 mg, gelatin - 94.08 mg. The total weight of the capsule is 376 mg.
Description
Capsules hard gelatin No. 0 white. The contents of the capsule is a mixture containing granules and powder from white or white with a greenish-yellow or cream color to light yellow or light yellow with a greenish tint.
Pharmacotherapeutic group: antiviral agent.
ATX code: J05AX13
Pharmacological properties
Pharmacodynamics
Antiviral agent. Specifically inhibits in vitro influenza viruses A and B ( Influenza virus A, B ), including highly pathogenic subtypes A ( H1 N1) pdm09 and A ( H5 N1) , as well as other viruses that cause acute respiratory viral infections (ARVI) (coronavirus ( C oronavirus ) associated with severe acute respiratory syndrome (SARS), rhinovirus ( Rhinovirus ), adenovirus ( Adenovirus ), respiratory syncytial virus ( Pneumovirus ) and parainfluenza virus ( Pamyxovirus ) ). In researchin vitro specifically suppresses the SARS-CoV-2 virus that causes a new coronavirus infection (COVID-19). The EC50 (half maximum effective concentration) in Vero E6 cells is 4.11 µmol, which corresponds to 2.11 µg/mL. The clinical significance of this requires further study.
According to the mechanism of antiviral action, it belongs to inhibitors of fusion (fusion), interacts with the hemagglutinin of the virus and prevents the fusion of the lipid envelope 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, the induction of interferons was noted already after 16 hours, and high titers of interferons remained in the blood up to 48 hours after administration. Stimulates cellular and humoral immune reactions: 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 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 incidence of complications associated with a viral infection and exacerbations of chronic bacterial diseases.
In the treatment of influenza or SARS 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 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 the drug leads to a higher frequency of relief of 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 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 virus RNA on the 4th day.
Refers to low-toxic drugs (LD50 > 4 g/kg). It does not have any negative effects on the human body when taken orally at recommended doses.
Pharmacokinetics
It is quickly absorbed and distributed to organs and tissues. The maximum plasma concentration when taken at a dose of 50 mg is achieved after 1.2 hours, at a dose of 100 mg - after 1.5 hours. It is metabolized in the liver. The half-life is on average 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 for use
Prevention and treatment in adults and children from 12 years of age: influenza A and B, other acute respiratory viral infections.
Complex therapy of recurrent herpetic infection.
Prevention of postoperative infectious complications.
Complex therapy of acute intestinal infections of rotavirus etiology in children over 12 years old.
Contraindications
Hypersensitivity to umifenovir or any component of the drug; children's age up to 12 years. First trimester of pregnancy. breastfeeding period.
Carefully
Second and third trimesters of pregnancy.
Use during pregnancy and during breastfeeding
In animal studies, no harmful effects on pregnancy, embryonic and fetal development, labor and postnatal development have been identified.
The use of the drug Arbidol® Maximum in the first trimester of pregnancy is contraindicated.
In the second and third trimester of pregnancy, Arbidol® Maximum 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® Maximum passes into breast milk in women during lactation. If necessary, the use of Arbidol® Maximum should stop breastfeeding.
The drug is started 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® Maximum for three days in the treatment of influenza and other acute respiratory viral infections, the severity of the symptoms of the disease persists, including high temperature (38 ° C or more), then you should consult a doctor to assess the validity of taking the drug.
Use the drug only according to the indications, the method of application and in the doses indicated in the instructions.
In the treatment of influenza and SARS, concomitant symptomatic therapy is possible, including the use of antipyretic drugs, mucolytic and local vasoconstrictors.
Side effect
The drug Arbidol® Maximum refers to low-toxic drugs and is usually well tolerated.
Side effects are rare, usually mild or moderate and transient.
The frequency of occurrence 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 from the available data).
Immune system disorders : rarely - allergic reactions.
If any of the side effects listed 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 administered with other drugs, no adverse effects were noted.
Special clinical studies devoted to the study of interactions of the drug Arbidol® Maximum with other drugs have not been conducted.
Information about the presence of undesirable interactions with antipyretic, mucolytic and local vasoconstrictor drugs in a clinical study was not identified.
special instructions
It is necessary to follow the scheme recommended in the instructions and the duration of taking the drug. In case of missing one dose of the drug, the missed dose should be taken as soon as possible and the course of taking the drug should be continued according to the started scheme.
If after using the drug Arbidol® Maximum for three days in the treatment of influenza and other acute respiratory viral infections, the severity of the symptoms of the disease persists, including high temperature (38 ° C or more), then you should consult a doctor to assess the validity of taking the drug.
Influence 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, incl. requiring increased attention and coordination of movements (transport drivers, operators, etc.).
Release form
Capsules 200 mg.
10 capsules in a blister pack made of PVC film and printed lacquered aluminum foil.
1 or 2 contour packs with instructions for use are placed in a cardboard box.
Storage conditions
Store at a temperature not exceeding 25°C. Keep out of the reach of children.
Best before date
2 years. Do not use after the expiry date stated on the packaging.
Holiday conditions
Released without a prescription.
Marketing Authorization Holder/Consumer Claims Receiver
OTCPharm JSC, Russia
123112, Moscow, st. Testovskaya, 10th
floor 12, room II, com. 29
Tel.: +7 (800) 775-98-19
Fax: +7 (495) 221-18-02
www.otcpharm.ru
www.arbidol.ru
Manufacturer
JSC "Pharmstandard-Leksredstva"
305022, Russia, Kursk,
st. 2nd Aggregatnaya, 1а/18,
tel./fax: (4712) 34-03-13,
www.pharmstd.ru