Ingavirin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INGAVIRIN

Composition:

Active ingredient:
imidazolethylamid pentandioic acid (vitaglutam);

1 capsule contains imidazolethylamid pentanedioic acid (vitaglutam) equivalent to 100% substance — 90 mg;

Excipients:
lactose monohydrate; potato starch; colloidal anhydrous silicon dioxide; magnesium stearate;

Capsule shell composition:
titanium dioxide (E 171), quinoline yellow (E 104), azorubine (E 122), ponceau 4R (E 124), gelatin.

Pharmaceutical form.
Capsules.

Main physicochemical properties:
size 1 capsules, red in color; capsule contents are granules and powder of white or white with cream-colored shade.

Pharmacotherapeutic group.
Antiviral agents for systemic use.

ATC code J05A X.

Pharmacological Properties

Pharmacodynamics

The medicinal product exerts antiviral effects and is effective against influenza viruses type A (A/H1N1, including swine A/H1N1 sw1, A/H3N2, A/H5N1), type B, adenovirus infection, parainfluenza, and respiratory syncytial infection.

The antiviral mechanism of action involves inhibition of viral replication at the nuclear phase, delaying the migration of newly synthesized viral NP protein from the cytoplasm into the nucleus. It modulates the functional activity of interferon: induces an increase in blood interferon levels up to physiological norms, stimulates and normalizes reduced α-interferon-producing capacity of blood leukocytes, and enhances γ-interferon-producing capacity of leukocytes.

It promotes the generation of cytotoxic lymphocytes and increases the levels of NK cells and T-cells, which exhibit high cytotoxic activity against virus-transformed cells and possess antiviral activity. Anti-inflammatory action is due to suppression of key pro-inflammatory cytokines [tumor necrosis factor (TNF-α), interleukins (IL-1β and IL-6)] and reduction in myeloperoxidase activity.

Therapeutic efficacy in influenza and other acute respiratory viral infections (ARVI) is manifested by a shortened fever period, reduced intoxication symptoms (headache, weakness, dizziness), decreased catarrhal symptoms, lower incidence of complications, and reduced overall duration of illness. Toxicological studies indicate low toxicity and high safety of the drug (LD50 exceeds the therapeutic dose by more than 3000 times). It has been established that the drug does not possess mutagenic, immunotoxic, allergenic, or carcinogenic effects and does not cause local irritation.

Ingavirin does not affect reproductive function and has no embryotoxic or teratogenic effects.

Pharmacokinetics

When administered at recommended doses, the drug cannot be detected in blood plasma using available analytical methods. In experiments using radiolabeling, it was established that the drug is rapidly absorbed into the bloodstream from the gastrointestinal tract. It distributes evenly in internal organs. Maximum concentrations in blood, plasma, and most organs are achieved within 30 minutes after administration. AUC values (area under the concentration-time pharmacokinetic curve) in kidneys, liver, and lungs slightly exceed those in blood (43.77 μg·h/g). AUC values in spleen, adrenal glands, lymph nodes, and thymus are lower than those in blood. MRT (mean residence time of the drug) in blood is 37.2 hours.

With a 5-day course of once-daily oral administration, the drug accumulates in internal organs and tissues. Qualitative characteristics of pharmacokinetic curves after each dose were identical: rapid increase in drug concentration after each intake, followed by slow decline over 24 hours. The drug is not metabolized in the body and is excreted unchanged.

The main elimination process occurs within 24 hours. During this period, 80% of the administered dose is excreted: 34.8% within the first 5 hours and 45.2% between 5 and 24 hours. Of this, 77% is excreted via the intestine and 23% via the kidneys.

Clinical characteristics.

Indications.

Treatment and prevention of influenza A and B and other acute respiratory infections (adenovirus infection, parainfluenza, respiratory syncytial infection).

Contraindications.

Hypersensitivity (allergy) to any component of the medicinal product.

Interaction with other medicinal products and other types of interactions.

There is no data regarding interactions with other medicinal products.

Usage Notes

Do not use simultaneously with other antiviral medicinal products. If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product. Patients with such rare hereditary disorders as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

The excipients azorubine (E 122) and Ponceau 4R (E 124) contained in the medicinal product may cause allergic reactions.

Use during pregnancy or breastfeeding

There is no data on the use of the drug during pregnancy and breastfeeding; therefore, the drug should not be used during these periods.

Ability to influence reaction speed when driving or operating machinery Does not affect.

Dosage and Administration.

Take orally, independent of food intake.

For the treatment of influenza and acute respiratory viral infections, take 1 capsule (90 mg) once daily for 5–7 days (depending on the severity of condition). The drug should be started at the first signs of illness, no later than 36 hours after onset of symptoms.

For prophylaxis of influenza and acute respiratory viral infections following contact with infected individuals, take 1 capsule (90 mg) once daily for 7 days.

Children.

There is no data available regarding the use of this drug in children; therefore, Ingavirin should not be prescribed to children.

Overdose.

Cases of overdose are unknown.

Side effects.

Allergic reactions, including rash, itching, urticaria, angioedema.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

7 capsules in blisters, one blister per cardboard pack.

Availability category.

Over-the-counter.

Manufacturer.

JSC "Tekhnolog", Ukraine.

Manufacturer's address and place of business.

8 Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.