Oxodihydroacridinylacetate sodium - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Interferon Inductors

Antiviral drugs (excluding HIV)

Included in the formulation

Neovir®

solution w / m

FARMSINTEZ, PAO Russia

АТХ:

L.03.A.X Other immunostimulants

Pharmacodynamics:

The drug induces the synthesis of endogenous interferons, especially interferon alpha, activates T-cellular immunity, macrophages, bone marrow stem cells. The drug promotes the formation of antiviral immunity.

Has antiviral activity against DNA and RNA genomic viruses. Has a pronounced anti-chlamydial effect

It shows immunomodulating activity, normalizing the balance between subpopulations of T-helper and T-suppressor cells. In a number of diseases, the drug is able to reduce the production of tumor necrosis factor (HIV infection, herpes) in the body and activate natural killer cells (for tumor diseases). Significantly increases the activity of polymorphonuclear leukocytes.

In HIV infection, the drug has an immunomodulating effect: it increases the absorption activity of blood serum, increases the ability of leukocytes to synthesize interferon alfa, stimulates the formation of reactive oxygen species by phagocytes.

Pharmacokinetics:

Peak activity of interferons in the blood and tissues is observed a few hours after the administration of the drug and persists for 16-20 hours.

With intramuscular injection, bioavailability is more than 90%.After the administration of the drug in a dose of 100-500 mg, the maximum concentration in the blood plasma is reached after 15-30 minutes and is 8.3 μg / ml. After 5 hours, only insignificant concentrations of the active substance are detected, and after 6 hours the drug is not detected in the blood plasma.

After 15-30 minutes after the administration, serum interferon titers begin to increase in the plasma. Two peaks of interferon content in plasma were detected: 70 IU / ml after 1.5-2 h and 110 IU / ml after 8-10 h, after which their decrease begins. After 24 hours, the concentration of serum interferons remains high enough, and returns to the initial values after 46-48 hours.

The drug is not metabolized, the half-life is 1 hour. Excreted by the kidneys in unchanged form.

Indications:

Oncological diseases.
Candidiasis of the skin and mucous membranes.
Multiple sclerosis.
Acute and chronic hepatitis B and C.
Treatment of HIV infection.
Cytomegalovirus infection in people with immunodeficiency.
Prevention and treatment of influenza and other acute respiratory diseases.
Radiation immunodeficiency.
Infections caused by the virus Herpes simplex type 1 and 2 and the virus Varicellazoster.
Venereal lymphogranuloma.
Encephalitis and encephalomyelitis of viral etiology.
Urethritis, epididymitis, prostatitis, cervicitis and salpingitis of chlamydial etiology.

ICD-10

I.A30-A49.A31 Infections caused by other microbacteria

I.A50-A64.A55 Chlamydial lymphogranuloma (venereal)

I.A70-A74.A74.9 Chlamydial infection, unspecified

I.B00-B09.B00 Infections caused by the herpes simplex virus [herpes simplex]

I.B00-B09.B01 Chicken Pox [varicella]

I.B00-B09.B02 Shingles [herpes zoster]

I.B15-B19.B16 Acute hepatitis B

I.B15-B19.B17.1 Acute hepatitis C

I.B15-B19.B18.0 Chronic viral hepatitis B with delta-agent

I.B15-B19.B18.2 Chronic viral hepatitis C

I.B25-B34.B25 Cytomegalovirus

I.B35-B49.B37.0 Candidiasis stomatitis

I.B35-B49.B37.2 Candidiasis of skin and nails

I.B35-B49.B37.3 Candidiasis of the vulva and vagina (N77.1 *)

I.B35-B49.B37.4 Candidiasis of other urogenital localizations

I.B35-B49.B37.7 Candida septicemia

I.B99 Other infectious diseases

VI.G00-G09.G05 * Encephalitis, myelitis and encephalomyelitis in diseases classified elsewhere

VI.G35-G37.G35 Multiple sclerosis

X.J00-J06 Acute respiratory infections of the upper respiratory tract

X.J10-J18.J11 Influenza, virus not identified

XXI.Z55-Z65.Z58.4 Impact of radiation contamination

Contraindications:

Hypersensitivity.
Severe renal and cardiovascular failure.
Hyperimmune variant of the fulminant form of acute viral hepatitis.
Autoimmune diseases.
Childhood.
Pregnancy and lactation.

Carefully:

Age over 65 years.

Pregnancy and lactation:

Category FDA not determined. Adequate and well-controlled studies in humans and animals have not been conducted. There is no information on the penetration into breast milk.

The drug is contraindicated in pregnancy and lactation.

Dosing and Administration:

For intramuscular administration, a single dose of 4-6 mg / kg, the maximum daily dose of 500 mg with an interval of 18-36 h (the course dose depends on the nature of the disease). The course of treatment - 5-7 intramuscular injections with an interval of 48 hours. With preventive use of the drug intervals between injections can be 3-7 days.

Inside, 30 minutes before meals, without chewing, 6 tablets (0.75 g) 48 hours 5 times (on the 1 st, 3 rd, 6 th, 9 th and 12 th day of treatment).

In the treatment of HIV infection used in combination therapy.

Side effects:

Allergic reactions, low-grade fever, accompanied by an ache in the joints. Local reactions: soreness in the injection site.

Overdose:

Not described, treatment is symptomatic.

Interaction:

Weaken the effect of immunosuppressive drugs.

Special instructions:

If the drug is poorly tolerated (painful at the injection site) it is permissible to combine the drug with 2 ml of 0.25-0.5% solution of novocaine.

Treatment should be carried out under the supervision of a doctor and when monitoring the immune status. With intolerance of the subfebrile condition, NSAIDs. Use with caution in patients with chronic sluggish and previously asymptomatic infectious processes (combine with antibiotics). In the treatment of chlamydia, they are used together with fluoroquinolones.

The turbidity of the solution (milk-white color) indicates a violation of storage conditions and unfitness to use.

Impact on the ability to drive vehicles and manage mechanisms not found.

Instructions

Oxodihydroacridinylacetate sodium (Natrii oxodihydroacridinylacetas)