Amizon^® (Tablets) Instructions for Use

Marketing Authorization Holder

Farmak, JSC (Ukraine)

ATC Code

J05AX17 (Enisamium iodide)

Active Substance

Enisamium iodide (Rec.INN registered by WHO)

Dosage Form

Amizon^®

Film-coated tablets, 250 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow or yellow-green in color, round, biconvex; the presence of minor inclusions on the surface is allowed.

	1 tab.
Enisamium iodide	250 mg

Excipients: lactose monohydrate (200) – 11 mg, microcrystalline cellulose 101 – 21 mg, povidone K17 – 9 mg, croscarmellose sodium – 6 mg, calcium stearate – 3 mg, Opadry II 85F Clear – 10 mg (polyethylene glycol – 1.5 mg, polysorbate 80 – 0.3 mg, polyvinyl alcohol – 5.2 mg, talc – 3 mg).

10 pcs. – blisters (1) – cartons.
10 pcs. – blisters (3) – cartons.
20 pcs. – blisters (1) – cartons.

Clinical-Pharmacological Group

Antiviral and immunomodulatory drug. Interferon synthesis inducer

Pharmacotherapeutic Group

Antiviral agent

Pharmacological Action

Amizon^® is an antiviral agent, a derivative of isonicotinic acid.

It effectively suppresses the action of influenza viruses and other pathogens of acute respiratory viral infections due to a direct (inhibitory) effect on the process of virus penetration through the cell membrane.

It has interferonogenic properties, promotes an increase in the concentration of endogenous interferon (interferon alpha and interferon gamma) in the blood plasma by 3-4 times.

It increases the body’s resistance to viral infections.

It reduces the acute clinical manifestations of viral intoxication and helps to reduce the duration of the disease.

Pharmacokinetics

After oral administration, methylbenzylcarbamidopyridinium iodide quickly enters the blood, C_max of methylbenzylcarbamidopyridinium iodide is observed after 2-2.5 hours. T_1/2 is 13.5-14 hours, it is metabolized in the liver, but is quickly eliminated from tissues (the elimination half-life is 2-3 hours).

It is eliminated from the body by 90-95% through the kidneys with urine in the form of metabolites.

Indications

Treatment of influenza and other acute respiratory viral infections, including as part of complex therapy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J06.9	Acute upper respiratory infection, unspecified
J10	Influenza due to identified seasonal influenza virus

ICD-11 code	Indication
1E30	Influenza due to identified seasonal influenza virus
CA07.0	Acute upper respiratory tract infection of unspecified site

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the tablets orally, strictly after meals. Swallow the tablet whole; do not chew or crush it.

The standard adult dosage is 500 mg (two 250 mg tablets) taken three times per day.

Do not exceed the maximum single dose of 1000 mg (four tablets). Do not exceed the maximum daily dose of 2000 mg (eight tablets).

Initiate treatment at the earliest signs of illness. Continue the treatment course for 5 to 7 days, or as directed by a physician.

Adjust the duration of therapy based on the clinical response and severity of the infection. The total treatment course should not exceed 7 consecutive days without medical supervision.

Adverse Reactions

Bitterness in the mouth, heartburn, burning sensation in the throat, slight swelling of the oral mucosa, which does not require additional treatment or drug withdrawal.

The drug is well tolerated; according to clinical studies, the frequency of adverse reactions is 6%.

Contraindications

Hypersensitivity to any of the components of the drug. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Children under 18 years of age, pregnancy, lactation period.

Use in Pregnancy and Lactation

Not recommended for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated: children under 18 years of age.

Special Precautions

Taking Amizon^® does not affect the ability to drive vehicles and various mechanical equipment.

Overdose

In case of drug overdose, an increase in the side effects described in the corresponding section is possible.

If they appear, gastric lavage and symptomatic treatment are performed.

Drug Interactions

Interaction with other medicinal products has not been sufficiently studied.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F).

Keep out of reach of children.

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.

Medical Disclaimer