Tubosan^® (Capsules) Instructions for Use

Marketing Authorization Holder

Biopharm Pravo-Alpha, LLC (Russia)

Manufactured By

Biopharm Pravo-Alpha, LLC (Russia)

Mega Pharm, CJS (Russia)

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

L03 (Immunostimulants)

Dosage Form

Tubosan^®

Capsules 200 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 1, yellow in color; the capsule contents are a white or white with a light brown tint powder.

	1 caps.
Methyldioxotetrahydropyrimidine sulfonylisonicotinoyl hydrazide	200 mg

Excipients: potato starch – 5 mg.

Capsule body composition iron oxide red dye (red iron oxide) – 0.5%, titanium dioxide – 1%, gelatin up to 100%.
Capsule cap composition iron oxide yellow dye (yellow iron oxide) – 0.5%, titanium dioxide – 1%, gelatin up to 100%.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Immunostimulating agent, affects all parts of the immune system; active against tuberculosis mycobacteria, leprosy (including resistant forms), herpes viruses.

Pharmacokinetics

Time to reach C_max – 6 h, therapeutic concentration is maintained for 12-18 h.

Excreted via the gastrointestinal tract – 50%.

Indications

Diseases against the background of a secondary immunodeficiency state: tuberculosis; leprosy; chlamydia; herpetic infection.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A15	Respiratory tuberculosis, bacteriologically and histologically confirmed
A30	Leprosy [Hansen's disease]
A56.0	Chlamydial infections of lower genitourinary tract
A56.1	Chlamydial infections of pelvic organs and other genitourinary organs
A60	Anogenital herpesviral infection [herpes simplex]
B00	Herpesviral [herpes simplex] infections
B02	Zoster [herpes zoster]
D84.9	Immunodeficiency, unspecified

ICD-11 code	Indication
1A81.0	Chlamydial infection of lower genitourinary tract
1A81.1	Chlamydial infection of internal reproductive organs
1A94.Z	Anogenital herpes simplex virus infection without further specification
1B10.0	Respiratory tuberculosis, bacteriologically or histologically confirmed
1B20.Z	Leprosy, unspecified
1E91.Z	Herpes zoster, unspecified
1F00.Z	Infections due to herpes simplex virus, unspecified
4A0Z	Unspecified primary immunodeficiencies

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 orally, 30 minutes before or 2 hours after a meal.

For adults, the standard single dose is 200 mg to 400 mg.

Do not exceed the maximum daily dose of 1.6 grams.

For acute diseases, such as active herpetic infection, prescribe a treatment course of 2 to 3 weeks.

For chronic diseases, including tuberculosis and leprosy, continue therapy for 6 to 12 months.

Adhere strictly to the prescribed duration of therapy to ensure clinical efficacy.

Adjust the dosing schedule based on the specific infection being treated and the patient’s clinical response.

Adverse Reactions

Allergic reactions.

Contraindications

Hypersensitivity; pregnancy; lactation period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Drug Interactions

Enhances the effect of antibacterial drugs (including macrolides, cephalosporins, aminoglycosides).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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