Ftivazide (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

J04AC (Hydrazides)

Active Substance

Ftivazide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Agents active against mycobacteria; antituberculosis drugs; hydrazides.

Pharmacological Action

Antituberculosis agent, a derivative of isonicotinic acid hydrazide. It possesses high selective activity against Mycobacterium tuberculosis.

It causes damage to the mycobacterial membrane, inhibits metabolic and oxidative processes, suppresses the synthesis of nucleic acids, and acts on mycobacteria both inside and outside the cell.

Pharmacokinetics

Absorption is high. C_max in blood plasma is reached within 1-2 hours, plasma protein binding is less than 10%.

It is metabolized in the liver to form the main metabolite, isonicotinic acid hydrazide, which subsequently undergoes hydrolysis and acetylation. T_1/2 is 2-5 hours.

It is excreted through the kidneys (95% as metabolites), a small amount is excreted through the intestines.

It crosses the placental barrier and is excreted in breast milk.

Indications

Treatment of active tuberculosis of all forms and localizations in adults and children.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A15	Respiratory tuberculosis, bacteriologically and histologically confirmed
A17	Tuberculosis of nervous system
A18	Tuberculosis of other organs

ICD-11 code	Indication
1B10.0	Respiratory tuberculosis, bacteriologically or histologically confirmed
1B11.Z	Tuberculosis of nervous system, unspecified
1B12	Tuberculosis of other systems and organs

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 with a full glass of water. Take tablets on an empty stomach, at least 1 hour before or 2 hours after meals, to ensure complete absorption.

The daily dosage is individualized based on the patient’s body weight, form and severity of tuberculosis, and treatment phase. Always use as part of a combination antituberculosis therapy regimen to prevent the development of drug resistance.

For adults, the typical daily dose ranges from 0.5 g to 1.0 g (500 mg to 1000 mg). Divide the total daily dose into two or three administrations.

For children, the daily dose is calculated as 20-30 mg per kg of body weight. The maximum daily dose for a child should not exceed 1.0 g. Administer the total daily dose in two divided doses.

In the initial intensive phase of treatment, typically the first 2 months, administer the drug daily. In the continuation phase, a supervised intermittent dosing regimen may be implemented under direct medical supervision.

For patients with concurrent pyridoxine deficiency, malnutrition, or a high risk of neuropathy, administer prophylactic pyridoxine (Vitamin B6) concurrently.

Regularly monitor liver function tests due to the risk of hepatotoxicity. Adjust or discontinue therapy if signs of liver injury appear.

Complete the full course of therapy as prescribed, even if symptoms improve, to ensure eradication of the infection and prevent relapse.

Adverse Reactions

From the nervous system headache, dizziness, sleep disorders, increased fatigue, depressive states, psychoses, memory impairment, euphoria, peripheral neuritis, increased frequency of epileptic seizures in patients with epilepsy.

From the organ of vision optic neuritis.

From the digestive system nausea, vomiting, dry mouth, decreased appetite, gastralgia, hepatitis.

Allergic reactions skin rash, fever.

Others increased bleeding, gynecomastia, menorrhagia, arthralgia, cardialgia.

Contraindications

Hypersensitivity to ftivazide; angina pectoris, chronic heart failure grade II-III (including against the background of decompensated heart defects), epilepsy, organic lesions of the CNS, liver and/or kidney diseases (non-tuberculous nature), chronic hepatic and/or renal failure, alcoholism; pregnancy, breastfeeding period; childhood – depending on the dosage form.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in liver diseases of non-tuberculous nature, in chronic hepatic failure.

Use in Renal Impairment

Contraindicated in kidney diseases of non-tuberculous nature, in chronic renal failure.

Pediatric Use

Use in children of appropriate age categories is possible strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the ftivazide drug leaflets regarding contraindications for the use of specific ftivazide dosage forms in children of different ages.

Special Precautions

During treatment, periodic examination of the fundus is necessary. To prevent the development of neuritis, vitamins B₁ and B₆ are prescribed simultaneously.

Alcohol consumption is not allowed during the use of ftivazide.

Effect on ability to drive vehicles and mechanisms

During treatment with ftivazide, a slowdown in the speed of psychomotor reactions is observed. Patients should avoid driving vehicles and other activities requiring high concentration and speed of psychomotor reactions.

Drug Interactions

With simultaneous use, Ftivazide enhances the side effects of paracetamol, ethanol, benzodiazepines, carbamazepine, hepatotoxic drugs, anticoagulants, antiplatelet agents; reduces the effects of mineralo- and glucocorticosteroids.

With simultaneous use, antacids slow down the absorption of ftivazide.

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

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Ftivazide [Avexima JSC (Russia)]
Tablets 100 mg: 10, 50 or 100 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Ftivazide

Tablets 100 mg: 10, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	100 mg

10 pcs. – blisters (10) – carton packs.
100 pcs. – jars (1) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – strips.

Ftivazide [Avexima JSC (Russia)]
Tablets 300 mg: 10, 50 or 100 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Ftivazide

Tablets 300 mg: 10, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	300 mg

10 pcs. – blisters (10) – carton packs.
100 pcs. – jars (1) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – strips.

Ftivazide [Avexima JSC (Russia)]
Tablets 500 mg: 10, 50 or 100 pcs.

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Form

Ftivazide

Tablets 500 mg: 10, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	500 mg

10 pcs. – blisters (10) – carton packs.
100 pcs. – jars (1) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – strips.

Ftivazide [Rozpharm CJSC (Russia)]
Tablets 500 mg: 50 pcs.

Marketing Authorization Holder

Rozpharm CJSC (Russia)

Dosage Form

Ftivazide

Tablets 500 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	500 mg

50 pcs. – polyethylene jars (1) – carton packs.

Ftivazide [Rozpharm CJSC (Russia)]
Tablets 300 mg: 50 or 100 pcs.

Marketing Authorization Holder

Rozpharm CJSC (Russia)

Dosage Form

Ftivazide

Tablets 300 mg: 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	300 mg

50 pcs. – polyethylene jars (1) – carton packs.
100 pcs. – polyethylene jars (1) – carton packs.
10 pcs. – contour cell packs (10) – carton packs.

Ftivazide [Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)]
Tablets 500 mg: 10, 20, 50, 60 or 100 pcs.

Marketing Authorization Holder

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

Dosage Form

Ftivazide

Tablets 500 mg: 10, 20, 50, 60 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow, round, flat-cylindrical, with a faint smell of vanillin, with a score and a chamfer.

	1 tab.
Ftivazide monohydrate (in terms of Ftivazide)	500 mg (469 mg)

Excipients : potato starch – 45 mg, calcium stearate monohydrate – 5 mg.

10 pcs. – contour cell packs (1) – carton packs.
10 pcs. – contour cell packs (2) – carton packs.
10 pcs. – contour cell packs (5) – carton packs.
10 pcs. – contour cell packs (6) – carton packs.
60 pcs. – jars (1) – carton packs.
100 pcs. – jars (1) – carton packs.

Ftivazide [Pharmasintez, JSC (Russia)]
Tablets 500 mg: 30, 50 or 100 pcs.

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Dosage Form

Ftivazide

Tablets 500 mg: 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets from light yellow to yellow, round, flat-cylindrical, with a chamfer and a score, with a faint smell of vanillin.

	1 tab.
Ftivazide	500 mg

Excipients : potato starch – 71 mg, calcium stearate – 4 mg.

10 pcs. – contour cell packs (5) – carton packs.
10 pcs. – contour cell packs (10) – carton packs.
30 pcs. – polymer jars with first opening control (1) – carton packs.

Ftivazide MS [Medisorb, JSC (Russia)]
Tablets 500 mg: 25, 30, 50 or 100 pcs.

Marketing Authorization Holder

Medisorb, JSC (Russia)

Dosage Form

Ftivazide MS

Tablets 500 mg: 25, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets	1 tab.
Ftivazide	500 mg

10 pcs. – blisters (10) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – blisters (3) – carton packs.
10 pcs. – strips (3) – carton packs.
10 pcs. – strips (5) – carton packs.
10 pcs. – strips (10) – carton packs.
25 pcs. – polymer jars (1) – carton packs.
50 pcs. – polymer jars (1) – carton packs.
100 pcs. – polymer jars (1) – carton packs.

Ftivazide MS [Medisorb, JSC (Russia)]
Tablets 300 mg: 50 or 100 pcs.