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Tizidone (Capsules) Instructions for Use

ATC Code

J04AK03 (Terizidone)

Active Substance

Terizidone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antituberculosis drug

Pharmacotherapeutic Group

Antitubercular agent

Pharmacological Action

Antituberculosis antibiotic. It has a broad spectrum of antimicrobial activity. It acts bacteriostatically.

Active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, as well as Staphylococcus aureus and Staphylococcus epidermidis. Enterococcus faecalis, Escherichia coli, Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa are also sensitive.

The development of secondary resistance is rare. No cross-resistance with other antituberculosis drugs is observed.

Pharmacokinetics

Absorption from the gastrointestinal tract is 70-90% (food intake does not affect the rate of absorption). Time to reach Cmax is 2-3 hours. Effective Cmin: for Mycobacterium tuberculosis – 10-40 mg/L, for staphylococci – 8-32 mg/L, for gram-negative bacteria (of clinical significance) – 20-250 mg/L.

It is well distributed in body tissues and fluids (lungs, bile, ascitic fluid, pleural effusion, synovial fluid, lymph, sputum).

It penetrates into the cerebrospinal fluid (80-100% of the serum concentration), a higher concentration in the cerebrospinal fluid is achieved with inflammatory changes in the meninges.

It is minimally metabolized.

T1/2 is 21 hours. It is excreted by the kidneys (unchanged – 60-70%), by the intestines (a small amount unchanged and as metabolites).

Indications

Tuberculosis of various forms and localizations as part of complex therapy for resistant forms of the disease.

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.

Capsules

Orally, regardless of food intake: for adults and children over 14 years of age weighing less than 60 kg – 300 mg 2 times/day (600 mg/day); weighing 60-80 kg – 300 mg 3 times/day (900 mg/day). For adults weighing more than 80 kg – 600 mg 2 times/day (1200 mg/day). It is taken for 3-4 months.

If creatinine clearance is less than 30 ml/min, the dose and frequency of administration are reduced.

Adverse Reactions

From the nervous system: headache, dizziness, increased excitability, tremor, insomnia, feeling of intoxication; in isolated cases – epileptiform convulsions, depression, psychosis.

From the digestive system: rarely – abdominal pain, flatulence, diarrhea.

Other: allergic reactions.

Contraindications

Organic diseases of the central nervous system (including cerebrovascular sclerosis), epilepsy, mental disorders, alcoholism, pregnancy, lactation period, children under 14 years of age, hypersensitivity to terizidone.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Use in Renal Impairment

Use with caution in chronic renal failure.

Pediatric Use

Contraindicated in children under 14 years of age.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in patients with chronic heart failure, in chronic renal failure, and in elderly patients.

Terizidone may cause cyanocobalamin and/or folic acid deficiency; appropriate examination and treatment are necessary.

Blood and urine parameters, liver function (ALT, AST, bilirubin) should be monitored monthly.

Patients should avoid consuming ethanol, as simultaneous use with terizidone increases the frequency of side effects (up to the development of convulsions).

Due to the possibility of developing side reactions from the nervous system (depression, behavior changes), it is necessary to monitor the patient’s mental status.

Effect on ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Ethanol increases the risk of epileptic seizures.

When used concomitantly with ethionamide, the risk of side effects from the central nervous system (especially convulsions) increases.

Concomitant use with isoniazid increases the frequency of dizziness and drowsiness.

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

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Tizidone Capsules 150 mg: 10, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No.0, body and cap green; capsule contents – a mixture of granules and powder from white to white with a yellowish tint.

1 caps.
Terizidone 150 mg

Excipients: Ludipress LCE 190 mg, talc 5 mg, magnesium stearate 10 mg, povidone 10 mg.

Capsule shell composition: titanium dioxide 1.152 mg, gelatin 94.625 mg, brilliant blue E133 0.05 mg, quinoline yellow E104 0.173 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Tizidone Capsules 250 mg: 10, 30, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No.0, body pink with a yellowish-orange tint, cap dark red; capsule contents – a mixture of granules and powder from white to white with a yellowish tint.

1 caps.
Terizidone 250 mg

Excipients: Ludipress LCE 90 mg, talc 5 mg, magnesium stearate 10 mg, povidone 10 mg.

Capsule shell composition: titanium dioxide 3.78 mg, gelatin 90.8585 mg, brilliant blue E133 0.0045 mg, carmoisine E122 0.699 mg, sunset yellow FCF E110 0.238 mg, ponceau 4R E124 0.42 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Marketing Authorization Holder

Simpex Pharma, Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Tizidone Capsules 300 mg: 10, 30, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No.00, body and cap blue; capsule contents – a mixture of granules and powder from white to white with a yellowish tint.

1 caps.
Terizidone 300 mg

Excipients: Ludipress LCE 360 mg, talc 10 mg, magnesium stearate 15 mg, povidone 20 mg.

Capsule shell composition: titanium dioxide 2.18 mg, gelatin 112.602 mg, brilliant blue E133 0.218 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

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