Terizidone - instructions for use, dose, side effects, contraindications

The composition of gelatinous hard brown capsules No. 1- for a dosage of 150 mg: gelatin- 83,0958%, titanium dioxide - 1,75 % , water - 14.5%, sodium lauryl sulfate - 0,15 %, bronopol - 0.1%, povidone - 0,1 %, methyl parahydroxybenzoate 0.075%, propyl parahydroxybenzoate 0.025%, iron oxide red (III) 0.2000%, iron oxide yellow (III) 0.0042%.

The composition of capsules of gelatinous solid, the case of yellow color, the cover of blue color No. 0 - for the dosage of 300 mg: gelatin -83.2267%, titanium dioxide - 1.667%, water - 14.5%, sodium lauryl sulfate - 0.15%bronopol - 0.1% povidone - 0.1% methyl parahydroxybenzoate - 0.075%, propyl parahydroxybenzoate - 0.025% dye quinoline yellow -0.1563% colorant Brilliant Blue - 0.1563%.

Description:

For dosage of 150 mg: Brown gelatin capsules № "1";

For dosage of 300 mg: Gelatin Capsules № 0. housing yellow capsule cap blue capsules.

The contents of the capsules are white or white with a yellowish tinge powder.

Pharmacotherapeutic group:anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K Other antituberculous drugs

Pharmacodynamics:Terizidone is a bacteriostatic antibiotic with a wide spectrum of action. Terizidone active with respect to Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and Staphylococcus aureus and Staphylococcus epidermidis. To this preparation are also sensitive Enterococcus faecalis, Escherichia coli, Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa. Cases of development of secondary resistance are rare. There is no cross-resistance between terizidone and other anti-tuberculosis drugs.

Pharmacokinetics:

After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). The maximum concentration in plasma is achieved in 2-3 hours. Food intake does not affect the rate of absorption.The effective minimum concentration for Mycobacterium tuberculosis - 10-40 mg / l, for Staphylococcus spp. - 8-32 mg / l, for gram-negative bacteria of clinical significance, 20-250 mg / l. The half-life (T1 / 2) is 21 hours. Widely distributed in tissues and body fluids, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, lymph and in sputum. Very well penetrates into the cerebrospinal fluid (80-100% of the concentration in the serum), a higher concentration in the cerebrospinal fluid is created by inflammatory changes in the meninges.

In organism terizidone is metabolized slightly. 60 to 70 % the drug is excreted by the kidneys unchanged; a small amount is excreted through the intestine and a small part in the form of metabolites.

Indications:Tuberculosis (various forms and localizations) in the complex treatment of drug-resistant forms of tuberculosis.

Contraindications:

- hypersensitivity, including cycloserine;

-organic diseases of the central nervous system, including

- Atherosclerosis of cerebral vessels;

- epilepsy;

- mental disorders;

- alcoholism;

- pregnancy;

- lactation period;

- children's age till 14 years;

- lactose intolerance, lactase deficiency and glucosogalactose malabsorption syndrome.

Carefully:

- elderly age;

- chronic heart failure;

- chronic renal failure.

Dosing and Administration:

Inside, every day, regardless of food intake

For adults and children (over 14 years): with a body weight of up to 60 kg - a daily dose of 600 mg divided into two doses;

with a body weight of 60 to 80 kg - a daily dose of 900 mg in three divided doses. For adults with a body weight of more than 80 kg - a daily dose of 1200 mg in two divided doses. The duration of the course of treatment is from 3 to 4 months.

When creatinine clearance is less than 30 ml / min, it is recommended to reduce the frequency of administration of the drug and reduce the single dose of the drug to 150 mg.

Patients older than 60 years and body weight less than 50 kg in the presence of renal failure drug prescribed 150 mg 2 times a day.

Side effects:

From the nervous system: headache, dizziness, increased excitability, tremor, insomnia and a sense of intoxication. In single cases - convulsions, depression, psychosis.

Co hand digestive system: abdominal pain, flatulence, diarrhea.

Other. Allergic reactions.

Overdose:

Symptoms: increased neurotoxicity, including convulsions, dysfunction of the gastrointestinal tract.

Treatment: symptomatic, Activated carbonanticonvulsant and sedative drugs are used to prevent and treat neurotoxic effects. Hemodialysis is effective.

Interaction:

Ethanol increases the risk of seizures.

Ethionamide increases the risk of side effects from the central nervous system, especially convulsive syndrome.

Isoniazid increases the incidence of dizziness, drowsiness.

Special instructions:

Terizidone can cause the development of insufficiency of cyanocobalamin and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment of the patient. It is recommended to monitor the blood and urine tests monthly, liver function indicators: activity alanine aminotransferase and aspartate aminotransferase, concentration bilirubin. The use of the drug against the background of alcohol intake is associated with an increased incidence of side effects, up to the development of convulsions, so during the intake of the drug should avoid the use of alcoholic beverages.

It is necessary to monitor the patient's condition: health workers monitoring patients in the hospital, as well as members of the family of outpatients who receive terizidone, should be informed about the possibility of developing side reactions from the central nervous system and instructed about the need to immediately inform the attending physician if depression or changes in the behavior of the patient occur.

Effect on the ability to drive transp. cf. and fur:

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 150 mg and 300 mg.

Packaging:

10 capsules in a blister of a polyvinylchloride film and aluminum foil foil.

For 1 or 3 blisters in a cardboard box with instructions for use.

At packing and packing at the enterprise of Open Society "Farmasintez" (Russia):

10 capsules in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2 or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

For 30 or 100 capsules are placed in a bag of low density polyethylene. One package together with the instruction for use is placed in a polymer can with a lid of polypropylene or high-pressure polyethylene with a control of the first opening or a can of polyethylene terephthalate for medicines with a screw cap or with the control of the first opening.

Storage conditions:

In dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-005097/10

Date of registration:01.06.2010

The owner of the registration certificate:ArSiAi Synthesis, ZAOArSiAi Synthesis, ZAO

Manufacturer: & nbsp

LOK-BETA PHARMACEUTICALS (I), Pvt. Ltd. India

Representation: & nbspPharmasynthesis, JSCPharmasynthesis, JSC

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Terizidone (Terizidon)