Resonizate - instructions for use, doses, side effects, contraindications

Composition:active substances: terizidone - 300 mg; auxiliary substances: ludypress LCE (lactose monohydrate 94,7% - 98,3%, povidone (cilidone 30) 3% - 4%) - 80 mg, talc - 12 mg, magnesium stearate - 8 mg; capsules hard gelatinous: titanium dioxide E 171 -1.33333%, iron coloring oxide yellow E 172 - 0.1%, gelatin - up to 100%.

Description:

Gelatin capsules № 00, cornThe pus and the lid are light yellow in color.

Contents of capsules - powder from baalogo to white with a yellowish tint of color. Conglomerates are allowed, which when pressed easily turn into powder.

Pharmacotherapeutic group:anti-tuberculosis drug.

ATX: & nbsp

J.04.A.K Other antituberculous drugs

Pharmacodynamics:

Terizidone.

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, Enterobacter, 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 level of the minimum effective concentration for mycobacteria tuberculosis is 10-40 mg / l, for staphylococci 8-32 mg / l, for gram-negative bacteria having a clinical value of 20-250 mg / l. The half-life (T1 / 2) is 21 hours.

Widespread in tissues and body fluids, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, lymph and 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. From 60 to 70% of 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 cerebrosclerosis;

- epilepsy;

-psychic disorders;

- alcoholism;

- pregnancy;

- lactation period;

- children's age till 14 years.

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 (1 capsule 2 times a day);

with a body weight of 60 - 80 kg - a daily dose of 900 mg (1 capsule 3 times a day).

For adults with a body weight of more than 80 kg - a daily dose of 1200 mg (2 capsules 2 times a day).The duration of the course of treatment is from 3 to 4 months.

When creatinine clearance is less than 30 ml / min dose and the frequency of drug intake is recommended to decrease.

Side effects:

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

From the digestive system: rarely - abdominal pain, flatulence, diarrhea. Allergic reactions (rarely).

Overdose:

Symptoms: increased neurotoxicity, including epileptomorphic seizures, a violation of the function of the gastrointestinal tract.

Treatment: symptomatic, Activated carbon, antiepileptic drugs. For the prevention of neurotoxic effects, anticonvulsant and sedative drugs are administered. Hemodialysis is effective.

Interaction:

Ethanol increases the risk of epileptic 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 deficiency of vitamin B12 and / or folic acid.

In these cases it is necessary to conduct an appropriate examination and treatment of the patient. Monthly monitoring of blood and urine tests, liver function parameters: ALT (alanine aminotransferase), ACT (aspartate aminotransferase), bilirubin concentration. 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 who monitor patients in the hospital, as well as members of the family of outpatients who receive terizidone, should be informed of the potential for adverse reactions with side of the central nervous system and instructed about the need to immediately inform the attending physician when 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,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 300 mg.

Packaging:

10 capsules per circuit cell packaging made of polyvinylchloride or polyvinylchloride / polyvinylidene chloride film and aluminum foil printed lacquer.

For 10 contour packagings together with the instructions for use are placed in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:4 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-010231/08

Date of registration:19.12.2008

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Representation: & nbspVALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Information update date: & nbsp23.09.2015

Illustrated instructions

Instructions

Resonisate® (Rezonisate®)