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

Description:Capsules number 0, body white, the lid is light yellow. The contents of the capsules are powder from almost white to white with a yellowish hue 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 is a bacteriostatic broad-spectrum antibiotic, active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and Staphylococcus aureus and Staphylococcus epidermidis. To terizidonu 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. Cross-resistance with other anti-tuberculosis drugs is not observed.

Pharmacokinetics:After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). 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. It is well distributed in tissues and body fluids (lungs, bile, ascites fluid, pleural effusion, synovial fluid, lymph, sputum). Penetrates into the cerebrospinal fluid - 80-100% of the concentration in the serum, a higher concentration is created by inflammatory changes in the meninges. In organism terizidone is metabolized slightly.From 60 to 70% of terizidone is excreted by the kidneys unchanged; a small amount is excreted through the intestine in unchanged form and in the form of metabolites.

Indications:

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

Contraindications:

- hypersensitivity to terizidon (including cycloserine), other components of the drug;

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

- 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.

Carefully:

Elderly age, chronic heart failure, chronic hepatic insufficiency, chronic renal failure.

Pregnancy and lactation:

Contraindicated in pregnancy.

If you need to use the drug during lactation at the time of treatment should stop breastfeeding.

Dosing and Administration:

Inside, daily, 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.

The duration of the course of treatment is 3-4 months or as prescribed by a doctor.

Side effects:

From the central and peripheral nervous system, headache, dizziness, increased excitability, tremor, insomnia, a feeling of intoxication; epileptomorphic convulsions, depression, psychosis.

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

Other: allergic reactions.

Overdose:

Symptoms: increased neurotoxicity (including convulsions), a violation of the function of the gastrointestinal tract.

Treatment: symptomatic, Activated carbon, antiepileptic drugs, the introduction of anticonvulsant and sedative drugs. 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, and negative effects from the nervous system.

With simultaneous use with protionamide, the risk of neurotoxicity increases. With simultaneous application with indirect anticoagulants, the effect of these drugs is enhanced.

With simultaneous use with phenytoin, an increase in the concentration of phenytoin in the blood plasma (risk of toxicity) is possible.

With the simultaneous use of suxamethonium chloride, its miorelaxing effect may be enhanced.

Special instructions:

Terizidone can cause a deficiency of cyanocobalamin and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment of the patient.

It is necessary to monitor monthly the analysis of blood, urine, indicators of liver function: concentration of alanine aminotransferase, aspartate aminotransferase, 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 seizures, so during the treatment the patient should avoid drinking alcohol.

During the treatment period, it is necessary to monitor the patient's mental status. Medical staff in the hospital, as well as family members of patients receiving Resonizate® outpatient, should be informed of the possibility of developing side effects from the central nervous system and are instructed to immediately inform the attending physician if symptoms of depression or changes in the behavior of the patient appear.

Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is necessary to refrain from driving vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 150 mg.

Packaging:10 capsules per contour cell packaging made of polyvinylchloride or polyvinyl chloride / polyvinylidene chloride film and aluminum foil printed lacquer.For 10 contour packagings together with the instruction for use are placed in a pack of cardboard for consumer containers.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002207

Date of registration:28.08.2013

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: & nbsp22.09.2015

Illustrated instructions

Instructions

Resonisate® (Rezonisate®)