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

Gelatin capsules № 00 of white color. The contents of the capsules are white to white powder 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:

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 terizidone 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 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, with inflammatory changes in the meninges., In the body terizidone is metabolized slightly. The half-life (T1 / 2) is 21 hours. From 60 to 70% of the drug 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, including cycloserine;

- organic diseases of the central nervous system, including cerebrosclerosis;

- epilepsy;

- mental disorders;

- alcoholism;

- pregnancy;

- lactation period;

- children's age till 14 years.

Carefully:Renal failure.

Pregnancy and lactation:

Contraindicated in pregnancy.

Penetrates into breast milk, if necessary, use the drug at the time of treatment should stop breastfeeding.

Dosing and Administration:

Inside, regardless of food intake.

The daily dose for adults and adolescents over 14 years is 750-1000 mg. (250 mg 3-4 times a day, every 6-8 hours or as directed by a doctor). The highest single dose of terizidone is 250 mg; the maximum daily dose is 1000 mg.Patients weighing up to 50 kg are recommended to use 1 capsule (250 mg) 3 times a day, patients with a body weight of more than 50 kg - 1 capsule (250 mg) 4 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 sense of intoxication, epileptomorphic convulsions, depression, psychosis.

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

Other: allergic reactions.

If any of the side effects indicated in the manual are aggravated, or any other side effects not indicated in the instructions are noted, you should inform the doctor immediately.

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, side effects from the nervous system.

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.

It is necessary to monitor monthly the analysis of blood, urine, indicators of liver function: 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 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 instructed about the needImmediately 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, the patient should refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Capsules 250 mg.

Packaging:

For 10 capsules in a "contoured cell pack of a film of PVC or PVC / PVDC (polyvinyl chloride / polyvinylidene chloride) and aluminum foil printed lacquered.

10 contour mesh packages-together with the instruction 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:

Shelf life 3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:PL-000305

Date of registration:17.02.2011

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: & nbsp26.09.2015

Illustrated instructions

Instructions

Resonisate® (Rezonisate®)