REZONIZAT
Active material: Terizidon
When ATH: J04AK03
CCF: TB drugs
ICD-10 codes (testimony): A15, A18
When CSF: 06.22.04
Manufacturer: OAO Valenta PHARMACEUTICS (Russia)
PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING
Capsules hard gelatin, size №00, and the housing lid pale yellow; contents of capsules – white or white with a yellowish tinge powder.
| 1 caps. | |
| terizidon | 300 mg |
Excipients: ludipress LTSE (lactose monohydrate, povidone (Kollidon 30)), talc, magnesium stearate.
The composition of hard gelatin capsules: Titanium dioxide (E172), dye iron oxide yellow (E172), gelatin.
10 PC. – packings Valium planimetric (10) – packs cardboard.
Pharmacological action
TB broad-spectrum antibiotic. Bacteriostatic.
It is active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, а также Staphylococcus aureus и Staphylococcus epidermidis, and also against Enterococcus faecalis, Escherichia col , Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae, Pseudomonas aeruginosa.
The cases of secondary resistance are rare. Between terizidone and other anti-TB drugs is not observed cross-resistance.
Pharmacokinetics
Absorption
After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). Cmax plasma achieved through 2-3 no. Eating does not affect the rate of absorption. The level of the minimum effective concentration for Mycobacterium tuberculosis is 10-40 mg / l, for staphylococci – 8-32 mg / l, for Gram-negative bacteria, have clinical significance – 20-250 mg / l.
Distribution
Widely distributed in tissues and body fluids, light, bile, ascites, pleural fluid and synovial fluid, lymph and sputum. Very good penetration into the cerebrospinal fluid (80-100%) concentration in serum, a higher concentration in the cerebrospinal fluid is created in the inflammatory changes of the meninges.
Metabolism and excretion
In the body it is metabolized slightly terizidone. 60-70% excreted by the kidneys in unchanged form; a small amount is output through the intestine and a small portion of metabolites.
T1/2 is 21 no.
Testimony
- Tuberculosis (Various shapes and localization) in the treatment of drug-resistant tuberculosis.
Dosage regimen
The drug is taken orally, daily, regardless of the meal.
To adults and children over 14 years old with a body weight up to 60 kg dose of 600 mg / day – by 300 mg (1 caps.) 2 times / day; body weight 60-80 kg – 900 mg / day – by 300 mg (1 caps.) 3 times / day.
To Adults weighing more than 80 kg dose of 1.2 g / day – by 600 mg (2 caps.) 2 times / day.
The duration of treatment ranged from 3 to 4 months.
At CC less than 30 ml / min the dose and frequency of dosing is recommended to reduce.
Side effect
CNS: headache, dizziness, hypererethism, tremor, insomnia and feeling of intoxication; in a few cases – epileptiform convulsions, depression, psychosis.
From the digestive system: rarely – abdominal pain, flatulence, diarrhea.
Other: rarely – allergic reactions.
Contraindications
- Organic diseases of the central nervous system, incl. I degree;
- Epilepsy;
- Mental disorders;
- Alcoholism;
- Pregnancy;
- Lactation;
- Children up to age 14 years;
- Hypersensitivity to the drug;
- Hypersensitivity to cycloserine.
FROM caution the drug should be used in patients with chronic heart failure, chronic renal failure, in elderly patients.
Pregnancy and lactation
The drug is contraindicated during pregnancy and lactation (breast-feeding).
Cautions
Terizidone can cause the development of vitamin B12 and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment.
It should hold monthly blood and urine tests, monitor liver function tests: GOLD, ACT, bilirubin.
Use of the drug on a background of alcohol intake is associated with an increased rate of side effects, until the development of seizures, so the period of treatment, the patient should avoid alcohol.
In the period of treatment is necessary to monitor the patient's condition. Medical personnel in hospital, as well as the family members of patients, receiving outpatient Rezonizat, should be informed of the possibility of adverse reactions from the central nervous system and instructed to immediately inform the treating physician if symptoms of depression or changes in the behavior of the patient.
Effects on ability to drive vehicles and management mechanisms
During treatment, the patient should refrain from driving vehicles and Occupation potentially hazardous activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: increased neurotoxicity, incl. epileptiform seizures, dysfunction of the gastrointestinal tract.
Treatment: symptomatic, Activated carbon, antiepileptic drugs. For the prevention of the neurotoxic effects of administered anticonvulsants and sedative drugs. Hemodialysis is effective.
Drug Interactions
In an application of the drug to ethanol increases the risk of seizures.
Ethionamide increases the risk of side effects from the CNS Rezonizata, especially seizures.
In an application with isoniazid increases the incidence of dizziness, drowsiness.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, dry, dark place at a temperature no higher than 25 ° C. Shelf life – 3 year.
