Composition, form of production and packaging
Capsules hard gelatinous, the size в„–00, with the case and a cover of light yellow color; the contents of the capsules are white or white with a yellowish tinge powder.
1 caps.
terizidone 300 mg
[PRING] Ludypress LCE (lactose monohydrate, povidone (kollidone 30)), talc, magnesium stearate.
The composition of hard gelatin capsules: titanium dioxide (E172), iron oxide, yellow oxide (E172), gelatin.
10 pieces. - packings cellular planimetric (10) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
Antituberculous antibiotic of a wide spectrum of action. It acts bacteriostatically.
It is active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, as well as Staphylococcus aureus and Staphylococcus epidermidis, aswell as with Enterococcus faecalis, Escherichia col, Citrobacter spp., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae, Pseudomonas aeruginosa.
Cases of development of secondary resistance are rare. There is no cross-resistance between terizidone and other anti-tuberculosis drugs.
PHARMACOKINETICS
Suction
After ingestion, the drug is almost completely absorbed from the digestive tract (70-90%). C max in plasma is achieved after 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.
Distribution
It is widely distributed in tissues and fluids of the body, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, in 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 with inflammatory changes in the meninges.
Metabolism and excretion
In the body, terizidone is metabolized insignificantly. 60-70% is excreted by the kidneys unchanged; a small amount is excreted through the intestine and a small part in the form of metabolites.
T 1/2 is 21 hours.
INDICATIONS
- tuberculosis (various forms and localizations) in the complex treatment of drug-resistant forms of tuberculosis.
DOSING MODE
The drug is taken orally, daily, regardless of food intake.
For adults and children older than 14 years with a body weight of up to 60 kg, the dose is 600 mg / day - 300 mg (1 caps.) 2 times / day; with a body weight of 60-80 kg - 900 mg / day - 300 mg (1 caps.) 3 times / day.
For adults weighing more than 80 kg, the dose is 1.2 g / day - 600 mg (2 caps.) 2 times / day.
The duration of the course of treatment is from 3 to 4 months.
With QC less than 30 ml / min dose and multiplicity of drug intake is recommended to reduce.
SIDE EFFECT
From the side of the central nervous system: headache, dizziness, increased excitability, tremor, insomnia and a sense of intoxication; in isolated cases - epileptiform cramps, depression, psychosis.
From the digestive system: rarely - pain in the abdomen, flatulence, diarrhea.
Other: rarely allergic reactions.
CONTRAINDICATIONS
- organic diseases of the central nervous system, incl. cerebrosclerosis;
- epilepsy;
- mental disorders;
- Alcoholism;
- Pregnancy;
- lactation period;
- children's age till 14 years;
- hypersensitivity to the components of the drug;
- Hypersensitivity to cycloserine.
With caution should be used in patients with chronic heart failure, chronic renal failure, in elderly patients.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy and lactation (breastfeeding).
APPLICATION FOR FUNCTIONS OF THE LIVER
Caution should be used in patients with chronic renal failure.
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 14 years.
APPLICATION IN ELDERLY PATIENTS
With caution should be used in elderly patients.
SPECIAL INSTRUCTIONS
Terizidone can cause the development of deficiency of vitamin B 12 and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment.
It is necessary to conduct monthly blood and urine tests, monitor liver function parameters: ALT, ACT, 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 it is necessary to monitor the patient's condition. Medical personnel in the hospital, as well as family members of patients receiving Resonizate on an outpatient basis, should be informed of the possibility of developing side effects from the CNS and are instructed to immediately inform the attending physician if symptoms of depression or changes in the behavior of the patient appear.
Impact on the ability to drive vehicles and manage mechanisms
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.
OVERDOSE
Symptoms: increased neurotoxicity, incl. epileptiform seizures, a violation of the function of the gastrointestinal tract.
Treatment: symptomatic, activated charcoal, antiepileptic medicines. For the prevention of neurotoxic effects, anticonvulsant and sedative drugs are administered.Hemodialysis is effective.
DRUG INTERACTION
With the simultaneous use of the drug with ethanol, the risk of epileptic seizures increases.
Ethionamide increases the risk of side effects of resonizate from the side of the central nervous system, especially convulsive syndrome.
When used simultaneously with isoniazid, the incidence of dizziness and drowsiness increases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 3 years.
