Composition, form of production and packaging
Capsules hard gelatinous, the size в„–00, with the case and a cover of yellow color; the contents of the capsules are white or white with a yellowish tinge powder.
1 caps.
terizidone 300 mg
pyridoxine hydrochloride 10 mg
[PRING] Ludypress LCE (lactose monohydrate, povidone (kollidone 30)), talc, magnesium stearate.
The composition of hard gelatin capsules: titanium dioxide (E171), 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 2013.
PHARMACHOLOGIC EFFECT
Terizidone
Terizidone is a bacteriostatic antibiotic with a wide spectrum of action. Terisidone is active against Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, as well as Staphylococcus aureus and Staphylococcus epidermidis. To this preparation are also sensitive Enterococcus faecalis, Escherichia coli, Citrobacter, Enterobacter, Morgahella 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.
Pyridoxine hydrochloride
Vitamin product. Participates in the metabolism. It is necessary for the normal functioning of the central and peripheral nervous systems. Has a neuroprotective effect.
PHARMACOKINETICS
Terizidone
After oral administration, 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. T 1/2 - 21 hours.
It spreads in tissues and body fluids, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, lymph and sputum.
It penetrates well into the cerebrospinal fluid (80-100%) of the concentration in the serum, a higher concentration in the CSF is created by inflammatory changes in the meninges.
In the body, terizidone is metabolized insignificantly. 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.
Pyridoxine hydrochloride
After taking the drug quickly absorbed throughout the small intestine, a greater amount is absorbed in the jejunum. Metabolized in the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). Pyridoxal phosphate with plasma proteins binds to 90%.
It penetrates well into all tissues; accumulates mainly in the liver, less in the muscles and the central nervous system. Penetrates through the placenta, with breast milk.T 1/2 - 15-20 days.
It is excreted by the kidneys (with iv in the introduction - with bile 2%), as well as during hemodialysis.
INDICATIONS
Tuberculosis (various forms and localizations) in the complex treatment of drug-resistant forms of tuberculosis.
DOSING MODE
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 (1 capsule 2 times / day);
- with a body weight of 60-80 kg - a daily dose of 900 mg (1 capsule 3 times / day).
For adults with a body weight of more than 80 kg - a daily dose of 1200 mg (2 capsules 2 times / 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 EFFECT
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 - pain in the abdomen, flatulence, diarrhea. Allergic reactions (rarely).
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.
With caution: the elderly; chronic heart failure; chronic renal failure.
PREGNANCY AND LACTATION
Contraindicated in pregnancy, during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in chronic kidney failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 14 years.
SPECIAL INSTRUCTIONS
Terizidone can cause the development of deficiency of vitamin B12 and / or folic acid. In these cases, the dose of vitamin B12 and / or folic acid should be increased.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 monitoring patients in the hospital, as well as members of the family of outpatients taking terizidone, should be informed of the possibility of developing side effects from the central nervous system and are instructed to immediately inform the attending physician when depression or changes in the behavior of the patient.
Effect of the drug on the ability to drive a vehicle or work on any machines
During the treatment period it is necessary to 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, including epileptomorphic 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
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.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, protected from light, at a temperature of no higher than 25 В° C.
Shelf life - 3 years. Do not use after the expiration date.
