Terizidon
Producer: JSC Pharmasintez Russia
Code of automatic telephone exchange: J04AK03
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: 150 mg or 300 mg of a terizidon.
Excipients: lactoses the monohydrate, talc purified.
Structure of the capsule: gelatin, titanium dioxide, water, sodium lauryl sulfate, бронопол, povidone, methylparahydroxybenzoate, пропилпарагидроксибензоат, dye quinolinic yellow.
Antitubercular antibiotic. Possesses a wide range of antimicrobic action. Works bacteriostatically.
Pharmacological properties:
Pharmacodynamics. Terizidon is a bacteriostatic antibiotic with a broad spectrum of activity. Terizidon is active concerning Mycobacterium tuberculosis, Mycobacterium bovis, Mycobacterium avium, and also Staphylococcus aureus and Staphylococcus epidermidis. Also Enterococcus faecalis, Escherichia coli, Citrobacter spp are sensitive to this drug., Enterobacter spp., Morganella morganii, Klebsiella pneumoniae and Pseudomonas aeruginosa. Cases of development of secondary resistance are noted seldom. Between terizidony and other antitubercular drugs cross stability is not observed.
Pharmacokinetics. After oral administration drug is almost completely soaked up from digestive tract (70-90%). The maximum concentration in plasma is reached in 2-3 hours. Meal does not influence absorption speed. Effective minimum concentration for Mycobacterium tuberculosis – 10-40 mg/l, for Staphylococcus spp. - 8-32 mg/l, for the gram-negative bacteria having clinical value - 20-250 mg/l. An elimination half-life (T1/2) - 21 hour. It is widely distributed in fabrics and liquids of an organism, lungs, bile, ascitic liquid, a pleural exudate and synovial fluid, a lymph and in a phlegm. Very well gets into cerebrospinal liquid (80-100% of concentration in serum), higher concentration in liquor is created at inflammatory changes of a meninx. In an organism теризидон it is metabolized slightly. From 60 to 70% of drug are removed by kidneys in not changed look; a small amount is removed through intestines and a small part in the form of metabolites.
Indications to use:
Tuberculosis (various forms and localizations) in complex therapy of drug resistant forms of tuberculosis. Contraindications: hypersensitivity, including to Cycloserinum; organic diseases of the central nervous system, including atherosclerosis of vessels of a brain; epilepsy; mental disturbances; alcoholism; pregnancy; lactation period; children's age up to 14 years; lactose intolerance, deficit of lactase and syndrome of glyukozogalaktozny malabsorption. With care: advanced age; chronic heart failure; chronic renal failure.
Route of administration and doses:
Inside, daily, irrespective of meal. For adults and children (14 years are more senior): with body weight to 60 kg – on 300 mg 2 times a day (600 mg/days); with the body weight of 60 - 80 kg – on 300 mg 3 times a day (900 mg/days). For adults with body weight more than 80 kg – 600 mg 2 times a day (1200 mg/days). Duration of a course of treatment makes from 3 to 4 months. At clearance of creatinine frequency rate of administration of drug is recommended to reduce lower than 30 ml/min. and to lower a drug dose.
Features of use:
Terizidon can cause development of insufficiency of cyanocobalamine and/or folic acid. In these cases it is necessary to conduct the corresponding examination and treatment of the patient.
It is recommended to control monthly blood test and urine, indicators of function of a liver: activity of alaninaminotranspherase and aspartate aminotransferase, concentration of bilirubin.
Use of drug against the background of alcohol intake is accompanied by the increased frequency of side effects, up to development of spasms therefore during administration of drug it is necessary to avoid the use of alcoholic beverages.
It is necessary to watch a condition of the patient: the workers of health care watching patients in a hospital as well as members of the family of the ambulatory patients accepting теризидон have to be informed on a possibility of development of side reactions from the central nervous system also are instructed about need to immediately inform the attending physician at emergence of a depression or changes in behavior of the patient.
Influence of drug on ability to manage the vehicle or to work at any cars. During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Side effects:
From a nervous system: headache, dizziness, hyperexcitability, tremor, sleeplessness and feeling of intoxication.
In isolated cases - spasms, a depression, psychosis.
From the alimentary system: abdominal pain, meteorism, diarrhea.
Others. Allergic reactions.
Interaction with other medicines:
Ethanol increases risk of development of spasms. At simultaneous use with Etioniamidum the risk of emergence of side effects from the central nervous system increases, especially convulsive syndrome. Simultaneous use with an isoniazid increases the frequency of developing of dizziness, drowsiness.
Contraindications:
Organic diseases of TsNS (including церебросклероз), epilepsy, mental disturbances, alcoholism, pregnancy, the lactation period, children's age up to 14 years, hypersensitivity to a terizidon.
Overdose:
Symptoms: strengthening of a neurotoxicity, including spasm, dysfunction of digestive tract. Treatment: symptomatic, absorbent carbon, anticonvulsant and sedative medicines. The hemodialysis is effective.
Storage conditions:
In the dry, protected from light place, at a temperature not over 25 ˚С.
Issue conditions:
According to the recipe
Packaging:
Capsules of 150 mg or 300 mg, on 100 capsules in a polymeric can.