Composition, form of production and packaging
Capsules hard gelatinous, в„–00, the case and a cover of red color.
1 caps.
terizidone 250 mg
pyridoxine hydrochloride 10 mg
[PRING] microcrystalline cellulose 26 mg, hypromellose 6 mg, talc 5 mg, disodium edetate 4 mg, magnesium stearate 3 mg, ethyl cellulose 1 mg.
The composition of the capsule: methylparahydroxybenzoate 0.5%, propyl parahydroxybenzoate 0.125%, sodium lauryl sulfate 0.155%, titanium dioxide 1.55%, iron dye red oxide 1.55%, gelatin up to 100%.
10 pieces. - strips of aluminum foil (1) - packs of cardboard.
10 pieces. - Strips of aluminum foil (3) - packs of cardboard.
10 pieces. - strips of aluminum foil (10) - packs of cardboard.
4 things. - strips of aluminum foil (1) - packs of cardboard.
4 things. - strips of aluminum foil (1) - polyethylene bags (10) - packs of cardboard.
100 pieces. - polyethylene bags (1) - plastic cans (for hospitals).
500 pcs. - polyethylene bags (1) - plastic cans (for hospitals).
1000 pcs. - polyethylene bags (1) - plastic cans (for hospitals).
Capsules hard gelatinous, в„–00, the case and a cover of yellow color.
1 caps.
terizidone 300 mg
pyridoxine hydrochloride 10 mg
[PRING] microcrystalline cellulose 31 mg, hypromellose 5 mg, talc 5 mg, disodium edetate 4 mg, magnesium stearate 4 mg, ethyl cellulose 1 mg.
The composition of the capsule: methylparahydroxybenzoate 0.5%, propyl parahydroxybenzoate 0.125%, sodium lauryl sulfate 0.155%, titanium dioxide 1.55%, iron dye oxide yellow 1.55%, dye quinoline yellow 0.255%, gelatin up to 100%.
10 pieces. - strips of aluminum foil (1) - packs of cardboard.
10 pieces. - Strips of aluminum foil (3) - packs of cardboard.
10 pieces. - strips of aluminum foil (10) - packs of cardboard.
4 things. - strips of aluminum foil (1) - packs of cardboard.
4 things. - strips of aluminum foil (1) - polyethylene bags (10) - packs of cardboard.
100 pieces. - polyethylene bags (1) - plastic cans (for hospitals).
500 pcs. - polyethylene bags (1) - plastic cans (for hospitals).
1000 pcs. - polyethylene bags (1) - plastic cans (for hospitals).
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Antituberculous means, which is a combination of two medicines terizidona and pyridoxine.
Terizidone is a bacter terpastatic 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 spp., Enterobacter spp., Organella 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 entering the body is phosphorylated, converted to pyridoxal-5-phosphate and is part of enzymes that carry out decarboxylation, transamination and racemization of amino acids, as well as enzymatic conversion of sulfur-containing and hydroxylated amino acids. Participates in the exchange of tryptophan (participation in the reaction of biosynthesis of seotonin) and reduces the neurotoxicity of isonicotinic acid hydrazides.
PHARMACOKINETICS
Terizidone. After oral administration, the drug is almost completely absorbed from the gastrointestinal tract (70-90%). The maximum concentration in the plasma is achieved after 2-3 hours. The intake of food does not affect the rate of absorption. The effective minimum concentration for Mycobacterium tuberculosis is 10-40 mg / l, for Staphylococcus spp. - 8-32 mg / l, for gram-negative bacteria of clinical significance - 20-250 mg / l. T 1/2 - 21 hours. Widely distributed in tissues and body fluids, lungs, bile, ascitic fluid, pleural effusion and synovial fluid, 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 by inflammatory changes in the meninges.
In the body, terizidone is metabolized slightly. 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 is absorbed rapidly throughout the small intestine, more is absorbed in the jejunum. Metabolised and the liver with the formation of pharmacologically active metabolites (pyridoxal phosphate and pyridoxamine phosphate). Pyridoxal phosphate with plasma proteins binds to 90%. Well penetrates into all tissues: accumulates mainly in the liver, less - in the muscles and the central nervous system. Penetrates through the placenta, is secreted with breast milk. T 1/2 - 15-20 days. It is excreted by the kidneys.
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 adolescents older than 14 years: with a body weight of less than 50 kg prescribed for 1 capsule (with a dosage of 250 mg + 10 mg) 3 times a day.
If necessary, the frequency of intake is reduced, increasing the dose - 1 capsule (300 mg + 10 mg) 2 times a day.
For adults with a chalk mass of 60-80 kg, the daily dose is 900 mg, in terms of terizidone, in 2-3 doses. For adults with a body weight of more than 80 kg - a daily dose of 1200 mg, in terms of terizidone, in 2 divided doses. On the prescription of the doctor, a single dose of the drug for patients with a body weight of more than 50 kg can be reduced to 250 mg, in terms of terizidone, with a frequency of reception 4 times a day.
When QC is below 30 ml / min, it is recommended to reduce the frequency of administration of the drug and reduce the single dose to 250 mg in terms of terizidone.The duration of the course of treatment is from 3 to 4 months.
SIDE EFFECT
Terizidone
From the nervous system: headache, dizziness, increased excitability, tremor, insomnia and a feeling of intoxication, convulsions, depression, psychosis.
From the digestive system: abdominal pain, flatulence, diarrhea.
Other: allergic reactions.
Pyridoxine
Allergic reactions, hypersecretion of hydrochloric acid, numbness of the limbs, the appearance of a feeling of compression in the limbs - a symptom of "stocking" and "gloves", skin rash, itching of the skin.
CONTRAINDICATIONS
- increased sensitivity to terizondop (including cycloserine), other components of the drug;
- organic diseases of the central nervous system, including atherosclerosis of cerebral vessels;
- epilepsy;
- mental disorders:
- Alcoholism;
- Pregnancy;
- lactation period;
- Children's age till 14 years.
Carefully:
- elderly age;
- Chronic heart failure;
- chronic renal failure;
- Stomach ulcer and duodenal ulcer;
- cardiac ischemia.
PREGNANCY AND LACTATION
Pregnant women drug Terizidon + Pyridoxine is contraindicated.
Preparation Terizidon + Pyridoxine penetrates into difficult milk, if you need to use the drug at the time of treatment should stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution in chronic kidney failure.
APPLICATION FOR CHILDREN
Contraindicated for children under 14 years.
APPLICATION IN ELDERLY PATIENTS
With caution in old age.
SPECIAL INSTRUCTIONS
Terizidone can cause the development of insufficiency of cyanocobalamin and / or folic acid. In these cases it is necessary to conduct an appropriate examination and treatment of the patient. It is recommended to monitor blood and urine tests every month, liver function indicators: ALT and AST activity, 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.
During the treatment period, it is necessary to monitor the patient's mental status. Medical personnel in the hospital, as well as family members of patients receiving the drug Terizidone + Pyridoxine, should be informed about the possibility of developing side effects from the central nervous system and instructed about the need to immediately inform the attending physician if symptoms of depression or changes in the behavior of the patient appear.
With severe liver damage, pyridoxine in high doses can cause deterioration of its function.
In the determination of urobilinogen with Ehrlich's reagent, pyridecene may distort results.
Impact on ability to drive and engage in other potentially hazardous activities
Given the profile of side effects (dizziness, feelings of intoxication and others), it is recommended during treatment to refrain from driving, from engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: increased neurotoxicity, including convulsions, dysfunction of the gastrointestinal tract.
Treatment: symptomatic, activated charcoal, anticonvulsant and sedative drugs are used to prevent and treat neurotoxic effects. Hemodialysis is effective.
DRUG INTERACTION
Terizidone
Ethanol increases the risk of seizures.
Ethionamide increases the risk of side effects from the neutral perineal system, especially convulsive syndrome. Isoniazid increases the incidence of dizziness, snotty.
Pyridoxine
Strengthens the action of diuretics; weakens the activity of levodopa. Isoniazid, penicillamine, cycloserine and estrogen-containing oral contraceptives weaken the effect of pyridoxine. It is combined with cardiac glycosides (pyridoxine contributes to the synthesis of contractile proteins in the myocardium), with glutamic acid and potassium and magnesium asparaginate.
Do not use together with tspkloserinom, since terizidone is its derivative.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 2 years.
