Composition, form of production and packaging
Tablets, film-coated 1 tab.
thioureidoimiminomethylpyridinium perchlorate 200 mg
10 pieces. - packings cellular planimetric (5) - packs cardboard.
10 pieces. - packings cellular planimetric (10) - packs cardboard.
50 pcs. - polymer cans (1) - packs of cardboard.
100 pieces. - polymer cans (1) - packs of cardboard.
Tablets, film-coated 1 tab.
thioureido imiminomethylpyridinium perchlorate 400 mg
10 pieces. - packings cellular planimetric (5) - packs cardboard.
10 pieces. - packings cellular planimetric (10) - packs cardboard.
50 pcs. - polymer cans (1) - packs of cardboard.
100 pieces. - polymer cans (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Anti-tuberculosis drug. The mechanism of action is not established. It is active against Mycobacterium tuberculosis and Mycobacterium bovis. Has a pronounced inhibitory effect on the viability of mycobacteria tuberculosis, including those resistant to other antituberculous drugs.
Perchlorone is a low-toxic substance that does not cause significant structural and functional damage to vital organs and systems, as well as irritating effects on the mucous membranes of the gastrointestinal tract.
The mechanism of action is not definitively established, the study continues.
PHARMACOKINETICS
After ingestion Perchloronum is rapidly absorbed in the gastrointestinal grant. The time to reach the maximum concentration in the blood (TC max ) is 1.5-3 hours.After a single oral intake at doses of 400 mg, 800 mg, 1200 mg and 1600 mg, the maximum concentration in the blood (C max ) is 2.61 В± 0.34 Ојg / ml, 5.07 В± 0.69 Ојg / ml, 5.42 В± 0.65 Ојg / ml and 8.17 В± 1.91 Ојg / ml, respectively.
The half-life is 12-27 hours. The time to establish a steady-state concentration (C ss ) of the active substance in the blood with prolonged use is 14 days. The concentration of active substance in the blood at the course of taking the drug (1 time per day), measured 15 minutes before the next dose is 23.4 Ојg per 1 ml of blood plasma.
The pathways of metabolism of the active substance are not established, the study continues.
INDICATIONS
- pulmonary tuberculosis, incl. with multidrug-resistant Mycobacterium tuberculosis (as part of combination therapy).
DOSING MODE
Inside, after eating 1 time per day.
The drug is administered to adults at the rate of 9.5-12.5 mg / kg / day: with a body weight of less than 50 kg , 400-600 mg / day; with a body weight of 50-80 kg - 800-1000 mg / day; with a body weight of more than 80 kg - not more than 1200 mg / day.
Duration of therapy up to 3 months.
SIDE EFFECT
From the nervous system: dizziness, headache, weakness, drowsiness, loss of consciousness, neuropsychiatric reactions (aggression, depression).
On the part of the cardiovascular system: tachycardia, palpitation, lowering blood pressure.
From the digestive system: pain in the epigastric region, increased activity of "liver" transaminases, nausea, vomiting.
Allergic reactions: itching, rash, skin hyperemia, toxic-allergic reactions, angioedema.
Other: bronchospasm. fever, eosinophilia. feeling of hot.
CONTRAINDICATIONS
- hypersensitivity to the active substance or to any components of the drug;
- a violation of the liver and / or kidney function (the possibility of using the drug in this category of patients has not been studied);
- Pregnancy;
- the period of breastfeeding;
- Children's age (up to 18 years).
Carefully
Elderly age.
PREGNANCY AND LACTATION
Propenate is contraindicated for use during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in the violation of kidney function (the possibility of using the drug in this category of patients has not been studied).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in violations of the liver (the possibility of using the drug in this category of patients has not been studied).
APPLICATION FOR CHILDREN
Contraindicated for children under 18 years.
APPLICATION IN ELDERLY PATIENTS
Use with caution for the elderly.
SPECIAL INSTRUCTIONS
When developing allergic reactions it is recommended to cancel the drug. To stop the fever do not use metamizole sodium (analgin). In case of development of other aforementioned adverse reactions, the possibility of reducing the dose to 400 mg / day or drug withdrawal should be considered.
Impact on the ability to drive vehicles and mechanisms
There was no special study of Perkhlozon's influence on the ability to drive and work with machinery. Such side effects of the drug as dizziness, weakness, drowsiness can worsen the reactivity and ability to concentrate. During treatment with Perchlorozon, vehicle management is not recommended, as is the employment of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
There are no data on acute overdose when Perchloron is taken in humans.
Treatment: a specific antidote is unknown. In case of an overdose, general supportive therapy with the control of basic physiological parameters should be carried out.
Recommended gastric lavage, the appointment of activated charcoal.
DRUG INTERACTION
Interaction with other drugs has not been adequately studied.
With the simultaneous use of Perchlorozone with other anti-tuberculosis drugs (isoniazid, amikacin, rifabutin, rifampicin), there is an increase in activity against mycobacteria tuberculosis, while the possibility of mutual potentiation of side effects should be taken into account.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry, protected from light place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 2 years.
