Перхлозон®
Producer: JSC Pharmasintez Russia
Code of automatic telephone exchange: J04AK
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 200 mg or 400 mg perchlorate thioureidoiminomethylpyridinium.
Excipients: silicon dioxide colloid, кросповидон, magnesium stearate, povidone, cellulose microcrystallic.
The cover is film: gipromeloza of E5 0,35 mg / 0,70 mg, gipromeloza of E15, dye ferrous oxide yellow, macrogoal 6000, talc, propylene glycol, titanium dioxide.
The antitubercular drug possessing the expressed inhibiting effect on viability of mycobacteria of tuberculosis, including steady against other antitubercular drugs.
Pharmacological properties:
Pharmacodynamics. Antituberculous remedy. The mechanism of action is not installed. It is active concerning Mycobacterium tuberculosis and Mycobacterium bovis. Possesses the expressed inhibiting effect on viability of mycobacteria of tuberculosis, including steady against other antitubercular drugs. Perkhlozon – low-toxic, does not cause essential structurally functional disturbances of vitals and systems, and also irritant action on mucous membranes of digestive tract. The mechanism of action is not finalized, studying continues.
Pharmacokinetics. After intake Perkhlozon is quickly soaked up in digestive tract. Time of achievement of the maximum concentration in blood (TCmax) – 1,5-3 hours. After a single dose inside in doses of 400 mg, 800 mg, 1200 mg and 1600 mg the maximum concentration in blood (Cmax) makes 2,61+0,34 mkg/ml, 5,07+0,69 mkg/ml, 5,42+0,65 mkg/ml and 8,17+1,91 mkg/ml respectively. The elimination half-life makes 12-27 hours. Time of establishment of stationary concentration (Css) of active agent in blood at long use – 14 days. The concentration of active agent in blood at course administration of drug (1 time a day) measured in 15 minutes prior to reception of the next dose makes 23,4 mkg on 1 ml of a blood plasma. Ways of metabolism of active agent are not established, studying continues.
Indications to use:
Pulmonary tuberculosis, including with multiple medicinal resistance of Mycobacterium tuberculosis (as a part of a combination therapy).
Route of administration and doses:
Inside, after meal once a day. Drug is appointed the adult at the rate of 9,5-12,5 mg/kg/days: at body weight less than 50 kg - 400-600 mg/days; with the body weight of 50-80 kg on 800-1000 mg/days, with body weight more than 80 kg no more than 1200 mg/days. Therapy duration – up to 3 months.
Features of use:
At development of allergic reactions it is recommended to cancel drug. For stopping of fever not to use metamizole sodium (analginum). In case of development of other above-mentioned side reactions it is necessary to consider the possibility of a dose decline to 400 mg/days or drug withdrawal.
Influence on ability to manage vehicles and mechanisms. It was not carried out special studying of influence of Perkhlozon on ability to drive the car and to work with the equipment. Such side effects of drug as dizziness, weakness, drowsiness (see also undressed "Side effect"), can worsen reactionary ability and ability to concentration of attention. During treatment by Perkhlozon the control of vehicles, and also occupation is not recommended by potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Side effects:
From a nervous system: dizziness, headache, weakness, drowsiness, loss of consciousness, neuromental reactions (aggression, depression).
From cardiovascular system: tachycardia, heart consciousness, lowering of arterial pressure.
From the alimentary system: pain in epigastric area, increase in activity of "hepatic" transaminases, nausea, vomiting.
Allergic reactions: itch, rash, dermahemia, toksiko-allergic reactions, Quincke's disease. Other: bronchospasm, fever, eosinophilia, feeling of heat.
Interaction with other medicines:
Interaction with other medicines is studied insufficiently. At simultaneous use of Perkhlozon with other antitubercular drugs (the isoniazid, amikacin, rifabutiny, rifampicin) note strengthening of activity concerning tuberculosis mycobacteria, at the same time it is necessary to consider a possibility of mutual potentiation of side effects.
Contraindications:
Hypersensitivity to active agent or to any components of drug, an abnormal liver function and/or kidneys (the possibility of use of drug for this category of patients is not studied), pregnancy, the breastfeeding period, children's age (up to 18 years).
With care. Advanced age.
Overdose:
Data on acute overdose at Perkhlozon's reception at people are absent. Treatment: the specific antidote is unknown. At overdose it is necessary to carry out the general maintenance therapy with control of the main physiological indicators. The gastric lavage, purpose of absorbent carbon is recommended.
Storage conditions:
In the dry, protected from light place, at a temperature not over 25 ºС. To store in the place, unavailable to children.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets place in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 50 or 100 tablets place in bank polymeric with the cover tense with control of the first opening. The free space is filled with medical cotton. On banks paste labels from paper label or writing or from polymeric materials, self-adhesive.
On 5 or 10 blister strip packagings together with the application instruction place in a pack from a cardboard for a retail container of subgroups chromic or chrome - ersatz, or other similar quality. Packs place in group packaging. After 1 bank together with the application instruction place in a pack from a cardboard for a retail container. Packs place in group packaging - a box from corrugated fibreboard.