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Brizezi 10 (Montelukast) 10 mg, 30 film-coated tablets


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Trade name
of Brizezi 10

International unlicensed

name Montelukast Dosage Form
Tablets, film coated 10 mg

One tablet contains
active agent – montelukast of sodium of 10.380 mg
(is equivalent to montelukast of 10 mg),
excipients: lactose anhydrous (categories DC), starch corn, hydroxypropyl cellulose, starch sodium glycollate, silicon dioxide colloidal, magnesium stearate,
cover: instakoat universal yellow IC-U-5855: including the titan dioxide (E171), gland (III) oxide yellow (E172), water cleaned.

The description
of the Tablet of round shape with a biconvex surface, film coated light yellow color, with the line of a break on one party.

Pharmacotherapeutic group
Other drugs for treatment of obstructive respiratory diseases for system use. Leukotriene receptors antagonists.
The code of automatic telephone exchange R03DC03

the Pharmacological

Pharmacokinetics Montelukast properties is quickly and almost completely soaked up after intake. The pharmacokinetics of montelukast keeps almost linear character at intake of doses to 50 mg. Intake of usual food does not affect bioavailability and the maximum concentration in plasma (Cmax) of tablets, film coated. At adults at reception on an empty stomach of tablets, film coated 10 mg of Cmax are reached in 3-4 hours. The bioavailability at intake is 64%.
Brizez 10 contacts proteins of blood plasma more, than for 99%. The volume of distribution of montelukast averages 8-11 liters.
Brizez 10 it is actively metabolized in a liver. When using therapeutic doses the concentration of metabolites of montelukast in plasma in an equilibrium state at adults and children is not defined.
It is supposed that isoenzymes of CYP (3A4 and 2C9) P450 cytochrome are involved in process of metabolism of montelukast, at the same time in therapeutic concentration montelukast is not inhibited by isoenzymes of CYP P450 cytochrome: 3A4, 2C9, 1A2, 2A6, 2C19 and 2D6.
The clearance of montelukast averages 45 ml/min. After oral administration of Brizezi 10, 86% of its quantity are removed with a stake within 5 days and less than 0.2% – with urine that confirms that montelukast and its metabolites are excreted almost only with bile.
Elimination half-life (T1/2) of drug makes from 2.7 to 5.5 hours. At reception of 1 times in day of tablets, film coated 10 mg cumulation of active agent in plasma is observed moderated (about 14%).
The pharmacodynamics
of Brizezi 10 specifically inhibits CysLT1-receptors of tsisteinilovy leukotrienes (LTS4, LTD4 and LTE4) — the most powerful mediators of the chronic persistent inflammation maintaining hyperreactivity of bronchial tubes in bronchial asthma. Reduces expressiveness of a spasm of smooth muscles of bronchioles and vessels, hypostasis, migration of eosinophils and macrophages, reduces secretion of slime and improves mukotsiliarny transport. Use of montelukast in the doses exceeding 10 mg a day is not followed by increase in efficiency of drug. Brizez 10 causes a bronkhodilatation within 2 hours after intake and shows synergism with ß2 – adrenomimetikam.

– prevention and long-term treatment of bronchial asthma at adults, including prevention of day and night symptoms of a disease, treatment of aspirinchuvstvitelny patients with bronchial asthma and prevention of the bronchospasm caused by physical activity
– stopping of day and night symptoms of seasonal allergic rhinitises and constant allergic rhinitises at adults

the Route of administration and doses
the Adult. Inside one tablet (10 mg) of 1 times a day irrespective of meal. For treatment of bronchial asthma of Brizezi 10 it is necessary to accept in the evening. At treatment of allergic rhinitises the dose can be accepted at the request of the patient at any time. The patients having bronchial asthma and allergic rhinitises in total have to take one pill Brizezi 10 once a day in the evening. Duration of a course of treatment is determined by the attending physician.
The general recommendations
Therapeutic action of Brizezi 10 on the indicators reflecting a course of bronchial asthma develops during the first day.
The patient should continue to accept Brizezi 10 as during achievement of control of symptoms of bronchial asthma, and during the periods of exacerbation of bronchial asthma.
For elderly patients, patients with a renal failure and also to patients with slight or medium-weight abnormal liver functions and also depending on a floor of special selection of a dose it is not required.

Side effects
– fervescence, weakness, fatigue
– cough, otitis, sinusitis, pharyngitis, laryngitis, flu
– abdominal pain, a gastroenteritis, nausea, vomiting, dyspepsia, diarrhea, increase in the ALT and nuclear Heating Plant level, hepatitis (including cholestatic, hepatocellular and mixed)
– skin rash
– hypersensitivity reactions (anaphylaxis, a Quincke’s disease, an itching, a small tortoiseshell), a knotty erythema
– a headache, dizziness, abnormal dreams, drowsiness, irritability, concern, hallucinations, agressive behavior, paresthesias/hypesthesias, a tremor, convulsive attacks, insomnia, a disorientation
– muscular spasms, myalgia, an arthralgia
– bleeding, hematomas
– heartbeat

– eosinophilic infiltration of a liver
– a system eosinophilia, vasculitis symptoms (similar to Charga-Stross’s syndrome at treatment by system corticosteroids, these cases are generally connected with reduction of a dose of oral corticosteroids)
Very seldom

Contraindication pancreatitis
– hypersensitivity to montelukast and other components of drug
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years

Medicinal interactions
of Brizezi it is possible to appoint hypostases 10 together with other medicines which are traditionally applied to prevention and long-term treatment of bronchial asthma. The recommended clinical dose of Brizezi 10 did not render clinically significant effect on pharmacokinetics of the following drugs: theophylline, Prednisonum, Prednisolonum, oral contraceptives (norethindrone of 1 mg / ethinylestradiol of 35 mkg), terfenadin, digoxin, warfarin.
In spite of the fact that special researches of medicinal interaction were not conducted, Brizezi 10 was applied together with a wide number of usually prescribed medicine in clinical trials. Among such drugs there were hormones of a thyroid gland, sedative and sleeping medicines, non-steroidal anti-inflammatory drugs, benzodiazepines and antiedematouses.
Phenobarbital at simultaneous use with a single dose of Brizezi 10 caused reduction of value of the area under a curve concentration time (AUC) approximately for 40%. However dose adjustment of Brizezi 10 at combined use with phenobarbital is not required.

It is not recommended to appoint special indications of Brizezi 10 for treatment of bad attacks of bronchial asthma. At treatment of a sharp course of bronchial asthma the patients should appoint the corresponding drugs. Treatment in combination with Brizezi 10 can be continued at exacerbations of bronchial asthma. Patients with the bronchial asthma caused by physical activity have to continue to apply inhalation β-agonists for prevention and also to have β-agonist of short action for stopping of attacks.
The dose of 10 inhalation glucocorticosteroids applied along with Brizezi can be reduced gradually under observation of the doctor. Brizez 10 cannot be replaced sharply inhalation or oral glucocorticosteroids.
Reduction of a system dose of glucocorticosteroids at the patients receiving antiasthmatic means, including blockers of leukotriene receptors, was followed in rare instances by emergence of one or several of below the listed phenomena: eosinophilias, vascular rash, deterioration in pulmonary symptoms, cardiological complications and/or the neuropathy sometimes diagnosed as Charg-Stross’s syndrome – a system eosinophilic vasculitis. Though to relationship of cause and effect of these undesirable phenomena with therapy by antagonists of leukotriene receptors it was not established, at decrease in a system dose of glucocorticosteroids at the patients accepting Brizezi 10 it is necessary to be careful and make the corresponding clinical observation.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Considering side effects of drug (dizziness, drowsiness), it is necessary to observe extra care at control of transport or potentially dangerous mechanisms.

Symptoms: feeling of thirst, drowsiness, headache, mydriasis, hyperkinesias, vomiting and abdominal pain.
Treatment: symptomatic. There are no data on a possibility of removal of montelukast by peritoneal dialysis or a hemodialysis.

Form of release and packing
of the Tablet, film coated 10 mg.
On 10 tablets place in blister strip packaging from aluminum foil from one party and aluminum printing foil on the other hand.
On 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To Store storage conditions in the dry, protected from light place, at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to use a period of storage after an expiration date.

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