Sinmeton

General characteristics. Structure:

Active ingredient: 500 or 750 mg of a nabumeton.

Excipients: cellulose microcrystallic, starch corn, polysorbate 80, sodium lauryl sulfate, sodium krokhmalglikolit (type A), silicon dioxide colloid anhydrous, talc, a gipromeloz, titanium dioxide (Е 171), polyethyleneglycol 6000, ferrous oxide red (Е 172), ethyl cellulose.

The selection non-steroidal anti-inflammatory drug for removal of symptoms of pain and an inflammation in joints and soft tissues.

Pharmacological properties:

Pharmacodynamics. Nabumeton – the substance selectively inhibiting cyclooxygenase-2. Due to influence on activity of enzyme of cyclooxygenase набуметон slows down metabolism of arachidonic acid and reduces products of prostaglandins.

Sinmeton renders the expressed antiinflammatory, analgetic and antipyretic action. At reception of a nabumeton oppression of exudative and proliferative processes in the inflammation center is noted, the level of bradikinin and a histamine decreases, and also the threshold of sensitivity of pain receptors raises. Decrease in body temperature at patients with a hyperthermia is caused by ability of a nabumeton to reduce the level of pyrogens in cerebrospinal fluid and a hypothalamic zone, and also increase in a thermolysis.

Pharmacokinetics. After intake набуметон it is well absorbed, bioavailability reaches 80%. About 35% of the accepted dose of a nabumeton are metabolized with formation pharmacological of an active metabolite. The elimination half-life of a nabumeton reaches 24 hours. About 75% of the accepted drug dose Sinmeton are excreted by kidneys within 48 hours.

Indications to use:

- acute osteoarthritis;
- chronic osteoarthritis;
- pseudorheumatism;
- rheumatism of soft tissues;
- ankilozivny spondylitis.

Route of administration and doses:

Sinmeton is intended for oral administration. Tablets, coated, Sinmeton it is necessary to swallow entirely (disturbance of integrity of a cover of a tablet can lead to disturbance of a pharmacokinetic profile of drug and increase in risk of development of undesirable effects from a digestive tract). The daily dose of a nabumeton is appointed, as a rule, to 1 reception.

At use of high doses of drug Sinmeton (more than 750 mg/days) the daily dose can be divided into 2 receptions. Nabumeton is recommended to accept in time or directly after meal (at reception once a day drug is recommended to be accepted in the evening). Sinmeton determines duration of therapy and a dose of drug the doctor.

As a rule, purpose of 500-750 mg of a nabumeton a day is recommended. In case of need it is possible to increase a dose to 1500-2000 mg of a nabumeton a day.

The maximum recommended daily dose of a nabumeton makes 2000 mg.

Features of use:

Risk of emergence of such gastrointestinal defeats as ulcer, bleeding and perforation. Patients who treat chronic diseases of non-steroidal anti-inflammatory drugs sometimes have serious displays of gastrointestinal intoxication, such as ulcer, bleeding and perforation to presence of the warning symptoms or without them.

Patients with heavy astmatichny reactions should appoint drug with care.

Were not established any general differences concerning efficiency or safety of administration of drug for such senior patients compared with young patients.

 

It is necessary to observe special care at appointment to patients with polipozy a nose, heart failure, peripheral hypostases, hepatonephric insufficiency, hemophilia, hypocoagulative states.

As there are no data on influence of a nabumeton on mental and physical capacities, it is necessary to warn the patient about need to be careful during the work with mechanisms and driving.

Nabumeton is not recommended for appointment to children since safety and efficiency of use it at children are not established.

Use of a nabumeton during ІІІ a trimester of pregnancy is not recommended because of the known effect of drugs which suppress synthesis of prostaglandins, on embrionny cardiovascular system (closing of channels of an artery). Influence of a nabumeton on patrimonial activity and delivery at women is unknown.

At rats whom watched during pregnancy increase in cases of dystonia and a delay of childbirth, as with other means which suppress synthesis of prostaglandins is recorded.

Nabumeton is not recommended to women during feeding by a breast as a result of possible undesirable effect of drug, as well as other drugs which suppress synthesis of prostaglandins, on babies. There are no data on whether gets набуметон, or its metabolite, 6-metoksi-2-naft_latsetinova acid, to milk of the feeding rats.

Side effects:

Sinmeton, as a rule, is not bad had by patients. Development of such undesirable reactions caused nabumetony was in some cases noted:

- from digestive tract: stomatitis, disturbances of a chair, the dispepsichesky phenomena, heartburn, pain in epigastric area, nausea. In isolated cases development of cankers of a mucous membrane of a duodenum and stomach, gastrointestinal bleedings and a gastropathy was also noted.

- from heart, vessels and system of blood: anemia, vasculitis, disturbances of a cordial rhythm, increase in arterial pressure, hypostases, heart failure, thrombocytopenia, agranulocytosis, leukopenia, granulocytopenia.

- from a nervous system and sense bodys: decrease in visual acuity, headache, sonitus, drowsiness, dizziness, sleeplessness.

Allergic reactions: urticaria, skin itch, bronchospasm, Quincke's edema.

Others: damages of kidneys, the increased sweating, a hamaturia, a dysuria, a crystalluria, an azotemia, an albuminuria.

Interaction with other medicines:

Nabumeton at the combined use exponentiates action of antiagregant, fibrinolitic and anticoagulating drugs.

Sinmeton at simultaneous use can increase expressiveness of undesirable effects of oral contraceptives and glucocorticosteroid drugs.

Holestiramin and antiacid means at the combined use with drug Sinmeton reduce absorption of a nabumeton.

It is not necessary to appoint drug Sinmeton combined with other non-steroidal anti-inflammatory drugs.

Contraindications:

Sinmeton do not appoint to patients with the known hypersensitivity to a nabumeton or other non-steroidal anti-inflammatory drugs (including the instruction to "an aspirinovy triad" in the anamnesis).

Sinmeton it is not necessary to apply to therapy of the patients suffering from a peptic ulcer of a duodenum and stomach in the period of an aggravation, hemorrhagic diathesis and the expressed disturbances of functions of kidneys and a liver.

Nabumeton do not use in pediatric practice.

It is necessary to be careful, appointing drug Sinmeton to the patients having tendency to development of a bronchospasm, and also patients with polipozy a nose, peripheral hypostases, heart failure, hemophilia and disturbances of coagulation.

Sinmeton is recommended to avoid driving of the car and control of potentially unsafe mechanisms during administration of drug.

Overdose:

At use of the overestimated drug doses Sinmeton at patients development of pain in abdominal area was noted. Besides, at overdose of a nabumeton at patients strengthening of expressiveness of the undesirable effects characteristic of drug is possible.

There is no specific antidote. Directly after reception of the overestimated dose it is necessary to wash out a stomach and to appoint enterosorbentny means. Therapy of the expressed overdose of a nabumeton should be carried out in the conditions of a hospital at constant control of function of kidneys, cardiovascular and respiratory system. If necessary carry out symptomatic therapy.

Storage conditions:

To store in the place, unavailable to children, at a temperature of 15-25 degrees Celsius

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in the blister. On 1 or 10 blisters in cardboard packaging.