Пироксикам-Акри®

General characteristics. Structure:

Active ingredient: 0,01 g or 0,02 g of piroxicam in 1 capsule.

Excipients: cellulose microcrystallic, silicon dioxide colloid (aerosil), potato starch, talc.

Pharmacological properties:

Pharmacodynamics. Piroxicam has the antiinflammatory, anesthetizing and febrifugal effect. The mechanism of action is connected with oppression of synthesis of prostaglandins owing to non-selective inhibition of cyclooxygenases 1 and 2.

Piroxicam weakens or completely eliminates pains of moderate intensity, reduces expressiveness of inflammatory reaction, reduces morning constraint of joints, promotes increase in volume of movements. The analgetic effect occurs in 30 minutes after intake and remains within a day.

Pharmacokinetics. It is well soaked up at intake. Food slows down absorption speed, but does not influence absorption volume. Bioavailability — 100%. Communication with proteins of plasma — 97%.

Concentration in plasma is proportional to the used dose. Time of achievement of the maximum concentration — 3-5 h. After a single dose of 20 mg the maximum concentration — 1,5-2 mkg/ml, after regular reception of 20 mg/days 3-8 mkg/ml. Equilibrium concentration is reached through — 7-12 days.

Gets into synovial fluid (40-50%), it is allocated with breast milk — 1-3%. It is metabolized in a liver by a hydroxylation of a pyridsilt ring of a side chain, with the subsequent conjugation with glucuronic acid and formation of inactive metabolites. An elimination half-life — 24-50 h. It is removed in the form of conjugates by kidneys and to a lesser extent — through intestines. In not changed look — 5%.

Indications to use:

Musculoskeletal system diseases: the rhematoid and gouty arthritis ankylosing a spondylitis (Bekhterev's disease), rheumatic defeat of soft tissues, an osteoarthrosis of peripheral joints and a backbone including with a radicular syndrome, a tendovaginitis, a bursitis. Pain syndrome: posttraumatic pain syndrome, альгодисменорея, neuralgia.

Route of administration and doses:

Inside. At diseases of a musculoskeletal system or diseases of joints (a pseudorheumatism, an osteoarthrosis, spondylites) 10-20 mg a day once are accepted to 1 or 2 receptions.

At acute diseases of a musculoskeletal system the first two days accept 40 mg a day, and then within 1-2 weeks of 20 mg a day. At a bad attack of gout accept on 40 mg within 3-5 days.

It is impossible to exceed the recommended daily doses as it increases danger of emergence of side effects.

Features of use:

The patients accepting piroxicam should abstain from occupations potentially dangerous types of activity requiring special attention and bystry mental and motor reactions (driving of the car, etc.).

It is strictly forbidden to take alcoholic drinks.

With extra care appoint piroxicam to patients with erosive and ulcer diseases of digestive tract and gastrointestinal bleedings in the anamnesis, to patients with dispeptic disturbances, chronic heart failure, disturbances of functions of a liver and/or kidneys, blood coagulation disturbances, bronchial asthma, allergic "hay" cold, polyps mucous a nose, and also at obstructive respiratory diseases, allergic reaction to acetylsalicylic acid and other NPVP.

Care at purpose of piroxicam is necessary for the elderly and weakened patients: especially at dysfunction of cardiovascular system, kidneys, a liver.

In the course of treatment by piroxicam control of a functional condition of a liver and a picture of peripheral blood is necessary.

Side effects:

From the alimentary system: nausea, loss of appetite, abdominal pain, meteorism, locks or diarrhea, digestive tract erosive cankers, bleeding and perforation of bodies of digestive tract; abnormal liver functions, increase in activity of "hepatic" transaminases; dryness in a mouth, stomatitis.

From a nervous system: dizziness, headache, drowsiness, sleeplessness, depression, irritability, hallucinations, paresthesias, block, change of mood.

From an urinary system: renal failure, intersticial nephrite, papillary necrosis, nephrotic syndrome.

From bodies of a hemopoiesis and system of a hemostasis: anemia, aplastic anemia, hemolitic anemia, leukopenia, eosinophilia, thrombocytopenia, decrease in level of a hematocrit; atrombotsitopenichesky purpura (Shenleyn-Genokh's disease).

From cardiovascular system: increase in arterial pressure, a lowering of arterial pressure, is rare — heartbeat, an asthma.

Others: hypostases of shins and feet, the increased sweating, increase in concentration of urea; hypoglycemia.

Allergic reactions: skin rash, itch, face edemas, throats, bronchospasm, malignant exudative erythema (Stephens-Johnson's syndrome), shock, photosensitization, vasculitis, serum disease.

Interaction with other medicines:

- at simultaneous use of Piroxicam and glucocorticosteroids and/or NPVP — the risk of emergence of side effects from digestive tract increases;

- acetylsalicylic acid — the level of concentration of piroxicam in blood serum goes down;

- phenobarbital — the level of concentration of piroxicam in blood serum goes down;

- Cimetidinum — the level of concentration of piroxicam in blood serum can increase that leads to strengthening of effect of piroxicam;

- Phenytoinum and/or lithium, and also kaliysberegayushchy diuretics — concentration level in plasma of Phenytoinum, lithium and potassium can increase;

- diuretics and antihypertensives — action of the last is weakened;

- anticoagulants — it is necessary to carry out control of coagulability of blood;

- a methotrexate — can lead to increase in concentration of a methotrexate and to strengthening of its toxic action.

Contraindications:

Hypersensitivity (including to other nonsteroid antiinflammatory drugs), "aspirinovy" asthma, a "aspirinovy" triad (a combination of bronchial asthma, a recurrent pollinosis of a nose and okolonosovy bosoms, and intolerance of acetylsalicylic acid and medicines of a pyrazolon row), hemopoiesis disturbances, various disturbances of a hemostasis (including hemophilia), the digestive tract erosive cankers in a phase of an aggravation, bleeding from digestive tract expressed an abnormal liver function and kidneys, pregnancy, the lactation period, children's age up to 14 years.

With care: the age is more senior than 65 years, a digestive tract disease (digestive tract erosive cankers in the anamnesis, a disease Krone, ulcer colitis), chronic heart failure, arterial hypertension, bronchial asthma, a chronic liver or renal failure, a diabetes mellitus, the postoperative period, in the presence of a hepatic porphyria, dehydration, deficit glyukozo-6-fosfatdegidro-genazy.

Overdose:

Symptoms: an abdominal pain, nausea, vomiting, drowsiness, a vision disorder, at reception of very high doses — a loss of consciousness, a coma.

Treatment: a gastric lavage with use of absorbent carbon, antacids are applied to delay of absorption. At a serious poisoning of the patient it is necessary to hospitalize. There is no specific antidote. Symptomatic treatment.

Storage conditions:

List B. In the dry, protected from light place unavailable to children, at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Capsules of 0,01 g or 0,02 g 2 blister strip packagings on 10 capsules in a pack from a cardboard.