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Atseklofenak

Препарат Ацеклофенак. SC Balkan Pharmaceuticals SRL (Балкан Фармасьютикалс) Республика Молдова


Producer: SC Balkan Pharmaceuticals SRL (Balkans Pharmasyyutikals) Republic of Moldova

Code of automatic telephone exchange: M01AB16, M02AA25

Release form: Firm dosage forms. Tablets.

Indications to use: Pseudorheumatism. Psoriasis arthritis. Juvenile pseudorheumatism. Bekhterev's disease (Ankylosing spondylarthritis). Acute gouty arthritis. Osteoarthrosis (Остеоартит).


General characteristics. Structure:

Active ingredient: 100 mg of an atseklofenak in 1 tablet.




Pharmacological properties:

Pharmacodynamics. NPVP derivative of phenylacetic acid; has the antiinflammatory, analgeziruyushchy and febrifugal effect connected with not selective suppression of TsOG1 and TsOG2 regulating synthesis of Pg.

Pharmacokinetics. Absorption — high. TCmax is 1,25–3 h. Gets into synovial fluid where its concentration reaches 57% of concentration level in plasma and TCmax on 2–4 h later, than in plasma. Distribution volume — 25 l. Communication with proteins of plasma (albumine) — 99%. Atseklofenak circulates mainly in not changed look, its main metabolite is 4-gidroksiatseklofenak. T1/2 is 4 h. It is removed by kidneys, it is preferential in the form of hydroxyderivatives (about 2/3 of the entered dose).


Indications to use:

Inflammatory diseases of a musculoskeletal system (a pseudorheumatism, the psoriasis and juvenile arthritis ankylosing a spondylarthritis; gouty arthritis, osteoarthrosis).


Route of administration and doses:

Inside, on 100 mg of 2 times a day. Tablets are swallowed entirely, washing down with enough liquid.


Features of use:

Because of an important role of Pg in maintenance of a renal blood-groove should show extra care at appointment the patients with a heart or renal failure, advanced age accepting diuretics and patients at whom for any reason decrease in OTsK is observed (for example after large surgical intervention). If in such cases appoint ацеклофенак, recommend to control function of kidneys as a precautionary measure.

At patients with a liver failure (chronic hepatitis, the compensated cirrhosis) the kinetics and metabolism do not differ from similar processes at patients with normal function of a liver.

When performing long therapy it is necessary to control function of a liver, a picture of peripheral blood, the analysis a calla on the occult blood.

During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.


Side effects:

From the alimentary system: gastralgia, nausea, vomiting, dyspepsia, meteorism, loss of appetite, increase in activity of "hepatic" transaminases, gastrointestinal bleeding, erosive cankers and perforation of a GIT, hematemesis, melena, fulminant hepatitis, locks.

From a nervous system: headache, dizziness, excitement, disturbances of perception, paresthesia, decrease in memory, disorientation, vision disorder, hearing, flavoring feelings, sonitus, sleep disorders (drowsiness or sleeplessness), irritability, spasms, depression, uneasiness, tremor, aseptic meningitis.

Allergic reactions: skin rash, it is rare — urticaria, eczema, an erythrosis, system anaphylactoid reactions, bronchial asthma, in some cases — a vasculitis, a pneumonitis, a multiformny exudative erythema (including Stephens-Johnson's syndrome), a toxic epidermal necrolysis (Lyell's disease).

From an urinary system: seldom — peripheral hypostases, in some cases — an acute renal failure, a hamaturia, a proteinuria, intersticial nephrite, a nephrotic syndrome.

From bodies of a hemopoiesis: thrombocytopenia, leukopenia, agranulocytosis, hemolitic anemia, aplastic anemia.

From CCC: tachycardia, increase in the ABP, HSN.


Interaction with other medicines:

Increases concentration in plasma of digoxin, the drugs Li + and Phenytoinum.

Against the background of a concomitant use of kaliysberegayushchy diuretics the risk of a hyperpotassemia, against the background of indirect anticoagulants — risk of bleedings amplifies (regular control of coagulability of blood is necessary).

Reduces efficiency of diuretic and hypotensive HP.

Increases probability of emergence of side effects of NPVP and GKS from a GIT, toxicity of a methotrexate (an interval between reception — 24 h) and nephrotoxicity of cyclosporine.

ASK reduces concentration of an atseklofenak in blood.

At simultaneous use with peroral hypoglycemic HP are possible both hypo - and a hyperglycemia (control of content of glucose in blood is necessary).

Myelotoxic HP strengthen manifestations of a gematotoksichnost of drug.


Contraindications:

Hypersensitivity (including to other NPVP), GIT erosive cankers (in an aggravation phase), a full or incomplete combination of bronchial asthma, the nose recuring a polypose and okolonosovy bosoms and intolerance of ASK or other NPVP (including in the anamnesis), disturbance of a hemopoiesis of not clear etiology, pregnancy (the III trimester), children's age (up to 18 years).

With care. HSN, diseases of a liver, kidneys and a GIT in the anamnesis, dispepsichesky symptoms at the time of purpose of drug, arterial hypertension, decrease in OTsK (including a state after operative measures), pregnancy (the I-II trimester), the lactation period, advanced age, HPN, reception of diuretics.


Overdose:

Symptoms: dizziness, a headache, a hyperventilation of lungs with the increased convulsive readiness, nausea, vomiting, pains in a stomach.

Treatment: gastric lavage, administration of absorbent carbon, symptomatic therapy. There is no specific antidote. The artificial diuresis, a hemodialysis are ineffective.


Storage conditions:

To store at a temperature of 15-25 °C, in dry, protected from light and the place, unavailable to children. Period of validity 3 years. Not to use after the expiry date specified on packaging.


Issue conditions:

According to the recipe


Packaging:

Tablets on 100 mg, 10 tablets in each blister, on one, two or three blisters together with the application instruction in cardboard packaging.



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