Arkoksia

Аркоксиа Drug photo

The description is actual on 06.06.2014

  • Latin name: Arcoxia
  • ATH code: M01AH05
  • Active ingredient: Etorikoksib (Etoricoxib)
  • Producer: GREW DIM (USA)

Structure

One tablet of Arkoksia contains active agent: etorikoksib – 30, 60, 90 or 120 mg depending on a dosage.

Excipients: calcium hydrophosphate, microcrystallic cellulose, croscarmellose sodium, magnesium stearate.

Structure of a cover: white Opadray of II, karnaubsky wax.

Structure of a film cover: monohydrate of lactose, a gipromelloz, titanium dioxide, triacetin, a varnish aluminum on the basis of indigo carmine, dye iron oxide yellow.

Release form

Medicine of Arkoksia represents tablets, coated turquoise color, biconvex, spherical shape, with a text of "ACX 30" from one edge and a text "101" – from another.

  • Tablets a dosage of 30 mg are issued on 2, 4, 7 or 14 pieces in the blister; 2, 1 or 4 such blisters in a cardboard pack.
  • Tablets of Arkoksia of 60 mg are issued on 7 pieces in the blister; 1 or 4 such blisters in a cardboard pack.
  • Tablets of Arkoksia of 90 mg are also issued on 7 pieces in the blister; 1 or 4 such blisters in a cardboard pack.
  • Tablets a dosage of 120 mg are issued on 7 pieces in the blister; 1 such blister in a cardboard pack.

Pharmacological action

Non-steroidal anti-inflammatory drug. Selective blocker of cyclooxygenase-2.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Etorikoksib — a peroral selective blocker of cyclooxygenase-2.

In clinical tests the drug Arcoxia dozozavisimo blocked cyclooxygenase-2 without suppression of cyclooxygenase-1 when using in a dose less than 150 mg a day. The Etorikoksib does not oppress products of prostaglandins of a stomach and does not change function of thrombocytes.

Cyclooxygenase regulates formation of prostaglandins. There are two of its forms — Tsiklookigenaza-1 and Tsiklookigenaza-2. The last is considered as the main factor which is responsible for products of mediators of pain, fever and inflammation. Tsiklookigenaza-2 it is involved in mechanisms of an ovulation, implantation and an obturauiya of an arterial channel, control of functions of a nervous system and kidneys. Also she participates in processes of scarring of ulcers.

Pharmacokinetics

The Etorikoksib is well adsorbed at peroral use. Absolute bioavailability reaches 100%. The maximum concentration of drug in blood is observed in one hour after reception on an empty stomach. At administration of drug during food significant influence on absorption level was not observed.

92% of etorikoksib contact blood proteins. Drug is actively metabolized, less than 2% of a dose are allocated with urine in an invariable look. At the person 5 metabolites of etorikoksib are investigated. The main metabolite is 6-carboxyl acid which is formed at oxidation 6 hydroxymethyls. These substances or biologically are not active, or are slaboaktivny blockers of TsOG-2. Any of them does not suppress TsOG-1. 70% of drug are allocated with urine, about 25% — with a stake. The elimination half-life is equal to 22 hours.

The pharmacokinetics at patients of advanced age (65 years are more senior) is identical that at persons of younger age and does not depend on a floor.

The drug pharmacokinetics at children till 12 flyings was not studied. Safety and efficiency of use of etorikoksib at children is not proved.

Indications to use of Arkoksia

Indications to drug use:

  • symptomatic treatment of a pseudorheumatism, the osteoarthritis, ankylosing spondylitis which are followed by inflammatory symptomatology and pain;
  • short-term therapy of a moderate acute pain after stomatologic operations;
  • acute gouty arthritis.

Making decision on purpose of a selective blocker of TsOG-2 has to be accepted considering all individual risks for the patient.

Contraindications

Arkoksia it is contraindicated:

  • at a sensitization to active agent, to any other substance as a part of drug or to other non-steroidal anti-inflammatory drugs;
  • at an active ulcer or a gastromenia or intestines;
  • during feeding by a breast and pregnancies;
  • at severe damages of a liver (blood albumine less than 25 g/l);
  • to persons with renal clearance of creatinine less than 30 ml/min.;
  • to the children who did not reach 16 years;
  • to persons with inflammatory diseases of intestines;
  • at heart failure with developments of stagnation;
  • to patients with an arterial hypertension at whom arterial pressure is constant more than 140/90 mm of mercury.;
  • at coronary heart disease, pathology of peripheral arteries or other cardiovascular diseases.

Side effects

Purpose of drug can cause the following by-effects:

  • From the central nervous system: in less than 10% of cases — dizziness, head pains, weakness; in less than 1% of cases — drowsiness, sleep disorders, disturbance of taste, paresthesia, alarm, disturbances of concentration, a hyperesthesia, a depression, in less than 0.01% of cases — hallucinations, confusion of consciousness.
  • From system of digestion: in less than 10% of cases – pain in the upper floor of a stomach, diarrhea, dyspepsia, nausea, a meteorism; in less than 1% of cases — an eructation, abdominal distention, a lock, strengthening of a vermicular movement, gastritis, dryness mucous a mouth, an ulcer mucous a stomach or a duodenum, an esophagitis, ulcers mucous a mouth, vomiting; in less than 0.01% of cases — stomach ulcer and intestines with perforation or bleeding.
  • From a liver: in less than 0.01% of cases — hepatitis.
  • From ENT organs: in less than 1% of cases — conjunctivitis, a sonitus, a sight illegibility, vertigo.
  • From immunity: in less than 0.01% of cases — anaphylactic reactions, including strong pressure drop and shock.
  • From urinogenital system: in less than 1% of cases — a proteinuria; in less than 0.01% of cases — a reversible renal failure.
  • From respiratory system: in less than 1% of cases — short wind, cough, nasal bleeding; in less than 0.01% of cases — a bronchospasm.
  • From cardiovascular system: in less than 10% of cases — heartbeat, increase of arterial pressure; in less than 1% of cases — disturbance of cerebral circulation, inflow, fibrillation of auricles, changes of an ECG; in less than 0.01% of cases — hypertensive crisis.
  • Infections: in less than 1% of cases — a gastroenteritis, infections of an urinary path, respiratory tracts.
  • From skin and hypodermic cellulose: in less than 10% of cases — ecchymomas; in less than 1% of cases — puffiness of the person, an itch, rash; in less than 0.0 1% of cases — Stephens-Johnson's syndrome, the small tortoiseshell, a Lyell's disease.
  • Disturbances of a metabolism: in less than 10% of cases — hypostases; in less than 1% of cases — appetite changes.
  • From a musculoskeletal path: in less than 1% of cases — an arthralgia, spasms, a mialgiya.
  • Others: often — a grippopodobny syndrome; infrequently — thorax pains.
  • Changes in clinical analyses: in less than 10% of cases — increase of transaminases; in less than 1% of cases — decrease in a hematocrit, increase in activity of a kreatinfosfokinaza, a hyperpotassemia, hemoglobin lowering, thrombocytopenia, a leukopenia, increase in creatinine of serum, uric acid; in less than 0.01% of cases — increase in sodium in blood.

Application instruction of Arkoksia (Way and dosage)

The application instruction of Arkoksia orders to take this medicine inside, disregarding reception of food. After a proglatyvaniye of the tablet Arcoxia to wash down with water.

  • At an osteoarthrosis: the recommended dose — 60 or 30 mg of drug once a day.
  • Ankylosing spondylitis and pseudorheumatism: to take the pill Arcoxia 90mg once a day.
  • Acute gouty arthritis: in the acute period the dose of drug makes 120 mg once a day. Duration of use of the drug Arcoxia in a dose of 120 mg should not exceed 8 days.

It is recommended to use the minimum effective dosage the shortest possible course.

Overdose

During tests it was not reported about overdose of Arkoksia.

If the condition of overdose after all developed, emergence of undesirable symptoms from a stomach and intestines, kidneys and cardiovascular system is possible. Treatment — symptomatic. The Etorikoksib is not allocated when carrying out a hemodialysis.

Interaction

Lithium. Non-steroidal anti-inflammatory drugs slow down removal of lithium with urine, increasing its level in blood.

Methotrexate. At simultaneous use of etorikoksib and a methotrexate it is necessary to carry out monitoring concerning strengthening of toxic influence of the last.

Oral contraceptives. Joint reception with peroral contraceptives can detain their removal, and as a result increase the frequency of development of by-effects (a thromboembolism of veins).

Digoxin. The Etorikoksib strengthens toxic effects of digoxin.

Rifampicin. Simultaneous use of etorikoksib and rifampicin leads to decrease in maintenance of etorikoksib in blood for 65%.

Antacids. Do not exert significant impact on pharmacokinetics of etorikoksib.

Terms of sale

It is everywhere released strictly according to the recipe.

Storage conditions

To store at a temperature below 30 degrees. To protect from children.

Period of validity

Three years. Not to apply after the termination of a period of validity.

Special instructions

Reception of Arkoksia demands a constant control of arterial pressure. All patients at purpose of this drug need to carry out monitoring of arterial pressure during the first 14 days of treatment. Also it is regularly recommended to exercise control of indicators of a condition of kidneys and a liver.

In case of increase in level of liver enzymes three times and more rather normal level drug needs to be cancelled.

Considering emergence of the increased risk of emergence of side effects because of increase in duration of reception it is regularly necessary to estimate need of extension of use of Arkoksia and a possibility of reduction of a dose.

It is forbidden to use drug together with other non-steroidal anti-inflammatory drugs.

The cover of drug contains lactose in a small amount – it should be considered at purpose of Arkoksia the patient with a lactose intolerance.

During treatment it is necessary to observe extra care at management of motor transport and occupation of potentially dangerous activity demanding concentration of attention and speed of psychomotor reactions. Persons at whom in the anamnesis episodes of dizzinesses, weaknesses are noted have to refrain from similar occupations.

Analogs of Arkoksia

Coincidence on the ATH code of the 4th level:

The only analog of Arkoksia containing etorikoksib is Eksinef (Spain/the Netherlands). Drugs the having similar structures and effects of active ingredient: Denebol, Dinastat, Ranseleks, Tselebreks and others. Price of analogs in most cases low prices of Arkoksia.

Zdravzona

  • Arkoksia of 60 mg No. 28 of a tablet
  • Arkoksia of 60 mg No. 7 of a tablet
  • Arkoksia of 90 mg No. 7 of a tablet
  • Arkoksia of 90 mg No. 28 of a tablet
  • Arkoksia of 120 mg No. 7 of a tablet

Drugstore of IFC

  • Arkoksia tbl p / about 90 mg No. 28, Merck Sharp & Dohmeniderlandy
  • Arkoksia tbl p / about 60 mg No. 28, Merck Sharp & Dohmeniderlandy
  • Arkoksia tbl p / about 120 mg No. 7, Merck Sharp & Dohmeniderlandy
  • Arkoksia tbl p / about 60 mg No. 7, Merck Sharp & Dohmeniderlandy
  • Arkoksia tbl p / about 90 mg No. 7, Merck Sharp & Dohmeniderlandy
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BIOSPHERE

  • Аркоксиа® 90 mg No. 28 tabl.p.p.o. Merck Sharp and Doum B. V. (Netherlands)
  • Аркоксиа® 120 mg No. 28 tabl.p.p.o. Merck Sharp and Doum B. V. (Netherlands)
  • Аркоксиа® 60 mg No. 28 tabl.p.p.o. Merck Sharp and Doum B. V. (Netherlands)
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Section: Anesthetics
in more detail

Education: Graduated from the Vitebsk state medical university majoring in "Surgery". At university headed Council of students' scientific society. Professional development in 2010 - in "Oncology" and in 2011 - in "A mammology, visual forms of oncology".

Experience: Work in an all-medical network 3 years the surgeon (The Vitebsk hospital of an emergency medical service, Lioznensky TsRB) and in combination the regional oncologist and the traumatologist. Work farm the representative within a year in the Rubicon company.

Provided 3 improvement suggestions on the subject "Optimization of an Antibioticotherapia depending on Species Composition of Microflora", 2 works took prizes in a republican competition review of student's scientific works (1 and 3 categories).
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