Arcoxia, 30 mg 28 pcs

NSAIDs. Etoricoxib is a selective COX-2 inhibitor, in therapeutic concentrations it blocks formation of prostaglandins and has anti-inflammatory, analgesic and antipyretic effects.

The selective inhibition of COX-2 by etoricoxib is accompanied by a decrease in the severity of clinical symptoms associated with the inflammatory process, with no effect on platelet function and the mucosa of the gastrointestinal tract.

Etoricoxib has a dose-dependent COX-2 inhibitory effect with no effect on COX-1 at daily doses up to 150 mg.

The drug has no effect on the production of prostaglandins in the gastric mucosa and bleeding time.

In the studies conducted, there was no reduction in arachidonic acid and platelet aggregation caused by collagen.

Indications

Osteoarthritis, Osteoarthritis, Rheumatoid arthritis, Gout, Arthritis

Symptomatic therapy for the following diseases and conditions:

• Osteoarthritis.
• Rheumatoid Arthritis.
• Ankylosing Spondylitis.
• Pain and inflammatory symptoms associated with acute gouty arthritis.

Therapy of moderate to severe acute pain after dental surgery.

Active ingredient

Etoricoxib

Composition

Active ingredient:

Etoricoxib 30 mg.

Associates:

Calcium hydrophosphate;

Cellulose microcrystalline;

Croscarmellose sodium;

Magnesium stearate.

Coating composition:

Opadray II Blue-Green 39K11526;

Carnauba wax.

The composition of the film coating:

Lactose monohydrate;

Hypromellose;

Titanium dioxide;

Tricetin;

Aluminum varnish based on indigo carmine dye (E132);

Iron oxide yellow dye (E172).

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How to take, the dosage

The drug is taken at the mouth, regardless of meals, with a small amount of water.

In osteoarthritis the recommended dose is 60 mg once daily. The daily dose in osteoarthritis should not exceed 60 mg.

In rheumatoid arthritis and ankylosing spondylitis the recommended dose is 90 mg once daily. The daily dose in rheumatoid arthritis and ankylosing spondylitis should not exceed 90 mg.

In acute gouty arthritis the recommended dose in the acute period is 120 mg once daily. The daily dose in acute gouty arthritis should not exceed 120 mg.

The duration of use of the drug in a dose of 120 mg is not more than 8 days. The minimum effective dose should be used for the shortest possible course.

The average therapeutic dose for pain syndrome is 60 mg once.

Acute pain after dental surgery: The recommended dose is 90 mg once daily. In the treatment of acute pain, the drug Arcoxia should be used only in the acute symptomatic period, limited to a duration of not more than 8 days. Daily dose for pain relief after dental surgery should not exceed 90 mg.

In patients with hepatic impairment (Child-Pugh score 5-9)it is recommended that the daily dose of 60 mg not be exceeded.

Interaction

Pharmacokinetic interaction

Lithium:There is evidence that non-selective NSAIDs and selective COX-2 inhibitors may increase the plasma concentration of lithium. This interaction should be taken into account when treating patients taking ARCOXIA concomitantly with lithium.

Methotrexate: Two studies examined the effects of ARCOXIA at doses of 60, 90, and 120 mg once daily for seven days in patients who received once-weekly methotrexate at doses of 7.5 to 20 mg for rheumatoid arthritis. ARCOXIA at doses of 60 and 90 mg had no effect on plasma concentrations (by AUC) and renal clearance of methotrexate. In one study, ARCOXIA at a dose of 120 mg had no effect on the plasma concentration (AUC) and renal clearance of methotrexate. In another study, ARCOXIA at a dose of 120 mg increased plasma concentration of methotrexate by 28% (AUC) and decreased renal clearance of methotrexate by 13%. When concomitant administration of ARCOXIA in doses above 90 mg per day and methotrexate, the possible occurrence of toxic effects of methotrexate should be monitored.

Peroral contraceptives: Taking ARCOXIA at a dose of 120 mg with oral contraceptives containing 35 mcg ethinylestradiol (EE) and 0.5 to 1 mg of norethindrone for 21 days simultaneously or 12 hours apart increases the steady-state AUC0-24h for EE by 50-60%. However, norethisterone concentrations are not usually increased to a clinically significant degree. This increase in EE concentration should be taken into account when choosing an appropriate oral contraceptive for concomitant use with ARCOXIA. Such a fact may lead to an increased incidence of thromboembolism, due to an increase in EE exposure. No significant pharmacokinetic interaction with glucocorticosteroids was found.

Digoxin:toricoxib has no effect on equilibrium AUC0-24h or elimination of digoxin. However, etoricoxib increases Cmax (by an average of 33%), which may be important in the development of digoxin overdose.

Rifampicin:Concomitant administration of ARCOXIA and rifampicin, a potent inducer of hepatic metabolism, results in a 65% decrease in plasma AUC for etoricoxib. This interaction should be considered when concomitant administration of ARCOXIA with rifampicin.

Antacids and ketoconazole (potent CYP3A4 inhibitor) have no clinically significant effect on the pharmacokinetics of ARCOXIA.

Pharmacodynamic interaction

Orderal anticoagulants (warfarin): In patients receiving warfarin, administration of ARCOXIA at a dose of 120 mg daily was accompanied by an approximately 13% increase in International Normalized Ratio (MHO) prothrombin time. In patients receiving warfarin or similar medications, MHO values should be monitored at the time of initiation or modification of ARCOXIA treatment, particularly in the first few days.

Diuretics, angiotensin-converting enzyme (ACE) inhibitors: There are reports that non-selective NSAIDs and selective COX-2 inhibitors may weaken the hypotensive effect of ACE inhibitors. This interaction should be taken into account when treating patients taking ARCOXIA simultaneously with ACE inhibitors. In patients with impaired renal function (e.g., in dehydration or elderly patients) this combination may aggravate functional renal failure.

Acetylsalicylic acid: ARCOXIA can be used simultaneously with low-dose acetylsalicylic acid intended for the prevention of cardiovascular disease. However, concomitant administration of low-dose acetylsalicylic acid and ARCOXIA may result in an increased incidence of gastrointestinal ulcers and other complications compared to administration of ARCOXIA alone. In equilibrium, etoricoxib at a dose of 120 mg once daily has no effect on the antiplatelet activity of acetylsalicylic acid at low doses (81 mg daily). The drug does not replace the prophylactic effect of acetylsalicylic acid in cardiovascular diseases.

Cyclosporine and tacrolimus increase the risk of nephrotoxicity when taking the drug.

Special Instructions

The administration of the drug ARCOXIA requires close monitoring of blood pressure. All patients should have their blood pressure monitored during the first two weeks of treatment and periodically thereafter.

Hepatic and renal function parameters should also be monitored regularly. In case of a 3-fold or more increase in the level of “hepatic” transaminases relative to the upper limit of normal, the drug should be discontinued.

With increasing risk of adverse effects with increasing duration of use, the need to continue the drug and the possibility of reducing the dose should be periodically assessed.

The drug should not be used simultaneously with other NSAIDs.

The use of the drug may adversely affect female fertility and is not recommended for women planning to become pregnant.

The coating of the drug ARCOXIA contains a small amount of lactose, which must be taken into account when prescribing the drug to patients with lactase deficiency.

When using the drug, caution must be exercised while driving and engaging in other potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Patients who have had episodes of dizziness, drowsiness, or weakness should refrain from activities that require concentration.

Contraindications

• Erolytic and ulcerative changes of the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding.
• Complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis and intolerance to acetylsalicylic acid and other NSAIDs (including a history of intolerance).
• Inflammatory bowel disease (Crohn’s disease, non-specific ulcerative colitis) in the acute phase.
• Hemophilia and other blood clotting disorders.
• Developed heart failure (NYHA functional class II-IV).
• Developed liver failure (greater than 9 points on the Child-Pugh scale) or active liver disease.
• Severe renal failure (CKR less than 30 ml/min), advanced renal disease, confirmed hyperkalemia.
• Period after coronary artery bypass grafting; peripheral artery disease, cerebrovascular disease, clinically significant CHD.
• Persistent BP greater than 140/90 mm Hg in uncontrolled arterial hypertension
• Pregnancy.
• Period of lactation (breastfeeding).
• Children under 16 years of age.
• High sensitivity to any component of the drug.

With caution: the drug is used in patients with history of gastrointestinal ulcers, Helicobacter pylori infection, elderly patients, patients with prolonged use of NSAIDs, frequent alcohol consumption, severe somatic diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, arterial hypertension, edema and fluid retention, smoking, patients with IQ <60 ml/min, concomitant therapy with the following medicinal agents anticoagulants (e.g., warfarin), antiaggregants (e.g., acetylsalicylic acid, clopidogrel), GCS (e.g., prednisolone), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

Side effects

Nervous system disorders:often – headache, dizziness, weakness; infrequently – taste disorders, drowsiness, sleep disorders, sensory disturbances, including paresthesia/hyperesthesia, anxiety, depression, concentration disorders, very rarely – hallucinations, confusion.

Digestive system disorders: often – epigastric pain, nausea, diarrhea, dyspepsia, flatulence; infrequent – bloating, belching, increased peristalsis, constipation, dry oral mucosa, gastritis, gastric or 12 duodenal ulcer, irritable bowel syndrome, esophagitis, oral mucosa ulcers, vomiting; very rare – GI ulcers (with bleeding or perforation).

Hepatobiliary system disorders:very rarely – hepatitis.

Sensory system disorders: infrequent – blurred vision, conjunctivitis, tinnitus, vertigo.

Urinary system disorders: infrequent – proteinuria; very rare – renal failure, usually reversible upon discontinuation of the drug.

Allergic reactions:very rarely – anaphylactic/anaphylactoid reactions, including marked decrease in blood pressure and shock;

Cardiovascular system disorders: often – palpitations, increased BP; infrequent – flushes, impaired cerebral circulation, atrial fibrillation, congestive heart failure, nonspecific ECG changes; myocardial infarction, very rare – hypertensive crisis.

In the respiratory system: infrequent – cough, dyspnea, nasal bleeding; very rare – bronchospasm.

Skin disorders:often – ecchymoses; infrequently – facial swelling, skin itching, rash; very rarely – urticaria, Stevens-Johnson syndrome, Lyell syndrome.

Infections: infrequent – gastroenteritis, infections of the upper respiratory tract, urinary tract.

Muscular system disorders:infrequent – muscle cramps, arthralgia, myalgia.

Metabolic disorders:often – edema, fluid retention; infrequently – changes in appetite, weight gain.

Others:often – flu-like syndrome; infrequently – chest pain.

Results of laboratory tests: often – increased “hepatic” transaminases; infrequent – increased nitrogen in blood and urine, increased creatine phosphokinase activity, decreased hematocrit, decreased hemoglobin, hyperkalemia, leukopenia, thrombocytopenia, increased serum creatinine, increased uric acid; rare – increased serum sodium.

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Overdose

Symptoms:In case of overdose of the drug, adverse effects on the gastrointestinal tract, cardiovascular system and kidneys may occur.

Treatment:Symptomatic therapy is carried out. Etoricoxib is not excreted by hemodialysis, excretion of the drug in peritoneal dialysis has not been studied.

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Similarities

Kostarox, Atorika tablets, Bixitor, Etoricoxib-Teva