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

Symptomatic treatment of the following diseases and conditions:

Osteoarthritis.
Rheumatoid arthritis.
Ankylosing spondylitis.
Pain and inflammatory symptoms associated with acute gouty arthritis.

Treatment of moderate and severe acute pain after dental surgery.

Pharmacological effect

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

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

Etoricoxib has a dose-dependent effect of inhibiting COX-2, without affecting COX-1 at a daily dose of up to 150 mg.

The drug does not affect the production of prostaglandins in the gastric mucosa and bleeding time.

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

Special instructions

Taking the drug ARKOXIA requires careful monitoring of blood pressure. When prescribing the drug, all patients should have their blood pressure monitored during the first two weeks of treatment and periodically thereafter.

Liver and kidney function tests should also be regularly monitored. If the level of “liver” transaminases increases by 3 times or more relative to the upper limit of normal, the drug should be discontinued.

Given the increasing risk of adverse effects with increasing duration of use, it is necessary to periodically evaluate the need to continue taking the drug and the possibility of reducing the dose.

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 pregnancy.

The shell of the drug ARKOXIA contains lactose in small quantities, which should be taken into account when prescribing the drug to patients with lactase deficiency.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Patients who have experienced episodes of dizziness, drowsiness or weakness should refrain from activities requiring concentration.

Active ingredient

Etoricoxib

Composition

Active ingredient:

Etoricoxib 30 mg.

Excipients:

Calcium hydrophosphate;

Microcrystalline cellulose;

Croscarmellose sodium;

Magnesium stearate.

Shell composition:

Opadry II Blue-green 39K11526;

Carnauba wax.

Film shell composition:

Lactose monohydrate;

Hypromellose;

Titanium dioxide;

Triacetin;

Aluminum varnish based on indigo carmine dye (E132);

Iron oxide yellow dye (E172).

Contraindications

Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding, cerebrovascular or other bleeding.
Complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history).
Inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase.
Hemophilia and other bleeding disorders.
Severe heart failure (II-IV functional classes according to the NYHA classification).
Severe liver failure (more than 9 points on the Child-Pugh scale) or active liver disease.
Severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, confirmed hyperkalemia.
The period after coronary artery bypass surgery; peripheral arterial diseases, cerebrovascular diseases, clinically significant ischemic heart disease.
Persistent blood pressure values ​​exceeding 140/90 mmHg. Art. with uncontrolled arterial hypertension.
Pregnancy.
Lactation period (breastfeeding).
Children’s age up to 16 years.
Hypersensitivity to any component of the drug.

With caution: use the drug in the presence of anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, Helicobacter pylori infection, in the elderly, in patients who have been using NSAIDs for a long time, frequently drinking alcohol, with severe somatic diseases, dyslipidemia/hyperlipidemia, with diabetes mellitus, arterial hypertension, edema and fluid retention, smoking, in patients with creatinine clearance less than 60 ml/min, with concomitant therapy the following medications: anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), corticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Side Effects

From the nervous system: often – headache, dizziness, weakness; uncommon – taste disturbance, drowsiness, sleep disturbances, sensory disturbances, incl. paresthesia/hyperesthesia, anxiety, depression, concentration problems, very rarely – hallucinations, confusion.

From the digestive system: often – epigastric pain, nausea, diarrhea, dyspepsia, flatulence; uncommon – bloating, belching, increased peristalsis, constipation, dry oral mucosa, gastritis, ulcer of the gastric or duodenal mucosa, irritable bowel syndrome, esophagitis, ulcers of the oral mucosa, vomiting; very rarely – gastrointestinal ulcers (with bleeding or perforation).

From the hepatobiliary system: very rarely – hepatitis.

From the senses: infrequently – blurred vision, conjunctivitis, tinnitus, vertigo.

From the urinary system: infrequently – proteinuria; very rarely – renal failure, usually reversible when the drug is discontinued.

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

From the cardiovascular system: often – palpitations, increased blood pressure; uncommon – hot flashes, cerebrovascular accident, atrial fibrillation, congestive heart failure, nonspecific ECG changes; myocardial infarction, very rarely – hypertensive crisis.

From the respiratory system: infrequently – cough, shortness of breath, nosebleeds; very rarely – bronchospasm.

From the skin: often – ecchymosis; infrequently – swelling of the face, itching, rash; very rarely – urticaria, Stevens-Johnson syndrome, Lyell’s syndrome.

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

From the musculoskeletal system: infrequently – muscle cramps, arthralgia, myalgia.

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

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

Laboratory test results: often – increased liver transaminases; uncommon – increased nitrogen in the blood and urine, increased creatine phosphokinase activity, decreased hematocrit, decreased hemoglobin, hyperkalemia, leukopenia, thrombocytopenia, increased serum creatinine, increased uric acid; rarely – increased sodium in the blood serum.

Interaction

Pharmacokinetic interaction

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

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

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

Digoxin: etoricoxib does not affect the steady-state AUC0-24h or the elimination of digoxin. At the same time, 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 the plasma AUC of etoricoxib. This interaction should be taken into account when ARCOXIA is co-administered with rifampicin.

Antacids and ketoconazole (a potent inhibitor of CYP3A4) do not have a clinically significant effect on the pharmacokinetics of ARKOXIA.

Pharmacodynamic interaction

Oral anticoagulants (warfarin): In patients receiving warfarin, ARCOXIA 120 mg daily was associated with an approximately 13% increase in International Normalized Ratio (INR) prothrombin time. In patients receiving warfarin or similar drugs, MHO levels should be monitored when starting or changing treatment for ARCOXIA, especially in the first few days.

Diuretics, angiotensin-converting enzyme (ACE) inhibitors: There are reports that non-selective NSAIDs and selective COX-2 inhibitors may reduce the hypotensive effect of ACE inhibitors. This interaction should be taken into account when treating patients taking ARCOXIA concomitantly with ACE inhibitors. In patients with impaired renal function (for example, with dehydration or in old age), such a combination may aggravate renal failure.

Acetylsalicylic acid: ARKOXIA can be used simultaneously with acetylsalicylic acid in low doses, intended for the prevention of cardiovascular diseases. However, simultaneous administration of low doses of acetylsalicylic acid and ARCOXIA may lead to an increase in the incidence of gastrointestinal ulcers and other complications compared to taking ARCOXIA alone. At steady state, etoricoxib 120 mg once daily has no effect on the antiplatelet activity of low-dose acetylsalicylic acid (81 mg daily). The drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

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

Overdose

Symptoms: in case of an overdose of the drug, undesirable effects from the gastrointestinal tract, cardiovascular system and kidneys may occur.

Treatment: carry out symptomatic therapy. Etoricoxib is not eliminated by hemodialysis; elimination of the drug by peritoneal dialysis has not been studied.

Manufacturer

Rovi Pharma Industrial Services S.A., Spain