Arcoxia pills 30mg 28pcs

Composition

Active ingredient:

Etoricoxib 30 mg.

Auxiliary substances:

Calcium hydrophosphate;

Microcrystalline cellulose;

Croscarmellose sodium;

Magnesium stearate.

Shell composition:

Opadray II Blue-green 39 K 11526;

Carnauba wax.

Composition of the film shell:

Lactose monohydrate;

Hypromellose;

Titanium dioxide;

Triacetin;

Aluminum varnish based on indigo carmine dye (E 132);

Iron oxide yellow dye (E 172).

Pharmacological action

of NSAIDs. Etoricoxib is a selective COX-2 inhibitor, blocks the formation of prostaglandins in therapeutic concentrations, 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 hm effect of COX-2 inhibition, without affecting COX-1 when used at a daily dose of up to 150 mg.

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

In the conducted studies, there was no decrease in arachidonic acid levels 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 to severe acute pain after dental surgery.

Contraindications

• Erosive and ulcerative changes in the gastric or duodenal mucosa, 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 in the anamnesis).
• Inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase.
• Hemophilia and other blood clotting disorders.
• Severe heart failure (NYHA functional classes II-IV).
• Severe liver failure (more than 9 points on the Child-Pugh scale) or active liver disease.
• Severe renal insufficiency (creatinine clearance less than 30 ml / min), progressive kidney disease, confirmed hyperkalemia.
• Period after coronary artery bypass grafting; peripheral artery diseases, cerebrovascular diseases, clinically pronounced coronary heart disease.
• Persistent BP values exceeding 140/90 mm Hg in patients with uncontrolled arterial hypertension.
• Pregnancy.
• The period of lactation (breastfeeding).
• Children under 16 years of age.
• 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 used NSAIDs for a long time, often use 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 with the following drugs: anticoagulants (for example antiplatelet agents (e. g., acetylsalicylic acid, clopidogrel), corticosteroids (e. g., prednisone), 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, sensitivity disorders, including paresthesia/hyperesthesia, anxiety, depression, concentration disorders, very rarely – hallucinations, confusion.

From the digestive system: often, epigastric pain, nausea, diarrhea, dyspepsia, flatulence; rarely, bloating, belching, increased peristalsis, constipation, dryness of the mucous membrane of the mouth, gastritis, ulcer of the mucous membrane of the stomach or duodenum 12, irritable bowel syndrome, esophagitis, ulcers of the mucous membrane of the mouth, vomiting; rarely – gastrointestinal ulcers (bleeding or perforation).

From the side of the hepatobiliary system:  very rarely – hepatitis.

From the side of 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; infrequently-hot flashes, impaired cerebral circulation, atrial fibrillation, congestive heart failure, non-specific ECG changes; myocardial infarction, very rarely-hypertensive crisis.

Respiratory system disorders: infrequently-cough, shortness of breath, nosebleeds; very rarely – bronchospasm.

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

Infections: infrequently-gastroenteritis, upper respiratory tract infections, urinary tract infections.

Musculoskeletal disorders: infrequently-muscle cramps, arthralgia, myalgia.

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

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

Results of laboratory tests: often-an increase in “hepatic” transaminases; infrequently-an increase in nitrogen in the blood and urine, an increase in creatine phosphokinase activity, a decrease in hematocrit, a decrease in hemoglobin, hyperkalemia, leukopenia, thrombocytopenia, an increase in serum creatinine, an increase in uric acid; rarely-an increase in serum sodium.

Interaction

Pharmacokinetic interaction

Lithium: There is evidence that non-selective NSAIDs and selective COX-2 inhibitors can increase the concentration of lithium in plasma. 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 treated with 7.5 to 20 mg methotrexate once weekly for rheumatoid arthritis. ARCOXIA at doses of 60 and 90 mg did not affect the plasma concentration (AUC) and renal clearance of methotrexate. In one study, ARCOXIA 120 mg had no effect on plasma concentrations (AUC) and renal clearance of methotrexate. In another study, ARCOXIA 120 mg increased the concentration of methotrexate in plasma by 28% (AUC) and reduced the renal clearance of methotrexate by 13%. Concomitant use of ARCOXIA at doses above 90 mg per day and methotrexate should be monitored for possible toxic effects of methotrexate.

Oral contraceptives:  taking ARCOXIA 120 mg with an oral contraceptive containing 35 mcg of ethinyl estradiol (EE) and 0.5 to 1 mg of norethindrone for 21 days, simultaneously or with a difference of 12 hours, increases the inpatient AUC0-24 hours for EE by 50-60%. However, the concentration of norethisterone usually does not increase to a clinically significant degree. This increase in EE concentration should be taken into account when selecting an appropriate oral contraceptive for concomitant use with ARCOXIA. This fact can lead to an increase in the frequency of thromboembolism, due to increased EE exposure. No significant pharmacokinetic interaction with glucocorticosteroids was found.

Digoxin: etoricoxib does not affect steady-state AUC0-24 h or digoxin elimination. However, etoricoxib increases Cmax (by an average of 33%), which may be important in the development of digoxin overdose.

Rifampicin: Concomitant use of ARCOXIA and rifampicin, a potent inducer of hepatic metabolism, resulted in a 65% reduction in plasma AUC for etoricoxib. This interaction should be considered when ARCOXIA is co-administered with rifampicin.

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

of ARCOXIA.

Oral anticoagulants (warfarin): In patients receiving warfarin, ARCOXIA 120 mg daily was associated with an increase of approximately 13% in the International Normalized Ratio (MHO) of prothrombin time. In patients receiving warfarin or similar medications, MHO values should be monitored at the time of initiation or modification of ARCOXIA treatment, especially in the first few days.

Diuretics, angiotensin converting enzyme (ACE)inhibitors:  Non-selective NSAIDs and selective COX-2 inhibitors have been reported to weaken the antihypertensive 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 the elderly), such a combination may worsen the functional insufficiency of the kidneys.

Acetylsalicylic Acid: ARCOXIA can be used simultaneously with acetylsalicylic acid in low doses, intended for the prevention of cardiovascular diseases. However, concomitant use of low doses of acetylsalicylic acid and ARCOXIA may lead to an increased incidence of gastrointestinal ulceration and other complications compared to taking ARCOXIA alone. At steady state, etoricoxib 120 mg once daily had 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.

How to take, course of use and dosage

The drug is taken orally, regardless of food intake, with a small amount of water.

In osteoarthritis, the recommended dose is 60 mg 1 time/day. The daily dose for osteoarthritis should not exceed 60 mg.

For rheumatoid arthritis and ankylosing spondylitis, the recommended dose is 90 mg once a day. The daily dose for rheumatoid arthritis and ankylosing spondylitis should not exceed 90 mg.

In acute gouty arthritis, the recommended dose in the acute period is 120 mg 1 time/day. The daily dose for acute gouty arthritis should not exceed 120 mg.

The duration of use of the drug in a dose of 120 mg is no more than 8 days. The minimum effective dose should be used in 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 1 time/day. In the treatment of acute pain, Arcoxia should be used only in the acute symptomatic period, limited to a maximum of 8 days. The daily dose for pain relief after dental surgery should not exceed 90 mg.

In patients with hepatic insufficiency (5-9 points on the Child-Pugh scale), it is recommended not to exceed the daily dose of 60 mg.

Overdose

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

Treatment: conduct symptomatic therapy. Etoricoxib is not eliminated by hemodialysis, and elimination of the drug by peritoneal dialysis has not been studied.

Special instructions

Taking the drug ARCOXIA requires careful monitoring of blood pressure. All patients who are prescribed the drug should be monitored for blood pressure during the first two weeks of treatment and periodically thereafter.

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

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

Do not use the drug simultaneously with other NSAIDs.

The use of the drug may negatively affect female fertility and is not recommended for women planning pregnancy.

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

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

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

Form of production

Film-coated tablets.

Active ingredient

Etoricoxib

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as prescribed by a doctor, Children over 16 years of age, Children as prescribed by a doctor

Indications

Arthritis, Osteoarthritis, Gout, Osteoarthritis, Rheumatoid Arthritis