Arcoxia 120 mg №7

Symptomatic therapy for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, as well as pain and inflammation associated with acute gouty arthritis.

Short-term treatment of moderate postoperative pain associated with dental surgery.

The decision to designate a selective COX-2 inhibitor should be based on an assessment of all individual risks in the patient.

Arcoxia® is used orally. The drug can be taken regardless of food intake. The onset of the effect of the drug comes faster when fasting. This should be taken into account when necessary to quickly relieve symptoms.

As the risk of cardiovascular system disorders with etoricoxib increases with dose and duration of exposure, the shortest courses of treatment should be given when using the lowest effective daily doses. The need for symptomatic relief and response to treatment, especially in patients with osteoarthritis, should be periodically reassessed.

Osteoarthritis

The recommended dose is 30 mg once a day. In some patients, with insufficient relief of symptoms, increasing the dose to 60 mg once daily may increase efficacy. In the absence of an improvement in the effect, other possible treatments should be considered.

Rheumatoid arthritis

The recommended dose is 60 mg once a day. In some patients, with insufficient reduction of symptoms, increasing the dose to 90 mg once daily may improve the therapeutic effect. When achieving clinical stabilization of the patient, it is advisable to reduce the dose to 60 mg once a day. In the absence of an improvement in the effect, other possible treatments should be considered.

Ankylosing spondylitis

The recommended dose is 60 mg once a day. In some patients, with insufficient reduction of symptoms, increasing the dose to 90 mg once daily may improve the therapeutic effect. When achieving clinical stabilization of the patient, it is advisable to reduce the dose to 60 mg once a day. In the absence of an improvement in the effect, other possible treatments should be considered.

Acute pain

In the case of acute pain, etoricoxib is used only during the acute symptomatic period.

Acute gouty arthritis

The recommended dose is 120 mg once a day. In clinical studies of acute gouty arthritis, etoricoxib was administered for 8 days.

Post-operative pain associated with dental surgery Recommended dose - 90 mg once a day for a maximum of 3 days. For some patients, additional postoperative anesthesia may be required.

Doses in excess of those recommended for each indication are either not effective or have not been studied. So:

• The dose for osteoarthritis should not exceed 60 mg per day.
• The dose for rheumatoid arthritis and ankylosing spondylitis should not exceed 90 mg per day.
• Acute gout dose should not exceed 120 mg per day for a maximum treatment period of 8 days.
• The dose for acute pain after dental surgery should not exceed 90 mg per day for a maximum of 3 days.

Elderly patients

No dosage adjustment is necessary for elderly patients. As with other drugs, the drug should be administered with caution to elderly patients.

Disorders of the liver

Regardless of the indication, patients with impaired hepatic function (5‒6 points on the Child ’Pew scale) should not exceed 60 mg once daily. Patients with moderate-to-severe hepatic impairment (7–9 points on the Child-Pew scale) should not exceed the 30 mg dose once daily, regardless of indication.

Clinical experience is limited, especially in patients with impaired hepatic function, so the drug should be administered with caution. No clinical experience in the use of the drug in patients with severe hepatic impairment (≥10 points on Child and Pew scale); therefore, the drug is contraindicated in such patients.

Impairment of kidney function

No dose adjustment is required for patients with creatinine clearance ≥30 ml / min. The use of etoricoxib in patients with creatinine clearance <30 ml / min is contraindicated.

Arcoxia® is contraindicated for:

• hypersensitivity to the active substance or to any of the excipients;
• patients with active peptic ulcer or active gastrointestinal bleeding;
• patients who have bronchospasm, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic reactions following the use of acetylsalicylic acid or NSAIDs, including COX-2 inhibitors (cyclooxyhexanase-2);
• during pregnancy and lactation;
• for severe liver dysfunction (serum albumin <25 g / l or ≥10 points on a Child ‒ Pew scale);
• if renal creatinine clearance <30 ml/min is calculated;
• children under 16;
• inflammatory bowel diseases;
• congestive heart failure (NYHA II ‒ IV);
• patients with hypertension in whom blood pressure is constantly higher than 140/90 mm Hg. Art. and insufficiently controlled;
• diagnosed with ischemic heart disease, peripheral artery disease and / or cerebrovascular disease.

Active substance: etoricoxib;

1 tablet contains 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib.

Excipients: calcium anhydrous phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Tablet cover: Opadray® II color blue-green 39K11526 (for dosage of 30 mg), Opadray® II green 39K11520 (for dosage of 60 mg), Opadray® II white 39K18305 (for dosage of 90 mg), Opadray® II green 39K11529 (for dosage 120 mg), Carnauba wax.

Composition of dye Opadray® II blue-green 39K11526, Opadray® II green 39K11520, Opadray® II green 39K11529: lactose, monohydrate; hypromellose; titanium dioxide (E 171); triacetin; indigocarmine (E 132); yellow iron oxide (E 172).

Composition of the dye Opadray® II white 39K18305: lactose, monohydrate; hypromellose; titanium dioxide (E 171); triacetin.

Tablets coated with a film sheath.

Basic physical and chemical properties:

60 mg tablets: apple-shaped biconvex tablets, film coated in dark green, engraved <200> on one side and <ARCOXIA 60> on the other.

90 mg tablets: Apple-shaped biconvex tablets coated with white film, engraved <202> on one side and <ARCOXIA 90> on the other.

120 mg tablets: apple-shaped biconvex tablets, film coated in pale green, engraved <204> on one side and <ARCOXIA 120> on the other.

Store in the original package at a temperature not exceeding 30°C out of the reach of children.

Merck Sharp & Dohme B.V., the Netherlands.

№1438 from 24.06.2019

UA/10704/01/03