Arcoxia (etoricoxib) 90mg 28 tablets — Made in Netherlands — Free Delivery

Product description

Arcoxia tablets are used for the following indications:

• symptomatic therapy for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, as well as pain and signs of inflammation associated with acute gouty arthritis;
• short-term treatment of moderate postoperative pain associated with dental surgery.

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

Structure

Active substance: etoricoxib;

1 tablet contains 30 mg, 60 mg, 90 mg or 120 mg etoricoxib;

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

Tablet shell dye Opadray® II blue-green 39K11526 (for a dosage of 30 mg), Opadray® II green 39K11520 (for a dosage of 60 mg), Opadray® II white 39K18305 (for a dosage of 90 mg), Opadray® II green 39K11529 (for a dosage of 120 mg), carnauba wax;

Composition of the dye Opadray® II blue-green 39K11526, Opadray® II green 39K11520, Opadray® II green 39K11529: lactose monohydrate, hypromellose; titanium dioxide (E 171) triacetin; indigo (E 132) iron oxide yellow (E172);

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

Contraindications

The preparation Arcoxia is contraindicated:

• with hypersensitivity to the active or any auxiliary substance of the preparation;
• with active peptic ulcer or active gastrointestinal bleeding;
• patients who develop bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria or other allergic reactions after using acetylsalicylic acid or NSAIDs, including COX-2 inhibitors (cyclooxyhexanase-2);
• during pregnancy and lactation;
• with severe liver dysfunction (serum albumin <25 g / l or ≥ 10 points on the Child-Pugh scale);
• if the calculated renal creatinine clearance is <30 ml / minute;
• children under 16;
• with inflammatory bowel diseases;
• with congestive heart failure (NYHA II-IV);
• patients with arterial hypertension, whose blood pressure indicators are constantly above 140/90 mm Hg and are not sufficiently controlled;
• with diagnosed coronary heart disease, peripheral arterial disease and / or cerebrovascular disease.

Mode of application

The preparation is administered orally. The preparation can be taken with or without food. The onset of the preparations effect occurs faster when taken before meals. This should be taken into account when it is necessary to quickly relieve symptoms.

Since the risk of cardiovascular disorders with the use of etoricoxib increases with increasing dose and duration of exposure, short courses of treatment should be carried out using the most effective daily doses. The need for symptom relief and the response to treatment should be periodically re-evaluated, especially in patients with osteoarthritis.

Application features

Pregnant

Etoricoxib is contraindicated during pregnancy. If a woman becomes pregnant during treatment, etoricoxib should be discontinued.

Children

Etoricoxib is contraindicated in children under 16 years of age.

Drivers

Patients who experience dizziness, vertigo or drowsiness while using etoricoxib should not drive vehicles or operate other mechanisms.

Overdose

In clinical studies, the use of a single dose of etoricoxib up to 500 mg or repeated administration of up to 150 mg per day for 21 days did not produce significant toxic effects. Acute overdose of etoricoxib has been reported, although in most cases no adverse reactions have been reported. Adverse reactions, which were more common, were consistent with the safety profile of etoricoxib (eg, gastrointestinal, cardiac, and renal reactions).

In case of an overdose, it is advisable to take the usual supportive measures, for example, removing the unabsorbed preparation from the gastrointestinal tract, conducting clinical observation, and, if necessary, carrying out supportive treatment.

Etricoxib is not excreted during hemodialysis; it is not known whether the preparation is excreted during peritoneal dialysis.

Side effects

Metabolic and nutritional disorders: often (≥ 1/100, <1/10) - edema / fluid retention.

From the nervous system: often (≥ 1/100, <1/10) - dizziness, headache.

From the side of the heart: often (≥ 1/100, <1/10) - palpitations, arrhythmia.

From the vascular system: often (≥ 1/100, <1/10) - hypertension.

From the respiratory system, chest and mediastinum: often (≥ 1/100, <1/10) - bronchospasm.

From the gastrointestinal tract: very often (≥ 1/10) - abdominal pain; often (≥ 1/100, <1/10) - constipation, flatulence, gastritis, heartburn / acid reflux, diarrhea, dyspepsia / epigastric discomfort, nausea, vomiting, esophagitis, oral ulcers.

On the part of the digestive system: often (≥ 1/100, <1/10) - an increase in ALT, an increase in AST.

On the part of the skin and subcutaneous tissue: often (≥ 1/100, <1/10) - ecchymosis.

Violations of the general condition and disorders associated with the method of administration: often (≥ 1/100, <1/10) - asthenia / fatigue, flu-like symptoms.

Interaction

Voriconazole and miconazole. Concomitant use of oral voriconazole or miconazole oral gel for topical use (potent CYP3A4 inhibitors) with Etoricoxib caused a slight increase in Etoricoxib exposure, which, however, was not considered clinically significant according to published data.

Rifampicin. The simultaneous administration of etoricoxib and rifampicin (a powerful inducer of CYP enzymes) led to a decrease in the concentration of etoricoxib in blood plasma by 65%. This may be accompanied by a recurrence of symptoms when used concomitantly with Etoricoxib. While such data may indicate a need for dose escalation, it is not recommended to use etoricoxib in doses exceeding those indicated for each indication, since the combined use of rifampicin and etoricoxib at such doses has not been studied.

Storage conditions

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

Shelf life is 3 years.