Arcoxia (etoricoxib) coated tablets 60 mg. №7

active ingredient : etoricoxib;

1 tablet contains 60 mg etoricoxib;

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

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

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

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

Film-coated tablets.

Basic physical and chemical properties:

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

Non-steroidal anti-inflammatory drugs. Coxibs. ATX code M01A H05.

Mechanism of action

Etoricoxib 60 is an oral selective cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range.

In clinical pharmacology studies, Arcoxia® dose-dependently inhibited COX-2 without COX-1 inhibition at doses up to 150 mg per day. Etoricoxib does not inhibit gastric prostaglandin synthesis and does not affect platelet function.

Cyclooxygenase is responsible for the formation of prostaglandins. Two isoforms have been identified, COX-1 and COX-2. COX-2 is an isoform of the enzyme, is induced by the proinflammatory impulse and is considered as the main factor responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. COX-2 is also involved in the processes of ovulation, implantation and closure of the arterial duct, regulation of kidney and central nervous system function (induction of fever, pain sensation, cognitive function). It may also be involved in the healing process of ulcers. COX-2 has been identified in the tissue surrounding human gastric ulcers, but significance for ulcer healing has not been established.

Efficiency

In patients with osteoarthritis, etoricoxib 60 mg once daily significantly improved pain and the patient’s assessment of disease status. These positive effects were observed already on the second day of treatment and persisted for up to 52 weeks. In studies using etoricoxib 30 mg once daily, the efficacy of this drug exceeded placebo for 12 weeks of treatment (estimates used in other studies were used). In a dose titration study, etoricoxib 60 mg showed a significantly greater improvement than 30 mg for all 3 primary endpoints after 6 weeks of treatment. The 30 mg dose has not been studied in osteoarthritis of the hand.

In patients with rheumatoid arthritis, etoricoxib 60 mg and 90 mg once daily significantly improved pain, inflammation, and mobility. In studies evaluating doses of 60 mg and 90 mg, positive effects were maintained during the 12-week treatment period. In a dose evaluation study of 60 mg versus 90 mg, both doses of etoricoxib, 60 mg once daily and 90 mg once daily, were more effective than placebo. The 90 mg dose was more effective than the 60 mg dose according to the Total Patient Pain Assessment method (0-100 mm visual analog scale), with a mean improvement of -2.71 mm (95% CI: -4.98 mm, -0. 45 mm).

In patients with acute gouty arthritis attacks, etoricoxib 120 mg once daily for 8 days improved moderate to severe joint pain and inflammation compared with indomethacin 50 mg three times daily. A decrease in the severity of pain is observed within 4 hours after the start of treatment.

In patients with ankylosing spondylitis, etoricoxib 90 mg once daily provides significant improvement in spinal pain, inflammation, movement limitation, and functional capacity. The clinical benefits of etoricoxib were observed on the second day after initiation of therapy and were maintained throughout the 52-week treatment period. In a second study evaluating a 60 mg dose versus a 90 mg dose, etoricoxib 60 mg once daily and 90 mg once daily showed similar efficacy compared to naproxen 1000 mg daily. In patients who did not respond adequately to a dose of 60 mg daily for 6 weeks, increasing the dose to 90 mg daily improved the assessment of back pain intensity (0-100 mm visual analog scale) compared with continuing to take 60 mg daily,

In a clinical study of postoperative toothache, etoricoxib 90 mg was administered once daily for up to three days. In the subgroup of patients with moderate pain at baseline, etoricoxib 90 mg had an analgesic effect similar to that of ibuprofen 600 mg (16.11 vs 16.39; P = 0.722) and was superior to that of paracetamol/codeine 600 mg/60 mg ( 11.00; P<0.001) and placebo (6.84; P<0.001), as defined by total pain relief in 6 hours (TOPAR6). The proportion of patients who reported using rescue medication within 24 hours was 40.8% in the etoricoxib 90 mg group, 25.5% in the ibuprofen 600 mg every 6 hours group, and 46.7% in the paracetamol / codeine 600 mg/60 mg every 6 hours compared to 76.2% of patients taking a placebo. In this study, the onset of analgesic action (appreciable pain relief) of 90 mg etoricoxib was observed as early as 28 minutes after dosing.