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Etoricoxib (Etorelex) 90 mg – [7 tablets]

$12.42

Nsaids

SKU: 63468 Category:

Description

Etorelex Pharmacodynamics
When administered orally at therapeutic concentrations, etoricoxib is a selective inhibitor of cyclooxygenase-2 (COX-2). In clinical pharmacological studies, etoricoxib inhibited COX-2 in a dose-dependent manner, with no effect on COX-1 at a daily dose up to 150 mg. The drug Etorelex does not inhibit the synthesis of prostaglandins in the gastric mucosa and does not affect platelet function.
Cyclooxygenase is responsible for formation of prostaglandins. Two isoforms of cyclooxygenase, COX-1 and COX-2, have been isolated. COX-2 is an isoenzyme that is induced by various proinflammatory mediators and is considered the main enzyme responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. COX-2 is involved in the processes of ovulation, implantation and closure of the arterial duct, renal and CNS function (fever induction, pain sensation, cognitive function), and may also play a role in the healing of ulcers. COX-2 has been detected in the tissues surrounding gastric ulcers in humans, but its importance in ulcer healing has not been established.

Efficacy

In patients with osteoarthritis (OA), Etorelex, when administered at a dose of 60 mg once daily, provided a significant reduction in pain and improvement in patients’ assessment of their condition. These favorable effects were observed on the second day of treatment and persisted for 52 weeks. Studies of etoricoxib at a dose of 30 mg once daily (using similar evaluation methods) demonstrated efficacy compared to placebo during the treatment period of 12 weeks. In a study conducted to determine the optimal dose, etoricoxib, when used at a dose of 60 mg, demonstrated significantly greater improvement than the 30 mg dose for all three primary endpoints after 6 weeks of treatment. The 30 mg dose has not been studied in osteoarthritis of the hand joints.

In patients with rheumatoid arthritis (RA), Etorelex at a dose of 90 mg once daily provided a significant reduction in pain and inflammation and improved mobility. These favorable effects were maintained during the treatment period of 12 weeks.
In patients with acute gouty arthritis, etoricoxib at a dose of 120 mg once daily for the entire treatment period of 8 days reduced moderate to severe joint pain and inflammation. The efficacy was comparable to that of indomethacin when used in a dose of 50 mg 3 times/day. Pain reduction was noted as early as 4 hours after the start of treatment.
In patients with ankylosing spondylitis, etoricoxib at a dose of 90 mg once daily provided a significant reduction in back pain, inflammation, stiffness, as well as improved function. The clinical efficacy of etoricoxib was observed as early as the second day of treatment and was maintained throughout the entire treatment period of 52 weeks.

In a clinical study of pain after dental surgery, Etorelex at a dose of 90 mg was administered once daily for 3 days. In a subgroup of patients with moderate pain (at baseline), etoricoxib had the same analgesic effect as ibuprofen at a dose of 90 mg (16.11 versus 16.39; P=0.722) and was superior to the paracetamol/codein combination at 600 mg/60 mg (11.00; and placebo (6.84; according to the overall pain reduction score, within the first 6 h (THORAM). The proportion of patients who required rapid-acting pain medication within the first 24 h after administration of the study drugs was 40.894 with etoricoxib at 90 mg, 25.594 with ibuprofen at 600 mg every 6 h, and 46.70/0 with the paracetamol/codeine combination at 600 mg/60 mg every 6 h, compared with 76.20/0 in the placebo group. In this study, the median onset of action (perceptible pain reduction) with etoricoxib at a dose of 90 mg was 28 min after drug administration.

Indications
Symptomatic therapy of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, pain and inflammation associated with acute gouty arthritis.
Short-term therapy for moderate acute pain after dental surgery.
Contraindications
  • Hypersensitivity to any component of the drug;
  • Gastric and duodenal ulcer in the acute stage, active gastrointestinal bleeding;
  • Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including history).
  • Pregnancy, breastfeeding period.
  • Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score);
  • Severe renal insufficiency (creatinine clearance less than 30 ml/minute);
  • Childhood under 16 years of age;
  • Inflammatory bowel disease;
  • Chronic heart failure (NYHA functional class II-W);
  • Uncontrolled arterial hypertension in which BP values persistently exceed 140/90 mmHg;
  • Confirmed coronary heart disease, peripheral arterial disease or cerebrovascular disease;
  • Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
  • Confirmed hyperkalemia;
  • Progressive renal disease.
Dosage and administration
  • Orally, with a small amount of water and regardless of meals.
  • The drug Etorelex@ should be used in the lowest effective dose for the shortest possible course.
  • Osteoarthritis.
  • The recommended dose is 30 mg once daily or 60 mg once daily.
  • Rheumatoid arthritis and ankylosing spondylitis.
  • The recommended dose is 60 mg or 90 mg once daily. The minimum effective daily dose is 60 mg once daily. In some patients, taking a dose of 90 mg once daily may increase the therapeutic effect.
  • In conditions accompanied by acute pain, etoricoxib should be used only in the acute symptomatic period.
  • Acute gouty arthritis.
  • The recommended dose in the acute period is 120 mg 1 time per day.
  • The duration of use of the drug in a dose of 120 mg is not more than 8 days.
  • Acute pain after dental surgery
  • The recommended dose is 90 mg once a day. In the treatment of acute pain, etoricoxib should be used only in the acute period not more than Z days.
  • Doses in excess of those recommended for each indication either have no additional efficacy or have not been studied. Thus:
  • The daily dose for osteoarthritis should not exceed 60 mg;
  • The daily dose for rheumatoid arthritis should not exceed 90 mg;
  • daily dose in ankylosing spondylitis should not exceed 90 mg;
  • daily dose in acute gouty arthritis should not exceed 120 mg; for a period not exceeding 8 days;
  • daily dose for pain relief after dental surgery should not exceed 90 mg; for a period not exceeding 3 days.
  • Special patient groups
  • Elderly
  • No dose adjustment is required in elderly patients. As with the use of other drugs in elderly patients, caution should be exercised when using etoricoxib (see section “Cautions”).
  • Patients with impaired liver function.
  • Regardless of indications for use of this medicine, patients with liver dysfunction of mild degree of severity (5-6 points on Child-Puo scale) should not exceed the dose of 60 mg once a day, patients with liver dysfunction of moderate degree of severity (7-9 points on Child-Puo scale) – 30 mg once a day.
  • Caution is recommended when using etoricoxib in patients with moderate hepatic impairment, since clinical experience with etoricoxib in this group of patients is limited. Due to the lack of clinical experience of etoricoxib use in patients with severe hepatic impairment (210 points by Child-Pugh score) the drug is contraindicated for this group of patients (see section “Pharmacological properties”, subsection “Pharmacokinetics” as well as sections “Contraindications” and “Cautions”).
  • Patients with impaired renal function.
  • No dose adjustment is required in patients with creatinine clearance “min (see section “Pharmacological properties”, subsection “Pharmacokinetics”). The use of etoricoxib in patients with creatinine clearance of mL/min is contraindicated (see sect.
  • contraindications” and “Special indications”).
  • Children
  • Etorelex is contraindicated to children and adolescents under 16 years of age (see section “Contraindications”).