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Etoricoxib Tablets

Function and Efficacy

Etoricoxib is a nonsteroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects in animal models. It is an orally active, selective cyclooxygenase-2 inhibitor within or above the clinical dose range. Two isoforms of cyclooxygenase have been discovered: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is involved in normal prostaglandin-mediated physiological functions such as gastric mucosal cell protection and platelet aggregation. Non-selective nonsteroidal anti-inflammatory drugs inhibit the production of COX-1, thereby causing gastric mucosal damage and reduced platelet aggregation. COX-2 is mainly involved in the production of inflammatory prostaglandins, causing pain, inflammation and fever. Etoricoxib is a selective inhibitor of cyclooxygenase-2, which can alleviate these symptoms and signs, reduce gastrointestinal side effects and do not affect platelet function.

Ingredients

The main ingredient is etoricoxib.

Name Description Content CAS NO. Manufacturer
EtoricoxibIngredients

A selective cyclooxygenase-2 inhibitor with anti-inflammatory, analgesic and antipyretic effects, it can relieve pain, inflammation and fever symptoms, reduce gastrointestinal side effects and does not affect platelet function.

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202409-33-4 15

Appearance

White, apple-shaped, biconvex, film-coated tablets engraved with ARCOXIA 90 on one side and 202 on the other side

Indication

This product is suitable for: 1. Treating the symptoms and signs of acute and chronic osteoarthritis. 2. Treating acute gouty arthritis.

Usage and Dosage

1. This product is for oral administration and can be taken with food or alone. Arthritis, osteoarthritis - the recommended dose is 30 mg once a day. For patients whose symptoms cannot be adequately relieved, it can be increased to 60 mg once a day. When the efficacy of this product is not obvious after 4 weeks of taking 60 mg once a day, other treatments should be considered. 2. Acute gouty arthritis - the recommended dose is 120 mg, once a day. This product 120 mg is only suitable for acute attacks of symptoms and can be used for up to 8 days. 3. Elderly, gender, race - the elderly, people of different genders and races do not need to adjust the dose. 4. Impaired liver function - for patients with mild hepatic insufficiency (Child-Pugh score 5-6), the dose of this product should not exceed 60 mg once a day. Moderate liver function

Adverse Reactions

1. Abnormalities of the blood and lymphatic system: thrombocytopenia. 2. Abnormalities of the immune system: allergic reactions, including anaphylactic or anaphylactic-like reactions including shock. 3. Metabolic and nutritional disorders: hyperkalemia. 4. Mental disorders: insomnia, confusion, hallucinations, restlessness. 5. Abnormalities of the nervous system: taste disorders. 6. Abnormalities of breathing, chest and mediastinum: bronchospasm; 7. Abnormalities of the gastrointestinal tract: abdominal pain, oral ulcers, peptic ulcers including perforation and bleeding (mainly in elderly patients). 8. Abnormalities of the liver and gallbladder: hepatitis, jaundice. 9. Abnormalities of the skin and subcutaneous tissue: angioedema, itching, erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. 10. Abnormalities of the kidney and urinary system: renal insufficiency, including renal failure.

Precautions

The following patients are contraindicated to use this product: 1. Allergic to any of its ingredients. 2. Patients with active peptic ulcer/bleeding, or patients with recurrent ulcer/bleeding in the past. 3. Patients who have asthma, urticaria or allergic reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. 4. Congestive heart failure (New York Heart Association [NYHA] heart function class II-IV). 5. Confirmed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).

Special Population Medication

Precautions for children: The safety and efficacy of this product in pediatric patients have not been established. Precautions for pregnancy and lactation: Pregnant women: Reproduction studies in rats showed that no developmental abnormalities were found when this product was used at doses up to 15 mg/kg/day [equivalent to 1.5 times the human dose (90 mg)]. In experimental studies in rabbits, a very low incidence of cardiovascular malformations and an increased incidence of (post-implantation) failure were found at doses approximately equivalent to twice the human dose (90 mg), while no developmental abnormalities were found at doses approximately equivalent to or lower than the daily human dose (90 mg). Although animal reproduction studies do not always predict human responses, appropriate, strictly controlled studies have not been conducted in pregnant women. Therefore, during the first 6 months of pregnancy, this product should only be used if the possible benefits outweigh the potential risks to the fetus. Lactating women: This product can be secreted in the milk of lactating rats. Precautions for the elderly: The pharmacokinetic properties of the elderly (65 years and older) are similar to those of young patients. Clinical studies have shown that elderly patients have a higher incidence of adverse events than younger patients; the differences between the etoricoxib group and the control group for elderly and younger patients are similar. A greater sensitivity in some elderly patients cannot be excluded.

Drug Interactions

1. Warfarin - For patients who are stable on long-term warfarin treatment, the international normalized ratio (INR) of prothrombin time increases by approximately 13% when this product is used 120 mg daily. 2. Rifampicin - Rifampicin is a strong inducer of liver metabolism. The combination of this product with rifampicin can reduce the plasma area under the curve (AUC) of this product by 65%. When this product is used in combination with rifampicin, their interaction should be considered. 3. Methotrexate - Two studies have observed the situation in which patients with rheumatoid arthritis who were taking methotrexate 7.5 mg to 20 mg once a week received this product 60, 90 or 120 mg once a day for 7 consecutive days. This product had no effect on the plasma concentration of methotrexate (determining AUC) and renal clearance at the 60 and 90 mg levels. 4. Diuretics, angiotensin-converting enzyme (ACE)

Storage

Sealed.

Packaging Specification

90mg

Validity Period

36 months

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