מדינה: מלזיה
שפה: אנגלית
מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETORICOXIB
KOTRA PHARMA (M) SDN. BHD.
ETORICOXIB
100 Tablets; 3x10tablet Tablets
KOTRA PHARMA (M) SDN. BHD.
AXCEL ETORICOXIB-60MG TABLET _Etoricoxib 60mg _ _ _ _ _ 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What Axcel Etoricoxib-60mg Tablet is used for. 2. How Axcel Etoricoxib-60mg Tablet works. 3. Before you use Axcel Etoricoxib-60mg Tablet. 4. How to use Axcel Etoricoxib- 60mg Tablet. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Axcel Etoricoxib-60mg Tablet. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT AXCEL ETORICOXIB-60MG TABLET IS USED FOR It helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. It is also use for the treatment of acute pain, including that related to menstrual pain and minor dental procedures. _What is osteoarthritis? _ Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability. _What is rheumatoid arthritis? _ Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body. _What is gout? _ Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint. _What is ankylosing spondylitis? _ Ankylosing spondylitis is an inflammatory disease of the spine and large joints. HOW AXCEL ETORICOXIB-60MG TABLET WORKS Etoricoxib is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), that exhibits anti-inflammatory, analgesic, and antipyretic activities. BEFORE YOU USE AXCEL ETORICOXIB- 60MG TABLET _When you must not use it _ You must not use Axcel Etoricoxib- 60mg Tablet if you: קרא את המסמך השלם
_ACUTE PAIN _ In the following acute painful conditions, Etoricoxib should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment: _Acute Gouty Arthritis_ The recommended dose is 120 mg once daily. _Primary Dysmenorrhea _ The recommended dose is 120 mg once daily. _Minor Dental Procedures _ The recommended dose is 90 mg once daily. Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore: The dose for osteoarthritis should not exceed 60 mg daily. The dose for rheumatoid arthritis should not exceed 90 mg daily. The dose for ankylosing spondylitis should not exceed 90 mg daily. The dose for acute gout should not exceed 120 mg daily. The dose for acute pain and primary dysmenorrhea should not exceed 120 mg daily. The dose for minor dental procedures should not exceed 90 mg daily. As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically. _ELDERLY, GENDER, RACE_ No dosage adjustment in Etoricoxib is necessary for the elderly or based on gender or race. _HEPATIC INSUFFICIENCY _ In patients with mild hepatic insufficiency (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9), the dose should be reduced; a dose of 60 mg every other day should not be exceeded, administration of 30 mg once daily can also be considered. There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9). _RENAL INSUFFICIENCY _ In patients with advanced renal disease (creatinine clearance <30 mL/min), treatment with Etoricoxib is not recommended. No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearance ≥ קרא את המסמך השלם