Este medicamento se utiliza para el tratamiento del dolor y la inflamación en padecimientos como osteoartritis, artritis reumatoide, espondilitis anquilosante, ataques agudos de gota y dolor agudo. El etoricoxib es un antiinflamatorio no esteroideo (AINE) selectivo de la COX-2 que ayuda a reducir la inflamación y el dolor.
El consumo de este producto es responsabilidad de quien lo recomienda y de quien lo usa. Consulte a su médico antes de consumir cualquier medicamento.
THERAPEUTIC INDICATIONS:
ARCOXIA ® is indicated for:
• Acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
• Treatment of ankylosing spondylitis.
• Treatment of acute gouty arthritis.
• Relief of acute and chronic pain.
• Treatment of primary dysmenorrhea.
The decision to prescribe a selective inhibitor of COX-2 should be based on individual assessment of every patient's risks (see WARNINGS).
CONTRAINDICATIONS: ARCOXIA ® is contraindicated in patients with hypersensitivity to any component of this product.
Congestive heart failure (class II-IV NYHA).
Established ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty).
GENERAL PRECAUTIONS: Clinical studies suggest that the class of selective inhibitors of COX-2 may be associated, compared to placebo and some NSAIDs (naproxen), with increased risk of thrombotic events (specifically myocardial infarction and stroke) . As the cardiovascular risks of selective inhibitors of COX-2 may increase with dose and duration of treatment, use the lowest effective daily dose for the shortest time possible. Should periodically re-evaluate the symptoms and treatment response according to patient needs.
Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration.
Selective inhibitors of COX-2 are not a substitute for aspirin for cardiovascular prophylaxis because no effect on platelets. Because etoricoxib, a member of that class, does not inhibit platelet aggregation should not be discontinued antiplatelet therapy.
The risk of gastrointestinal adverse reactions (ulcers or other gastrointestinal complications) for etoricoxib, other selective inhibitors of COX-2 or NSAID, is greater when taken concomitantly with acetylsalicylic acid (even at low doses). Not been adequately evaluated in long-term studies the relative difference in GI safety between selective inhibitors of COX-2 plus aspirin vs. acetylsalicylic acid.
Not recommended ARCOXIA ® to treat patients with advanced renal disease. Clinical experience in patients with estimated creatinine clearance <30 ml / min is very limited. If you have to start treatment with Arcoxia ® in these patients, it is advisable to closely monitor your kidney function.
The long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal damage type. Renal prostaglandins may have a compensatory role in maintaining renal perfusion. Therefore, if renal perfusion is compromised, Arcoxia ® administration may decrease the formation of prostaglandins and secondary renal blood flow and thereby impair renal function. Patients at greatest risk of this disorder are those who have significantly decreased renal function, uncompensated heart failure, or liver cirrhosis. In these patients should consider monitoring renal function. As with other drugs that inhibit prostaglandin synthesis, it is expected that the discontinuation of Arcoxia ®, the condition will return to before treatment.
Caution should be exercised when initiating treatment with Arcoxia ® in patients significantly dehydrated. It is advisable to rehydrate these patients before starting to administer ARCOXIA ®.
As with other drugs that inhibit prostaglandin synthesis, some patients have presented ARCOXIA ® fluid retention, edema and hypertension. Keep in mind the possibility of fluid retention, edema or hypertension when used ARCOXIA ® in patients with edema, hypertension or pre-existing heart failure. Etoricoxib may be associated with more frequent and severe hypertension than other NSAIDs or selective inhibitors of COX-2, particularly with higher doses. Therefore, it should pay special attention to monitoring blood pressure during treatment with etoricoxib, if blood pressure rises significantly, you can consider other treatment alternatives.
Physicians should be aware that some patients may experience upper gastrointestinal ulcers or their complications regardless of treatment they are receiving. Although the risk of gastrointestinal toxicity is not eliminated Arcoxia ®, the MEDAL Program results show that patients treated with Arcoxia ®, the risk of gastrointestinal toxicity with ARCOXIA ® 60 or 90 mg once daily is significantly less than with diclofenac 150mg per day. In clinical studies with ibuprofen and naproxen, the risk of upper gastrointestinal ulcers detected by endoscopy was lower in patients treated with Arcoxia ® 120 mg once daily than in those treated with nonselective NSAIDs. Although the incidence of ulcers detected by endoscopy was low in patients treated with 120 mg of Arcoxia ®, was higher than in those receiving placebo. Upper gastrointestinal ulcers have occurred or its complications in patients treated with Arcoxia ®. These events can occur at any time during use and without warning symptoms. Irrespective of treatment, it is known that the risk of perforation, ulcer or gastrointestinal bleeding is higher in patients with a history of these disorders and over 65 years.
In clinical trials have reported increases in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) in approximately 1% of patients treated up to a year with 30, 60 and 90 mg daily ARCOXIA ®. In lots of active treatment compared with clinical trials, the incidence of these increases in ALAT and ASAT was similar in patients treated with 60 and 90 mg daily ARCOXIA ® and those treated with naproxen 1,000 mg daily, but significantly lower than in those treated with diclofenac 150 mg daily. These increases were stopped in patients treated with Arcoxia ® in approximately half of the cases stopped while patients were taking Arcoxia ®. In controlled clinical studies of Arcoxia ® 30 mg daily to ibuprofen 2,400 mg daily or celecoxib 200 mg daily, the incidence of increases in ALAT and ASAT was similar.
In a patient with symptoms and / or signs suggesting liver dysfunction or had evidence of abnormal liver function should be investigated if the abnormality persists. If the abnormality persists (at three or more times the upper limit of normal values), discontinue the administration of ARCOXIA ®.
DOSAGE ANDADMINISTRATION:Arcoxia® is administeredorally.Arcoxia® can be takenwith or without food.
Acute gouty arthritis:The recommended dosageis 120mgonce aday.This dosageshould be used onlyduringthe acute symptomatic period, limited toa maximum of 8days of treatment.
analgesia:
Reliefof acute pain andprimary dysmenorrhea:The recommended dosageis 120mgonce aday.This dosageshould be used onlyduringthe acute symptomatic period, limited toa maximum of 8days of treatment.
Este medicamento se utiliza para el tratamiento del dolor y la inflamación en padecimientos como osteoartritis, artritis reumatoide, espondilitis anquilosante, ataques agudos de gota y dolor agudo. El etoricoxib es un antiinflamatorio no esteroideo (AINE) selectivo de la COX-2 que ayuda a reducir la inflamación y el dolor.
El consumo de este producto es responsabilidad de quien lo recomienda y de quien lo usa. Consulte a su médico antes de consumir cualquier medicamento.
THERAPEUTIC INDICATIONS:
ARCOXIA ® is indicated for:
• Acute and chronic treatment of signs and symptoms of osteoarthritis and rheumatoid arthritis.
• Treatment of ankylosing spondylitis.
• Treatment of acute gouty arthritis.
• Relief of acute and chronic pain.
• Treatment of primary dysmenorrhea.
The decision to prescribe a selective inhibitor of COX-2 should be based on individual assessment of every patient's risks (see WARNINGS).
CONTRAINDICATIONS: ARCOXIA ® is contraindicated in patients with hypersensitivity to any component of this product.
Congestive heart failure (class II-IV NYHA).
Established ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease (including patients who have recently undergone coronary revascularization or angioplasty).
GENERAL PRECAUTIONS: Clinical studies suggest that the class of selective inhibitors of COX-2 may be associated, compared to placebo and some NSAIDs (naproxen), with increased risk of thrombotic events (specifically myocardial infarction and stroke) . As the cardiovascular risks of selective inhibitors of COX-2 may increase with dose and duration of treatment, use the lowest effective daily dose for the shortest time possible. Should periodically re-evaluate the symptoms and treatment response according to patient needs.
Patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with etoricoxib after careful consideration.
Selective inhibitors of COX-2 are not a substitute for aspirin for cardiovascular prophylaxis because no effect on platelets. Because etoricoxib, a member of that class, does not inhibit platelet aggregation should not be discontinued antiplatelet therapy.
The risk of gastrointestinal adverse reactions (ulcers or other gastrointestinal complications) for etoricoxib, other selective inhibitors of COX-2 or NSAID, is greater when taken concomitantly with acetylsalicylic acid (even at low doses). Not been adequately evaluated in long-term studies the relative difference in GI safety between selective inhibitors of COX-2 plus aspirin vs. acetylsalicylic acid.
Not recommended ARCOXIA ® to treat patients with advanced renal disease. Clinical experience in patients with estimated creatinine clearance <30 ml / min is very limited. If you have to start treatment with Arcoxia ® in these patients, it is advisable to closely monitor your kidney function.
The long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal damage type. Renal prostaglandins may have a compensatory role in maintaining renal perfusion. Therefore, if renal perfusion is compromised, Arcoxia ® administration may decrease the formation of prostaglandins and secondary renal blood flow and thereby impair renal function. Patients at greatest risk of this disorder are those who have significantly decreased renal function, uncompensated heart failure, or liver cirrhosis. In these patients should consider monitoring renal function. As with other drugs that inhibit prostaglandin synthesis, it is expected that the discontinuation of Arcoxia ®, the condition will return to before treatment.
Caution should be exercised when initiating treatment with Arcoxia ® in patients significantly dehydrated. It is advisable to rehydrate these patients before starting to administer ARCOXIA ®.
As with other drugs that inhibit prostaglandin synthesis, some patients have presented ARCOXIA ® fluid retention, edema and hypertension. Keep in mind the possibility of fluid retention, edema or hypertension when used ARCOXIA ® in patients with edema, hypertension or pre-existing heart failure. Etoricoxib may be associated with more frequent and severe hypertension than other NSAIDs or selective inhibitors of COX-2, particularly with higher doses. Therefore, it should pay special attention to monitoring blood pressure during treatment with etoricoxib, if blood pressure rises significantly, you can consider other treatment alternatives.
Physicians should be aware that some patients may experience upper gastrointestinal ulcers or their complications regardless of treatment they are receiving. Although the risk of gastrointestinal toxicity is not eliminated Arcoxia ®, the MEDAL Program results show that patients treated with Arcoxia ®, the risk of gastrointestinal toxicity with ARCOXIA ® 60 or 90 mg once daily is significantly less than with diclofenac 150mg per day. In clinical studies with ibuprofen and naproxen, the risk of upper gastrointestinal ulcers detected by endoscopy was lower in patients treated with Arcoxia ® 120 mg once daily than in those treated with nonselective NSAIDs. Although the incidence of ulcers detected by endoscopy was low in patients treated with 120 mg of Arcoxia ®, was higher than in those receiving placebo. Upper gastrointestinal ulcers have occurred or its complications in patients treated with Arcoxia ®. These events can occur at any time during use and without warning symptoms. Irrespective of treatment, it is known that the risk of perforation, ulcer or gastrointestinal bleeding is higher in patients with a history of these disorders and over 65 years.
In clinical trials have reported increases in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) in approximately 1% of patients treated up to a year with 30, 60 and 90 mg daily ARCOXIA ®. In lots of active treatment compared with clinical trials, the incidence of these increases in ALAT and ASAT was similar in patients treated with 60 and 90 mg daily ARCOXIA ® and those treated with naproxen 1,000 mg daily, but significantly lower than in those treated with diclofenac 150 mg daily. These increases were stopped in patients treated with Arcoxia ® in approximately half of the cases stopped while patients were taking Arcoxia ®. In controlled clinical studies of Arcoxia ® 30 mg daily to ibuprofen 2,400 mg daily or celecoxib 200 mg daily, the incidence of increases in ALAT and ASAT was similar.
In a patient with symptoms and / or signs suggesting liver dysfunction or had evidence of abnormal liver function should be investigated if the abnormality persists. If the abnormality persists (at three or more times the upper limit of normal values), discontinue the administration of ARCOXIA ®.
DOSAGE ANDADMINISTRATION:Arcoxia® is administeredorally.Arcoxia® can be takenwith or without food.
Acute gouty arthritis:The recommended dosageis 120mgonce aday.This dosageshould be used onlyduringthe acute symptomatic period, limited toa maximum of 8days of treatment.
analgesia:
Reliefof acute pain andprimary dysmenorrhea:The recommended dosageis 120mgonce aday.This dosageshould be used onlyduringthe acute symptomatic period, limited toa maximum of 8days of treatment.
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