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ETORICOXIB USV is a brand name for Etoricoxib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Etoricoxib USV is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. Etoricoxib USV is indicated in adults and adolescents 16…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. 1). Osteoarthritis The recommended dose is 30 mg once daily.
In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. Rheumatoid arthritis The recommended dose is 60 mg once daily.
In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
Ankylosing spondylitis The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate.
In the absence of an increase in therapeutic benefit, other therapeutic options should be considered. Acute pain conditions For acute pain conditions, etoricoxib should be used only for the acute symptomatic period. • Acute gouty arthritis The recommended dose is 120 mg once daily.
In clinical trials for acute gouty arthritis, etoricoxib was given for 8 days. • Postoperative dental surgery pain The recommended dose is 90 mg once daily, limited to a maximum of 3 days. Some patients may require other postoperative analgesia in addition to Etoricoxib USV during the three day treatment period.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Therefore:
The dose for OA should not exceed 60 mg daily. The dose for RA and ankylosing spondylitis should not exceed 90 mg daily. The dose for acute gout should not exceed 120 mg daily, limited to a maximum of 8 days treatment. The dose for postoperative acute dental surgery pain should not exceed 90 mg daily, limited to a maximum of 3 days.
Summary of the safety profile In clinical trials, etoricoxib was evaluated for safety in 9,295 individuals, including 6,757 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).
In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer. In a clinical study for acute gouty arthritis, patients were treated with etoricoxib 120 mg once daily for eight days.
The adverse experience profile in this study was generally similar to that reported in the combined OA, RA, and chronic low back pain studies. In a cardiovascular safety outcomes programme of pooled data from three active comparator-controlled trials, 17, 412 patients with OA or RA were treated with etoricoxib (60 mg or 90 mg) for a mean duration of approximately 18 months.
1. In clinical studies for acute postoperative dental pain following surgery including 614 patients treated with etoricoxib (90 mg or 120 mg), the adverse experience profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain studies.
Tabulated list of adverse reactions The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg up to the recommended dose for up to 12 weeks; in the MEDAL Programme studies for up to 3½ years; in short term acute pain studies for up to 7 days; or in post-marketing experience (see Table 1): Table 1: System Organ Class Adverse Reactions Frequency Category* Infections and infestations alveolar osteitis Common gastroenteritis, upper respiratory infection, urinary tract infection Uncommon Blood and lymphatic system disorders anaemia (primarily associated with gastrointestinal bleeding), leukopenia, thrombocytopenia Uncommon Immune system disorders hypersensitivity‡ ß Uncommon angioedema/anaphylactic /anaphylactoid reactions including shock‡ Rare Metabolism and nutrition disorders oedema/fluid retention Common appetite increase or decrease, weight gain Uncommon Psychiatric disorders anxiety, depression, mental acuity decreased, hallucinations‡ Uncommon confusion‡, restlessness‡ Rare Nervous system disorders dizziness, headache Common dysgeusia, insomnia, paresthaesia/ hypaesthesia, somnolence Uncommon Eye disorders blurred vision, conjunctivitis Uncommon Ear and labyrinth disorders tinnitus, vertigo Uncommon Cardiac disorders palpitations, arrhythmia‡ Common atrial fibrillation, tachycardia‡, Uncommon congestive heart failure, non- specific ECG changes, angina pectoris‡, myocardial infarction§ Vascular disorders Hypertension Common flushing, cerebrovascular accident§, transient ischaemic attack, hypertensive crisis‡, vasculitis‡ Uncommon Respiratory, thoracic and mediastinal disorders bronchospasm‡ Common cough, dyspnoea, epistaxis Uncommon Gastrointestinal disorders abdominal pain Very common Constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, oesophagitis, oral ulcer.
Gastrointestinal effects Upper gastrointestinal complications [perforations, ulcers or bleedings (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with etoricoxib. Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the elderly, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.
There is a further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when etoricoxib is taken concomitantly with acetylsalicylic acid (even at low doses).
A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs. 1). Cardiovascular effects Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI) and stroke), relative to placebo and some NSAIDs.
As the Deleted: medicinal products cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. 1). g. 1). COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect.
). Renal effects Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.
Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Monitoring of renal function in such patients should be considered. Fluid retention, oedema and hypertension As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
1. • Active peptic ulceration or active gastro-intestinal (GI) bleeding. • Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions.
3). • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10). • Estimated renal creatinine clearance <30 ml/min. • Children and adolescents under 16 years of age. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV).
• Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled. • Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Special populations Elderly patients No dosage adjustment is necessary for elderly patients. 4). Patients with hepatic impairment Regardless of indication, in patients with mild hepatic dysfunction (Child- Pugh score 5-6) a dose of 60 mg once daily should not be exceeded.
In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 30 mg once daily should not be exceeded. Clinical experience is limited particularly in patients with moderate hepatic dysfunction and caution is advised.
2). 2). 4). 3). Method of administration Etoricoxib USV is for oral use. The film-coated tablets may be taken with or without food. The onset of the effect of the medicinal product may be faster when Etoricoxib USV is administered without food.
This should be considered when rapid symptomatic relief is needed.
4) Uncommon General disorders and administration site conditions asthenia/fatigue, flu-like disease Common chest pain Uncommon Investigations blood urea nitrogen increased, creatine phosphokinase increased, hyperkalaemia, uric acid increased Uncommon blood sodium decreased Rare *Frequency Category: Defined for each Adverse Experience Term by the incidence reported in the clinical trials data base: Very Common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very Rare (<1/10,000).
‡ This adverse reaction was identified through post-marketing surveillance. Its reported frequency has been estimated based upon the highest frequency observed across clinical trial data pooled by indication and approved dose. † The frequency category of “Rare” was defined per the Summary of Product Characteristics (SmPC) guidance (rev.
2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of subjects treated with Etoricoxib in the analysis of the Phase III data pooled by dose and indication (n=15,470).
ß Hypersensitivity includes the terms "allergy", "drug allergy", "drug hypersensitivity", "hypersensitivity", "hypersensitivity NOS", "hypersensitivity reaction" and "nonspecific allergy" § Based on analyses of long-term placebo and active controlled clinical trials, selective COX- 2 inhibitors have been associated with an increased risk of serious thrombotic arterial events, including myocardial infarction and stroke.
The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon). The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of […]
All Nonsteroidal Anti-inflammatory Drugs (NSAIDs), including etoricoxib, can be associated with new onset or recurrent congestive heart failure. 1. Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-- existing oedema from any other reason.
If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken. Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses.
3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib. Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter. If blood pressure rises significantly, alternative treatment should be considered.
Hepatic effects Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily.
Any patients with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver function test has occurred, should be monitored. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests (three times the upper limit of normal) are detected, etoricoxib should be discontinued.
General If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered. Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.
Caution should be used when initiating treatment with etoricoxib in patients with dehydration. It is advisable to rehydrate patients prior to starting therapy with etoricoxib. 8). Patients appear to be at highest risk for these reactions early in the course of therapy with the onset of the reaction occurring in the majority of cases within the first month of treatment.
8). Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy. Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Etoricoxib may mask fever and […]