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Onsenal is a brand name for Celecoxib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see section 4.4). The effect of Onsenal-induced reduction of polyp burden on the risk of intestinal cancer has not been…
Verbatim from this product's EMA label. Tap a section to expand.
2). Usual medical care for FAP patients should be continued while on celecoxib. The maximum recommended daily dose is 800 mg. 2). Caution should be used as there is no experience in such patients at doses higher than 200 mg. 2). 1).
CYP2C9 Poor Metabolizers:
Patients who are known or suspected to be CYP2C9 poor metabolizers based on genotyping or previous history/experience with other CYP2C9 substrates should be administered celecoxib with caution, as the risk of dose-dependent adverse effects is increased.
Patients with the CYP2C9*3 allele, and, in particular those with CYP2C9*3*3 homozygous genotype, may be exposed to celecoxib levels that are higher than those for which safety has been studied in clinical trials. Therefore, the risk for high celecoxib exposure in poorMedicinal product no longer authorised 3 metabolizers should be considered carefully when treating FAP patients.
2).
Elderly:
The dose for elderly FAP patients has not been established. 2).
01% and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. In additional studies using non-selective NSAID comparators, approximately 7400 arthritis patients have been treated with celecoxib at daily doses up to 800 mg, including approximately 2300 patients treated for 1 year or longer.
The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1. - Adverse drug reactions from post-marketing surveillance as spontaneously reported during a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications).
Because not all adverse drug reactions are reported to the MAH and included in the safety database, the frequencies of these reactions cannot be reliably determined. TABLE 1 Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency Not Known (Post-marketing experience)1 Infections and infestations Sinusitis, upper respiratory tract infection, urinary tract infection Blood and lymphatic system disorders Anemia Leucopenia, thrombocytopenia Pancytopenia Immune system disorders Allergy aggravated Serious allergic reactions, anaphylactic shock, anaphylaxis Psychiatric disorders Insomnia Anxiety, depression, tiredness Confusion Hallucinations Metabolism and nutrition Hyperkaelemia Nervous system disorders Dizziness, hypertonia Paraesthesia, somnolence Ataxia, taste alteration Headache, aggravated epilepsy, meningitis aseptic, ageusia , anosmia, fatal intracranial haemorrhage Eye disorders Blurred vision Conjunctivitis, ocular haemorrhage, retinal artery or vein occlusion Ear and labyrinth disorders Tinnitus Decreased hearingMedicinal product no longer authorised 8 Cardiac disorders Heart failure, palpitations, tachycardia Myocardial infarction2 Arrhythmia Vascular disorders Hypertension, hypertension aggravated Flushing, vasculitis, pulmonary embolism Respiratory, thoracic, and mediastinal disorders Pharyngitis, rhinitis, cough Dyspnoea Bronchospasm Gastrointestinal disorders Abdominal pain, diarrhoea, dyspepsia, flatulence Constipation, eructation, gastritis, stomatitis, vomiting, aggravation of gastrointestinal inflammation Duodenal, gastric, oesophageal, intestinal, and colonic ulceration; dysphagia, intestinal perforation; oesophagitis, melaena; pancreatitis Nausea, acute pancreatitis, gastrointestinal haemorrhage, colitis/colitis aggravated Hepatobiliary disorders Abnormal hepatic function, increased SGOT and SGPT Elevation of hepatic enzymes Hepatitis, hepatic failure jaundice Skin and subcutaneous tissue disorders Rash, pruritus Urticaria Alopecia, photosensitivity Ecchymosis, bullous eruption, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema Musculoskeletal and connective tissue disorders Leg cramps Arthralgia, myositis Renal and urinary disorders Increased creatinine, BUN increased Acute renal failure, interstitial nephritis, hyponatraemia Reproductive system and breast disorders Menstrual disorder General disorders and administration site conditions Flu-like symptoms, peripheral oedema/ fluid retention Chest pain 1 Adverse drug reactions spontaneously reported to the safety surveillance database over a period in which an estimated >70 million patients were treated with celecoxib (various doses, durations, and indications).
Treatment with celecoxib in FAP has been studied for up to 6 months and has not been shown to reduce the risk of gastrointestinal or other form of cancer or the need for surgery. Therefore, the usual care of FAP patients should not be altered because of the concurrent administration of celecoxib.
In particular, the frequency of routine endoscopic surveillance should not be decreased and FAP-related surgery should not be delayed. Gastro-intestinal disorder Upper gastrointestinal complications [perforations, ulcers or bleeds (PUBs)], some of them resulting in fatal outcome, have occurred in patients treated with celecoxib.
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 further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications) when celecoxib is taken concomitantly with acetylsalicylic acid (even at low doses). A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
The concomitant use of celecoxib and a non-aspirin NSAID should be avoided. FAP patients carrying an ileorectal anastomosis or ileo pouch-anal anastomosis can develop anastomotic ulcerations. If an anastomotic ulcer is present, patients should not receive concomitant treatment with anticoagulants or acetyl salicylic acid.
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. 1). As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib.
1). • Known hypersensitivity to sulphonamides. • Active peptic ulceration or gastrointestinal (GI) bleeding. • Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or non steroidal anti- inflammatory drugs (NSAIDs) including COX-2 (cyclooxigenase-2) selective inhibitors.
3) • Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >10) (Class C). • Patients with renal insufficiency with estimated creatinine clearance <30 ml/ min. • Inflammatory bowel disease. • Congestive heart failure (NYHA II-IV).
• Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
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As a result, the frequencies of these adverse drug reactions cannot be reliably determined. Adverse drug reactions listed for the post-marketing population are only those that are not already listed for the arthritis trials (Table 1)Medicinal product no longer authorised 9 or the polyp prevention trials (Table 2).
7 events per 1000 patients (Rare) and there was no excess of strokes. 1, Pharmacodynamic properties: Cardiovascular Safety – Long-Term Studies Involving Patients With Sporadic Adenomatous Polyps). TABLE 2 Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Infections and infestations Ear infection, fungal infection (fungal infections were primarily nonsystemic) Helicobacter infection, herpes zoster, erysipelas, wound infection, gingival infection, labrynthitis, bacterial infection Neoplasms Lipoma Psychiatric Sleep disorder Nervous system disorders Cerebral infarction Eye disorders Vitreous floaters; conjunctival hemorrhage Ear and labyrinth disorders Hypoacusis Cardiac disorders Angina pectoris; myocardial infarction Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertropy Vascular disorders Hypertension* Deep vein thrombosis; hematoma Respiratory, thoracic, and mediastinal disorders Dyspnoea Dysphonia Gastrointestinal disorders Diarrhoea* Nausea, gastroesophageal reflux disease, diverticulum, vomiting,* dysphagia, irritable bowel syndrome Haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, stomatitis Skin and subcutaneous tissue disorders Dermatitis allergic […]
Therefore, celecoxib should be used with caution in patients with history of cardiac failure, left ventricular dysfunction or hypertension, and in patients with pre-existing oedema from any other reason, since prostaglandin inhibition may result in deterioration of renal function and fluid retention.
Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia. As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy. In the event of elderly patients with mild to moderate cardiac dysfunction requiring therapy, special care and follow up is warranted.
Compromised renal or hepatic function and especially cardiac dysfunction are more likely in the elderly and therefore medically appropriate supervision should be maintained. Renal and hepatic disorders NSAIDs, including celecoxib, may cause renal toxicity.
Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs. Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, and the elderly.
Such patients should be carefully monitored while receiving treatment with celecoxib. 2). If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
8). Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment. 8). 3). Celecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
2). Medicinal product no longer authorised 5 In patients on concurrent therapy with warfarin, serious bleeding events have been reported. […]