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TENOXICAM is a brand name for Tenoxicam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tenoxicam tablets are for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries.
Verbatim from this product's MHRA label. Tap a section to expand.
The tablets are for oral use and should be taken with water or other fluid, preferably with or after food.
Adults:
The recommended dosage is a single daily dose of 20mg taken at the same time each day. As there is no significantly greater therapeutic effect at higher doses, and higher doses may result in an increase of adverse events, oral doses greater than recommended should be avoided.
Tenoxicam 20 mg Tablets should only be used for up to a maximum of 2 weeks in cases of severe acute musculoskeletal disorders. Usually treatment of up to 7 days is sufficient.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.
The patient should be monitored regularly for GI bleeding for 4 weeks following initiation of NSAID therapy.
Children:
Tenoxicam 20mg Tablets should not be used in children until sufficient data become available. g. in nephrotic syndrome) or when bilirubin concentrations are high. There are insufficient data to make dosage recommendations for Tenoxicam in patients with pre-existing hepatic impairment.
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Usually, the undesirable effects reported were mild and transient. In a small proportion of patients the interruption of treatment due to undesirable effects was necessary. The most commonly observed adverse events are gastrointestinal in nature.
4). 4) have been reported following administration. Less frequently, gastritis has been observed. Should any of these be reported during treatment, Tenoxicam should be stopped immediately and appropriate treatment instituted. Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Blood and lymphatic disorders Not known: agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leukopenia, thrombocytopenia, non-thrombocytopenic purpura, eosinophilia.
Decreases in haemoglobin, unrelated to gastro-intestinal bleeding, have occurred. g. insomnia), Rare: depression, nervousness, dream abnormalities, mental confusion, paraesthesia. 4), depression, nervousness, confusional state, hallucinations, dream abnormalities, insomnia, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness, have been reported Eye disorders Not known: visual disturbances (such as visual impairment and vision blurred), swollen eyes, eye irritation, optic neuritis.
No evidence of ocular changes has been revealed by ophthalmoscopy and slit- lamp examination. Ear and labyrinth disorders Uncommon: vertigo Not known: tinnitus Cardiac disorders Uncommon: palpitations Not known: cardiac failure The possibility of precipitating congestive cardiac failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.
4 Special warnings and special precautions for use). 4). 4). • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of gastrointestinal bleeding (melaena, haematemesis) or perforation, related to previous NSAIDs therapy or severe gastritis.
• Patients with a known hypersensitivity to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs (symptoms of asthma, rhinitis, angioedema or urticaria). 6). 2, and GI and cardiovascular risks below). 5). Care should be taken to regularly monitor the patients to detect possible interactions with concomitant therapy and to review renal, hepatic and cardiovascular function which may be potentially influenced by NSAIDs.
2). Debilitated patients seem to tolerate ulceration or bleeding less well than others. Most of the fatal gastrointestinal events associated with nonsteroidal anti-inflammatory drugs occurred in the elderly and/or debilitated patients.
Particular care should be taken to regularly monitor elderly patients to detect possible interactions with concomitant therapy and to review renal, hepatic and cardiovascular function which may be potentially influenced by non- steroidal anti-inflammatory drugs.
Cardiovascular, Renal and Hepatic Impairment:
In rare cases, NSAIDs may cause interstitial nephritis, glomerulonephritis, papillary necrosis and the nephrotic syndrome. Such agents inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased.
Administration of a NSAID in these patients may precipitate overt renal decompensation, which returns to the pre-treatment state upon withdrawal of the drug. Patients at greatest risk of such a reaction are those with pre-existing renal disease (including diabetics with impaired renal function), nephrotic syndrome, volume depletion, hepatic disease, congestive cardiac failure and those patients receiving concomitant therapy with diuretics or potentially nephrotoxic drugs and the elderly.
4). • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of gastrointestinal bleeding (melaena, haematemesis) or perforation, related to previous NSAIDs therapy or severe gastritis.
• Patients with a known hypersensitivity to ibuprofen, aspirin or other non- steroidal anti-inflammatory drugs (symptoms of asthma, rhinitis, angioedema or urticaria). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. 4). Although tenoxicam has not shown to increase thrombotic events such as myocardial infarction, there are insufficient data to exclude such a risk with tenoxicam. Respiratory, thoracic and mediastinal disorders Rare: bronchospasm, aggravated asthma, dyspnoea Not known: epistaxis Bronchospasm and aggravated asthma have been reported following treatment with NSAIDs.
Gastrointestinal disorders Very common: stomatitis Common: gastric, epigastric and abdominal pain and discomfort, dyspepsia, nausea, peptic ulcer, sometimes fatal, particularly in the elderly Uncommon: gastrointestinal haemorrhage (including haematemesis and melaena), gastrointestinal ulcers, constipation, diarrhoea, vomiting, mouth ulceration, gastritis, dry mouth Very rare: pancreatitis Not known: Gastrointestinal perforation, exacerbation of colitis and Crohn’s disease, flatulence Hepatobiliary disorders Uncommon: increased hepatic enzymes Not known: hepatitis, jaundice Skin and subcutaneous tissue disorders Uncommon: pruritus, erythema, exanthema, rash, urticaria Rare: vesiculo-bullous reactions.
4) Not known: photosensitivity reaction. Nail disorders and, photosensitivity reaction, alopecia, erythema, purpura and more rarely exfoliative, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme) have been reported rarely following treatment with NSAIDs.
g. renal failure, interstitial nephritis, nephrotic syndrome).
Reproductive system and breast disorders Not known:
Female infertility* *Isolated cases of female infertility have been reported with drugs known to inhibit cyclooxygenase/prostaglandin synthesis including tenoxicam. General disorders and administration site conditions Uncommon: fatigue, oedema Not known: Malaise Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
3), and the dose should be kept as low as possible in patients with renal, hepatic or cardiac impairment. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with NSAID administration.
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients. Occasional elevations of serum transaminases or other indicators of liver function have been reported.
The reports in most cases have been small and transient increases above the normal range. If the abnormality is significant or persistent, Tenoxicam should be stopped and follow-up tests carried out. Particular care is required in patients with pre-existing hepatic disease.
Cardiovascular and cerebrovascular effects Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for Tenoxicam. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with tenoxicam after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. 3), and in the elderly. These patients should commence treatment on the lowest dose available.
g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely […]