TENOXICAM

4). Adults Tenoxicam Lyophilisate should be given IV or IM. A single daily dose of 20mg for one to two days initially to be continued with the oral form, with administration at the same time each day. The lyophilisate should be dissolved in 2ml of sterile water for injections and the reconstituted solution should be used immediately.

Higher doses should be avoided as they do not usually achieve significantly greater therapeutic effect but may be associated with a higher risk of adverse events. In acute musculoskeletal disorders treatment should not normally be required for more than 7 days, but in severe cases it may be continued up to a maximum of 14 days.

Elderly As with other non-steroidal anti-inflammatory drugs, Tenoxicam Lyophilisate should be used with special caution in elderly patients. 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 during NSAID therapy. Children There are insufficient data to make a recommendation for administration of Tenoxicam Lyophilisate to children.

g. in nephrotic syndrome) or when bilirubin concentrations are high. There is insufficient information to make dosage recommendations for Tenoxicam Lyophilisate in patients with pre-existing hepatic impairment.

8 Possible side effects For most patients, any side-effects are transient and resolve without discontinuation of treatment. The most commonly observed adverse events are gastrointestinal in nature.

Cardiovascular and cerebrovascular:

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. Palpitations and dyspnoea have been reported rarely. 4).

Dermatological:

Photosensitivity and bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare) have been reported.

Eye disorders:

Visual disturbances (such as visual impairment and blurred vision) have been reported with frequency unknown.

Gastrointestinal disorders:

The most common side-effects relate to the gastro- intestinal tract. 4). 4). Less frequently, gastritis has been observed. Pancreatitis has been reported very rare.

Haematological:

Decreases in haemoglobin, unrelated to gastro-intestinal bleeding, have occurred. Anaemia, aplastic anaemia, haemolytic anaemia, thrombocytopenia and non-thrombocytopenic purpura, leucopenia, neutropenia and eosinophilia have been reported.

Epistaxis has been reported infrequently. Rare cases of agranulocytosis have been reported.

Hepatic:

Abnormal liver function. As with most other non-steroidal anti- inflammatory drugs, changes in various liver function parameters have been observed. Some patients may develop raised serum transaminase levels during treatment. g. eosinophilia, rash), Tenoxicam Lyophilisate should be discontinued.

Hepatitis and jaundice have also been reported.

Hypersensitivity:

Hypersensitivity reactions have been reported following treatment with NSAIDs, these include: a) Non specific allergic reactions and anaphylaxis b) Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea or c) Assorted skin disorders; including rashes of various types.

Angiodema, pruritus, and purpura have been reported. Nail disorders, alopecia, erythema, urticaria, and photosensitivity reactions have been reported rarely. As with other non-steroidal anti-inflammatory drugs, exfoliative and bullous dermatoses, including epidermal necrolysis, erythema multiforme and Stevens-Johnson syndrome.

Vesiculo-bullous reactions and vasculitis have also been reported rarely.

Metabolism:

Metabolic abnormalities, such as weight decrease or increase and hyperglycaemia, have occurred rarely.

Nervous system disorders:

Malaise and tinnitus may occur.

Other less common reports include:

Aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation, dizziness, malaise, fatigue and drowsiness.

Headache, insomnia, depression, nervousness, dream abnormalities, and vertigo have been reported rarely. Somnolence and paraesthesia have been reported with frequency unknown.

Psychiatric disorders:

Confusional state and hallucinations have been reported with frequency unknown.

Renal:

Nephrotoxicity has been reported in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. 4). 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.

5). 2, and GI and cardiovascular risks below). 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).

Cardiovascular, renal and hepatic impairment:

The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at a greater risk of this reaction are those taking diuretics and the elderly. 3). Occasional elevations of serum transaminases or other indicators of liver function have been reported.

In most cases these have been small and transient increases above the normal range. If the abnormality is significant or persistent, Tenoxicam Lyophilisate should be stopped and follow-up tests carried out. Particular care is required in patients with pre-existing hepatic disease.

In rare cases, non-steroidal anti-inflammatory drugs 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.

In these patients, administration of a non-steroidal anti-inflammatory drug 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, cardiac impairment and those patients receiving concomitant therapy with diuretics or potentially nephrotoxic drugs.

Such patients should have their renal, hepatic and cardiac functions carefully monitored. The dose should be kept as low as possible in these patients. NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration.

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. Tenoxicam Lyophilisate should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

2). 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.

Impaired female fertility:

The use of Tenoxicam Lyophilisate may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of fertility, withdrawal of Tenoxicam Lyophilisate should be considered.

Gastrointestinal bleeding, ulceration and perforation:

NSAIDs should only be given with care to patients with a history of gastrointestinal disease. 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. 5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

5). Any patient being treated with Tenoxicam Lyophilisate who presents with […]

1. Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding), ulcerative colitis, Crohn’s disease, severe gastritis, or history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

2. Hypersensitivity to tenoxicam or to any of the excipients. Tenoxicam Lyophilisate is also contraindicated in patients who have previously shown hypersensitivity reactions (symptoms of asthma, rhinitis, angioedema or urticaria) to other non-steroidal anti-inflammatory drugs, including ibuprofen and aspirin, as the potential exists for cross-sensitivity to tenoxicam.

3. 4). 4. 6).