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PHENYLBUTAZONE is a brand name for Phenylbutazone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ankylosing spondylitis Phenylbutazone should only be used where other therapies have been found unsuitable. Route of administration: oral.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration. To be taken preferably with or after food. 4). 4) and the dosage should be adjusted to the needs of each patient taking account of the patient’s age and general condition. Phenylbutazone tablets should be swallowed whole with a meal together with liquid.
Patients with sensitive stomachs should be given sodium-free antacid at the same time. Adults: for the initial 48 hours 400-600mg daily in divided doses. Thereafter, reduce to the minimum amount necessary, usually 200-300mg daily in divided doses.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. 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: not recommended for children under 14 years.
Gastrointestinal:
Gastrointestinal disorders are the most commonly observed adverse events. 4 ‘Special warnings and precautions for use’). 4 ‘Special warnings and precautions for use’) have been reported. Less frequently, gastritis has been observed. Isolated cases of pancreatitis, oesophagitis, oesophageal ulcer, benign stricture of the oesophagus and small bowel obstruction have also been reported.
Hypersensitivity:
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) associated skin disorders including rashes of various types, pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including Stevens Johnson syndrome, epidermal necrolysis and erythema multiforme).
Isolated cases of serum sickness, lymphadenopathy, vasculitis, systemic lupus erythematosus-like syndrome, eosinophilic pulmonary infiltrates and fever have also been reported.
Cardiovascular and cerebrovascular:
Oedema, hypertension and cardiac failure, have been reported in association with NSAID treatment. 4 ‘Special warnings and precautions for use’). Rare: congestive heart failure, pulmonary oedema. Isolated cases: hypertension, myocarditis, pericarditis.
Body as a whole:
Frequent: oedema, water / sodium retention.
Endocrine system:
Occasional: goitre, lowering of plasma thyroid hormone concentration. Isolated cases: hypothyroidism. 4 ‘Special warnings and precautions for use’), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise and drowsiness.
Phenylbutazone should be used only under close medical supervision. 2 and GI and cardiovascular risks below). 2). Particular caution should be exercised. Blood dyscrasias Blood dyscrasias may occur suddenly after a small dose or insidiously after prolonged therapy particularly in the elderly.
If treatment is expected to continue for more than one week, blood counts should be monitored before and regularly during therapy. g. decrease in leucocyte and/or platelet counts or in the haematocrit, phenylbutazone should be withdrawn.
g. bruising, fever, sore throat, rash, mouth ulceration), and patients should be advised of this. Granulocytopenia or aplastic anaemia have to be excluded in patients with stomatitis before treatment with phenylbutazone is started, as stomatitis might indicate a pre-existing haematological abnormality of this type.
Gastro-intestinal bleeding, ulceration and perforation Serious gastro-intestinal reactions such as bleeding, ulceration and perforation, which can be fatal, have been reported with 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.
Although minor upper gastrointestinal reactions such as dyspepsia are common, usually developing early in therapy, physicians should watch for ulceration and bleeding in patients treated with non-steroidal anti-inflammatory drugs, even in the absence of previous gastro-intestinal tract symptoms.
If any of the symptoms or signs suggestive of gastro-intestinal toxicity occur, phenylbutazone should be discontinued immediately. 5). g. misoprostol or proton pump inhibitors) should be considered for these patients. When GI bleeding or ulceration occurs in patients receiving phenylbutazone, the treatment should be withdrawn.
• Hypersensitivity to phenylbutazone or to any of the excipients. • Patients who have shown hypersensitivity reactions or in asthmatic patients in whom attacks of asthma, urticaria, angioedema or acute rhinitis are precipitated by non-steroidal anti-inflammatory drugs including acetylsalicylic acid and ibuprofen or by other drugs with prostaglandin synthetase inhibiting activity.
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. 5). 8). • Blood dyscrasias and/or haemorrhagic diathesis.
4); or pulmonary insufficiency, oedema or hypertension, where there is danger of cardiac decompensation. 6). • Thyroid disease. • Sjogrens’ syndrome.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Isolated cases: peripheral neuropathy, excitation, blurred vision, retinal haemorrhage, hearing loss.
Haematological:
Rare: anaemia due to occult gastrointestinal blood loss, haemolytic anaemia, thrombocytopenia, neutropenia, agranulocytosis, leucopenia, pancytopenia, bone marrow depression, aplastic anaemia.
Hepatic:
Rare: increase in serum transaminases, hepatitis and jaundice. Isolated cases: fulminant hepatitis. Frequency unknown: abnormal liver function. Renal Rare: impaired renal function, acute renal failure, haematuria, proteinuria. Isolated cases: acute tubular necrosis, acute interstitial nephritis, nephrotic syndrome, glomerulonephritis, papillary necrosis, ureteral obstruction with uric acid crystal formation.
Frequency unknown: nephrotoxicity in various forms.
Respiratory tract:
Isolated cases: exacerbation of bronchial asthma and of an “acute pulmonary syndrome” – marked by dyspnoea, fever, shadows in radiographs of the lungs and sometimes also by eosinophilia have been reported. Although a casual relationship with the latter has not been proven, the drug should be withdrawn at first signs of this potentially serious syndrome for the treatment of which corticosteroids and supportive cardiotherapy may be necessary.
Dermatological :
Very rare: bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis. Frequency unknown: photosensitivity.
Others:
Occasional stomatitis. Rare: salivary gland enlargement, dry mouth. 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.
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8). 5). Respiratory disorders NSAIDs inhibit prostaglandin synthetase activity and can precipitate acute attacks of bronchospasm in patients suffering from, or with a previous history of, bronchial asthma. Caution is required when administering phenylbutazone to these patients.
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 phenylbutazone. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with phenylbutazone after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Cardiovascular, renal & hepatic impairment NSAIDs cause dose dependent reduction in prostaglandin formation, can cause oedema and fluid/sodium retention and may precipitate renal failure.
Patients at greatest risk are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. 3 and Monitoring – blood tests, below). Severe hepatic reactions including jaundice and hepatitis have been reported with phenylbutazone.
If abnormal liver tests (see below Monitoring – blood tests) persist or worsen, or clinical signs and symptoms consistent with liver disease develop, the drug should be discontinued. 8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in most […]