Treatment of inflammation and pain in: ankylosing spondylitis, discopathy, acute gouty attack, thrombophlebitis.
Composition:
1 suppository contains 250 mg of phenylbutazone.
Action:
Phenylbutazone - a derivative of pyrazole from the group of non-steroidal anti-inflammatory drugs. It inhibits cyclooxygenase activity. In addition to anti-inflammatory properties, it also has analgesic and weak antipyretic effects. It is transported through the blood in a form associated with plasma proteins. In the liver, it induces microsomal enzymes. With their participation, phenylbutazone is metabolised to derivatives, of which oxyphenylbutazone is a potent product. T0,5 ranges from 54 to 99 (mean 77) h, increases to 105 h in geriatric patients in the elderly. The body stays for 7-10 days, it easily accumulates. It is excreted in 75% in urine, the remaining part with faeces.
Contraindications:
Hypersensitivity to phenylbutazone or other ingredients of the preparation. Peptic ulcer of the stomach and / or duodenum. Inflammation of the gastrointestinal mucosa. Changes in the mucous membrane of the rectum. Enlargement of the salivary glands. Failure of circulation. Hypertension. Severe heart failure. Edema. Liver failure. Renal failure. Thyroid disease. Changes in blood count indicators. Do not use in patients taking drugs that interfere with bone marrow function and in children under 14 years of age.
Precautions:
Particularly cautiously use in patients who are at increased risk of gastrointestinal ulceration and bleeding (patients with peptic ulcer disease and / or duodenal ulcers, especially complicated haemorrhage and gastrointestinal perforation, patients receiving systemic corticosteroids, anticoagulants, antiplatelet, selective serotonin reuptake inhibitors, elderly people) - the smallest possible therapeutic dose of phenylbutazone should be used in these patients. The concomitant use of phenylbutazone with other NSAIDs, including selective COX-2 inhibitors, should be avoided. Special care should be taken in patients with renal or cardiac dysfunction, taking diuretics or nephrotoxic drugs, with hypovolaemia of various aetiologies, with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease or cerebrovascular disease, with fluid retention or edema, risk factors for cardiovascular disease (hypertension, hyperlipidemia, diabetes, smoking), blood coagulation disorders, patients with asthma, allergic rhinitis, nasal edema, chronic obstructive pulmonary disease, chronic infections respiratory tract, Quincke's edema, urticaria and patients with allergy to other medicines, patients with ulcerative colitis, Crohn's disease, liver dysfunction, porphyria and low body weight; especially in the case of treatment exceeding 7 days. In case of bleeding or ulceration of the gastrointestinal tract, skin rash, mucosal lesions or any symptoms of hypersensitivity, and if abnormal liver function test results or clinical signs suggest liver dysfunction occur, the drug should be immediately discontinued. The medicine may mask the symptoms of an existing infection.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding. The use of phenylbutazone may impair fertility in women - for women who have difficulty conceiving or are tested for infertility, the end of treatment should be considered. It is not recommended to give the drug to women planning pregnancy.
Side effects:
Common: nausea, vomiting, epigastric pain, diarrhea.Not known: agranulocytosis, thrombocytopenia, bone marrow depression, reduced blood clotting, headache and dizziness, optic neuritis, visual disturbances, ulcer (including bleeding) of the gastrointestinal tract, salivary gland enlargement, inflammation and renal failure, hematuria, skin rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal exfoliation, exfoliative dermatitis, hyperglycemia, edema, circulatory failure, hypertension, hypersensitivity reactions (anaphylactic and anaphylactoid reactions), hepatitis, jaundice, benign prostatic hyperplasia. In addition, agranulocytosis may be manifested by inflammation of mucous membranes such as ulcerative mucositis of the mouth and throat, inflammation of the mucous membrane of the anus and rectum, pharyngitis, fever (chronic or recurrent) and haemorrhage. In contrast, the symptoms of thrombocytopenia are bleeding and ecchymosis on the skin and mucous membranes. Nause, hypertension and heart failure have been reported in relation to NSAID treatment. Clinical studies and epidemiological data suggest that the intake of certain NSAIDs (especially long-term at high doses) is associated with a small increase in the risk of arterial blockages (e.g., myocardial infarction or stroke).
Dosage:
Rectally. Adults and adolescents over 14 years of age: 1 suppository (250 mg) 1-2 times daily. The drug should not be used for more than 7 days. Suppositories should not be divided.