Active Ingredient: Aspirin, Phenylbutazone, Dexamethasone
Dosage: 200 mg / 100 mg / 0.5 mg
Route of Administration: Oral
Dosage Form: Dragee
Quantity per package: 20
Zolidime is prescribed for the treatment of rheumatism, rheumatoid arthritis, infectious-allergic myocarditis, fever during infectious and inflammatory diseases, pain syndrome, weak and medium intensity of various origins (including neuralgia, myalgia, headache). It can be used as a prevention of thrombosis and embolism, primary and secondary prevention of myocardial infarction, prevention of violations of cerebral circulation by ischemic type.
Zolidime is indicated for the treatment of chronic and degenerative acute rheumatic musculoskeletal conditions accompanied by inflammation; pain and functional disability. Some of the main therapeutic indications for Zolidime are the short-term treatment of acute painful rheumatic conditions or the exacerbation of chronic musculoskeletal diseases such as acute gouty arthritis, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, bursitis and tendosynovitis. It is also effective for the resolution of the inflammatory process in thrombophlebitis and trauma.
Zolidime should not be used in patients with gastrointestinal disease such as gastritis, gastric ulcer or duodenal, active or recent gastrointestinal bleeding. The drug will not be indicated in kidney, heart, thyroid, hematopoietic disease, liver dysfunction or in patients under anticoagulant therapy. It will not be administered when there is hypersensitivity to the components of the formula. The drug is contraindicated in subjects with arterial hypertension. The toxic effects of phenylbutazone are more intense in the elderly and therefore it should not be used in such patients. Its administration in children under 14 years of age is not advisable. Due to the immunosuppressive effect of dexamethasone, the use of Zolidime is contraindicated in systemic mycoses, infectious processes and in concomitant administration with live virus vaccines.
It is also cntraindicated in the following cases:
- hypersensitivity to salicylates and other similar substances;
- active peptic acid disease;
- history of bronchial asthma induced by salicylates or substances of similar action, especially non-steroidal anti-inflammatory drugs;
- use in combination with methotrexate at doses of 15 mg per week or more bleeding diathesis;
- last trimester of pregnancy;
- renal and/or hepatic failure.
Due to its relative potential for toxicity, Zolidime should be used with care within the limits of recommended dosages and should not be prescribed for prolonged periods. In short treatments of 1 to 2 weeks, the toxicity of phenylbutazone dexamethasone is rarely a problem. Toxic reactions to Phenylbutazone include:
- skin rash;
- serum sickness-like hypersensitivity reaction;
- erythema pruritus;
- sodium retention;
- peptic ulceration;
- blood dyscrasias;
- prothrombin depression.
The most severe side effects of Zolidime include peptic ulcer or its reactivation with bleeding or perforation hypersensitivity reactions such as Stevens-Johnson syndrome, ulcerative stomatitis, hepatitis, nephritis, aplastic anemia, leukopenia, agranulocytosis, and thrombocytopenia. Death cases have been reported, especially from aplastic anemia and agranulocytosis.
The use of the drug should be discontinued immediately if pharyngitis, fever or other lesions of the mouth appear, skin rashes, itching, jaundice, weight gain, or melena. Regarding dexamethasone, it has been recorded that its prolonged use may cause the frequency and severity of osteoporosis in rheumatic disease. The use of dexamethasone can decrease resistance to acquired or reactivated infections. The therapeutic use of dexamethasone can cause two classes of toxic effects: those that occur due to the withdrawal of steroid treatment and those that appear due to continuous and prolonged use.
The most common adverse reaction to steroid suppression is a worsening of the fundamental disease, the most severe complication is acute adrenal insufficiency, which depends on too rapid suppression after prolonged treatment, which suppresses the hypothalamic-pituitary-adrenal axis. Complications arising from continuous use of steroids at supraphysiological doses include: fluid and electrolyte abnormalities, hypertension, hyperglycemia, increased sensitivity to infection, osteoporosis, myopathy, behavioral disturbances, cataracts, growth interruption, fat redistribution, stretch marks, ecchymosis, acne and hirsutism and possible increased risk of peptic ulcers.
- Anticoagulants: the effect is enhanced.
- Corticosteroids: risk of gastrointestinal bleeding.
- Antirheumatic drugs and methotrexate: action and side effects are intensified.
- Sulfonylureas: whenever high doses of acetylsalicylic acid are used, the hypoglycemic effect can be increased.
- Spironolactone furosemide and hypouricemic drugs: the effect is reduced.
- Valproic acid: greater toxicity of valproic acid due to displacement of protein binding sites.
- Alcohol: greater damage to the gastrointestinal mucosa and prolonged bleeding time due to the additive effects of acetylsalicylic acid and alcohol.
- When corticosteroids and diuretics that increase potassium excretion are administered concurrently, the possible development of hypokalaemia should be carefully monitored.
- Due to the phenomenon of adsorption of antacids on tranquilizing drugs, antibiotics (tetracyclines), chemotherapies, antituberculous drugs and antianemias, digestive absorption may decrease, so it is advisable to administer these drugs two hours after taking Zolidime due to the content of aluminum hydroxide.