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The most frequent adverse reactions observed with TRILISATE (choline magnesium trisalicylate) preparations in clinical trials (7- 12) are tinnitus and gastrointestinal complaints (including nausea, vomiting, gastric upset, indigestion, heartburn, diarrhea, constipation and epigastric pain). These occur in less than twenty percent (20%) of patients. Should tinnitus develop, reduction of daily dosage is recommended until the tinnitus is resolved. Less frequent adverse reactions, occurring in less than two percent (2%) of patients, are: hearing impairment, headache, lightheadedness, dizziness, drowsiness, and lethargy. Adverse reactions occurring in less than one percent (1%) of patients are: gastric ulceration, positive fecal occult blood, elevation in serum BUN and creatinine, rash, pruritus, anorexia, weight gain, edema, epistaxis and dysgeusia.
Spontaneous reporting has yielded isolated or rare reports of the following adverse experiences: duodenal ulceration, elevated hepatic transaminases, hepatitis, esophagitis, asthma, erythema multiforme, urticaria, ecchymoses, irreversible hearing loss and/ or tinnitus, mental confusion, hallucinations.
DRUG ABUSE AND DEPENDENCE
Drug abuse and dependence have not been reported with TRILISATE (choline magnesium trisalicylate) preparations.
Read the Trilisate (choline magnesium trisalicylate) Side Effects Center for a complete guide to possible side effects
Foods and drugs that alter urine pH may affect renal clearance of salicylate and plasma salicylate concentrations. Raising urine pH, as with chronic antacid use, can enhance renal salicylate clearance and diminish plasma salicylate concentration; urine acidification can decrease urinary salicylate excretion and increase plasma levels.
When salicylate drug products are concurrently dosed with other plasma protein bound drug products, adverse effects may result. Although TRILISATE (choline magnesium trisalicylate) preparations are a rational choice for anti- inflammatory and analgesic therapy in patients on oral anticoagulants due to their demonstrated lack of effect in vivo and in vitro on platelet aggregation, bleeding time, platelet count, prothrombin time, and serum thromboxane B2 generation (7), the potential exists for increased levels of unbound warfarin with their concurrent use. Prothrombin time should be closely monitored and warfarin dose appropriately adjusted when therapy with TRILISATE (choline magnesium trisalicylate) preparations is initiated. The effect of TRILISATE (choline magnesium trisalicylate) on blood prothrombin levels has not been established. Salicylates may increase the therapeutic as well as toxic effects of methotrexate, particularly when administered in chemotherapeutic doses, by inhibition of renal methotrexate excretion and by displacement of plasma protein bound methotrexate. Caution should be exercised in administering TRILISATE (choline magnesium trisalicylate) to rheumatoid arthritis patients on methotrexate. When sulfonylurea oral hypoglycemic agents are co- administered with salicylates, the hypoglycemic effect may be enhanced via increased insulin secretion or by displacement of sulfonylurea agents from binding sites. Insulin- treated diabetics on high doses of salicylates should also be closely monitored for a similar hypoglycemic response. Other drugs with which salicylate competes for protein binding sites, and whose plasma concentration or free fraction may be altered by concurrent salicylate administration, include the following: phenytoin, valproic acid, and carbonic anhydrase inhibitors.
The efficacy of uricosuric agents may be decreased when administered with salicylate products. Although low doses of salicylate (1 to 2 grams per day) have been reported to decrease urate excretion and elevate plasma urate concentrations, intermediate doses (2 to 3 grams per day) usually do not alter urate excretion. Larger salicylate doses (over 5 grams per day) can induce uricosuria and lower plasma urate levels.
Corticosteroids can reduce plasma salicylate levels by increasing renal elimination and perhaps by also stimulating hepatic metabolism of salicylates. By monitoring plasma salicylate levels, salicylate dosage may be titrated to accommodate changes in corticosteroid dose or to avoid salicylate toxicity during corticosteroid taper.
Read the Trilisate Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/8/2004
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