Concomitant observations, clinical trial

This critical section should include individual patient data in a tabulated form. Demographic values (age, sex, race, etc.), patient inclusion and exclusion criteria, relevant clinical measures for the particular study must also be included. Special clinical and laboratory measures used for the study must have a rationale for these tests as well as an explanation for the significance of the results. All concomitant medications used during the clinical trial must be listed for each patient admitted into the study. Other clinical observations of less relevance should be addressed. 

GRAPEFRUIT JUICE ANTIPSYCHOTICS -PIMOZIDE Possibly t efficacy and t adverse effects. Interaction may occur rapidly, but clinical significance is uncertain Not evaluated in clinical trials Avoid concomitant use. No interaction was observed with haloperidol... 

Pancytopenia is a rare but potentially fatal complication, and numerous reports have been published. The characteristics and incidence of pancytopenia have been carefully re-evaluated from case reports and clinical trials published from 1980 to 1995 (38). Of 70 reported cases, 12 patients died (17%). Impaired renal function was the most important contributing factor (54%), particularly in fatal cases (10/12). Other important susceptibility factors included advanced age (over 65 years), hypoalbuminemia, concurrent infection, and/or concomitant multiple medications (particularly co-trimoxazole). The mean cumulative dosage was 675 (10-4800) mg, and the minimal cumulative methotrexate dose leading to fatal pancytopenia was 10 mg. This confirms that pancytopenia can occur at any time during treatment, even in the absence of known susceptibility factors. Bone marrow biopsy showed megaloblastosis and hypocellularity. Eosinophilia and increased mean corpuscular volume were rarely observed. In an overall review of five long-term prospective studies (511 patients), the calculated incidence of methotrexate-induced pancytopenia was 1.4%. Although severe myelo-suppression sometimes required folinic acid, there are as yet no data to determine whether prophylactic folate supplementation can reduce the incidence of pancytopenia. 

Adjunctive therapy (600 mg/day twice/day) - If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals the recommended daily dose is 1200 mg/day. Daily doses more than 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects. Observe and monitor closely the plasma levels of the concomitant AEDs during the period of oxcarbazepine titration, especially at oxcarbazepine doses more than 1200 mg/day. 

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