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Information on the incidence of adverse events in clinical investigations conducted in the U.S. was obtained from 33 controlled and 15 uncontrolled clinical studies in which 2499 patients received acrivastine and 2631 patients received acrivastine plus pseudoephedrine hydrochloride for treatment periods ranging from one day to one year. The majority of patients in clinical trials were exposed to acrivastine or acrivastine plus pseudoephedrine for less than 90 days. Acrivastine dosage ranged from 3 to 96 mg/day; 1336 patients received dosages equal to or greater than acrivastine 24 mg/day. Acrivastine plus pseudoephedrine hydrochloride dosages ranged from acrivastine 8 to 48 mg/day plus pseudoephedrine hydrochloride 60 to 240 mg/day. A total of 2335 patients received three or four daily doses of acrivastine 8 mg plus pseudoephedrine hydrochloride 60 mg.
In controlled clinical trials, only 12 spontaneously elicited adverse events were reported with frequencies greater than 1% in the acrivastine plus pseudoephedrine hydrochloride treatment group (see table).
TABLE 1: ADVERSE EVENTS REPORTED IN CLINICAL TRIALS* (PERCENT
OF PATIENTS REPORTING)†
|Pseudo-ephedrine (n= 887)
||Acrivastine plus Pseudo-ephedrine
|*Includes all events regardless of casual
relationship to treatment.
†Includes all adverse events with a reported frequency of > 1% for the acrivastine plus pseudoephedrine treatment group.
‡SEMPREX-D (acrivastine and pseudoephedrine) demonstrates a statistically higher frequency of events than placebo, p ≤ 0.05.
The nature and overall frequencies of adverse events from international clinical trials (35 studies involving approximately 1600 patients) were similar to the results obtained in the U.S. studies.
Post-marketing clinical experience reports with acrivastine and acrivastine plus pseudoephedrine have included rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme. No deaths associated with use of acrivastine or acrivastine plus pseudoephedrine have been reported.
Read the Semprex D (acrivastine and pseudoephedrine) Side Effects Center for a complete guide to possible side effects »
MAO inhibitors and beta-adrenergic agonists increase the effects of sympathomimetic amines. Concomitant use of sympathomimetic amines with MAO inhibitors can result in a hypertensive crisis (see CONTRAINDICATIONS). Because MAO inhibitors are longacting, SEMPREX-D (acrivastine and pseudoephedrine) Capsules should not be taken with an MAO inhibitor or for 14 days after stopping use of an MAO inhibitor. Because of their pseudoephedrine content, SEMPREX-D (acrivastine and pseudoephedrine) Capsules may reduce the antihypertensive effects of drugs that interfere with sympathetic activity. Care should be taken in the administration of SEMPREX-D (acrivastine and pseudoephedrine) Capsules concomitantly with other sympathomimetic amines because the combined effects on the cardiovascular system may be harmful to the patient Concomitant administration of SEMPREX-D (acrivastine and pseudoephedrine) Capsules with alcohol and other CNS depressants may result in additional reductions in alertness and impairment of CNS performance and should be avoided.
No formal drug interaction studies between SEMPREX-D (acrivastine and pseudoephedrine) Capsules and other possibly co-administered drugs have been performed.
Last reviewed on RxList: 5/20/2009
This monograph has been modified to include the generic and brand name in many instances.
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