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Semprex-D (Acrivastine / Pseudoephedrine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE EXPERIENCES

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)
Controlled Studies
Placebo
(N = 1767)
Acrivastine
(N = 1935)
Pseudoephedrine
(N = 887)
Acrivastine plus
Pseudoephedrine
(N = 1650)
*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 demonstrates a statistically higher frequency of events than placebo, p ≤ 0.05.
CNS
    Somnolence
6

12

8

12
   Headache18191919
   Dizziness2333
   Nervousness1243
   Insomnia1164
MISCELLANEOUS
   Nausea2332
   Dry Mouth2357
   Asthenia2322
   Dyspepsia1122
   Pharyngitis2113
   Cough Increase1212
   Dysmenorrhea1232

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.

Pseudoephedrine may cause ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea (see WARNINGS and OVERDOSAGE).

Drug label data at the top of this Page last updated: 2008-05-27

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