A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Semprex D Side Effects, and Drug Interactions - Acrivastine and Pseudoephedrine
Semprex D Side Effects, and Drug Interactions - Acrivastine and Pseudoephedrine
SIDE EFFECTS
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 dosages 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).
ADVERSE EVENTS REPORTED IN CLINICAL TRIALS* (PERCENT
OF PATIENTS REPORTING) t
| |
Controlled Studies
|
|
Placebo
(n= 1767)
|
Acrivastine
(n= 1935)
|
Pseudo-ephedrine
(n= 887)
|
Acrivastine
plus
Pseudo-ephedrine
(n= 1650)
|
CNS
|
| Somnolence † |
6
|
12
|
8
|
12
|
| Headache |
18
|
19
|
19
|
19
|
| Dizziness |
2
|
3
|
3
|
3
|
| Nervousness † |
1
|
2
|
4
|
3
|
| Insomnia † |
1
|
1
|
6
|
4
|
MISCELLANEOUS
|
| Nausea |
2
|
3
|
3
|
2
|
| Dry Mouth † |
2
|
3
|
5
|
7
|
| Asthenia |
2
|
3
|
2
|
2
|
| Dyspepsia |
1
|
1
|
2
|
2
|
| Pharyngitis |
2
|
1
|
1
|
3
|
| Cough Increase |
1
|
2
|
1
|
2
|
| Dysmenorrhea |
1
|
2
|
3
|
2
|
- * Includes all events regardless of causal relationship
to treatment.
- t 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 ³ 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.
Pseudoephedrine may cause
ephedrine-like reactions such as tachycardia, palpitations, headache,
dizziness, or nausea (see
WARNINGS and OVERDOSAGE).
DRUG INTERACTIONS
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 long-acting,
SEMPREX-D Capsules should not be taken with an MAO
inhibitor or for two weeks
after stopping use of an MAO inhibitor.
Because of their pseudoephedrine content, SEMPREX-D Capsules may reduce
the antihypertensive
effects of drugs that interfere with sympathetic
activity. Care should be taken in the administration
of SEMPREX-D 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 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 Capsules and other possibly co-administered
drugs have been performed.
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