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
Allegra-D Side Effects, and Drug Interactions - Fexofenadine HCl and Pseudoephedrine HCl
Allegra-D Side Effects, and Drug Interactions - Fexofenadine HCl and Pseudoephedrine HCl
SIDE EFFECTS
Fexofenadine HCl; Pseudoephedrine HCl
In one clinical trial (n=651) in which 215 patients with seasonal allergic
rhinitis received the 60 mg fexofenadine HCl/120 mg pseudoephedrine HCl combination
tablet twice daily for up to 2 weeks, adverse events were similar to those reported
either in patients receiving fexofenadine HCl 60 mg alone (n=218 patients) or
in patients receiving pseudoephedrine HCl 120 mg alone (n=218). A placebo group
was not included in this study.
Events that have been reported during controlled clinical trials involving
seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences
less than 1% and similar to placebo and have been rarely reported during postmarketing
surveillance include: insomnia, nervousness, and sleep disorders or paranoia.
In rare cases, rash, urticaria, pruritis and hypersensitivity reactions with
manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic
anaphylaxis have been reported.
The percent of patients who withdrew prematurely because of adverse events
was 3.7% for the fexofenadine HCl; pseudoephedrine HCl combination group,
0.5% for the fexofenadine HCl group, and 4.1% for the pseudoephedrine
HCl group. All adverse events that were reported by greater than 1% of
patients who received the recommended daily dose of the fexofenadine HCl;
pseudoephedrine HCl combination are listed in TABLE 2.
|
TABLE 2 Adverse Experiences Reported
in One Active-Controlled Seasonal Allergic Rhinitis Clinical Trial
at Rates of Greater than 1%
|
|
Adverse Experience
|
60 mg Fexofenadine
Hydrochloride/120 mg Pseudoephedrine
Hydrochloride Combination Tablet Twice Daily (n=215) |
Fexofenadine Hydrochloride 60 mg
Twice Daily (n=218) |
Pseudoephedrine Hydrochloride 120 mg
Twice Daily (n=218) |
| Headache |
13.0% |
11.5% |
17.4% |
| Insomnia |
12.6% |
3.2% |
13.3% |
| Nausea |
7.4% |
0.5% |
5.0% |
| Dry Mouth |
2.8% |
0.5% |
5.5% |
| Dyspepsia |
2.8% |
0.5% |
0.9% |
| Throat Irritation |
2.3% |
1.8% |
0.5% |
| Dizziness |
1.9% |
0.0% |
3.2% |
| Agitation |
1.9% |
0.0% |
1.4% |
| Back Pain |
1.9% |
0.5% |
0.5% |
| Palpitation |
1.9% |
0.0% |
0.9% |
| Nervousness |
1.4% |
0.5% |
1.8% |
| Anxiety |
1.4% |
0.0% |
1.4% |
| Upper Respiratory Infection |
1.4% |
0.9% |
0.9% |
| Abdominal Pain |
1.4% |
0.5% |
0.5% |
Many of the adverse events occurring in the fexofenadine HCl; pseudoephedrine
HCl combination group were adverse events also reported predominately
in the pseudoephedrine HCl group, such as insomnia, headache, nausea,
dry mouth, dizziness, agitation, nervousness, anxiety, and palpitation.
Fexofenadine HCl
In placebo-controlled clinical trials, which included 2461 patients receiving
fexofenadine HCl at doses of 20 mg to 240 mg twice daily, adverse events
were similar in fexofenadine HCl and placebo-treated patients. The incidence
of adverse events, including drowsiness, was not dose related and was
similar across subgroups defined by age, gender, and race. The percent
of patients who withdrew prematurely because of adverse events was 2.2%
with fexofenadine HCl vs 3.3% with placebo.
Pseudoephedrine HCl
Pseudoephedrine HCl may cause mild CNS stimulation in hypersensitive
patients. Nervousness, excitability, restlessness, dizziness, weakness,
or insomnia may occur. Headache, drowsiness, tachycardia, palpitation,
pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic
drugs have also been associated with other untoward effects such as fear,
anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory
difficulty, dysuria, and cardiovascular collapse.
DRUG INTERACTIONS
Fexofenadine HCl and Pseudoephedrine HCl do not influence the pharmacokinetics
of each other when administered concomitantly.
In two separate studies, fexofenadine HCl 120 mg twice daily (twice the
recommended dose) was co-administered with erythromycin 500 mg every 8
hours or ketoconazole 400 mg once daily under steady-state conditions
to normal, healthy volunteers (n=24, each study). No differences in adverse
events or QTc interval were observed when subjects were administered
fexofenadine HCl alone or in combination with erythromycin or ketoconazole.
The pharmacokinetic findings of these studies are summarized in TABLE
1.
|
TABLE 1 Effects on Steady-State
Fexofenadine Pharmacokinetics After 7 Days of Co-Administration
with Fexofenadine HCl 120 mg Every 12 Hours (twice recommended dose)
in Normal Volunteers (n=24)
|
| Concomitant Drug |
Cmax,ss (Peak plasma
concentration) |
AUCss(0-12h) (Extent of systemic
exposure) |
| Erythromycin (500 mg every 8 hrs) |
+82% |
+109% |
| Ketoconazole (400 mg once daily) |
+135% |
+164% |
The mechanisms of these interactions are unknown, and the potential for
interaction with other azole antifungal or macrolide agents has not been
studied. These changes in plasma levels were within the range of plasma
levels achieved in adequate and well-controlled clinical trials. Fexofenadine
had no effect on the pharmacokinetics of erythromycin or ketoconazole.
Fexofenadine HCl; pseudoephedrine HCl tablets (pseudoephedrine component)
are contraindicated in patients taking monoamine oxidase inhibitors and
for 14 days after stopping use of an MAO inhibitor. Concomitant use with
antihypertensive drugs which interfere with sympathetic activity (e.g.,
methyldopa, mecamylamine, and reserpine) may reduce their antihypertensive
effects. Increased ectopic pacemaker activity can occur when pseudoephedrine
is used concomitantly with digitalis.
Care should be taken in the administration of fexofenadine HCl; pseudoephedrine
HCl concomitantly with other sympathomimetic amines because combined effects
on the cardiovascular system may be harmful to the patient (see WARNINGS).
top
