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ALLEGRA-D®
(fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg)
Extended-Release Tablets
INDICATION:
Allegra-D is indicated in the United States for seasonal allergic rhinitis (SAR) and nasal congestion, in adults and children 12 years and older. SAR is an allergic condition occurring predominantly during spring and fall allergy seasons and is characterized by sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes, and nasal congestion.
MODE OF ACTION:
The antihistamine component in Allegra-D interacts with H1-histamine receptors, blocking histamine reactions and preventing allergy symptoms. Exposure to allergens causes the body to release histamine, which affects the upper respiratory system by causing excess mucus production or runny nose, sneezing, and itchy, watery eyes.
The decongestant component in Allegra-D reduces the swelling of the nasal passages and nasal congestion.
KEY BENEFITS:
Rapid Onset of Action
The onset of action of Allegra® (fexofenadine HCl) 60-mg capsules, the antihistamine component of Allegra-D, was observed at 60 minutes following a single 60 mg fexofenadine dose administered to patients with SAR who were exposed to ragweed pollen in an environmental exposure unit.*
Continuous Relief
Studies demonstrated that allergy sufferers continued feeling relief throughout the 12-hour dosing period. In addition, two-week trials showed that Allegra-D provided significant symptom relief throughout the full course of therapy. Allegra-D offers twice-a-day dosing.
Nonsedating
Allegra-D has been clinically shown to be nonsedating.
Excellent Safety Profile
Unlike some antihistamines, fexofenadine undergoes negligible metabolism by the liver. Studies have demonstrated Allegra (fexofenadine HCl) is safe for use with the macrolide antibiotic erythromycin and the antifungal
ketoconazole.
*The Environmental Exposure Unit (EEU) is an enriched pollen environment in an artificial study setting.
SAFETY PROFILE:
Because Allegra-D® (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg) Extended-Release Tablets contain pseudoephedrine (the decongestant in most over-the-counter allergy medicines), Allegra-D must not be taken if you are also taking MAO inhibitors (medicines that treat depression) or if you retain urine or have glaucoma, severe high blood pressure, or severe heart disease. Also, let your doctor know before you take Allegra-D if you have high blood pressure, diabetes, heart disease, glaucoma, thyroid disease, impaired kidney function, or symptoms of an enlarged prostate such as difficulty urinating. The most commonly reported adverse experiences with Allegra-D compared to pseudoephedrine alone were headache (13.0% vs. 17.4%), insomnia (12.6% vs. 13.3%), and nausea (7.4% vs. 5.0%).
Fexofenadine hydrochloride,
the active ingredient of ALLEGRA, is a histamine
H1-receptor antagonist with the chemical name (±)-4-[1
hydroxy-4-
[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-a,
a-dimethyl benzeneacetic
acid hydrochloride. It has the following chemical structure:

The molecular weight is 538.13
and the empirical formula is C32H39NO4•HCl.
Fexofenadine hydrochloride is
a white to off-white crystalline powder. It is freely soluble
in methanol and ethanol, slightly soluble in chloroform and
water, and insoluble in hexane. Fexofenadine hydrochloride is
a racemate and exists as a zwitterion in aqueous media at
physiological pH.
ALLEGRA is formulated as a
capsule or tablet for oral administration. Each capsule
contains 60 mg fexofenadine hydrochloride and the following
excipients: croscarmellose sodium, gelatin, lactose,
microcrystalline cellulose, and pregelatinized starch. The
printed capsule shell is made from gelatin, iron oxide,
silicon dioxide, sodium lauryl sulfate, titanium dioxide, and
other ingredients.
Each tablet contains 30, 60,
or 180 mg fexofenadine hydrochloride (depending on the dosage
strength) and the following excipients: croscarmellose sodium,
magnesium stearate, microcrystalline cellulose, and
pregelatinized starch. The aqueous tablet film coating is made
from hydroxypropyl methylcellulose, iron oxide blends,
polyethylene glycol, povidone, silicone dioxide, and titanium
dioxide.
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