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Allegra-D (Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride) - Summary



ALLEGRA-D® (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets for oral administration contain 60 mg fexofenadine hydrochloride for immediate-release and 120 mg pseudoephedrine hydrochloride for extended-release. Tablets also contain as excipients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, silicon dioxide, hypromellose and polyethylene glycol.

ALLEGRA-D is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.

ALLEGRA-D should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).

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Media Articles Related to Allegra-D (Fexofenadine / Pseudoephedrine)

Nasal Filter: A New Tool in the Fight Against Hay Fever?
Source: Medscape Allergy & Clinical Immunology Headlines [2015.07.20]
People plagued by seasonal allergic rhinitis might try a new nasal filter to prevent symptoms before they start, the Danish researchers who designed it suggest.
Reuters Health Information

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Published Studies Related to Allegra-D (Fexofenadine / Pseudoephedrine)

Single-dose and steady-state bioequivalence of fexofenadine and pseudoephedrine combination tablets compared with individual formulations in healthy adults. [2005.05]
CONCLUSIONS: These findings demonstrate that the pharmacokinetics of the new 24-h FEX 180 mg/PSE 240 mg combination formulation are bioequivalent to the concurrent administration of the individual drug components. Furthermore, both treatments were well tolerated in this population.

Fexofenadine HCl 60 mg/ pseudoephedrine HCl 120 mg has a 60-minute onset of action in the treatment of seasonal allergic rhinitis symptoms, as assessed in an allergen exposure unit. [2004.09]
Although antihistamine-decongestant combinations are frequently used for allergic rhinitis, published data about the onset of action of these combination agents are limited. This randomized, double-blind, placebo-controlled, parallel-group study investigated the onset of action, efficacy, and safety of fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg or placebo in patients with moderate-to-severe seasonal allergic rhinitis in an allergen exposure unit...

Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis. [2004.01]
BACKGROUND: Antihistamine-decongestant combinations are used routinely for the treatment of seasonal allergic rhinitis. Recently, the combination of an antihistamine and a leukotriene receptor antagonist has been shown to be efficacious. OBJECTIVE: To compare the 2 combinations in the treatment of seasonal allergic rhinitis... CONCLUSIONS: Fexofenadine-pseudoephedrine and loratadine-montelukast have comparable efficacy in improving symptoms, RQLQ scores, and nasal obstruction in seasonal allergic rhinitis. The lack of improvement in sleep in the fexofenadine-pseudoephedrine group is probably related to insomnia, a known adverse effect of pseudoephedrine.

Onset of action, efficacy, and safety of fexofenadine 60 mg/pseudoephedrine 120 mg versus placebo in the Atlanta allergen exposure unit. [2002.07]
BACKGROUND: Second-generation antihistamine-decongestant combinations are often used to treat seasonal allergies. However, onset of action and efficacy data for these agents in a controlled setting are limited. OBJECTIVE: Determine onset of action of fexofenadine-pseudoephedrine (Allegra-D, Aventis, Bridgewater, NJ) for treating moderate-to-severe seasonal allergies in an allergen exposure unit... CONCLUSIONS: Fexofenadine-pseudoephedrine was safe and effective in treating a broad range of allergy symptoms, with a rapid onset of action at 45 minutes.

The efficacy and safety of fexofenadine HCl and pseudoephedrine, alone and in combination, in seasonal allergic rhinitis. [1999.07]
BACKGROUND: Antihistamines effectively treat seasonal allergic rhinitis (SAR), although the ability of this drug class to reduce nasal congestion is limited. Nasal decongestants effectively treat nasal congestion but not the histamine-related components of SAR. Therefore antihistamine/nasal decongestant combinations are commonly used to maximize the treatment of SAR. Fexofenadine HCl is a nonsedating, long-acting H1 receptor antagonist that provides fast and effective relief from SAR. It is well tolerated, with no sedative or cardiotoxic effects. OBJECTIVE: We sought to compare the efficacy and safety of a fexofenadine HCl/pseudoephedrine HCl combination with that of each individual component in the treatment of ragweed allergy... CONCLUSION: Combination therapy is more effective than fexofenadine alone or pseudoephedrine alone in relieving the full spectrum of SAR symptoms (ie, both the primarily histamine-related symptoms and nasal congestion).

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Clinical Trials Related to Allegra-D (Fexofenadine / Pseudoephedrine)

Food Study of Fexofenadine Tablets 180 mg and AllegraŽ Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' AllegraŽ 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fed conditions.

Fasting Study of Fexofenadine Tablets 180 mg and AllegraŽ Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180 mg tablets to Aventis' AllegraŽ 180 mg tablets following a single, oral 180 mg (1 x 180 mg) dose administered under fasting conditions.

Fexofenadine (AllegraŽ) in Healthy Adults Who Have Been Identified as Slow Metabolizers for Desloratadine [Completed]
To evaluate the single-dose and steady-state pharmacokinetics of desloratadine and fexofenadine in desloratadine slow metabolizers. To evaluate the safety and tolerability of desloratadine compared to fexofenadine following single and multiple oral doses administered to desloratadine slow metabolizers.

Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel [Completed]
To compare the effects of fexofenadine HCl 180 mg, cetirizine 10 mg, and placebo on computerized scores derived from the Aeromedical Vigilance Task (AVT), a computerized objective measure of attention, accuracy and reaction time in healthy naval flight personnel. Specifically, the primary objective is to compare the AVT overall (average of the 18 blocks) mean change from baseline in total number of errors (commission errors + omission errors) between fexofenadine HCl and cetirizine 10 mg. Safety of these single-dose treatments also will be assessed.

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit [Completed]

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Based on a total of 2 ratings/reviews, Allegra D has an overall score of 9. The effectiveness score is 9 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.

Allegra D review by 39 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   allergies
Dosage & duration:   180 mg every 12 hours taken twice a day as needed for allergies for the period of two years
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   allergies were completely cleared up while on the medication.
Side effects:   dry mouth was the main side effect. the other was that after taking my evening dose, I would go to bed at an appropriate hour and fall asleep, but would wake up after about 5 hours and would be WIDE AWAKE until bed time.
Comments:   mostly for seasonal allergies or occasional reactions to things like dust or pet dander. was on the medicine for about two years but now my allergies are much more mild than they were at that time (moved to a different climate where the allergens are not as prevalent).


Allegra D review by 44 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   Allergies
Dosage & duration:   1x per day (1800 mg) taken daily for the period of One year
Other conditions:   None
Other drugs taken:   None
Reported Results
Benefits:   Decongestion, elimination of sinus pressure and tearing of eyes
Side effects:   Jittery feeling, sleeplessness and on occasion nausea. This medication always makes me nauseas if I take it with other vitamins or other medication such as Advil.
Comments:   I switched from 12 hour to 24 hour however feel that the 12 hour tablet met my needs better than the 24 hour tablet. The 24 hour tablet seemed to run out of steam and during the heavy allergy season, my syptoms would reappear.

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Page last updated: 2015-07-20

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