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Allegra D (Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride) - Summary

 
 



ALLEGRA D SUMMARY

ALLEGRA-D® 12 HOUR (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 12 HOUR Extended-Release Tablets are 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 12 HOUR should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired (see CLINICAL PHARMACOLOGY).


See all Allegra D indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Allegra D (Fexofenadine / Pseudoephedrine)

Hay Fever (Allergic Rhinitis)
Source: MedicineNet Allergic Cascade Specialty [2015.08.18]
Title: Hay Fever (Allergic Rhinitis)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/18/2015 12:00:00 AM

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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)

Preference for Clarinex Tablets vs Allegra Tablets in Patients With Seasonal Allergies (P03178) [Completed]
This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03179) [Completed]
This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.

Preference for Clarinex Tablets vs. Allegra Tablets in Patients With Seasonal Allergies (Study P03177) [Completed]
This was a crossover study designed to see if patients with seasonal allergy symptoms preferred Clarinex® or Allegra®. Patients were randomized to take 7 days of Clarinex or Allegra treatment, followed by a 5 to 28-day washout period (days when no drug is given), followed by 7 days of the opposite treatment. At the end of each 7-day treatment, patients were asked questions to determine which drug, Clarinex or Allegra, the patient prefers more.

Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions [Completed]

Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition [Completed]
To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing

fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U. S.

LLC, Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor adverse events and ensure the safety of subjects.

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PATIENT REVIEWS / RATINGS / COMMENTS

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

  Rating
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

  Rating
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: 2015-08-18

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