ALLEGRA-D 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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NEWS HIGHLIGHTSMedia Articles Related to Allegra-D (Fexofenadine / Pseudoephedrine)
Nonallergic Rhinitis Symptoms More Severe Than Allergic Rhinitis
Source: Allergy News From Medical News Today [2009.10.06]
A comparison of symptoms in patients with allergic rhinitis (AR) and non-allergic rhinitis (NAR) revealed that those with the NAR experienced worse symptoms. The findings are according to new research presented at the 2009 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO, in San Diego, CA.
Patients With Allergic Rhinitis And Obstructive Sleep Apnea Plagued By Stress, Fatigue
Source: Allergy News From Medical News Today [2009.10.06]
Patients who suffer from both allergic rhinitis and obstructive sleep apnea (OSA) may experience escalated symptoms of stress and fatigue. In a paper presented at the 2009 American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO in San Diego, researchers studied 34 people who were diagnosed with obstructive sleep apnea. Among them, 12 people were classified in the allergic rhinitis group and 22 people in the control group.
Botox Sponge Treats Intrinsic Rhinitis Without Needles
Source: Ear, Nose and Throat News From Medical News Today [2009.10.16]
Injecting botulinum toxin (botox) to treat intrinsic or allergic rhinitis may be a thing of the past as researchers have now shown that sponges soaked in botox are equally effective in treating the condition. The research published in BioMed Central's open access journal Head & Face Medicine offers a potential needle-free treatment to the millions of people who suffer from rhinitis.
STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet V 1) Of Birch Pollen: Positive Results For A Phase IIb/III Trial
Source: Allergy News From Medical News Today [2009.09.17]
Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by birch pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1. This study is the first ever to use a recombinant allergen as an active substance. To Stallergenes' knowledge, the use of a recombinant protein in dry form is also a world first. The VO59.
Chlorinated Pools Increase Risk Of Allergic Diseases
Source: Allergy News From Medical News Today [2009.09.15]
Chlorine is effective at killing pathogens in swimming pools, but it also irritates the skin, eyes and upper respiratory tract of swimmers. Recent research has found swimming in outdoor or indoor chlorinated pools can increase asthma risks. The study, "Impact of Chlorinated Swimming Pool Attendance on the Respiratory Health of Adolescents" found that children who swam in chlorinated pools had a higher risk of asthma, as well as other allergic diseases such as hay fever and allergic rhinitis.
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).
Clinical Trials Related to Allegra-D (Fexofenadine / Pseudoephedrine)
Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180
mg tablets to Aventis' Allegra® 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 Allegra® Tablets 180 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's fexofenadine 180
mg tablets to Aventis' Allegra® 180 mg tablets following a single, oral 180 mg (1 x 180 mg)
dose administered under fasting conditions.
Fexofenadine (Allegra®) 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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Allegra D has an overall score of 10. The effectiveness score is 10 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). |
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Page last updated: 2009-10-16
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