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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ALLEGRA-D NEWS HIGHLIGHTS Media Articles Related to Allegra-D (Fexofenadine / Pseudoephedrine)
New All-Natural Capsaicin-Based, Zinc-Free Nasal Spray Is Effective In Relieving Symptoms Of Allergic Rhinitis
Source: Allergy News From Medical News Today [2009.06.18]
Researchers from Strategic BioSciences, together with investigators from the Institute for Asthma and Allergy (Wheaton, MD) reported that the new all-natural product is safe and effective in relieving symptoms of allergic rhinitis. MucoAd® is a mucoadhesive molecule (hypromellose) that prolongs contact with the nasal surface so that the nasal spray is well tolerated, lasts longer, and repeat dosing is needed less frequently.
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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ALLEGRA-D PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Allegra-D has an overall score of 8.67. The effectiveness score is 8.67 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
| | Allegra-D review by 24 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | allergies |
| Dosage & duration: | | 1 pill taken every morning for the period of 2 years |
| Other conditions: | | deviated septum |
| Other drugs taken: | | femcon, astelin | | |
Reported Results |
| Benefits: | | Allegra-D successfully alleviates most of my allergy symptoms (runny nose, itchy eyes, headache, nasal congestion, post-nasal drip). On occasion additional use of Astelin nose spray helps when my allergies are especially bad. After taking Allegra-D regularly my chronic sinus infections have ceased, as have my allergy related headaches. I wouldn’t be able to make it through late spring (my worst allergy season) without Allegra-D. |
| Side effects: | | The main side effect that I experience with Allegra-D is loss of appetite. This actually helped me lose the 10 pounds I put on in college. I started taking Allegra-D two years ago before graduation and I lost the weight in about three months. I have a healthy appetite while on Allegra-D--it just seems to cut my cravings for junk. Regular Allegra without the decongestant does not have this effect. My brother also experiences this effect, but my friend does not, so it's relative. Also, Allegra-D causes a slight spike in my blood pressure sometimes, but not always. |
| Comments: | | I take Allegra-D once every morning an hour before eating. When my allergies are especially bad I take Allegra-D once in the morning and once at night. I take Allegra-D every day during allergy season (spring) and as needed the rest of the year. |
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| | Allegra-D review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Allergies |
| Dosage & duration: | | 1 tablet taken once per day for the period of 6 years |
| Other conditions: | | muscle spasms |
| Other drugs taken: | | Cyclobenzaprine | | |
Reported Results |
| Benefits: | | Taking Allegra-D once in the morning manages my allergy symptoms for the entire day. Allegra-D alleviates my nasal congestion, itchy nose, throat, and eyes, and my post-nasal drip. It also helps prevent sinus infections by keeping me decongested, which I am prone to. |
| Side effects: | | Appetite suppression, slightly dry nose and mouth, sometimes raises my blood-pressure |
| Comments: | | I take Allegra-D everyday to help alleviate my allergy symptoms. During peak allergy season for me (Spring), I take Allegra-D twice per day. When my nasal congestion is worse than average, I also use the nose spray Astelin in conjunction with Allegra-D for added decongestion. |
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| | Allegra-D review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Allergies |
| Dosage & duration: | | 1 tablet taken once per day for the period of 6 years |
| Other conditions: | | muscle spasms |
| Other drugs taken: | | Cyclobenzaprine | | |
Reported Results |
| Benefits: | | Taking Allegra-D once in the morning manages my allergy symptoms for the entire day. Allegra-D alleviates my nasal congestion, itchy nose, throat, and eyes, and my post-nasal drip. It also helps prevent sinus infections by keeping me decongested, which I am prone to. |
| Side effects: | | Appetite suppression, slightly dry nose and mouth, sometimes raises my blood-pressure |
| Comments: | | I take Allegra-D everyday to help alleviate my allergy symptoms. During peak allergy season for me (Spring), I take Allegra-D twice per day. When my nasal congestion is worse than average, I also use the nose spray Astelin in conjunction with Allegra-D for added decongestion. |
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Page last updated: 2009-06-18
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