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Fexofenadine HCl + Pseudoephedrine HCl
Fexofenadine HCl + Pseudoephedrine HCl is a Antihistamine + decongestant combination Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently FDA-approved for Allergic rhinitis with nasal congestion, Urticaria with decongestant support. Also known as: Allegra-D 24 hour ER Tablets.
Fexofenadine blocks histamine H1 receptors to reduce allergic symptoms, while pseudoephedrine acts as a sympathomimetic decongestant to relieve nasal congestion.
Fexofenadine blocks histamine H1 receptors to reduce allergic symptoms, while pseudoephedrine acts as a sympathomimetic decongestant to relieve nasal congestion. Used for Allergic rhinitis with nasal congestion, Urticaria with decongestant support.
At a glance
| Generic name | Fexofenadine HCl + Pseudoephedrine HCl |
|---|---|
| Also known as | Allegra-D 24 hour ER Tablets |
| Sponsor | Dr. Reddy's Laboratories Limited |
| Drug class | Antihistamine + decongestant combination |
| Target | H1 receptor (fexofenadine); alpha-1 adrenergic receptor (pseudoephedrine) |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | FDA-approved |
Mechanism of action
Fexofenadine is a selective peripheral H1-receptor antagonist that prevents histamine-mediated allergic responses without significant central nervous system penetration. Pseudoephedrine is an alpha-1 adrenergic agonist that causes vasoconstriction in nasal blood vessels, reducing mucosal edema and congestion. Together, they provide combined antihistamine and decongestant effects for comprehensive allergy symptom relief.
Approved indications
- Allergic rhinitis with nasal congestion
- Urticaria with decongestant support
Common side effects
- Headache
- Insomnia or nervousness
- Dry mouth
- Tachycardia
- Tremor
Key clinical trials
- Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (PHASE4)
- Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis. (PHASE3)
- Evaluation of Efficacy of Dellegra in Exposure Unit (PHASE4)
- A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge (PHASE2)
- Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis (PHASE3)
- The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis (PHASE2)
- Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions (PHASE1)
- 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 (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fexofenadine HCl + Pseudoephedrine HCl CI brief — competitive landscape report
- Fexofenadine HCl + Pseudoephedrine HCl updates RSS · CI watch RSS
- Dr. Reddy's Laboratories Limited portfolio CI
Frequently asked questions about Fexofenadine HCl + Pseudoephedrine HCl
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Related
- Drug class: All Antihistamine + decongestant combination drugs
- Target: All drugs targeting H1 receptor (fexofenadine); alpha-1 adrenergic receptor (pseudoephedrine)
- Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
- Therapeutic area: All drugs in Allergy/Immunology
- Indication: Drugs for Allergic rhinitis with nasal congestion
- Indication: Drugs for Urticaria with decongestant support
- Also known as: Allegra-D 24 hour ER Tablets
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