Delving into the Latest Updates on Loratadine/Pseudoephedrine Sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Compound Loratadine, Loratadine and Pseudoephedrine, Loratadine and Pseudoephedrine sulfate

+ [10]

Target

ADRA1 x ADRA2 x H1 receptor x β1-adrenergic receptor x β2-adrenergic receptor x β3-adrenergic receptor

Mechanism

ADRA1 agonists(Adrenergic receptor alpha-1 agonists), ADRA2 agonists(Adrenergic receptors alpha-2 agonists), H1 receptor antagonists(Histamine H1 receptor antagonists)

+ [3]

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [2]

Active Indication

Common ColdFeverRhinitis, Allergic, Seasonal+ [1]

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Schering-Plough Corp.Bayer Healthcare LLC

Inactive Organization

Bayer AG

Drug Highest PhaseApproved

First Approval Date

US (14 Nov 1994),

Rhinitis, Allergic, SeasonalUpper respiratory tract allergy

Regulation-

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Structure

Molecular FormulaC10H17NO5S

InChIKeyXVPDSDYVNYOVMP-KXNXZCPBSA-N

CAS Registry7460-12-0

View All Structures (2)

A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5 mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-Heist) Under Fed Conditions in Healthy Adult Subjects

To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

Start Date24 Apr 2018

Sponsor / Collaborator

Bayer AG

NCT03517930 / CompletedPhase 1

A Randomized, Crossover Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-SAG) to a Single Oral Dose of Claritin-D® 12-Hour Extended Release Tablet (Loratadine 5 mg/Pseudoephedrine Sulfate 120 mg, Manufacturer-Heist) Under Fasted Conditions in Healthy Adult Subjects

To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering-Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.

Start Date17 Apr 2018

Sponsor / Collaborator

Bayer AG

NCT03443843 / CompletedPhase 4

A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit

The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.

Start Date21 Feb 2018

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Loratadine/Pseudoephedrine Sulfate

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100 Translational Medicine associated with Loratadine/Pseudoephedrine Sulfate

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100 Patents (Medical) associated with Loratadine/Pseudoephedrine Sulfate

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8

Literatures (Medical) associated with Loratadine/Pseudoephedrine Sulfate

01 May 2006·International Journal of Paediatric DentistryQ3 · MEDICINE

Erosive effect of an antihistamine‐containing syrup on primary enamel and its reduction by fluoride dentifrice

Q3 · MEDICINE

Article

Author: I. C. S. Almeida ; C. C. Costa ; L. C. Costa Filho

Summary. Aim. This study evaluated the action of an antihistamine‐containing syrup (Claritin D) on enamel that was subsequently submitted or not to applications of fluoride dentifrice.Methods. Two hundred sixty‐four slices (n = 44 per subgroup) prepared from exfoliated primary molars were evaluated in hardness tests. Six subgroups were submitted to different treatments for 10 days. The controls underwent pH cycling with (positive control) or without (negative control) three daily immersions in fluoride dentifrice/distilled water slurry. The test subgroups related to daytime use of the antihistamine syrup underwent pH cycling and two 5‐min applications of Claritin D, coupled or not to the three daily immersions in the fluoride slurry. The subgroups related to nocturnal use of the syrup were submitted to the same procedures of daytime subgroups, respectively, but with one of the applications of Claritin D lasting for 8 h.Results. The median hardness values obtained after use of the syrup were significantly lower than the initial ones. Equivalent values for subgroups submitted to fluoride applications in addition to treatment with the syrup were significantly higher.Conclusion. It was concluded that the antihistamine‐containing syrup reduced the hardness of primary enamel and that, in this experiment, the use of fluoride dentifrice was able to diminish this erosive effect.

01 Jan 2004·Pharmacoepidemiology and Drug SafetyQ4 · MEDICINE

The risk of esophageal obstruction associated with an anti‐allergy medication (Claritin‐D® 24‐Hour—original formulation)

Q4 · MEDICINE

Article

Author: Bharati Manda ; Carol R. Drinkard ; Deborah Shatin ; David J. Graham

AbstractPurposeTo investigate a possible increased risk of esophageal obstruction among users of loratadine and pseudoephedrine (Claritin‐D® 24‐Hour ‘C‐D 24’, the original, round, extended‐release formulation) compared to two other tablet formulations of loratadine.MethodsPharmacy data of 12 managed care plans were screened to identify users in the three groups from 1 September 1996 to 31 December 1998. Users with a medical claim following their first loratadine prescription (Index prescription) indicating an esophageal obstruction or endoscopic procedure were considered claims‐identified cases. Medical records were reviewed to validate case status.ResultsThere were 233 901 users (61% female) and 245 claims‐identified cases occurring within 30 days after the first prescription. The incidence rate per 10 000 users of claims‐identified cases occurring on the Index prescription date was higher among C‐D 24 users (IR = 1.4) than Claritin® Regular (C‐R) users (IR = 0.07; p < 0.002) or Claritin‐D® 12‐Hour (C‐D 12) users (IR = 0.3; p > 0.05). Medical record review of 15 claims‐identified cases confirmed two cases of acute esophageal obstruction, both among C‐D 24 users.ConclusionsClaims‐based analysis suggested an increased risk of endoscopic procedures on the Index date among C‐D 24 users compared to C‐R users. However, after medical record review, the study did not provide conclusive evidence of an association between C‐D 24 use and esophageal obstruction. This study highlights the importance of validating findings from claims data using medical records. Copyright © 2003 John Wiley & Sons, Ltd.

01 Jul 1998·American Journal of TherapeuticsQ4 · MEDICINE

Comparative Efficacy and Safety of Once-Daily Versus Twice-Daily Loratadine-Pseudoephedrine Combinations Versus Placebo in Seasonal Allergic Rhinitis

Q4 · MEDICINE

Article

Author: Georgitis, J W ; Banov, C H ; Harrison, J E ; Bernstein, D I ; Berkowitz, R R ; Rooklin, A R ; Sholler, L J ; Mendelson, L M ; Lorber, R R ; Bronsky, E A ; Kaiser, H B ; Danzig, M R ; Stricker, W W

The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P

100 Deals associated with Loratadine/Pseudoephedrine Sulfate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Loratadine/Pseudoephedrine Sulfate	R01BA52	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Common Cold	US	Bayer Healthcare LLC	23 Aug 1996
Fever	US	Bayer Healthcare LLC	23 Aug 1996
Rhinitis, Allergic, Seasonal	US	Bayer Healthcare LLC	14 Nov 1994
Upper respiratory tract allergy	US	Bayer Healthcare LLC	14 Nov 1994

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03443843 (Pubmed \| Ann Allergy Asthma Immunol)	Phase 4	Rhinitis, Allergic	82	Loratadine-Pseudoephedrine tablet	(ycdhrajuxf) = emyqcfxuvl gttknsnyaz (ccokzsbglm )	-	14 May 2021
				Fluticasone propionate nasal spray	(ycdhrajuxf) = ywdtnliwpj gttknsnyaz (ccokzsbglm )