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

Action

agonists, antagonists

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 ColdFeverHypersensitivity+ [2]

Inactive Indication-

Originator Organization

Bayer AG

Active Organization

Bayer Healthcare LLCSchering-Plough Corp.

Inactive Organization

Bayer AG

Drug Highest PhaseApproved

First Approval Date

United States (14 Nov 1994),

Rhinitis, Allergic, SeasonalUpper respiratory tract allergy

Regulation-

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Structure/Sequence

Molecular FormulaC10H17NO5S

InChIKeyXVPDSDYVNYOVMP-KXNXZCPBSA-N

CAS Registry7460-12-0

View All Structures (2)

主要目的：研究空腹/餐后状态下受试制剂氯雷他定片（雪苏®，规格：10mg/片）与参比制剂氯雷他定片（Claritine®，规格：10mg/片）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要目的：研究受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To study the pharmacokinetics of the test preparation loratadine tablets (Xuesu®, specification: 10 mg/tablet) and the reference preparation loratadine tablets (Claritine®, specification: 10 mg/tablet) in healthy subjects in the fasting/fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state. Secondary objective: To study the safety of the test preparation and the reference preparation in healthy subjects.

Start Date04 May 2018

Sponsor / Collaborator

Shanghai Haini Pharmaceutical Co. Ltd.

NCT03517943

/ 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 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

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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9

Literatures (Medical) associated with Loratadine/Pseudoephedrine Sulfate

01 Sep 2021·Annals of Allergy, Asthma & ImmunologyQ2 · MEDICINE

Comparative nasal airflow with loratadine-pseudoephedrine and fluticasone nasal spray for allergic rhinitis

Q2 · MEDICINE

Article

Author: Ng, Charlene C ; Walker, Terry J ; Stevens, David A ; Ellis, Anne K ; Adams, Daniel E ; Romaikin, Daniel ; Steacy, Lisa M

BACKGROUNDAlthough it is known that oral antihistamine-pseudoephedrine combination tablets have a faster onset than intranasal corticosteroid sprays in the treatment of allergic rhinitis after the first dose, the magnitude of change has not been measured in a comparative manner. Furthermore, the sensation of sprayed liquid in the nose may lead patients to mistakenly believe that intranasal steroid sprays work instantly.OBJECTIVETo evaluate, numerically, nasal airflow changes provided by a single dose of loratadine-pseudoephedrine tablet (LP) and fluticasone propionate nasal spray (FP) in participants experiencing allergic rhinitis symptoms, including nasal congestion.METHODSThis single-center, double-blinded, placebo-controlled, crossover study evaluated objective nasal airflow changes in patients with a documented sensitivity to ragweed pollen. Participants were randomized to receive 1 of 4 treatment sequences, and their peak nasal inspiratory flow (PNIF) was measured in a span of 4 hours after pollen exposure in an environmental exposure unit.RESULTSAverage change in PNIF was 31% with LP in the course of the study, significantly greater than with placebo and FP (12% and 15%, respectively; P < .001). Nevertheless, FP did not produce a significant change compared with its placebo. At hour one post-dose, LP had a clinically significant 31% increase in PNIF, whereas FP only yielded an 8.6% increase (P < .001). Measurable nasal airflow improvements are associated with the opening of nasal passages, allowing congested patients to breathe more freely.CONCLUSIONA single dose of LP quickly and significantly (P < .001) improved nasal airflow after ragweed pollen challenge in an environmental exposure unit. Comparatively, FP did not display this same benefit.TRIAL REGISTRATIONClinicalTrials.gov Identifier: NCT03443843.

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.

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	United States	Bayer Healthcare LLC	23 Aug 1996
Fever	United States	Bayer Healthcare LLC	23 Aug 1996
Hypersensitivity	United States	Bayer Healthcare LLC	23 Aug 1996
Rhinitis, Allergic, Seasonal	United States	Bayer Healthcare LLC	14 Nov 1994
Upper respiratory tract allergy	United States	Bayer Healthcare LLC	14 Nov 1994