{"id":"pseudoephedrine-levocetirizine","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Insomnia or nervousness"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Tachycardia"},{"rate":null,"effect":"Somnolence"}]},"_chembl":null,"_fixedAt":"2026-03-30T17:21:12.339787","_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pseudoephedrine acts as an alpha-adrenergic agonist that constricts blood vessels in the nasal mucosa, reducing swelling and congestion. Levocetirizine is the active S-enantiomer of cetirizine, a second-generation antihistamine that selectively blocks H1 receptors to reduce histamine-mediated allergic responses including itching, sneezing, and rhinorrhea. Together, they provide dual symptomatic relief for allergic rhinitis with nasal congestion.","oneSentence":"This combination drug reduces nasal congestion via pseudoephedrine (a sympathomimetic decongestant) and allergic symptoms via levocetirizine (a selective H1-receptor antagonist).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:52:09.450Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis with nasal congestion"}]},"_fixedFields":["pubmed(8)"],"trialDetails":[{"nctId":"NCT05637710","phase":"PHASE3","title":"Parallel, Double-dummy, Superiority Study Levocetirizine/Pseudoephedrine x Zina for Allergic Rhinitis in Brazil","status":"WITHDRAWN","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-03","conditions":"Allergic Rhinitis","enrollment":""},{"nctId":"NCT05348148","phase":"NA","title":"Comparison of the Effects for Lightening the Shiners Among Different Treatments for Rhinitis","status":"RECRUITING","sponsor":"Camillians Saint Mary's Hospital Luodong","startDate":"2020-06-16","conditions":"Allergic Rhinitis, Vasomotor Rhinitis","enrollment":450},{"nctId":"NCT03590912","phase":"PHASE4","title":"Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion","status":"COMPLETED","sponsor":"Lumbini Medical College","startDate":"2018-09-05","conditions":"Otitis Media With Effusion","enrollment":160},{"nctId":"NCT01509209","phase":"PHASE3","title":"Efficacy/Safety of Pseudoephedrine Plus Levocetirizine Versus Placebo in Patients With Vasomotor Rhinitis","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2011-05","conditions":"Vasomotor Rhinitis","enrollment":137}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"recentPublications":[{"date":"2006","pmid":"30000658","title":"Levocetirizine.","journal":""},{"date":"2025 Mar 31","pmid":"40152722","title":"Comparison table: Some oral drugs for allergic rhinitis.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2025 Mar 31","pmid":"40152721","title":"Treatment of allergic rhinitis and allergic conjunctivitis.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2021 Apr 19","pmid":"33848282","title":"Comparison table: Some oral drugs for allergic rhinitis.","journal":"The Medical letter on drugs and therapeutics"},{"date":"2021 Apr 19","pmid":"33848281","title":"Drugs for allergic rhinitis and allergic conjunctivitis.","journal":"The Medical letter on drugs and therapeutics"}],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Cossac L"],"phase":"phase_3","status":"active","brandName":"Pseudoephedrine / Levocetirizine","genericName":"Pseudoephedrine / Levocetirizine","companyName":"Hanmi Pharmaceutical Company Limited","companyId":"hanmi-pharmaceutical-company-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination drug reduces nasal congestion via pseudoephedrine (a sympathomimetic decongestant) and allergic symptoms via levocetirizine (a selective H1-receptor antagonist). Used for Allergic rhinitis with nasal congestion.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}