US2021100793A1PendingUtilityA1

Dosing regimen for injectable cetirizine

Assignee: JDP THERAPEUTICS LLCPriority: Oct 7, 2019Filed: Oct 18, 2019Published: Apr 8, 2021
Est. expiryOct 7, 2039(~13.2 yrs left)· nominal 20-yr term from priority
Inventors:Jie Du
A61K 31/495A61P 37/08A61K 9/0019A61P 17/04
72
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Claims

Abstract

Described herein is a method of administering injectable cetirizine or levocetirizine including intravenously injecting a mammal in need thereof with a therapeutically effective amount of an injectable cetirizine or levocetirizine composition, wherein the mammal receives a maximum daily dose of the cetirizine or levocetirizine that is no more than 15 times a maximum recommended daily clinical dose for the mammal.

Claims

exact text as granted — not AI-modified
1 . A method of administering injectable cetirizine or levocetirizine to treat acute urticaria, comprising
 intravenously injecting a human patient in an emergency department or clinic with a therapeutically effective amount of an injectable cetirizine or levocetirizine composition,   determining, by the patient, a patient rated pruritus severity score at baseline and at a 1 hour assessment, and   a physician determining readiness to discharge as effective treatment of the acute urticaria based on the patient rated pruritus score reduction of at least 1 unit at the 1 hour assessment compared to the baseline assessment, wherein the human patient spends 1.7±0.9 hours in the emergency department or clinic.   
     
     
         2 . The method of  claim 1 , wherein the therapeutically effective amount is the maximum recommended daily clinical dose. 
     
     
         3 . The method of  claim 2 , wherein the maximum recommended human daily clinical dose is 2.5, 5 or 10 mg of cetirizine dihydrochloride administered once daily. 
     
     
         4 . The method of  claim 3 , wherein the human subject is a child 6 months to 5 years and the maximum recommended human daily clinical dose of cetirizine dihydrochloride is 2.5 mg; the human subject is a child 6 to 11 years and the recommended human daily clinical dose of cetirizine dihydrochloride is 5 or 10 mg; or the human subject is an adult of adolescent 12 years or older and the maximum recommended daily clinical dose of cetirizine dihydrochloride is 10 mg. 
     
     
         5 . The method of  claim 2 , wherein the maximum recommended human daily clinical dose is 1.25, 2.5 or 5 mg of levocetirizine dihydrochloride administered once daily. 
     
     
         6 . The method of  claim 5 , wherein the human subject is a child 6 months 5 years and the recommended human daily clinical dose of levocetirizine dihydrochloride is 1.25 mg; the human subject is a child 6 to 11 years and the recommended human daily clinical dose of levocetirizine dihydrochloride is 2.5 or 5 mg; or the human subject is an adult of adolescent 12 years or older and the recommended daily clinical dose of levocetirizine dihydrochloride is 5 mg. 
     
     
         7 . The method of  claim 1 , wherein the human patient returns to the emergency department or clinic. 
     
     
         8 . (canceled) 
     
     
         9 . The method of  claim 1 , wherein the human subject has concomitant angioedema. 
     
     
         10 . The method of  claim 1 , wherein the cetirizine dihydrochloride composition is a 10 mg/mL aqueous solution.

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