IP Library Granted Patent US 12,268,685
Granted Patent B2
US 12,268,685 · App. 18/919,625 · Granted Apr 8, 2025

Dosing regimen for injectable cetirizine

Inventor: Jie Du (Lansdale, PA)
Assignee: JDP THERAPEUTICS LLC
A61K31/495A61K9/0019A61P17/04A61P37/08
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Quick Facts
Patent No.
US 12,268,685
App. No.
18/919,625
Granted
Apr 8, 2025
Kind
B2
Abstract

Described herein is a method of administering injectable cetirizine or levocetirizine to treat acute urticaria, with or without concomitant angioedema, without life-threatening airway swelling by intravenously injecting a human patient within minutes to hours of developing acute urticaria in an emergency department or clinic with a therapeutically effective amount of an injectable cetirizine or levocetirizine composition. In the method, the injectable cetirizine or levocetirizine is the only treatment administered in the emergency department or clinic. The method can include determining, by the patient, a patient rated pruritus severity score at a 1 hour assessment, and optionally at a 2 hours assessment, and a physician discharging the human patient after 1.7±0.9 hours in the emergency department or clinic, wherein the human patient has a patient rated pruritus severity score reduction of at least 1 unit and baseline sedation at the time of discharge.

Claims (12)

1. A method of administering injectable cetirizine or levocetirizine to a human subject, comprising intravenously injecting the human subject in need thereof with an overdose of a maximum human daily clinical dose of the cetirizine or levocetirizine,

wherein the human subject is a child 6 months to 5 years and the maximum human daily clinical dose of cetirizine dihydrochloride is 2.5 mg; the human subject is a child 6 to 11 years and the maximum human daily clinical dose of cetirizine dihydrochloride is 5 to 10 mg; or the human subject is an adult of adolescent 12 years older and the maximum human daily clinical dose of cetirizine dihydrochloride is 10 mg,

wherein the overdose is no more than 14 times the maximum human daily clinical dose of the cetirizine or levocetirizine.

2. The method of claim 1 , wherein the overdose is intentional.

3. The method of claim 2 , wherein the human subject is not responding to the maximum human daily clinical dose.

4. The method of claim 1 , wherein the human subject is suffering from acute urticaria.

5. The method of claim 4 , wherein the human subject has concomitant angioedema.

6. The method of claim 1 , wherein the injectable composition is a 10 mg/mL aqueous cetirizine dihydrochloride solution.

7. The method of claim 1 , wherein the administering occurs in an emergency department or in an urgent care center.

8. The method of claim 1 , wherein the overdose is an overdose administered, prescribed by, or suggested by a physician or health care worker.

9. The method of claim 1 , wherein the maximum human daily clinical dose of the cetirizine or levocetirizine provides a highest no observable adverse effect level of the cetirizine or levocetirizine.

10. The method of claim 1 , wherein the human subject is not responding to the maximum human daily clinical dose.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 7, 2026
From: JDP THERAPEUTICS LLC
To: ESTEVE PHARMACEUTICALS S.A.
Reel/Frame 074302/0818 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 18, 2024
From: DU, JIE
To: JDP THERAPEUTICS LLC
Reel/Frame 068937/0746 →
Continuity (4)
Continuation 18520024 · Nov 27, 2023
Continuation 16656656 · Oct 18, 2019
Continuation 16594919 · Oct 7, 2019
Related Publication 20250041289A1 · Feb 6, 2025
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