IP Library Patent Application 16863567
Patent Application
App. No. 16/863,567

METHOD OF INITIATING AND ESCALATING SOTALOL HYDROCHLORIDE DOSING

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Patent No.
US None
App. No.
16/863,567
Abstract

The present invention provides novel methods of initiating and escalating sotalol hydrochloride in patients in need thereof.

Claims (56)

1 . A method of initiating or escalating oral sotalol therapy, comprising:

A intravenously (IV) administering sotalol hydrochloride over a period of 1 hour, to a hospitalized patient in need thereof, wherein the IV dosage is selected from dosages I(a)-IV(d):

I for patients having creating clearance (CrCl) of >90 mL/min;

(a) 60 mg for a patient naïve to sotalol and having a target of 80 mg;

(b) 90 mg for a patient naïve to sotalol and having a target of 120 mg;

(c) 75 mg for a patient previously receiving 80 mg of sotalol;

(d) 90 mg for a patient previously receiving 120 mg of sotalol;

II for patients having creating clearance (CrCl) of >60-90 mL/min;

(a) 82.5 mg for a patient naïve to sotalol and having a target of 80 mg;

(b) 125 mg for a patient naïve to sotalol and having a target of 120 mg;

(c) 82.5 mg for a patient previously receiving 80 mg of sotalol;

(d) 105 mg for a patient previously receiving 120 mg of sotalol;

III for patients having creating clearance (CrCl) of >30-60 mL/min;

(a) 75 mg for a patient naïve to sotalol and having a target of 80 mg;

(b) 112.5 mg for a patient naïve to sotalol and having a target of 120 mg;

(c) 82.5 mg for a patient previously receiving 80 mg of sotalol;

(d) 105 mg for a patient previously receiving 120 mg of sotalol;

IV for patients having creating clearance (CrCl) of 10-30 mL/min;

(a) 75 mg for a patient naïve to sotalol and having a target of 80 mg;

(b) 112.5 mg for a patient naïve to sotalol and having a target of 120 mg;

(c) 82.5 mg for a patient previously receiving 80 mg of sotalol; and,

(d) 105 mg for a patient previously receiving 120 mg of sotalol; and,

B orally administering sotalol hydrochloride to the patient at a dosage and interval selected from (I)-(IX):

I 80 mg BID, starting 4 hours after completion of IV doses I(a) and II(a);

II 120 mg BID, starting 4 hours after completion of IV doses I(b), I(c), II(b), and II(c);

III 160 mg BID, starting 4 hours after completion of IV doses I(d) and II(d);

IV 80 mg QID, starting 6 hours after completion of IV dose III(a);

V 120 mg QID, starting 6 hours after completion of IV doses III(b) and III(c);

VI 160 mg QID, starting 6 hours after completion of IV dose III(d);

VII 80 mg once every 48 h, starting 12 hours after completion of IV dose IV(a);

VIII 120 mg once every 48 h, starting 12 hours after completion of IV doses IV(b) and IV(c); and,

IX 160 mg once every 48 h, starting 12 hours after completion of IV dose IV(d).

2 . The method of claim 1 , wherein the patient has a CrCl of >90 mL/min.

3 . The method of claim 1 , wherein the patient has a CrCl of >60-90 mL/min.

4 . The method of claim 1 , wherein the patient has a CrCl of >30-60 90 mL/min.

5 . The method of claim 1 , wherein the patient has a CrCl of 10-30 90 mL/min.

6 . The method of claim 1 , wherein dosing regimen A.I(a), B.I is followed.

7 . The method of claim 1 , wherein dosing regimen A.I(b), B.II is followed.

8 . The method of claim 1 , wherein dosing regimen A.I(c), B.II is followed.

9 . The method of claim 1 , wherein dosing regimen A.I(d), B.III is followed.

10 . The method of claim 1 , wherein dosing regimen A.II(a), B.I is followed.

11 . The method of claim 1 , wherein dosing regimen A.II(b), B.II is followed.

12 . The method of claim 1 , wherein dosing regimen A.II(c), B.II is followed.

13 . The method of claim 1 , wherein dosing regimen A.II(d), B.III is followed.

14 . The method of claim 1 , wherein dosing regimen A.III(a), B.IV is followed.

15 . The method of claim 1 , wherein dosing regimen A.III(b), B.V is followed.

16 . The method of claim 1 , wherein dosing regimen A.III(c), B.V is followed.

17 . The method of claim 1 , wherein dosing regimen A.III(d), B.VI is followed.

18 . The method of claim 1 , wherein dosing regimen A.IV(a), B.VII is followed.

19 . The method of claim 1 , wherein dosing regimen A.IV(b), B.VIII is followed.

20 . The method of claim 1 , wherein dosing regimen A.IV(c), B.VIII is followed.

21 . The method of claim 1 , wherein dosing regimen A.IV(d), B.IX is followed.

22 . The method of claim 1 , wherein the hospitalized patient is able to be discharged after 2-4 oral dosages.

23 . The method of claim 1 , wherein the hospitalized patient is able to be discharged after 2 oral dosages.

24 . The method of claim 1 , wherein the hospitalized patient is able to be discharged after 3 oral dosages.

25 . The method of claim 1 , wherein the hospitalized patient is able to be discharged after 4 oral dosages.

Assignments (3)
ASSIGNMENT OF SECURITY INTEREST IN PATENT COLLATERAL Recorded Jul 14, 2023
From: SAGARD HEALTHCARE ROYALTY PARTNERS, LP
To: SAGARD HEALTHCARE PARTNERS (DELAWARE) LP
Reel/Frame 064275/0433 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 29, 2021
From: SOMBERG, JOHN CHARIN; KASHFIAN, BRANDON IRA; MOLNAR, JANOS
To: ALTATHERA PHARMACEUTICALS LLC
Reel/Frame 055820/0938 →
SECURITY INTEREST Recorded Feb 26, 2021
From: ALTATHERA PHARMACEUTICALS LLC
To: SAGARD HEALTHCARE ROYALTY PARTNERS, LP
Reel/Frame 055427/0934 →