Methods of administering sotalol hydrochloride in an amount effective for treating one or more cardiovascular disease or disorder in pediatric patients are described and include IV and/or oral doses based on age-specific creatinine clearance ranges.
A61K 31/145 - Amines, e.g. amantadine having sulfur atoms, e.g. thiurams (N—C(S)—S—C(S)—N or N—C(S)—S—S—C(S)—N)Sulfinylamines (—N=SO)Sulfonylamines (—N=SO2)
A61K 9/00 - Medicinal preparations characterised by special physical form
Computer-implemented methods of predicting the QTc of a subject in response to administration of QTc prolonging drugs, especially those that are dose adjusted for renal function, such as antiarrhythmic drugs. Included is a method of administering an antiarrhythmic drug to a subject, comprising: providing as inputs into a treatment management application i) Baseline QTc and ii) at least a Creatinine Clearance, Weight, Age, Sex, or Heart Rate; the treatment management application providing as an output one or more predicted QTc or predicted QTc range for the subject expected from administration of a 1-5 hour IV dose, alone or followed by one or more oral doses, of an antiarrhythmic drug to the subject; and upon the one or more QTc or QTc range being within an acceptable range, administering the 1-5 hour IV dose to the subject optionally followed by administering one or more of the oral doses to the subject.
G16H 20/10 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
Methods of administering one or more IV doses of sotalol hydrochloride to a patient in need thereof are described. In embodiments, one or more of the IV doses of sotalol hydrochloride are administered as substitute(s) for one or more oral dose(s) of sotalol hydrochloride, with the substitute IV dosing based on the subject's creatinine clearance and when repeated as a selected interval is capable of providing a sotalol concentration commensurate with the steady state concentration expected from multiple sequential oral doses.
Methods of administering a 5-hour IV loading dose of sotalol and one or more oral maintenance dose(s) or one or more 5-hour IV maintenance dose(s) in amounts effective for treating a cardiovascular condition are described. Methods of administering a 1-hour IV loading dose of sotalol and one or more 5-hour IV maintenance dose(s) in amounts effective for treating a cardiovascular condition are also described. The subject can be discharged prior to administration of any maintenance doses, after administration of a single maintenance dose, or after administration of two or more maintenance doses.
Methods of administering dofetilide in an amount effective for treating a cardiovascular condition are described. An initial IV loading dose can be administered over a period of about one hour. The patient can be discharged from the medical facility providing cardiac monitoring prior to administration of oral maintenance doses. The IV and oral doses can be administered in a manner such that maximum serum concentration of dofetilide is reached within about 1 hour of the start of the administration of the IV loading dose.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61K 31/145 - Amines, e.g. amantadine having sulfur atoms, e.g. thiurams (N—C(S)—S—C(S)—N or N—C(S)—S—S—C(S)—N)Sulfinylamines (—N=SO)Sulfonylamines (—N=SO2)
A61K 9/00 - Medicinal preparations characterised by special physical form
This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.
A61K 31/136 - Amines, e.g. amantadine having aromatic rings, e.g. methadone having the amino group directly attached to the aromatic ring, e.g. benzeneamine
A61K 9/00 - Medicinal preparations characterised by special physical form
Methods of administering dofetilide in an amount effective for treating a cardiovascular condition are described. An initial IV loading dose can be administered intravenously as a loading dose, such as in the range of ±50% of a target oral dose, and over a duration of from 1-5 hours. One or more maintenance dose(s) can be given orally (and/or infused intravenously as an IV maintenance dose over a duration of from 1-5 hours), such as in an amount of up to about 1000 μg. In embodiments, the loading and maintenance dose(s) are selected to enable maximum serum concentration of the subject in less than 24 hours, such as within 1 hour, from the start of the IV administering and within a range of ±25% of a Cmax at steady state predicted for the subject for an oral dosing protocol of 125 μg, 250 μg, or 500 μg dofetilide.
A61K 31/145 - Amines, e.g. amantadine having sulfur atoms, e.g. thiurams (N—C(S)—S—C(S)—N or N—C(S)—S—S—C(S)—N)Sulfinylamines (—N=SO)Sulfonylamines (—N=SO2)
Methods of administering dofetilide in an amount effective for treating a cardiovascular condition are described. An initial IV dose can be administered over a period of about 10 minutes to a patient/subject admitted to a medical facility providing cardiac monitoring. The patient/subject can be administered one or more oral or IV maintenance doses before or after being discharged from the medical facility. The IV dosage can be administered in a manner such that maximum serum concentration of dofetilide is reached during the administering of the IV loading dose.
The disclosure relates to a method which includes i) prompting input of: a creatinine clearance (CrCl) of a subject; an amount of an oral or IV maintenance dosage of dofetilide for the subject; and optionally a projected start time for dofetilide infusion; and ii) executing computer executable instructions to derive from a set of rules a dofetilide dosing protocol for the subject based on the inputs. The disclosure also relates to systems and medical devices configured to perform one or more steps of the method, as well as a non-transitory computer-readable storage medium comprising computer-executable instructions or software stored thereon capable of performing one or more steps of the method.
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
A61K 31/145 - Amines, e.g. amantadine having sulfur atoms, e.g. thiurams (N—C(S)—S—C(S)—N or N—C(S)—S—S—C(S)—N)Sulfinylamines (—N=SO)Sulfonylamines (—N=SO2)
A61K 9/00 - Medicinal preparations characterised by special physical form
A61J 7/00 - Devices for administering medicines orally, e.g. spoonsPill counting devicesArrangements for time indication or reminder for taking medicine
13.
METHODS OF INTRAVENOUSLY ADMINISTERING SOTALOL HYDROCHLORIDE
Methods of administering sotalol hydrochloride in an amount effective for treating a cardiovascular condition are described. An initial IV loading dose can be administered over a period of up to about 10 minutes. The patient can be discharged from the medical facility providing cardiac monitoring prior to administration of oral doses, after administration of a single oral dose, or after administration of two or more oral doses. The IV can be administered in a manner such that maximum serum concentration of sotalol is reached before administration of a first oral dose.
Methods of administering dofetilide in an amount effective for treating a cardiovascular condition are described. An IV dose can be administered over a selected period of time, such as about one hour, followed by a first oral dose. The patient can be discharged from the medical facility providing cardiac monitoring prior to administration of additional oral doses. The IV and first oral doses can be administered in a manner such that maximum serum concentration of dofetilide is reached and the patient can be discharged within about 7-8 hours.
Methods of administering sotalol hydrochloride in an amount effective for treating a cardiovascular condition are described. An initial IV loading dose can be administered over a period of about one hour. The subject/patient can be discharged from the medical facility providing cardiac monitoring prior to administration of oral doses. The IV can be administered in a manner such that maximum serum concentration of sotalol is reached and the subject/patient can be discharged before administration of a first oral dose.
Methods of administering sotalol hydrochloride in an amount effective for treating a cardiovascular condition are described. An initial IV loading dose can be administered over a period of about one hour, followed by a first oral dose. The patient can be discharged from the medical facility providing cardiac monitoring prior to administration of additional oral doses. The IV and first oral doses can be administered in a manner such that maximum serum concentration of sotalol is reached and the patient can be discharged within about 7-8 hours.
The disclosure relates to a method which includes i) prompting input of: a creatinine clearance (CrCl) of a subject; whether the subject is being initiated or escalated on sotalol hydrochloride; an amount of an oral target dosage of sotalol hydrochloride for the subject; and optionally a projected start time for sotalol hydrochloride infusion; and ii) executing computer executable instructions to derive from a set of rules a sotalol hydrochloride dosing protocol for the subject based on the inputs. The disclosure also relates to systems and medical devices configured to perform one or more steps of the method, as well as a non-transitory computer-readable storage medium comprising computer-executable instructions or software stored thereon capable of performing one or more steps of the method.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
Methods of administering an anti-arrhythmic, such as dofetilide, to a patient in an amount effective for treating a cardiovascular condition are described. The drug can be administered intravenously for at least one hour. A loading dose of 0.1 to 12 μg/kg bodyweight over a duration of up to 60 minutes can be administered and/or a maintenance dose of 0.1 to 10 μg/kg/hr can be administered intravenously over a duration of at least 1 hour, optionally alternatively or in addition wherein the amount of the loading dose and/or the IV maintenance dose is in the range of about ±50% of a maintenance dofetilide dose. The cardiovascular condition can include atrial fibrillation or flutter, ventricular tachycardia, hemodynamically stable or unstable ventricular tachycardia, paroxysmal atrial fibrillation, ventricular fibrillation, paroxysmal supraventricular tachycardia, heart failure, coronary artery disease, or pulmonary artery hypertension. A patient's QT interval and/or a creatinine clearance can be measured, and the effective amount can be selected based on either or both of the QT interval or the creatinine clearance measurements.
The disclosure relates to a method which includes i) prompting input of: a creatinine clearance (CrCl) of a subject; whether the subject is being initiated or escalated on sotalol hydrochloride; an amount of an oral target dosage of sotalol hydrochloride for the subject; and optionally a projected start time for sotalol hydrochloride infusion; and ii) executing computer executable instructions to derive from a set of rules a sotalol hydrochloride dosing protocol for the subject based on the inputs. The disclosure also relates to systems and medical devices configured to perform one or more steps of the method, as well as a non-transitory computer-readable storage medium comprising computer-executable instructions or software stored thereon capable of performing one or more steps of the method.
G16H 20/17 - ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
A61M 5/172 - Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters electrical or electronic
This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.
The present invention provides a novel intravenous, prophylactic, antiarrhythmic method of sotalol loading and maintenance for cardiothoracic surgery patients.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/145 - Amines, e.g. amantadine having sulfur atoms, e.g. thiurams (N—C(S)—S—C(S)—N or N—C(S)—S—S—C(S)—N)Sulfinylamines (—N=SO)Sulfonylamines (—N=SO2)
23.
Method of converting atrial fibrillation to normal sinus rhythm and loading oral sotalol in a shortened time frame
The present invention provides a novel method of converting AF and monitoring normal sinus rhythm using an initial IV dose of sotalol followed by oral sotalol maintenance therapy. This method provides a method of acute assessment of QTc prolongation to determine the safety of chronic oral sotalol therapy and reduces the hospitalization stay required for conversion and sotalol initiation.
This disclosure provides a method of safely and rapidly initiating or escalating oral sotalol therapy by administering an intravenous dosage of sotalol followed by oral sotalol twice daily.
This disclosure provides method of safely and efficaciously treating or preventing atrial fibrillation, atrial flutter, or a combination thereof via rapid intravenous introduction of sotalol hydrochloride to a subject in need thereof.
