SOTALOL- sotalol hydrochloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)

זמין מ:

Bayshore Pharmaceuticals LLC

INN (שם בינלאומי):

SOTALOL HYDROCHLORIDE

הרכב:

SOTALOL HYDROCHLORIDE 80 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Sotalol Hydrochloride Tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol Hydrochloride Tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Sotalol Hydrochloride Tablets, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [ see Warnings and Precautions (5.2) .] Sotalol Hydrochloride Tablets are contraindicated in patients with: - Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present - Congenital or acquired long QT syndromes - Cardiogenic shock or decompensated heart failure - Serum potassium <4 mEq/L - Bronchial asthma or related bronchospastic conditions - Hypersensitivity to sotalol Pregnancy Category B There are no adequate and well-controlled studies in pregnant women. Sotalol has been shown to cross the placenta, and is found in amniotic fluid. In animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (MRHD, based on surface area). Animal reproductive studies are not always predictive of human response. Reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the MRHD (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. In rabbits, a dose of sotalol 6 times the MRHD produced a slight increase in fetal death as well as maternal toxicity. This effect did not occur at sotalol dose 3 times the MRHD. In rats a sotalol dose 18 times the MRHD increased the number of early resorptions, while a dose 2.5 times the MRHD, produced no increase in early resorptions. Sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. Discontinue nursing on Sotalol Hydrochloride Tablets. The safety and effectiveness of sotalol in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see Dosage and Administration (2.4) and Clinical Pharmacology (12.2) ]. Sotalol is mainly eliminated via the kidneys. Dosing intervals should be adjusted based on creatinine clearance [ see Dosage and Administration (2.5) ].

leaflet_short:

Sotalol Hydrochloride Tablets, USP; capsule-shaped light-blue scored tablets, imprinted with the strength and “B104”, “B105”, and “B106” are available as follows: 80 mg strength, bottles of 100 (NDC 76385-114-01) 80 mg strength, bottles of 500 (NDC 76385-114-50) 120 mg strength, bottles of 100 (NDC 76385-115-01) 120 mg strength, bottles of 500 (NDC 76385-115-50) 160 mg strength, bottles of 100 (NDC 76385-116-01) 160 mg strength, bottles of 500 (NDC 76385-116-50) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SOTALOL- SOTALOL HYDROCHLORIDE TABLET
BAYSHORE PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL HYDROCHLORIDE TABLETS CAN CAUSE LIFE THREATENING VENTRICULAR
TACHYCARDIA
ASSOCIATED WITH QT INTERVAL PROLONGATION.
IF THE QT INTERVAL PROLONGS TO 500 MSEC OR GREATER, REDUCE THE DOSE,
LENGTHEN THE
DOSING INTERVAL, OR DISCONTINUE THE DRUG.
INITIATE OR REINITIATE IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION AND
CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING.
ADJUST THE DOSING INTERVAL BASED ON CREATININE CLEARANCE.
INDICATIONS AND USAGE
Sotalol Hydrochloride Tablets are an antiarrhythmic indicated for:
the treatment of life threatening ventricular arrhythmias (1.1)
LIMITATIONS OF USE
Avoid use in patients with asymptomatic ventricular premature
contraction (1.1)
DOSAGE AND ADMINISTRATION
Sotalol Hydrochloride Tablets: Initial dosage in adults is 80 mg twice
daily. Increase the dose as needed
in increments of 80 mg/day, every 3 days to a maximum 320 mg total
daily dose (2.2)
Pediatrics: Dosage depends on age (2.4)
DOSAGE FORMS AND STRENGTHS
80 mg,120 mg and 160 mg tablets (3)
CONTRAINDICATIONS
For the treatment of ventricular arrythmias
Sinus bradycardia, 2nd or 3rd degree AV block, sick sinus syndrome (4)
Congenital or acquired long QT syndrome, (4)
Serum potassium <4 mEq/L(4)
Cardiogenic shock, decompensated heart failure (4)
Bronchial asthma or related bronchospastic conditions (4)
Hypersensitivity to sotalol (4)
WARNINGS AND PRECAUTIONS
QT prolongation, bradycardia, AV block, hypotension, worsening heart
failure: Reduce dose or
discontinue (5.1)
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptl