SORINE- sotalol hydrochloride tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

Sotalol Hydrochloride (UNII: HEC37C70XX) (Sotalol - UNII:A6D97U294I)

Dostępny od:

Upsher-Smith Laboratories, Inc.

INN (International Nazwa):

Sotalol Hydrochloride

Skład:

Sotalol Hydrochloride 80 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

SORINE (sotalol hydrochloride) tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use : SORINE (sotalol hydrochloride) tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of SORINE (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)]. SORINE (sotalol hydrochloride) tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use : Because SORINE (sotalol hydrochloride) tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given SORINE (sotalol hydrochloride) tablets. SORINE (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 For the treatment of AFIB/AFL, SORINE (sotalol hydrochloride) tablets are also contraindicated in patients with: - Baseline QT interval >450 ms - Creatinine clearance <40 mL/min 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 SORINE. 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)].

Podsumowanie produktu:

SORINE® (sotalol hydrochloride tablets, USP) 80 mg, 120 mg, 160 mg and 240 mg are white, capsule-shaped, scored tablets supplied as follows: 80 mg tablets are imprinted "US" to the left and "12" to the right of the score and "80" on the unscored side. They are available as follows: 120 mg tablets are imprinted "US" to the left and "13" to the right of the score and "120" on the unscored side. They are available as follows: 160 mg tablets are imprinted "US" to the left and "14" to the right of the score and "160" on the unscored side. They are available as follows: 240 mg tablets are imprinted "US" to the left and "15" to the right of the score and "240" on the unscored side. They are available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SORINE- SOTALOL HYDROCHLORIDE TABLET
UPSHER-SMITH LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SORINE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SORINE .
SORINE (SOTALOL HYDROCHLORIDE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE-THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
SORINE (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
SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for:
the treatment of life-threatening ventricular arrhythmias (1.1)
the maintenance of normal sinus rhythm in patients with atrial
fibrillation or flutter (AFIB/AFL) (1.2)
LIMITATIONS OF USE
Avoid use in patients with asymptomatic ventricular premature
contraction (1.1)
Avoid use in patients with minimally symptomatic or easily reversible
AFIB/AFL (1.2)
DOSAGE AND ADMINISTRATION
SORINE (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, 160 mg and 240 mg tablets (3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrhythmias
Sinus bradycardia, 2
or 3
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)
For the treatment of AFIB/AFL al