SOTALOL HYDROCHLORIDE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Oxford Pharmaceuticals, LLC

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Sotalol hydrochloride tablets are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use Sotalol hydrochloride tablets have not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. Sotalol hydrochloride tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use: Because 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 sotalol hydrochloride tablets. Sotalol hydrochloride tablets are contraindicated in patients with: - Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pac

Produkt oppsummering:

Sotalol hydrochloride tablets, USP; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength debossed “841” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-841-10           Bottles of 500: NDC 69584-841-50 120 mg strength debossed “842” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-842-10           Bottles of 300: NDC 69584-842-30 160 mg strength debossed “843” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-843-10 240 mg strength debossed “844” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-844-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature ].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
OXFORD 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 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)
the maintenance of normal sinus rhythm in patients with atrial
fibrillation or flutter (AFIB/AFL) (1.2)
LIMITATIONS OF USE
Sotalol hydrochloride tablets have not been shown to enhance survival
in patients with life-threatening
ventricular arrhythmias (1.1)
Avoid use in patients with minimally symptomatic or easily reversible
AFIB/AFL (1.2)
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, 160 mg and 240 mg tablets (3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrythmias
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)
Hyp