SOTALOL HYDROCHLORIDE injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Mylan Institutional LLC

INN (nemzetközi neve):

Sotalol hydrochloride

Összetétel:

Sotalol hydrochloride 15 mg in 1 mL

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

New Drug Application

Termékjellemzők

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE INJECTION
MYLAN INSTITUTIONAL LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL HYDROCHLORIDE INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOTALOL
HYDROCHLORIDE INJECTION.
SOTALOL HYDROCHLORIDE INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•
•
•
•
INDICATIONS AND USAGE
Sotalol hydrochloride for intravenous use is an antiarrhythmic agent
indicated for:
•
Oral sotalol is indicated for:
•
•
DOSAGE AND ADMINISTRATION
Intravenous sotalol must be diluted. Appropriate diluents are saline,
5% dextrose in water (D5W), or Ringer's lactate.
Intravenous sotalol is administered by a volumetric infusion pump over
5 hours at a constant infusion rate. See full
prescribing information for general rules and safety measures (2.1),
dose selection (2.2) and preparation of infusion (2.3)
MAINTENANCE OF SOTALOL THERAPY – REPLACEMENT OF ORAL DOSING
The intravenous dose is approximately equal to the oral dose and
administered at the same dosing frequency. 75 mg of
intravenous sotalol is approximately equal to 80 mg of oral sotalol
(2.2)
INITIATION OF THERAPY
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
SOTALOL CAN CAUSE LIFE THREATENING VENTRICULAR TACHYCARDIA ASSOCIATED
WITH QT INTERVAL PROLONGATION.
DO NOT INITIATE SOTALOL THERAPY IF THE BASELINE QTC IS LONGER THAN 450
MS. IF THE QT INTERVAL PROLONGS
TO 500 MS OR GREATER, THE DOSE MUST BE REDUCED, THE DURATION OF THE
INFUSION PROLONGED OR THE DRUG
DISC O NTINUE D.
PATIENT SHOULD BE HOSPITALIZED IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION AND CONTINUOUS
ELECTROCARDIOGRAPHIC MONITORING.
ADJUST THE DOSING INTERVAL BASED ON CREATININE CLEARANCE.
Substitution for oral sotalol in patients who are unable to take
sotalol orally (1.1)
Maintenance of normal sinus rhythm in pati