Sotacor

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sotalol hydrochloride 10 mg/mL

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Sotalol hydrochloride 10 mg/mL

Dosage:

40mg/4mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Sotalol hydrochloride 10 mg/mL

Units in package:

Ampoule, glass, 5 x 4ml, 20 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cambrex Profarmaco Milano Srl

Product summary:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 4ml - 20 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1984-05-09

Summary of Product characteristics

NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 1 of 16
1 PRODUCT NAME
SOTACOR sotalol hydrochloride 80mg tablet
SOTACOR sotalol hydrochloride 160mg tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg or 160 mg of sotalol hydrochloride.
For the full list of excipients, see SECTION 6.1.
3 PHARMACEUTICAL FORM
The 80 mg tablet is plain on one side and engraved “BMS 621” with
a bisect bar on the other side.
The 160 mg tablet is plain on one side and engraved “BMS 160” with
a bisect bar on the other side.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Sotacor is indicated for use in the prevention and treatment of
supraventricular and ventricular
arrhythmias.
4.2
Dose and method of administration
Sotacor is administered orally for the prevention and treatment of
arrhythmias.
As with other antiarrhythmic agents, Sotacor should be initiated and
doses increased in a facility
capable of monitoring and assessing cardiac rhythm. The dosage must be
individualized for each
patient on the basis of therapeutic response and tolerance.
Proarrhythmic events can occur not only
at initiation of therapy, but also with each upward dosage adjustment.
Oral dosage of Sotacor should be adjusted gradually allowing 2-3 days
between dosing increments in
order to attain steady-state, and to allow monitoring of QT intervals.
Graded dose adjustment will
help prevent the use of doses which are higher than necessary to
control the arrhythmia. The
recommended initial oral dosing schedule is 160mg/daily, given in two
divided doses at
approximately 12 hour intervals. This dose may be increased, if
necessary, after appropriate
evaluation to 240 or 320mg/day. In most patients, a therapeutic
response is obtained at a total daily
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.1 March 2017
Page 2 of 16
dose of 160-320mg/day, given in 2 divided doses. Some patients with
life-threatening refractory
ventricular arrhythmias may require doses as high as 480-640mg/day;
however, these