SORINE- sotalol hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

Sotalol Hydrochloride

Composition:

Sotalol Hydrochloride 80 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oral Sorine® (Sotalol Hydrochloride Tablets, USP) are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of Sorine® (Sotalol Hydrochloride Tablets, USP) treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have bee

Product summary:

Sorine® (Sotalol Hydrochloride Tablets, USP) are white, capsule-shaped, scored tablets with the following tablet deboss, respectively: 80 mg "US" to the left and "12" to the right of the score, "80" strength on the unscored side Overbagged with 10 tablets per bag, NDC 55154-5616-0 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between (15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container (USP). Manufactured by UPSHER-SMITH LABORATORIES, INC . Maple Grove, MN 55369 Distributed By: Cardinal Health Dublin, OH 43017 L35230571118 Revised 0515

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SORINE- SOTALOL HYDROCHLORIDE TABLET
CARDINAL HEALTH
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SORINE
(SOTALOL HYDROCHLORIDE TABLETS, USP)
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
REINITIATED ON SORINE
SHOULD BE PLACED FOR A MINIMUM OF THREE DAYS (ON THEIR MAINTENANCE
DOSE) IN A FACILITY THAT
CAN PROVIDE CARDIAC RESUSCITATION AND CONTINUOUS ELECTROCARDIOGRAPHIC
MONITORING.
CREATININE CLEARANCE SHOULD BE CALCULATED PRIOR TO DOSING. FOR
DETAILED INSTRUCTIONS
REGARDING DOSE SELECTION AND SPECIAL CAUTIONS FOR PEOPLE WITH RENAL
IMPAIRMENT, SEE
DOSAGE AND ADMINISTRATION. SOTALOL IS ALSO INDICATED FOR THE
MAINTENANCE OF
NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL
FIBRILLATION/ATRIAL FLUTTER
(AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN
SINUS RHYTHM
AND IS MARKETED UNDER THE BRAND NAME BETAPACE AF . THIS PRODUCT IS NOT
APPROVED FOR THE
AFIB/AFL INDICATION AND SHOULD NOT BE SUBSTITUTED FOR BETAPACE AF
BECAUSE ONLY BETAPACE
AF IS DISTRIBUTED WITH A PATIENT PACKAGE INSERT THAT IS APPROPRIATE
FOR PATIENTS WITH
AFIB/AFL.
RX ONLY
DESCRIPTION
Sorine
(Sotalol Hydrochloride Tablets, USP) are an antiarrhythmic drug with
Class II (beta-
adrenoreceptor blocking) and Class III (cardiac action potential
duration prolongation) properties. It is
supplied as a white, capsule-shaped tablet for oral administration.
Sotalol hydrochloride, USP is a
white, crystalline solid with a molecular weight of 308.8. It is
hydrophilic, soluble in water, propylene
glycol and ethanol, but is only slightly soluble in chloroform.
Chemically, sotalol hydrochloride, USP
is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]
methane-sulfonamide
monohydrochloride. The molecular formula is C
H N O S·HCl and is represented by the following
structural formula:
Sorine
Tablets contain the following inactive ingredients: microcrystalline
cellulose, lactose
monohydrate, corn starch, stearic acid, magnesium stearate and silicon
dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Sotalol hydrochloride has both betaadrenoreceptor