sotalol hydrochloride- sotalol hydrochloride tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

MUTUAL PHARMACEUTICAL CO., INC.

INN (International Name):

sotalol hydrochloride

약제 형태:

TABLET

구성:

80 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Sotalol is 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 sotalol 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 been used to determine the response to antiarrhythmic therapy, including sotalol. In the

제품 요약:

SOTALOL HYDROCHLORIDE TABLETS are available as follows: Sotalol hydrochloride tablets, 80 mg, light blue, capsule shaped, scored, debossed MP 514 Bottles of 50           NDC 53489-288-02 Bottles of 100         NDC 53489-288-01 Bottles of 250         NDC 53489-288-03 Bottles of 500         NDC 53489-288-05 Bottles of 1000       NDC 53489-288-10 Sotalol hydrochloride tablets, 120 mg, light blue, capsule shaped, scored, debossed MP 515 Bottles of 50           NDC 53489-289-02 Bottles of 100         NDC 53489-289-01 Bottles of 250         NDC 53489-289-03 Bottles of 500         NDC 53489-289-05 Bottles of 1000       NDC 53489-289-10 Sotalol hydrochloride tablets, 160 mg, light blue, capsule shaped, scored, debossed MP 516 Bottles of 50           NDC 53489-290-02 Bottles of 100         NDC 53489-290-01 Bottles of 250         NDC 53489-290-03 Bottles of 500         NDC 53489-290-05 Bottles of 1000       NDC 53489-290-10 Sotalol hydrochloride tablets, 240 mg, light blue, capsule shaped, scored, debossed MP 517 Bottles of 50           NDC 53489-291-02 Bottles of 100         NDC 53489-291-01 Bottles of 250         NDC 53489-291-03 Bottles of 500         NDC 53489-291-05 Bottles of 1000       NDC 53489-291-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

제품 특성 요약

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
MUTUAL PHARMACEUTICAL CO., INC.
----------
SOTALOL HYDROCHLORIDE TABLETS
RX ONLY
To minimize the risk of induced arrhythmia, patients initiated or
re-initiated on sotalol should be
placed for a minimum of three days (on their maintenance dose) in a
facility that can provide
cardiac resuscitation, 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
flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are
currently in sinus rhythm and
is marketed under the brand name Betapace AF. Sotalol 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.
DESCRIPTION
Sotalol is an antiarrhythmic drug with Class II (beta-adrenoreceptor
blocking) and Class III (cardiac
action potential duration prolongation) properties. It is supplied as
a light-blue, capsule-shaped tablet
for oral administration. Sotalol hydrochloride 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 is
d,l-N-[4-[l-hydroxy-2-[(l-
methylethyl)amino]ethyl]phenyl]methane-sulfonamide monohydrochloride.
The molecular formula is
C
H N 0 S•HCl and is represented by the following structural formula:
Each tablet for oral administration contains 80 mg, 120 mg, 160 mg or
240 mg of sotalol hydrochloride.
In addition, each tablet contains the following inactive ingredients:
anhydrous lactose, colloidal silicon
dioxide, corn starch, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, sodium
starch gl