Sotalol Hydrochloride (Sotalol Hydrochloride)

Trade Name : sotalol hydrochloride

Eon Labs, Inc.

TABLET

Strength 120 mg/1

SOTALOL HYDROCHLORIDE Antiarrhythmic [EPC],Cardiac Rhythm Alteration [PE],Adrenergic beta-Antagonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sotalol Hydrochloride (Sotalol Hydrochloride) which is also known as sotalol hydrochloride and Manufactured by Eon Labs, Inc.. It is available in strength of 120 mg/1 per ml. Read more

Sotalol Hydrochloride (Sotalol Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Sotalol hydrochloride USP 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 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--[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is CHNOSu2022HCl and is represented by the following structural formula:
Each sotalol hydrochloride tablet USP, for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, FD&C blue No. 1 aluminum lake, hydroxypropyl cellulose, lactose anhydrous, lactose monohydrate, magnesium stearate, pregelatinized starch and sodium starch glycolate.

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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 hydrochloride tablets (see ), including a 1.5% to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, their 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 hydrochloride tablet 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 been used to determine the response to antiarrhythmic therapy, including sotalol hydrochloride tablets USP.
In the ESVEM Trial, response by Holter monitoring was tentatively defined as 100% suppression of ventricular tachycardia, 90% suppression of non-sustained VT, 80% suppression of paired VPCs, and 75% suppression of total VPCs in patients who had at least 10 VPCs/hour at baseline; this tentative response was confirmed if VT lasting 5 or more beats was not observed during treadmill exercise testing using a standard Bruce protocol. The PES protocol utilized a maximum of three extrastimuli at three pacing cycle lengths and two right ventricular pacing sites. Response by PES was defined as prevention of induction of the following: 1) monomorphic VT lasting over 15 seconds; 2) non-sustained polymorphic VT containing more than 15 beats of monomorphic VT in patients with a history of monomorphic VT; 3) polymorphic VT or VF greater than 15 beats in patients with VF or a history of aborted sudden death without monomorphic VT; and 4) two episodes of polymorphic VT or VF of greater than 15 beats in a patient presenting with monomorphic VT. Sustained VT or NSVT producing hypotension during the final treadmill test was considered a drug failure.
In a multicenter open-label long-term study of sotalol hydrochloride tablets USP in patients with life-threatening ventricular arrhythmias which had proven refractory to other antiarrhythmic medications, response by Holter monitoring was defined as in ESVEM. Response by PES was defined as non-inducibility of sustained VT by at least double extrastimuli delivered at a pacing cycle length of 400 msec. Overall survival and arrhythmia recurrence rates in this study were similar to those seen in ESVEM, although there was no comparative group to allow a definitive assessment of outcome.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
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. Sotalol hydrochloride tablets USP are 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.

Sotalol hydrochloride is contraindicated in patients with bronchial asthma, sinus bradycardia, second and third degree AV block, unless a functioning pacemaker is present, congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol hydrochloride.

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During pre-marketing trials, 3,186 patients with cardiac arrhythmias (1,363 with sustained ventricular tachycardia) received oral sotalol hydrochloride, of whom 2,451 received the drug for at least two weeks. The most important adverse effects are Torsade de Pointes and other serious new ventricular arrhythmias (see ), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of sotalol hydrochloride are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.
Occasional reports of elevated serum liver enzymes have occurred with sotalol hydrochloride therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol hydrochloride and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.
The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1,292 patients with sustained VT/VF.
In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30 mg/m, 90 mg/m and 210 mg/m with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 mg/mand 210 mg/m daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QT u2265 525 msec were seen in 2 patients at the 210 mg/mdaily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.
Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol hydrochloride during investigational use and foreign marketing experience.

Intentional or accidental overdosage with sotalol hydrochloride has rarely resulted in death.
The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 grams to 16 grams) of sotalol hydrochloride the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolongation of QT interval, Torsade de Pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with sotalol hydrochloride should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm. The occurrence of hypotension following an overdose may be associated with an initial slow drug elimination phase (half life of 30 hours) thought to be due to a temporary reduction of renal function caused by the hypotension. In addition, if required, the following therapeutic measures are suggested:
Bradycardia
or Cardiac
Asystole
:
Heart Block:
Hypotension:
Bronchospasm:
Torsade de Pointes:

As with other antiarrhythmic agents, sotalol hydrochloride tablets should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment (see ). Sotalol hydrochloride tablets should be administered only after appropriate clinical assessment (see ) and the dosage of sotalol hydrochloride tablets 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.

Sotalol Hydrochloride Tablets USP, for oral administration, are available as follows:
80 mg:n- E
NDC 0185-0171-09 bottles of 90
NDC 0185-0171-01 bottles of 100
NDC 0185-0171-05 bottles of 500
120 mg:n- E
NDC 0185-0170-09 bottles of 90
NDC 0185-0170-01 bottles of 100
NDC 0185-0170-05 bottles of 500
160 mg:n- E
NDC 0185-0177-09 bottles of 90
NDC 0185-0177-01 bottles of 100
NDC 0185-0177-05 bottles of 500
240 mg:n- E
NDC 0185-0174-09 bottles of 90
NDC 0185-0174-01 bottles of 100
NDC 0185-0174-05 bottles of 500
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Store in a dry place. Keep tightly closed. Avoid excessive heat.
Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.
BETAPACE AF is a trademark of Bayer Healthcare.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or .
Sandoz Inc.
Princeton, NJ 08540
OS7554
REV. 05/12
MF0171REV05/12
MG #18481

NDC 0185-0171-01
Sotalol Hydrochloride Tablets USP
80 mg
Rx only
100 Tablets
Sandoz

NDC 0185-0170-01
Sotalol Hydrochloride Tablets USP
120 mg
Rx only
100 Tablets
Sandoz

NDC 0185-0177-01
Sotalol Hydrochloride Tablets USP
160 mg
Rx only
100 Tablets
Sandoz

NDC 0185-0174-01
Sotalol Hydrochloride Tablets USP
240 mg
Rx only
100 Tablets
Sandoz

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Sotalol Hydrochloride (Sotalol Hydrochloride)

Trade Name : sotalol hydrochloride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Sotalol Hydrochloride (Sotalol Hydrochloride)

Trade Name : sotalol hydrochloride

TABLET

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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