Sotalol Hydrochloride (Sotalol Hydrochloride)

Trade Name : Sotalol Hydrochloride

Teva Pharmaceuticals USA, 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 Teva Pharmaceuticals USA, 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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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.n
  • Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation.n
  • If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.n
  • Calculate creatinine clearance to determine appropriate dosing n
  • WARNING: LIFE THREATENING PROARRHYTHMIA
  • See full prescribing information for complete boxed warning.
  • Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation.
  • If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.
  • Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
  • Adjust the dosing interval based on creatinine clearance.
  • Sotalol hydrochloride tablets are an antiarrhythmic indicated for:
  • Limitations of Use
  • No data
  • Sotalol hydrochloride tablets: Initial dosage in adults is 80 mg twice daily. Increase the dose as needed in increments of 80 mg/day, every 3 days to a maximum 320 mg total daily dose ()
  • Pediatrics: Dosage depends on age ()
  • Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c61u201d on each side of the score, and plain on the other side.
  • Sotalol hydrochloride tablets USP, 120 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c1060u201d on each side of the score, and plain on the other side.
  • Sotalol hydrochloride tablets USP, 160 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c62u201d on each side of the score, and plain on the other side.
  • Sotalol hydrochloride tablets USP, 240 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c63u201d on each side of the score, and plain on the other side.
  • 80 mg, 120 mg, 160 mg, and 240 mg tablets ()
  • Sotalol hydrochloride tablets are contraindicated in patients with:
  • For the treatment of AFIB/AFL, sotalol hydrochloride tablets are also contraindicated in patients with:
  • For the treatment of AFIB/AFL or ventricular arrhythmias
  • For the treatment of AFIB/AFL also contraindicated for:
  • No data
  • QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose or discontinue ()
  • Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue ()
  • Correct any electrolyte disturbances ()
  • May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor ()
  • The most common adverse reactions (u22652%) for sotalol hydrochloride are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. ()
  • No data
  • Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use ()
  • Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure ()
  • Dosage of insulin or antidiabetic drugs may need adjustment ()
  • Aluminum or magnesium-based antacids reduce sotalol exposure ()
  • No data
  • Intentional or accidental overdosage with sotalol has resulted in death.
  • Symptoms and Treatment of Overdosage
  • The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2 to 16 grams) of sotalol 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 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:
  • Sotalol hydrochloride tablets USP contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties Sotalol hydrochloride tablets USP are supplied as a light blue, oval-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 CHNO Su2219HCl and is represented by the following structural formula:
  • Sotalol hydrochloride tablets USP contain the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone, and FD&C Blue No. 2.
  • No data
  • No evidence of carcinogenic potential was observed in rats during a 24-month study at 137 to 275 mg/kg/day (approximately 30 times the maximum recommended human oral dose (MRHD) as mg/kg or 5 times the MRHD as mg/m) or in mice, during a 24-month study at 4141 to 7122 mg/kg/day (approximately 450 to 750 times the MRHD as mg/kg or 36 to 63 times the MRHD as mg/m).
  • Sotalol has not been evaluated in any specific assay of mutagenicity or clastogenicity.
  • No significant reduction in fertility occurred in rats at oral doses of 1000 mg/kg/day (approximately 100 times the MRHD as mg/kg or 18 times the MRHD as mg/m) prior to mating, except for a small reduction in the number of offspring per litter.
  • Reproduction studies in rats and rabbits during organogenesis at 100 and 22 times the MRHD as mg/kg (9 and 7 times the MRHD as mg/m), respectively, did not reveal any teratogenic potential associated with sotalol HCl. In rabbits, a high dose of sotalol HCl (160 mg/kg/day) at 16 times the MRHD as mg/kg (6 times the MRHD as mg/m) produced a slight increase in fetal death, and maternal toxicity. Eight times the maximum dose (80 mg/kg/day or 3 times the MRHD as mg/m) did not result in an increased incidence of fetal deaths. In rats, 1000 mg/kg/day sotalol HCl, 100 times the MRHD (18 times the MRHD as mg/m), increased the number of early resorptions, while at 14 times the maximum dose (2.5 times the MRHD as mg/m), no increase in early resorptions was noted. However, animal reproduction studies are not always predictive of human response.
  • No data
  • Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c61u201d on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1061-01).
  • Sotalol hydrochloride tablets USP, 120 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c1060u201d on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1060-01).
  • Sotalol hydrochloride tablets USP, 160 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c62u201d on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1062-01).
  • Sotalol hydrochloride tablets USP, 240 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers u201c93u201d and u201c63u201d on each side of the score, and plain on the other side. They are available in bottles of 100 (NDC 0093-1063-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Czech Republic By:
  • TEVA CZECH INDUSTRIES s.r.o.
  • Opava-Komarov, Czech Republic
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. M 6/2016
  • No data
  • No data
  • No data
  • No data

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