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Sotalol Hydrochloride (Betapace)

Trade Name : BETAPACE

Covis Pharma

TABLET

Strength 80 mg/1

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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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 (Betapace) which is also known as BETAPACE and Manufactured by Covis Pharma. It is available in strength of 80 mg/1 per ml. Read more

Sotalol Hydrochloride (Betapace) 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

Packaging and Delivery

Validated Cold Chain Shipment

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.
  • 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.
  • Calculate creatinine clearance to determine appropriate dosing .
  • WARNING: LIFE THREATENING PROARRHYTHMIA
  • See full prescribing information for complete boxed warning.
  • Betapace/Betapace AF 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.
  • Betapace/Betapace AF is an antiarrhythmic indicated for:
  • Limitations of Use
  • No data
  • Betapace is supplied as capsule-shaped, light-blue, scored tablets:
  • Betapace AF is supplied as capsule-shaped, white scored tablet:
  • 80 mg,120 mg and 160 mg tablets ()
  • Betapace/Betapace AF is contraindicated in patients with:
  • For the treatment of AFIB/AFL, Betapace/Betapace AF is also contraindicated in patients with:
  • For the treatment of AFIB/AFL or ventricular arrythmias
  • For the treatment of AFIB/AFL also contraindicated for:
  • No data
  • The most common adverse reactions (u22652%) for Betapace are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. ()n n
  • To report SUSPECTED ADVERSE REACTIONS, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • 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 (2u201316 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:
  • Betapace/Betapace AF contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Betapace is supplied as a light-blue, capsule-shaped tablet for oral administration. Betapace AF is supplied as a white, 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--[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is CHNO Su00b7HCl and is represented by the following structural formula:
  • Betapace
  • Betapace AF
  • No data
  • No evidence of carcinogenic potential was observed in rats during a 24-month study at 137u2013275 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 4141u20137122 mg/kg/day (approximately 450u2013750 times the MRHD as mg/kg or 36u201363 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
  • Betapace (sotalol hydrochloride); capsule-shaped light-blue scored tablets, imprinted with the strength and u201cBETAPACE,u201d are available as follows:
  • Betapace AF (sotalol hydrochloride); capsule-shaped white scored tablets, imprinted with the strength and u201cBHCPu201d are available as follows:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59u201386u00b0F) [See USP Controlled Room Temperature].
  • u00a92016, Covis Pharma. All rights reserved.
  • Manufactured for:
  • Covis PharmaZug, 6300 Switzerland
  • Rev. 05/2016
  • NDC 70515-105-10u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n
  • Betapacen (sotalol HCl)
  • 80 mg
  • Rx only
  • COVIS
  • Each tablet contains 80 mg of sotalol hydrochloride.
  • Dosage: See package insert.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F)[See USP Controlled Room Temperature].
  • Dispense in a well-closedcontainer (USP).
  • Mfd for:Covis PharmaZug, 6300Switzerland
  • Made in Switzerland
  • Rev. 4/18100318
  • AC003980 210A0
  • NDC 70515-109-10n n
  • Betapacen (sotalol HCl)
  • 120 mg
  • Rx only
  • COVIS
  • Each tablet contains 120 mg of sotalol hydrochloride.
  • Dosage: See package insert.
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F)[See USP Controlled RoomTemperature].
  • Dispense in a well-closedcontainer (USP).
  • Mfd for:Covis PharmaZug, 6300Switzerland
  • Made in Switzerland
  • Rev. 4/18100320
  • AC0039120 210A
  • NDC 70515-106-10n n
  • Betapacen (sotalol HCl)
  • 160 mg
  • Rx only
  • COVIS
  • Each tablet contains 160 mg of sotalol hydrochloride.
  • Dosage: See package insert.
  • Store at 25u00b0C (77u00b0F); excursions permitted to15-30u00b0C (59-86u00b0F) [See USP Controlled RoomTemperature].
  • Dispense in a well-closedcontainer (USP).
  • Mfd for:Covis PharmaZug, 6300Switzerland
  • Made in Switzerland
  • Rev. 4/18100322
  • AC0039160 210A0
  • NDC 70515-115-06n n
  • Arrayn- Arrayn- u00aen- Array
  • 80 mg
  • Rx only
  • COVIS
  • Each tablet contains 80 mg of sotalol hydrochloride.
  • Dosage: Take as prescribed by your physician.
  • Please see package insert.
  • Store at 25u00b0C (77u00b0F); excursionspermitted to 15-30u00b0C (59-86u00b0F)[See USP Controlled RoomTemperature].
  • Mfd for:Covis PharmaZug, 6300 Switzerland
  • Made in Switzerland
  • Rev. 4/18100324
  • AC003980 26AF
  • NDC 70515-119-06n n
  • Arrayn- Arrayn- u00aen- Array
  • 120 mg
  • Rx only
  • COVIS
  • Each tablet contains 120 mg of sotalol hydrochloride.
  • Dosage: Take as prescribed by your physician.
  • Please see package insert.
  • Store at 25u00b0C (77u00b0F); excursionspermitted to 15-30u00b0C (59-86u00b0F)[See USP Controlled RoomTemperature].
  • Mfd for:Covis PharmaZug, 6300 Switzerland
  • Made in Switzerland
  • Rev. 4/18100326
  • AC0039120 26AF
  • NDC 70515-116-06n n
  • Arrayn- Arrayn- u00aen- Array
  • 160 mg
  • Rx only
  • COVIS
  • Each tablet contains 160 mg of sotalol hydrochloride.
  • Dosage: Take as prescribed by your physician.
  • Please see package insert.
  • Store at 25u00b0C (77u00b0F); excursionspermitted to 15-30u00b0C (59-86u00b0F)[See USP Controlled RoomTemperature].
  • Mfd for:Covis PharmaZug, 6300 Switzerland
  • Made in Switzerland
  • Rev. 4/18100328
  • AC0039160 26AF

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