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(nebivolol and valsartan) Tablets
- When pregnancy is detected, discontinue BYVALSON as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
BYVALSON™ is available as tablets for oral administration. Each tablet contains 5.45 mg of nebivolol hydrochloride, which is equivalent to 5 mg of nebivolol free base, and 80 mg of valsartan. The inactive ingredients in the tablets are lactose monohydrate, microcrystalline cellulose, copovidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, talc, ferric oxide, hypromellose, polysorbate 80, and Opadry® II Purple film-coat. The Opadry® II is made of polyvinyl alcohol-part hydrolyzed, titanium dioxide, talc, polyethylene glycol, iron oxide red, and ferrosoferric oxide/black iron oxide.
BYVALSON™ tablets contain nebivolol hydrochloride as one of two active ingredients. Nebivolol hydrochloride is chemically described as (1RS,1'RS)-1,1'-[(2RS, 2'SR)-bis(6-fluoro-3,4-dihydro-2H-1benzopyran-2-yl)]-2,2'-iminodiethanol hydrochloride. Nebivolol hydrochloride is present as a racemic mixture of d-Nebivolol hydrochloride and l-Nebivolol hydrochloride with the stereochemical designations of [SRRR]-nebivolol hydrochloride and [RSSS]-nebivolol hydrochloride, respectively. The molecular formula of both the forms is C22H25F2NO4•HCl and their structural formulas are provided below:
Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene.
Valsartan, the other active ingredient in BYVALSON, is chemically described as N-(1-Oxopentyl)-N-[[2'(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine. Its molecular formula is C24H29N5O3, its molecular weight is 435.52, and its structural formula is:
Valsartan is a white or almost white fine powder. It is freely soluble in anhydrous ethanol, sparingly soluble in methylene chloride, and practically insoluble in water.
Last reviewed on RxList: 6/15/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Byvalson Information
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