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(aliskircn and valsartan, USP) Tablets, for Oral Use
WARNING: FETAL TOXICITY
- When pregnancy is detected, discontinue Valturna as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Valturna is a single tablet for oral administration of aliskiren (an orally active, nonpeptide, potent renin inhibitor) and valsartan (an orally active, nonpeptide, specific angiotensin II antagonist acting on the ATi receptor subtype).
Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is
Molecular formula: C30H53N3O6• 0.5 C4H4O4
Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.
Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(l-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-L-valine; its structural formula is
Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.
Valturna tablets are formulated for oral administration to contain aliskiren hemifumarate and valsartan, USP 150/160 mg, and 300/320 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropylcellulose, indigotin blue lake, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide and hypromellose.
What are the possible side effects of aliskiren and valsartan (Valturna)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- feeling like you might pass out; or
- slow heart rate, weak pulse, muscle weakness, tingly feeling.
Less serious side effects may be more likely to occur, such as:
- tired feeling;
- stuffy nose, sore throat, cough;
- stomach pain or upset, diarrhea,...
Last reviewed on RxList: 5/7/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Valturna Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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