Valturna (Aliskiren and Valsartan, USP Tablets) Drug Information: Overdosage and Contraindications

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May 27, 2012

Valturna

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High blood pressure facts

High blood pressure (hypertension) is designated as either essential (primary) hypertension or secondary hypertension and is defined as a consistently elevated blood pressure exceeding 140/90 mm Hg.
High blood pressure is called "the silent killer" because it often causes no symptoms for many years, even decades, until it finally damages certain critical organs.
Poorly controlled high blood pressure ultimately can cause damage to blood vessels in the eye, thickening of the heart muscle and heart attacks, hardening of the arteries (arteriosclerosis), kidney failure, and strokes.
Most antihypertensive medications can be used alone or in combination. Some are used only in combination. Some are preferred over others in certain specific medical situations. And some are not to be used (contraindicated) in other situations.
Several classes of antihypertensive medications are available, including ACE i...

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OVERDOSE

Aliskiren

Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, provide supportive treatment.

Aliskiren is poorly dialyzed. Therefore, hemodialysis is not adequate to treat aliskiren overexposure [see CLINICAL PHARMACOLOGY].

Valsartan

Limited data are available related to overdosage in humans. The most likely effect of overdose with valsartan would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. Depressed level of consciousness, circulatory collapse and shock have been reported. If symptomatic hypotension occurs, provide supportive treatment.

Valsartan is not removed from the plasma by hemodialysis.

Valsartan was without grossly observable adverse effects at single oral doses up to 2000 mg/kg in rats and up to 1000 mg/kg in marmosets, except for the salivation and diarrhea in the rat and vomiting in the marmoset at the highest dose (60 and 31 times, respectively, the maximum recommended human dose on a mg/m² basis). (Calculations assume an oral dose of 320 mg/day and a 60-kg patient.)