See Supplemental Patient Information
- Drugs acting directly on the renin-angiotensin-aldosterone system have been associated with fetal and neonatal morbidity, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure and death when administered during the second and third trimesters of pregnancy [US Black Box Warning]
- Apprise female patients of childbearing age about the potential hazard to the fetus, if this drug is used during pregnancy or if a patient becomes pregnant while on therapy
- Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients taking aliskiren; discontinue immediately and do not re-administer to patients who develop angioedema
- Symptomatic hypotension may occur after initiation of therapy in patients with volume or salt depletion due to high doses of diuretics. Correct these conditions prior to starting therapy or start treatment under careful medical supervision
- If excessive hypotension occurs, place the patient in supine position and, if indicated, give an IV infusion of normal saline
- In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment may be associated with oliguria and/or progressive azotemia and occasionally with acute renal failure or death. Use with caution in patients with severe CHF
- Monitor serum electrolytes periodically in patients who are at risk for hyperkalemia (e.g., those with renal impairment)
- Exercise caution while using this drug in combination with potassium sparing diuretics, potassium supplements, potassium containing salt substitutes, or other agents that increase potassium levels, as it may lead to increases in serum potassium
- Incidences of elevated serum creatinine or BUN have occurred in hypertensive patients with unilateral or bilateral renal artery stenosis
- Avoid co-administration of aliskiren with cyclosporine or itraconazole as it increases the concentration of aliskiren in blood
Cautions: Use cautiously in
- Severe renal impairment
- Severe hepatic impairment
- History of renal disease
- Patients undergoing surgery or dialysis
- Post-MI patients
- Hyponatremia
- Diabetes mellitus
Supplemental Patient Information
- Advise female patients of childbearing age about the consequences of exposure to drugs acting on renin-angiotensin-aldosterone system; instruct them to report pregnancies to their physicians as early as possible
- Caution patients about the potential for lightheadedness, especially during the first days of therapy; inform patients to discontinue therapy if syncope occurs and to consult their physician
- Advise patients not to use any potassium supplements or salt substitutes containing potassium during therapy
- Instruct patients to establish a routine pattern for taking this drug with regard to meals; inform them that high-fat meals decrease absorption substantially
Pregnancy Category:D
Breastfeeding: No data available on the use of valsartan during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 21 June 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Valturna (aliskiren/valsartan)
- TABS:
- 150 mg/160 mg
- 300 mg/320 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Valturna 150-160 MG TABS [Bottle] (NOVARTIS)
30 mg = $95.99
90 mg = $270.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Valturna (aliskiren hemifumarate 150 MG / valsartan 160 MG) Oral Tablet
Ingredient(s): Aliskiren mixture with valsartan
Imprint: NVR;HDU
Color(s): Red
Shape: Oval
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): silicon dioxide / crospovidone / hydroxypropyl cellulose / ferrosoferric oxide / ferric oxide red / ferric oxide yellow / magnesium stearate / cellulose, microcrystalline / polyethylene glycol / talc / titanium dioxide / fd&c blue no. 2
Drug Label Author:
Novartis Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
Drug Name: Valturna (aliskiren hemifumarate 300 MG / valsartan 320 MG) Oral Tablet
Ingredient(s): Aliskiren mixture with valsartan
Imprint: NVR;SNB
Color(s): Brown
Shape: Oval
Size (mm): 22.00
Score: 1
Inactive Ingredient(s): silicon dioxide / crospovidone / hydroxypropyl cellulose / ferrosoferric oxide / ferric oxide red / ferric oxide yellow / magnesium stearate / cellulose, microcrystalline / polyethylene glycol / talc / titanium dioxide / fd&c blue no. 2
Drug Label Author:
Novartis Pharmaceuticals Corporation
DEA Schedule:
Non-Scheduled
