Aliskiren and Valsartan

What is Aliskiren and Valsartan?

• Aliskiren and Valsartan (Valturna) is a combination of aliskiren, a renin inhibitor, and valsartan, an angiotensin II receptor blocker (ARB), indicated for the treatment of hypertension, to lower blood pressure.

Aliskiren

Valsartan skeletal

What are the uses of this medicine?

Valturna contains two prescription medicines in one tablet that work together to lower blood pressure. It contains:

• aliskiren (Tekturna), a direct renin inhibitor (DRI)
• valsartan (Diovan), an angiotensin receptor blocker (ARB)

• Aliskiren (Tekturna) reduces the effect of renin, and the harmful process that narrows blood vessels. Aliskiren also helps blood vessels relax and widen so blood pressure is lower.
• Valsartan (Diovan) can help lower your blood pressure by blocking a potent chemical, angiotensin II, that leads to blood vessel constriction and narrowing.

Valturna may be used to lower high blood pressure in adults:

• when one medicine to lower high blood pressure is not enough as the first medicine to lower high blood pressure if your doctor decides that you are likely to need more than one medicine.

How does this medicine work?

Aliskiren:

• Aliskiren (al' is key' ren) is a direct inhibitor of renin and acts to inhibit its ability to convert angiotensinogen to angiotensin 1, an early step in the renin-angiotensin system pathway.
• By inhibiting renin and the subsequent production of angiotensin II and aldosterone release, aliskiren results in a decrease in peripheral vasoconstriction and increase in sodium excretion.
• Aliskiren is effective in lowering blood pressure and can be used alone or in combination with other antihypertensive medications, including other inhibitors of the renin-angiotensin system such as the angiotensin converting enzyme (ACE) inhibitors and the angiotensin receptor blockers (ARBs).

valsartan:

• Valsartan (val sar' tan) was the second angiotensin II receptor blocker (ARB) to be approved for use in the United States and is widely used for therapy of hypertension.
• Valsartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its antihypertensive activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant
• are allergic to any of its ingredients

What drug interactions can this medicine cause?

Valturna may affect the way other medicines work, and other medicines may affect how Valturna works.

Especially tell your doctor if you are taking:

• other medicines for high blood pressure or a heart problem
• water pills (also called “diuretics”)
• medicines for treating fungus or fungal infections
• cyclosporine (a medicine used to suppress the immune system)
• potassium-containing medicines, potassium supplements, or salt substitutes containing potassium
• atorvastatin

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• Initiate with 150/160 mg.
• Titrate as needed up to a maximum of 300/320 mg.
• Majority of effect attained within 2 weeks.

Administration:

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets (mg aliskiren/mg valsartan): 150/160, 300/320.

This medicine is available in fallowing brand namesː

• Valturna

What side effects can this medication cause?

The most common side effects of this medicine include:

• Tiredness
• Sore throat
• Runny nose
• Diarrhea
• Upper respiratory tract infection
• Urinary tract infection
• Flu or flu-like symptoms
• Dizziness

Valturna may cause serious side effects:

• Injury or death to an unborn baby
• Low blood pressure (hypotension)
• Angioedema

What special precautions should I follow?

• Valturna can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus.
• Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with aliskiren and has necessitated hospitalization and intubation. Discontinue aliskiren immediately in patients who develop angioedema and do not readminister.
• An excessive fall in blood pressure (hypotension) was rarely seen in patients with uncomplicated hypertension treated with Valturna. If an excessive fall in blood pressure occurs with Valturna, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline.
• Hyperkalemia may occur. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.
• Decreases in renal function may be anticipated in Patients with renal impairment.
• In patients with hepatic impairment slower clearance may occur.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Aliskiren:

• The most likely manifestation of overdosage would be hypotension.

Valsartan:

• 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.

Management of overdosage:

• If symptomatic hypotension occurs, provide supportive treatment.
• Valsartan is not removed from the plasma by hemodialysis.

Can this medicine be used in pregnancy?

• Valturna may harm an unborn baby, causing injury and death.
• If you get pregnant, stop taking Valturna and call your doctor right away.
• If you plan to become pregnant, talk to your doctor about other medicines to treat your high blood pressure before taking Valturna.

Can this medicine be used in children?

• Valturna has not been studied in children under 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredients: Aliskiren and valsartan
• Inactive ingredients: 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

Who manufactures and distributes this medicine?

Manufactured by:

• Novartis Pharma Stein AG
• Stein, Switzerland

Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store Valturna tablets at room temperature between 59o F-86oF (15oC-30oC).
• Keep Valturna in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.

• Dailymed label info on Aliskiren and Valsartan
• FDA Aliskiren and Valsartan

Aliskiren and Valsartan Resources
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