aliskiren and valsartan

Generic Name: aliskiren and valsartan (a LIS ke rin and val SAR tan)Brand Names: Valturna

What is aliskiren and valsartan?

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

Valsartan is in a group of drugs called angiotensin II receptor antagonists. Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of aliskiren and valsartan is used to treat high blood pressure (hypertension).

Aliskiren and valsartan may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aliskiren and valsartan?Do not use this medication if you are pregnant or planning a pregnancy. Aliskiren and valsartan could cause birth defects in the baby if you take the medication during pregnancy, especially during the last 6 months. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Before you take aliskiren and valsartan, tell your doctor if you have kidney or liver disease, high levels of potassium in your blood (hyperkalemia), heart disease or recent heart attack, congestive heart failure, or if you are on a low-salt diet.

If you take aliskiren and valsartan with meals, avoid high-fat foods. They can make it harder for your body to absorb aliskiren and valsartan.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking aliskiren and valsartan. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my health care provider before taking aliskiren and valsartan?You should not use this medication if you are allergic to aliskiren (Tekturna) or valsartan (Diovan), or if you are also taking cyclosporine (Gengraf, Neoral, Sandimmune).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• kidney disease (or if you are on dialysis);

• liver disease;

• high levels of potassium in your blood (hyperkalemia);

• congestive heart failure;

• heart disease or recent heart attack; or

• if you are on a low-salt diet.

FDA pregnancy category D. Do not use this medication if you are pregnant or planning a pregnancy. Aliskiren and valsartan could cause birth defects in the baby if you take the medication during pregnancy, especially during the last 6 months. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. It is not known whether aliskiren and valsartan passes into breast milk or if it could harm a nursing baby. You should not use this medication while you are breast-feeding a baby.

How should I take aliskiren and valsartan?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take aliskiren and valsartan with a full glass of water.

You may take aliskiren and valsartan with or without food, but take it the same way every time.

If you take aliskiren and valsartan with meals, avoid high-fat foods. They can make it harder for your body to absorb aliskiren and valsartan.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking aliskiren and valsartan. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

It may take up to 2 weeks of using this medicine before your blood pressure improves. For best results, keep using the medication as directed.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store aliskiren and valsartan at room temperature away from moisture and heat.

See also: Aliskiren and valsartan dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include fast or slow heart rate, feeling light-headed, or fainting.

What should I avoid while taking aliskiren and valsartan?

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of aliskiren and valsartan.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use salt substitutes or potassium supplements while taking aliskiren and valsartan, unless your doctor has told you to.

Aliskiren and valsartan side effects

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, heartburn;

• numbness or tingly feeling; or

• muscle cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Aliskiren and valsartan Dosing Information

Usual Adult Dose for Hypertension:

Initial dose: 150/160 mg once a dayMaintenance dose: 150/160 mg or 300/320 mg once a dayMaximum dose: Titrate as needed to a maximum dose of 200/320 mg daily.The antihypertensive effect of aliskiren-valsartan is largely attained within 2 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of 300/320 mg.A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with aliskiren-valsartan. The usual initial dose is 150/160 mg once daily as needed to control blood pressure.For convenience, patients receiving aliskiren and valsartan from separate tablets may instead wish to receive a single tablet of aliskiren-valsartan containing the same component doses.

What other drugs will affect aliskiren and valsartan?

Tell your doctor about all other medications you use, especially other blood pressure medications, or:

• atorvastatin (Lipitor);

• cyclosporine (Gengraf, Neoral, Sandimmune);

• a diuretic (water pill) such as furosemide (Lasix);

• an antibiotic such as ketoconazole (Nizoral) or rifampin (Rifater, Rifadin, Rifamate);

• a potassium supplement such as K-Dur, Klor-Con; or

• salt substitutes that contain potassium.

This list is not complete and there may be other drugs not listed that can affect aliskiren and valsartan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about aliskiren and valsartan.

• Remember, keep this and all other medicines out of the reach of children. Never share your medicines with others and only use this medication for the condition prescribed.
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