Aliskiren is used to treat high blood pressure (hypertension) in people who are at least 6 years old and weigh at least 110 pounds (50 kg).

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

Do not use if you are pregnant. Stop using aliskiren and tell your doctor right away if you become pregnant.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take aliskiren with or without food, but take it at the same time each day.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking aliskiren. This can lead to very low blood pressure, electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often. Your blood may also need to be tested often.

Your treatment may also include diet, exercise, lifestyle changes, and other medications. Follow your doctor's instructions very carefully.

If you have high blood pressure, keep using aliskiren even if you feel well. High blood pressure often has no symptoms.

Keep the medicine in the original container, along with the packet or canister of moisture-absorbing preservative.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Comments:
-The antihypertensive effect is substantially attained by 2 weeks.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).
Aliskiren may be used alone or in combination with other antihypertensive agents.

Usual Pediatric Dose for Hypertension:

6 TO 17 YEARS:
Less than 20 kg: Not recommended
20 to 50 kg (not approved for use due to the lack of an appropriate dosage form): 75 mg orally once a day; if blood pressure remains inadequately controlled, the daily dose may be increased to 150 mg
50 kg or greater: 150 mg orally once a day; if blood pressure remains inadequately controlled, the daily dose may be increased to 300 mg

Comments: The antihypertensive effect of a given dose is 85% to 90% attained by 2 weeks.

You should not take aliskiren if you are allergic to it.

If you have diabetes, do not take aliskiren together with certain heart or blood pressure medicines, such as:

• azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or valsartan; or

• benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

Do not give aliskiren to children younger than 2 years old.

You may also need to avoid taking these heart or blood pressure medicines with aliskiren if you have kidney disease.

Tell your doctor if you have or have ever had:

• an allergic reaction to any blood pressure medicine;

• heart problems;

• diabetes;

• if you are on a low-salt diet; or

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

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Aliskiren can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should try to avoid eating a high fat meal (foods such as fried foods or fast foods) when taking aliskiren with a meal. You should not use salt substitutes containing potassium or take potassium supplements without first talking with your doctor.

Avoid taking aliskiren with a high-fat meal, or it could be harder for your body to absorb aliskiren.

Do not take potassium supplements or use salt substitutes, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Aliskiren may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• kidney problems--swelling, urinating less, feeling tired or short of breath; or

• high blood potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of aliskiren may include:

• diarrhea.

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.

Tell your doctor about all your current medicines. Many drugs can affect aliskiren, especially:

• any other heart or blood pressure medicines;

• cyclosporine;

• itraconazole;

• a diuretic or "water pill"; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect aliskiren. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order lab tests to check your body's response to aliskiren.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Tekturna® HCT (containing Aliskiren, Hydrochlorothiazide)
• Valturna® (containing Aliskiren, Valsartan)