Tekturna

Tekturna (aliskiren) is used alone or in combination with some medications to treat high blood pressure (hypertension) in people who are at least 6 years old and weigh at least 110 pounds (50 kg).

Tekturna belongs to a class of medications called direct renin inhibitors. Aliskiren works by decreasing certain natural chemicals that tighten the blood vessels, so blood vessels relax and the heart can pump blood more efficiently.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Take Tekturna exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Tekturna 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 Tekturna. 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 this medicine 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.

Do not Tekturna use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

If you have diabetes, do not use Tekturna together with certain heart or blood pressure medicines (such as Avalide, Benicar, Byvalson, Cozaar, Hyzaar, Diovan, Exforge, Lotrel, Monopril, Vasotec, Vasoretic, Zestoretic, and many others).

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

Conditions that may cause very low blood pressure include: 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 this medicine. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

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

If you have diabetes, do not take Tekturna 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 Tekturna to children younger than 2 years old.

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

To make sure Tekturna is safe for you, tell your doctor if you 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.

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

Tekturna 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 Tekturna side effects 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.

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). Tekturna 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.

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.

Avoid taking this Tekturna 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.

Tell your doctor about all your current medicines. Many drugs can interact with 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 interact with aliskiren. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: aliskiren hemifumarate. Tekturna tablets inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, silica, colloidal anhydrous, hypromellose, macrogol, talc, iron oxide, black (E172), iron oxide, red (E172), and titanium dioxide (E171). Tekturna oral pellets inactive ingredients: basic butylated methacrylate copolymer, basic colloidal silicon dioxide, crospovidone, povidone, dibutyl sebacate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulphate.

Noden Pharma USA Inc., 2800 Discovery Drive, Suite 100, Orlando, Florida 32826, USA.