Aliskiren, Oral

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KEY POINTS

• This medicine is taken by mouth to treat high blood pressure. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: renin inhibitor; antihypertensive

Generic and brand names: aliskiren, oral; Tekturna

What is this medicine used for?

This medicine is taken by mouth to treat high blood pressure. You may take this medicine alone or with other medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you start taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Edema (fluid buildup)
• Heart problems or a heart attack
• Kidney problems
• Imbalances of sodium or potassium in your blood

Tell your healthcare provider if you have diabetes and are taking an angiotensin-receptor-blocker (ARB) or angiotensin-converting-enzyme-inhibitor (ACE inhibitor) medicine. Also tell your provider if you are on a low-sodium diet.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Take it regularly every day even if you feel better. Do not stop taking this medicine unless your healthcare provider approves. You may need to take this medicine for a long time to control your blood pressure. If your provider has also prescribed another medicine, take it regularly.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food, but you should take it the same way every day. Taking it with meals may lessen the chance the drug will upset your stomach. Taking it with high-fat meals may keep the medicine from being absorbed properly.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: lightheadedness, fainting, fast heartbeat.

What should I watch out for?

This medicine may make you lightheaded or dizzy. Do not drive or operate machinery unless you are fully alert.

This medicine may cause a sudden drop in blood pressure, especially when you first start taking it. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. If you feel dizzy or faint while you are standing, lie down for a while and then get up slowly. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves.

Dizziness may get worse if you lose too much water from your body. You can lose water if you sweat a lot, vomit, or have diarrhea. Tell your provider if you feel dizzy after you have had diarrhea or vomiting.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Your healthcare provider will want to see you regularly to check your blood pressure and to adjust your dosage, if needed. You may also need blood tests regularly while you are taking this medicine. Keep all appointments.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, chest pain or tightness in your chest, trouble breathing; swelling of your lips, tongue, or throat); irregular or fast heartbeat; severe dizziness or fainting; trouble swallowing; severe stomach pain.

Serious (Report these to your healthcare provider right away.): Unexplained swelling; decreased urination; unexplained weight gain; severe sweating, vomiting, or diarrhea; confusion; severe weakness; numbness or tingling in hands or feet; severe skin redness, blistering, or peeling; seizures; yellowing of the skin or eyes; dark urine; unexplained loss of appetite; light-colored bowel movements

Other: Headache, tiredness, dizziness, lightheadedness, nausea, diarrhea, heartburn, back pain, cough.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and rifampin (Rifadin)
• Antidepressants such as duloxetine (Cymbalta), fluoxetine (Prozac), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ledipasvir/sofosbuvir (Harvoni) and simeprevir (Olysio)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Canagliflozin (Invokana)
• Cancer medicines such as abiraterone (Zytiga), crizotinib (Xalkori), ibrutinib (Imbruvica), lapatinib (Tykerb), nilotinib (Tasigna), sunitinib (Sutent), tamoxifen, vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), and simvastatin (Zocor)
• Clonidine (Catapres, Kapvay)
• Dexamethasone
• Dipyridamole (Persantine)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Drospirenone/estradiol (Angeliq)
• Eliglustat (Cerdelga)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• HIV medicines such as cobicistat (Tybost), darunavir (Prezista), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Ivacaftor (Kalydeco)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Mefloquine
• Methyldopa
• Natural remedies such as arginine, cats claw, devils claw, dong quai, garlic, ginger, ginseng, goldenseal, hawthorn, horny goat weed, kelp, ma huang, natural licorice, nettle, St. John’s wort, and yohimbe
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Potassium supplements or salt substitutes that contain potassium
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Ranolazine (Ranexa)
• Reserpine

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.