- Exforge®(as a combination product containing Amlodipine, Valsartan)
- Exforge®HCT (as a combination product containing Amlodipine, Hydrochlorothiazide, Valsartan)
- Valturna®(as a combination product containing Aliskiren, Valsartan)¶
This MedWatch affects the following medications:
- Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
- Tekturna (aliskiren hemifumarate)
- Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
- Tekamlo (aliskiren hemifumarate and amlodipine besylate)
- Valturna (aliskiren hemifumarate and valsartan). Valturna will no longer be marketed after July 2012.
[Posted 04/20/2012]ISSUE:FDA notified healthcare professionals of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min). The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, ''Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).''
BACKGROUND:Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.
RECOMMENDATION:Concomitant use of aliskiren with ARBs or ACEIs in patients with diabetes is contraindicated because of the risk of renal impairment, hypotension, and hyperkalemia. Avoid use of aliskiren with ARBs or ACEIs in patients with renal impairment where GFR < 60 mL/min. Patients should not stop taking aliskiren without talking to your healthcare professional. Stopping aliskiren suddenly can cause problems if your high blood pressure (hypertension) is not treated.
See the Drug Safety Communication for the Data Summary at: Web Sitefor a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: Web Siteand Web Site.
Tell your doctor if you are pregnant or plan to become pregnant. Do not take valsartan if you are pregnant. If you become pregnant while you are taking valsartan, stop taking valsartan and call your doctor immediately. Valsartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.
Valsartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat congestive heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. Valsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
Valsartan comes as a tablet to take by mouth. For the treatment of high blood pressure, it is usually taken once a day with or without food. For the treatment of heart failure or heart attack, it is usually taken twice a day with or without food. To help you remember to take valsartan, take it at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valsartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of valsartan and gradually increase your dose.
Valsartan controls high blood pressure and heart failure but does not cure them. Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of valsartan. Continue to take valsartan even if you feel well. Do not stop taking valsartan without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Valsartan is also sometimes used to treat diabetic nephropathy (kidney disease in people with diabetes and high blood pressure). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking valsartan,
- tell your doctor and pharmacist if you are allergic to valsartan,any other medications, or any of the ingredients in valsartan tablets.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and selective COX-2 inhibitors such as celecoxib (Celebrex);cyclosporine (Gengraf, Neoral,Sandimmune); diuretics ('water pills'), including potassium-sparing diuretics such as amiloride (Midamor, in Hydro-ride, in Moduretic), spironolactone (Aldactone, in Aldactazide), and triamterene (Dyrenium, in Dyazide, in Maxzide); other medications to treat high blood pressure or a heart problem; potassium supplements; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); and ritonavir (Norvir). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had blockage of the bile duct (condition when bile can not flow from the liver to the gallbladder and small intestine, which can occur with gallstones, tumors, or injury); heart, kidney, or liver disease.
- tell your doctor if you are breast-feeding.
- you should know that valsartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking valsartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.
Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Valsartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- excessive tiredness
- stomach pain
- back pain
- joint pain
- blurry vision
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- unexplained weight gain
Valsartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- fast or slow heartbeat
Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to valsartan.
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.
¶These branded products are no longer on the market and only generic alternatives are available.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2012.