| IMPORTANT WARNING:
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
- Amturnide®(as a combination product containing Aliskiren, Amlodipine, Hydrochlorothiazide)
- Azor®(as a combination product containing Amlodipine, Olmesartan)
- Caduet®(as a combination product containing Amlodipine, Atorvastatin)
- Exforge®(as a combination product containing Amlodipine, Valsartan)
- Exforge®HCT (as a combination product containing Amlodipine, Hydrochlorothiazide, Valsartan)
- Tekamlo®(as a combination product containing Aliskiren, Amlodipine)
- Tribenzor®(as a combination product containing Amlodipine, Hydrochlorothiazide, Olmesartan)
- Twynsta®(as a combination product containing Amlodipine, Telmisartan)
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.
WHY is this medicine prescribed?
Amlodipine is used alone or in combination with other medications to treat high blood pressure and chest pain (angina). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain.
HOW should this medicine be used?
Amlodipine comes as a tablet to take by mouth. It is usually taken once a day. To help you remember to take amlodipine, take it around the same time 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 amlodipine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of amlodipine and gradually increase your dose.
Amlodipine controls high blood pressure and chest pain (angina) but does not cure them. Continue to take amlodipine even if you feel well. Do not stop taking amlodipine without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking amlodipine,
- tell your doctor and pharmacist if you are allergic to amlodipine or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
- tell your doctor if you have or have ever had heart failure or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking amlodipine, call your doctor.
What SPECIAL DIETARY instructions should I follow?
If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.
What should I do IF I FORGET to take a dose?
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.
What SIDE EFFECTS can this medicine cause?
Amlodipine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- swelling of the hands, feet, ankles, or lower legs
- upset stomach
- stomach pain
- dizziness or lightheadedness
- excessive tiredness
- flushing (feeling of warmth)
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- more frequent or more severe chest pain
- rapid, pounding, or irregular heartbeat
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
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
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.
What should I do in case of OVERDOSE?
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:
- rapid heartbeat
What OTHER INFORMATION should I know?
Keep all appointments with your doctor. Your blood pressure should be checked regularly to determine your response to amlodipine.
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.
¶This branded product is no longer on the market. Generic alternatives may be 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.