(a lis kye' ren)
- Amturnide®(as a combination product containing Aliskiren, Amlodipine, Hydrochlorothiazide)
- Tekamlo®(as a combination product containing Aliskiren, Amlodipine)
- Tekturna®HCT (as a combination product containing Aliskiren, Hydrochlorothiazide)
- 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.
Do not take aliskiren if you are pregnant. If you become pregnant while taking aliskiren, call your doctor immediately. Aliskiren may harm the fetus.
WHY is this medicine prescribed?
Aliskiren is used alone or in combination with other medications to treat high blood pressure. Aliskiren is in a class of medications called direct renin inhibitors. It works by decreasing certain natural chemicals that tighten the blood vessels, so blood vessels relax and the heart can pump blood more efficiently.
HOW should this medicine be used?
Aliskiren comes as a tablet to take by mouth. It is usually taken once a day. Aliskiren should be taken the same way each time, either always with food or always without food. Take aliskiren at 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 aliskiren 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 an low dose of aliskiren and may increase your dose after you have been taking this medication for at least two weeks.
Aliskiren controls high blood pressure but does not cure it. Continue to take aliskiren even if you feel well. Do not stop taking aliskiren without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
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 aliskiren,
- tell your doctor and pharmacist if you are allergic to aliskiren or any other medications.
- 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 any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); antifungals such as ketoconazole (Nizoral); atorvastatin (Lipitor); diuretics ('water pills') such as hydrochlorothiazide (HCTZ) and furosemide (Lasix); irbesartan (Avapro); and other medications for heart disease or high blood pressure. 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 diabetes, seizures, or kidney disease.
- tell your doctor if you plan to become pregnant or are breast-feeding. Do not breast-feed while taking aliskiren.
- you should know that aliskiren may cause dizziness, lightheadedness, and fainting. Lie down if you feel faint or dizzy, and call your doctor right away.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
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?
Aliskiren may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty swallowing or breathing
Aliskiren may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
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). Do not remove the desiccant (drying agent) from the bottle, if one has been provided. 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:
- blurred vision
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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