• Aliskiren

    (a lis kye' ren)

    IMPORTANT WARNING:

    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: http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm for a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    IMPORTANT WARNING:

    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:
    • diarrhea
    • stomach pain
    • heartburn
    • cough
    • rash
    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
    • hoarseness
    • difficulty swallowing or breathing
    • lightheadedness
    • fainting
    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:
    • fainting
    • dizziness
    • blurred vision
    • nausea

    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.

    Brand Names

    • Tekturna®
    • 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)[¶]
    These branded products are no longer on the market and only generic alternatives are available.

    Hydrochlorothiazide

    (hye droe klor oh thye' a zide)

    IMPORTANT WARNING:

    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: http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm for a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    WHY is this medicine prescribed?

    Hydrochlorothiazide, a 'water pill,' is used to treat high blood pressure and fluid retention caused by various conditions, including heart disease. It causes the kidneys to get rid of unneeded water and salt from the body into the urine.
    This medicine is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    Hydrochlorothiazide comes as a tablet and liquid to take by mouth. It usually is taken once or twice a day. If you are to take it once a day, take it in the morning; if you are to take it twice a day, take it in the morning and in the late afternoon to avoid going to the bathroom during the night. Take this medication with a meal or snack. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take hydrochlorothiazide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Hydrochlorothiazide controls high blood pressure but does not cure it. Continue to take hydrochlorothiazide even if you feel well. Do not stop taking hydrochlorothiazide without talking to your doctor.

    Are there OTHER USES for this medicine?

    Hydrochlorothiazide may also be used to treat patients with diabetes insipidus and certain electrolyte disturbances and to prevent kidney stones in patients with high levels of calcium in their blood. Talk to your doctor about the possible risks of using this medicine for your condition.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking hydrochlorothiazide,
    • tell your doctor and pharmacist if you are allergic to hydrochlorothiazide, sulfa drugs, or any other drugs.
    • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other medicines for high blood pressure, anti-inflammatory medications such as ibuprofen (Motrin, Nuprin) or naproxen (Aleve), corticosteroids (e.g., prednisone), lithium (Eskalith, Lithobid), medications for diabetes, probenecid (Benemid), and vitamins. If you also are taking cholestyramine or colestipol, take it at least 1 hour after hydrochlorothiazide.
    • tell your doctor if you have or have ever had diabetes, gout, or kidney, liver, thyroid, or parathyroid disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking hydrochlorothiazide, call your doctor immediately.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking hydrochlorothiazide.
    • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
    • remember that alcohol can add to the drowsiness caused by this drug.
    • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Hydrochlorothiazide may make your skin sensitive to sunlight.

    What SPECIAL DIETARY instructions should I follow?

    Follow your doctor's directions. They may include following a daily exercise program or a low-salt or low-sodium diet, potassium supplements, and increased amounts of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice) in your 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 your 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?

    Frequent urination should go away after you take hydrochlorothiazide for a few weeks. Tell your doctor if any of these symptoms are severe or do not go away:
    • muscle weakness
    • dizziness
    • cramps
    • thirst
    • stomach pain
    • nausea
    • vomiting
    • diarrhea
    • loss of appetite
    • headache
    • hair loss
    If you experience any of the following symptoms, call your doctor immediately:
    • sore throat with fever
    • unusual bleeding or bruising
    • severe skin rash with peeling skin
    • difficulty breathing or swallowing
    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 http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medicine 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 allow the liquid to freeze. Throw away any medicine that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medicine.

    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.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly, and blood tests should be done occasionally.
    Do not let anyone else take your medicine. 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.

    Brand Names

    • HydroDIURIL®
    • Microzide®
    • Amturnide® (as a combination product containing Aliskiren, Amlodipine, Hydrochlorothiazide)
    • Apresazide® (as a combination product containing Hydralazine, Hydrochlorothiazide)
    • Accuretic® (as a combination product containing Quinapril, Hydrochlorothiazide)
    • Benicar® HCT (as a combination product containing Olmesartan, Hydrochlorothiazide)
    • Diovan® HCT (as a combination product containing Valsartan, Hydrochlorothiazide)
    • Dutoprol® (as a combination product containing Metoprolol, Hydrochlorothiazide)
    • Exforge® HCT (as a combination product containing Amlodipine, Hydrochlorothiazide, Valsartan)
    • Hydrap-ES® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Hydro-Reserp® (as a combination product containing Hydrochlorothiazide, Reserpine)
    • Hydropres® (as a combination product containing Hydrochlorothiazide, Reserpine)
    • Hydroserp® (as a combination product containing Hydrochlorothiazide, Reserpine)
    • Hydroserpine® (as a combination product containing Hydrochlorothiazide, Reserpine)
    • Hydra-Zide® (as a combination product containing Hydralazine, Hydrochlorothiazide)
    • Inderide® (as a combination product containing Hydrochlorothiazide, Propranolol)
    • Inderide® LA (as a combination product containing Hydrochlorothiazide, Propranolol)
    • Lopressor® HCT (as a combination product containing Metoprolol, Hydrochlorothiazide)
    • Mallopress® (as a combination product containing Hydrochlorothiazide, Reserpine)
    • Marpres® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Monopril® HCT (as a combination product containing Fosinopril, Hydrochlorothiazide)
    • Quinaretic® (as a combination product containing Quinapril, Hydrochlorothiazide)
    • Ser-Ap-Es® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Serathide® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Serpazide® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Serpex® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Tekturna® HCT (as a combination product containing Aliskiren, Hydrochlorothiazide)
    • Teveten® HCT (as a combination product containing Eprosartan, Hydrochlorothiazide)
    • Timolide® (as a combination product containing Timolol, Hydrochlorothiazide)
    • Tri-Hydroserpine® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Tribenzor® (as a combination product containing Amlodipine, Hydrochlorothiazide, Olmesartan)
    • Uni Serp® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Unipres® (as a combination product containing Hydralazine, Hydrochlorothiazide, Reserpine)
    • Uniretic® (as a combination product containing Moexipril, Hydrochlorothiazide)
    • Ziac® (as a combination product containing Bisoprolol, Hydrochlorothiazide)
    • Also available generically

    Amlodipine

    (am loe' di peen)

    IMPORTANT WARNING:

    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: http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm for a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    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
    • headache
    • upset stomach
    • stomach pain
    • dizziness or lightheadedness
    • drowsiness
    • 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
    • fainting
    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 http://www.fda.gov/Safety/MedWatch ] 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:
    • dizziness
    • fainting
    • 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.

    Brand Names

    • Norvasc®
    • 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)
    • Also available generically

    Valsartan

    (val sar' tan)

    IMPORTANT WARNING:

    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: http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm for a list of ACEI and ARB products, and additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    IMPORTANT WARNING:

    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.

    WHY is this medicine prescribed?

    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.

    HOW should this medicine be used?

    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.

    Are there OTHER USES for this medicine?

    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.

    What SPECIAL PRECAUTIONS should I follow?

    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.

    What SPECIAL DIETARY instructions should I follow?

    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.

    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?

    Valsartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • dizziness
    • headache
    • excessive tiredness
    • nausea
    • diarrhea
    • stomach pain
    • back pain
    • joint pain
    • blurry vision
    • cough
    • rash
    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
    • hoarseness
    • 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 http://www.fda.gov/Safety/MedWatch ] 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:
    • dizziness
    • fainting
    • fast or slow heartbeat

    What OTHER INFORMATION should I know?

    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.

    Brand Names

    • Diovan®
    • 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)[¶]
    These branded products are no longer on the market and only generic alternatives are available.
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