IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ALISKIREN/VALSARTAN - ORAL
COMMON BRAND NAME(S): Valturna
WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.
USES: This combination medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Both medications work by relaxing blood vessels so blood can flow more easily. Aliskiren blocks the hormone renin. Valsartan belongs to a class of drugs called angiotensin receptor blockers. It works by blocking the hormone angiotensin. This medication will be withdrawn from the US market July 20, 2012 due to concerns regarding possible side effects, especially in diabetics and those with kidney impairment. Do not stop taking this medication without talking to your doctor first. You may need to switch to another medication to control your blood pressure.
HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually once daily or as directed by your doctor. Some foods may decrease how well this drug is absorbed by the body. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. If you are unclear about how to take this medication, ask your doctor or pharmacist. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. The usual maximum dose is 300 milligrams of aliskiren with 320 milligrams of valsartan. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. For the treatment of high blood pressure, it may take 2 to 4 weeks before you get the full benefit of this drug. Tell your doctor if your condition worsens (for example your routine blood pressure readings increase).
SIDE EFFECTS: Diarrhea, dizziness, or lightheadedness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To lower your risk of lightheadedness, get up slowly when rising from a sitting or lying position. Drink plenty of fluids unless otherwise directed by your doctor. Heavy sweating or prolonged diarrhea or vomiting may increase your risk of dizziness. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast heartbeat, symptoms of a high potassium blood level (such as slow/irregular heartbeat, muscle weakness), change in the amount of urine. Seek immediate medical attention if any of these rare but very serious side effects occur: signs of infection (such as fever, chills, persistent sore throat), seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aliskiren or valsartan; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), diabetes, kidney disease (including kidney stones), gall bladder disease, gout, heart problems (such as recent heart attack, heart failure), liver disease, high blood levels of potassium, severe loss of body water and minerals such as sodium (volume depletion, dehydration). This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist. This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the effects of this drug, especially kidney effects. This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.) It is not known whether this drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.
DRUG INTERACTIONS: See also Precautions section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: furosemide, lithium, drugs that may increase the level of potassium in the blood (including amiloride, triamterene, ACE inhibitors such as lisinopril, birth control pills containing drospirenone). Other medications can affect the removal of aliskiren and valsartan from your body, which may affect how this medication works. Examples include atorvastatin, cyclosporine, quinidine, azole antifungals (such as itraconazole, ketoconazole), among others. Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure. Ask your pharmacist for more details.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/drowsiness, slow/fast heartbeat.
NOTES: Do not share this medication with others. Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Consult your doctor for more details. Laboratory and/or medical tests (such as kidney function, blood potassium/uric acid levels) may be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised August 2012. Copyright(c) 2012 First Databank, Inc.