Generic Name: aliskiren (AL-is-KYE-ren)
Brand Name: Tekturna
Aliskiren may cause injury or death to the fetus if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.
Aliskiren is used for:
Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
Aliskiren is a direct renin inhibitor. It works by relaxing blood vessels, which lowers blood pressure and helps the heart to pump blood more easily.
Do NOT use aliskiren if:
- you are allergic to any ingredient in aliskiren
- you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by treatment with aliskiren or another product that contains aliskiren
- you are pregnant
- you have either diabetes or kidney problems and you are also taking an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril) or an angiotensin receptor blocker (ARB) (eg, losartan)
- you are taking cyclosporine or itraconazole
Contact your doctor or health care provider right away if any of these apply to you.
Before using aliskiren:
Some medical conditions may interact with aliskiren. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), especially when taking an ACE inhibitor (eg, lisinopril) or an ARB (eg, losartan)
- if you have a history of gout or high blood uric acid levels, heart problems (eg, heart failure), diabetes, kidney problems (eg, renal artery stenosis), stroke, heart attack, seizures, or low blood pressure
- if you are dehydrated, have low blood volume, or receive dialysis treatment
- if you have high blood potassium levels or low blood sodium levels, or if you are on a low-salt (sodium) diet
- if you are taking another medicine for high blood pressure or heart problems
Some MEDICINES MAY INTERACT with aliskiren. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased
- Atorvastatin, azole antifungals (eg, itraconazole, ketoconazole), or cyclosporine because they may increase the risk of aliskiren's side effects, including low blood pressure
- Potassium-sparing diuretics (eg, spironolactone) or potassium supplements because the risk of high blood potassium levels may be increased
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease aliskiren's effectiveness and the risk of kidney problems and high blood potassium levels may be increased
- ACE inhibitors (eg, lisinopril) or ARBs (eg, losartan) because the risk of certain side effects (eg, kidney problems, high blood potassium levels, low blood pressure) may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if aliskiren may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use aliskiren:
Use aliskiren as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with aliskiren. Talk to your pharmacist if you have questions about this information.
- Take aliskiren by mouth with or without food. However, you must take it the same way each time you take it. If you take aliskiren on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
- You will need to take care not to become dehydrated while you are taking aliskiren. This may increase your risk of low blood pressure. Talk with your doctor if you have questions about avoiding dehydration.
- Take aliskiren on a regular schedule to get the most benefit from it.
- Aliskiren works best if it is taken at the same time each day.
- Continue to take aliskiren even if you feel well. Do not miss any doses.
- If you miss a dose of aliskiren, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use aliskiren.
Important safety information:
- Aliskiren may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use aliskiren with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Aliskiren may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- If vomiting, diarrhea, or excessive sweating occurs, you will need to take care not to become dehydrated. This could increase your risk of low blood pressure. Contact your doctor for instructions.
- Aliskiren may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
- It may take up to 2 weeks to get the full benefit from aliskiren. Do NOT change your dose or stop taking aliskiren without checking with your doctor.
- High-fat meals may decrease the amount of aliskiren that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take aliskiren consistently with regard to meals.
- Tell your doctor or dentist that you take aliskiren before you receive any medical or dental care, emergency care, or surgery.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
- If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Lab tests, including blood pressure, blood electrolyte levels, and kidney function, may be performed while you use aliskiren. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Aliskiren should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- Use aliskiren with caution in the ELDERLY; they may be more sensitive to its effects, especially diarrhea.
- PREGNANCY AND BREAST-FEEDING: Aliskiren may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if aliskiren is found in breast milk. Do not breast-feed while taking aliskiren.
Possible side effects of aliskiren:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; cough; diarrhea, dizziness; flu-like symptoms (eg, headache, muscle or joint aches, tiredness).
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the hands, eyes, mouth, face, lips, throat, or tongue; unusual hoarseness); decreased urination; irregular heartbeat; seizures; stomach pain; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); symptoms of low blood pressure (eg, fainting, severe dizziness, light-headedness); vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; severe dizziness or light-headedness.Proper storage of aliskiren:
Store aliskiren at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the original bottle, away from heat, moisture, and light. Keep the desiccant (drying agent) in the bottle to help keep your medicine dry. Do not store in the bathroom. Keep aliskiren out of the reach of children and away from pets.
- If you have any questions about aliskiren, please talk with your doctor, pharmacist, or other health care provider.
- Aliskiren is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take aliskiren or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about aliskiren. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aliskiren. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using aliskiren.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.