Generic Name: aliskiren/hydrochlorothiazide (AL-is-KYE-ren/HYE-droe-KLOR-oh-THYE-a-zide)
Brand Name: Tekturna HCT
Aliskiren/hydrochlorothiazide 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/hydrochlorothiazide is used for:
Treating high blood pressure in certain patients. It may also be used for other conditions as determined by your doctor.
Aliskiren/hydrochlorothiazide is a direct renin inhibitor and thiazide diuretic combination. The direct renin inhibitor works by relaxing blood vessels. The diuretic helps the kidneys to remove fluid from the body, which lowers blood pressure and helps the heart to pump blood more easily.
Do NOT use aliskiren/hydrochlorothiazide if:
- you are allergic to any ingredient in aliskiren/hydrochlorothiazide or to any other sulfonamide (sulfa) medicine (eg, sulfamethoxazole)
- 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/hydrochlorothiazide or another product that contains aliskiren
- you are pregnant
- you have severe kidney problems or are unable to urinate
- 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, dofetilide, itraconazole, or ketanserin
Contact your doctor or health care provider right away if any of these apply to you.
Before using aliskiren/hydrochlorothiazide:
Some medical conditions may interact with aliskiren/hydrochlorothiazide. 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
- if 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, lupus, asthma, heart problems (eg, heart failure), diabetes, kidney problems (eg, renal artery stenosis, kidney stones), liver problems, stroke, heart attack, seizures, low blood pressure, parathyroid gland problems, or high blood cholesterol or lipid levels
- if you are dehydrated, receive dialysis treatment, or have low blood volume
- if you have blood electrolyte problems (eg, sodium, potassium, magnesium, calcium) or you are on a low-salt (sodium) diet
- if you will be having surgery or you have recently had a certain type of nerve surgery (sympathectomy)
- if you drink alcohol
- if you are taking another medicine for high blood pressure or heart problems
Some MEDICINES MAY INTERACT with aliskiren/hydrochlorothiazide. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Digoxin, dofetilide, or ketanserin because the risk of irregular heartbeat may be increased
- Potassium-sparing diuretics (eg, spironolactone) or potassium supplements because the risk of high blood potassium 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
- Adrenocorticotropic hormone (ACTH), atorvastatin, azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), cyclosporine, other diuretics (eg, furosemide), or narcotic pain medicines (eg, codeine) because they may increase the risk of aliskiren/hydrochlorothiazide's side effects, including low blood pressure
- Cholestyramine or colestipol because they may decrease aliskiren/hydrochlorothiazide's effectiveness
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease aliskiren/hydrochlorothiazide's effectiveness and the risk of kidney problems and high blood potassium levels may be increased
- Diazoxide or lithium because the risk of their side effects may be increased by aliskiren/hydrochlorothiazide
- Anticoagulants (eg, warfarin) or insulin or other medicines for diabetes (eg, glipizide) because their effectiveness may be decreased by aliskiren/hydrochlorothiazide
This may not be a complete list of all interactions that may occur. Ask your health care provider if aliskiren/hydrochlorothiazide 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/hydrochlorothiazide:
Use aliskiren/hydrochlorothiazide as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with aliskiren/hydrochlorothiazide. Talk to your pharmacist if you have questions about this information.
- Take aliskiren/hydrochlorothiazide by mouth with or without food. However, you must take it the same way each time you take it. If you take aliskiren/hydrochlorothiazide on an empty stomach, always take it on an empty stomach. If you take it with food, always take it with food.
- Aliskiren/hydrochlorothiazide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with aliskiren/hydrochlorothiazide.
- You will need to take care not to become dehydrated while you are taking aliskiren/hydrochlorothiazide. This may increase your risk of low blood pressure. Talk with your doctor if you have questions about avoiding dehydration.
- Take aliskiren/hydrochlorothiazide on a regular schedule to get the most benefit from it.
- Aliskiren/hydrochlorothiazide works best if it is taken at the same time each day.
- Continue to take aliskiren/hydrochlorothiazide even if you feel well. Do not miss any doses.
- If you miss a dose of aliskiren/hydrochlorothiazide, 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/hydrochlorothiazide.
Important safety information:
- Aliskiren/hydrochlorothiazide may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use aliskiren/hydrochlorothiazide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Aliskiren/hydrochlorothiazide 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.
- It may take up to 4 weeks to get the full benefit from aliskiren/hydrochlorothiazide. Do NOT change your dose or stop taking aliskiren/hydrochlorothiazide without checking with your doctor.
- High-fat meals may decrease the amount of aliskiren/hydrochlorothiazide that is absorbed into your body. Discuss any questions or concerns with your doctor. Be sure you take aliskiren/hydrochlorothiazide consistently with regard to meals.
- Aliskiren/hydrochlorothiazide 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.
- 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.
- Tell your doctor or dentist that you take aliskiren/hydrochlorothiazide before you receive any medical or dental care, emergency care, or surgery.
- Aliskiren/hydrochlorothiazide contains a sulfonamide called hydrochlorothiazide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting aliskiren/hydrochlorothiazide. Contact your doctor right away if you experience symptoms such as vision changes (eg, decrease in vision) or eye pain.
- 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.
- Aliskiren/hydrochlorothiazide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to aliskiren/hydrochlorothiazide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- 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.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- 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.
- Aliskiren/hydrochlorothiazide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Aliskiren/hydrochlorothiazide may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Aliskiren/hydrochlorothiazide may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking aliskiren/hydrochlorothiazide.
- Lab tests, including blood pressure, blood electrolyte levels, and kidney function, may be performed while you use aliskiren/hydrochlorothiazide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use aliskiren/hydrochlorothiazide with caution in the ELDERLY; they may be more sensitive to its effects, especially diarrhea.
- Aliskiren/hydrochlorothiazide should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY AND BREAST-FEEDING: Aliskiren/hydrochlorothiazide 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. Aliskiren/hydrochlorothiazide is found in breast milk. Do not breast-feed while taking aliskiren/hydrochlorothiazide.
Possible side effects of aliskiren/hydrochlorothiazide:
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:
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 mouth, face, lips, throat, or tongue; unusual hoarseness); confusion; decreased urination; eye pain; fever, chills, or persistent sore throat; increased thirst; irregular heartbeat; mental or mood changes; muscle pain or cramps; seizures; severe or persistent nausea; shortness of breath; stomach pain; symptoms of low blood pressure (eg, fainting, light-headedness, severe dizziness); 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); unusual bruising or bleeding; unusual tiredness or weakness; unusually dry mouth; vision changes (eg, decrease in vision); 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, or emergency room immediately. Symptoms may include fainting; severe dizziness or light-headedness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).Proper storage of aliskiren/hydrochlorothiazide:
Store aliskiren/hydrochlorothiazide 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/hydrochlorothiazide out of the reach of children and away from pets.
- If you have any questions about aliskiren/hydrochlorothiazide, please talk with your doctor, pharmacist, or other health care provider.
- Aliskiren/hydrochlorothiazide 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/hydrochlorothiazide 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/hydrochlorothiazide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to aliskiren/hydrochlorothiazide. 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/hydrochlorothiazide.
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.