Description
Aliskiren is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure will reduce the risk of strokes and heart attacks.
Aliskiren is a renin inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax and this decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen that go to the heart is increased.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of aliskiren tablets in children 6 years of age and older weighing 50 kilograms (kg) or more. Safety and efficacy have not been established in children younger than 6 years of age or weighing less than 50 kg. Use is not recommended in children younger than 2 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Candesartan
- Captopril
- Enalapril
- Enalaprilat
- Eprosartan
- Fosinopril
- Irbesartan
- Lisinopril
- Losartan
- Moexipril
- Olmesartan Medoxomil
- Perindopril
- Quinapril
- Ramipril
- Sparsentan
- Telmisartan
- Trandolapril
- Valsartan
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Berotralstat
- Capmatinib
- Cyclosporine
- Itraconazole
- Nirmatrelvir
- Potassium Citrate
- Simeprevir
- Venetoclax
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Furosemide
- Rifampin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).
- Angioedema, history of—May increase the risk of this condition occurring again.
- Congestive heart failure, severe or
- Heart attack, history—Use may lead to kidney problems.
- Diabetes or
- Kidney disease—May increase risk of having high potassium in the blood.
- Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs)—Should not be used in patients with this condition.
- Electrolyte imbalances (eg, high potassium or low sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. May make these conditions worse.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop using this medicine without checking first with your doctor.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of food you eat, especially for foods that are high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.
Many patients who have high blood pressure will not notice any signs of the problem. In fact, many patients feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.
Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.
Take this medicine the same way every day. This means take it at the same time and consistently with or without food. Do not take this medicine with a high-fat meal.
If you cannot swallow the tablet whole, you may take the capsule containing the pellets instead. Do not swallow the capsule whole. Empty the contents of the capsule into a spoon. Swallow the pellets right away with milk (dairy or soy-based) or water. You may also mix the pellets with 1 or more teaspoons of vanilla pudding, vanilla ice cream, milk, or water. Do not chew or crush the pellets.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For high blood pressure:
- For oral dosage forms (pellets):
- Adults—At first, 150 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children 6 to 17 years of age—Dose is based on body weight and must be determined by your doctor:
- Weighing 50 kilograms (kg) or more—At first, 150 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
- Weighing 20 to 50 kg—At first, 75 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg per day.
- Children 2 to 5 years of age or weighing less than 20 kilograms (kg)—Should not be used in these patients.
- For oral dosage forms (tablets):
- Adults and children 6 years of age and older weighing 50 kilograms (kg) or more—At first, 150 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 300 mg per day.
- Children younger than 6 years of age or weighing less than 50 kg—Use and dose must be determined by your doctor.
- Children younger than 2 years of age—Should not be used in these patients.
- For oral dosage forms (pellets):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the tablets in its original container in a dry place.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, lips, tongue, or throat while you are using this medicine.
Dizziness or lightheadedness may occur while you are using this medicine, especially if you have been taking a diuretic (water pill). Do not drive or do anything else that could be dangerous until you know this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using this medicine until you have talked to your doctor.
Check with your doctor right away if you become sick while taking this medicine, especially if you have severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink of plenty of water during exercise or hot weather.
This may cause serious kidney problems, including kidney failure. Check with your doctor right away if you have a decrease in how much or how often you urinate.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.
You should not use this medicine (unless your doctor specifically tells you to) if you are also receiving cyclosporine (Gengraf®, Neoral®, Sandimmune®) or itraconazole (Sporanox®).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Body aches or pain
- chills
- cough
- diarrhea
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- nasal congestion
- runny nose
- sneezing
- sore throat
- unusual tiredness or weakness
Rare
- Ankle, knee, or great toe joint pain
- blood in the urine
- joint pain, stiffness, or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of bladder control
- loss of consciousness
- lower back or side pain
- nausea
- pain in the groin or genitals
- sharp back pain just below the ribs
- swelling of the feet or lower legs
- vomiting
Incidence not known
- Blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- itching
- muscle pain
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- sores, ulcers, or white spots in the mouth or on the lips
- tingling of the hands or feet
- unusual weight gain or loss
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Back pain
- belching
- dizziness
- heartburn
- indigestion
- muscle aches
- rash
- stomach discomfort, upset, or pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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