Description
Aliskiren, amlodipine, and hydrochlorothiazide is a combination of medicines that may be used alone or 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.
Amlodipine is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.
Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower blood pressure.
This medicine is available only with your doctor's prescription.
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 have not been performed on the relationship of age to the effects of aliskiren, amlodipine, and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren, amlodipine, and hydrochlorothiazide combination in the elderly.
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
- Dofetilide
- 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.
- Abametapir
- Acarbose
- Aceclofenac
- Acemetacin
- Acetyldigoxin
- Albiglutide
- Albuterol
- Alogliptin
- Amphetamine
- Amtolmetin Guacil
- Arsenic Trioxide
- Aspirin
- Atazanavir
- Avacopan
- Benzhydrocodone
- Benzphetamine
- Berotralstat
- Bromfenac
- Bromocriptine
- Bufexamac
- Buprenorphine
- Canagliflozin
- Capmatinib
- Carbamazepine
- Cefepime
- Celecoxib
- Ceritinib
- Chlorpropamide
- Choline Salicylate
- Clarithromycin
- Clonidine
- Clonixin
- Clopidogrel
- Codeine
- Conivaptan
- Cyclosporine
- Dantrolene
- Dapagliflozin
- Darunavir
- Deslanoside
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.
- Aminolevulinic Acid
- Amprenavir
- Aprepitant
- Bepridil
- Boceprevir
- Carbamazepine
- Cholestyramine
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Cobicistat
- Crizotinib
- Diltiazem
- Dronedarone
- Duvelisib
- Fluconazole
- Fluvoxamine
- Fosamprenavir
- Furosemide
- Ginkgo
- Gossypol
- Idelalisib
- Indinavir
- Ketoconazole
- Letermovir
- Licorice
- Lonafarnib
- Mifepristone
- Nefazodone
- Nelfinavir
- Nilotinib
- Posaconazole
- Ribociclib
- Rifampin
- Rifapentine
- Saquinavir
- Schisandra sphenanthera
- Telithromycin
- Troleandomycin
- Tucatinib
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:
- Angioedema (swelling of the face, mouth, arms, legs, or throat), history of—May increase the risk of this condition occurring again.
- Anuria (not able to pass urine) or
- Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) or
- Kidney disease, moderate or
- Sulfa drug allergy (e.g., sulfamethoxazole, sulfasalazine, Azulfidine®, Bactrim®, Septra®)—Should not be used in patients with these conditions.
- Asthma, history of—May increase likelihood of having an allergic reaction.
- Diabetes or
- Kidney problems—May increase risk of having high potassium in the blood.
- Electrolyte imbalances (e.g., high or low levels of calcium, magnesium, potassium, or sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
- Glaucoma, secondary angle closure or
- Gout or
- Hyperlipidemia (high cholesterol or fats in the blood) or
- Liver disease or
- Myopia (changes in the eyeball causing vision problems), acute or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Heart or blood vessel disease (e.g., severe obstructive coronary artery disease)—Use with caution. May increase the risk of experiencing chest pain or heart attacks.
Proper Use
This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.
This medicine comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. 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 a change in the types of foods you eat, especially foods 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 may 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 take it consistently with or without food. High-fat meals may decrease absorption of this medicine.
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 oral dosage form (tablets):
- For high blood pressure:
- Adults—Your doctor will determine your starting dose and may increase your dose as needed. However, the dose is usually not more than 300 milligrams (mg) of aliskiren, 10 mg of amlodipine, and 25 mg of hydrochlorothiazide once a day.
- Children—Use and dose must be determined by your doctor.
- For high blood pressure:
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 medicine in its original container.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. 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.
Call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.
You should not use this medicine (unless your doctor specifically tells you to) if you are also receiving cyclosporine (Gengraf®, Neoral®, Sandimmune®), itraconazole (Sporanox®), or lithium (Eskalith®, Lithobid®).
Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. 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, call your doctor right away.
Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.
This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack, especially in patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck. shortness of breath, or sweating.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.
Check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) 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:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- tingling of the hands or feet
- unusual weight gain or loss
Less common
- Dizziness
Rare
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual tiredness or weakness
Incidence not known
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
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
- Acid or sour stomach
- fever
- headache
- itching skin
- lack or loss of strength
- muscle aches
- rash
- sore throat
- stomach discomfort, upset, or pain
- stuffy or runny nose
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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