a-lis-KYE-ren, am-LOE-di-peen BES-i-late
When pregnancy is detected, discontinue aliskiren/amlodipine as soon as possible. Drugs that act directly on the renin-angiotensin-aldosterone system can cause injury and even death to the developing fetus .
Commonly used brand name(s)
In the U.S.
- Tekamlo
Available Dosage Forms:
- Tablet
Pharmacologic Class: Renin Inhibitor
Chemical Class: Amlodipine
Uses For aliskiren and amlodipine
Aliskiren and amlodipine 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
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 decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.
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 blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.
aliskiren and amlodipine is available only with your doctor's prescription.
Before Using aliskiren and amlodipine
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 aliskiren and amlodipine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to aliskiren and amlodipine 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 and amlodipine 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 and amlodipine combination in the elderly.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
Breast Feeding
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.
Interactions with Medicines
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 aliskiren and amlodipine, 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 aliskiren and amlodipine 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.
- Amiodarone
- Atazanavir
- Conivaptan
- Cyclosporine
- Dantrolene
- Droperidol
- Itraconazole
- Simvastatin
- Telaprevir
Using aliskiren and amlodipine 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.
- Acebutolol
- Alprenolol
- Atenolol
- Benazepril
- Betaxolol
- Bevantolol
- Bisoprolol
- Bucindolol
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Cilazapril
- Clopidogrel
- Dalfopristin
- Dilevalol
- Diltiazem
- Enalapril
- Esmolol
- Fluconazole
- Fosinopril
- Imatinib
- Indinavir
- Itraconazole
- Ketoconazole
- Labetalol
- Levobunolol
- Lisinopril
- Mepindolol
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Quinupristin
- Ramipril
- Rifampin
- Rifapentine
- Ritonavir
- Sotalol
- St John's Wort
- Talinolol
- Tertatolol
- Timolol
- Trandolapril
- Zofenopril
Interactions with Food/Tobacco/Alcohol
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 aliskiren and amlodipine 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 aliskiren and amlodipine, 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 aliskiren and amlodipine. Make sure you tell your doctor if you have any other medical problems, especially:
- Airway surgery, history of—May increase the risk of angioedema (swelling of the face, lips, tongue, throat, arms, or legs) occurring.
- Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition occurring again.
- Electrolyte imbalance (e.g., low levels of salt or sodium in the body) or
- Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. The blood pressure-lowering effects of aliskiren and amlodipine may be increased.
- 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.
- Hypotension (low blood pressure)—Use with caution. May make this condition worse.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of aliskiren and amlodipine
aliskiren and amlodipine comes with a patient information insert. Read the information carefully and make sure you understand it before taking aliskiren and amlodipine. Ask your doctor if you have any questions.
In addition to the use of aliskiren and amlodipine, 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 aliskiren and amlodipine 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.
You may take aliskiren and amlodipine with or without food. High-fat meals may affect absorption of aliskiren and amlodipine.
Dosing
The dose of aliskiren and amlodipine 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 aliskiren and amlodipine. 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—At first, one tablet containing 150 milligrams (mg) of aliskiren and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg of aliskiren and 10 mg of amlodipine 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 aliskiren and amlodipine, 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
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions While Using aliskiren and amlodipine
It is very important that your doctor check your progress at regular visits to make sure aliskiren and amlodipine is working properly. Blood tests may be needed to check for unwanted effects.
Using aliskiren and amlodipine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using aliskiren and amlodipine, tell your doctor right away.
Stop using aliskiren and amlodipine and 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.
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.
Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of sodium or potassium in the body).
Check with your doctor right away if you become sick while taking aliskiren and amlodipine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.
Hyperkalemia (high potassium in the blood) may occur while you are using aliskiren and amlodipine. 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 salt substitutes containing potassium without first checking with your doctor.
aliskiren and amlodipine may worsen the symptoms of angina (chest pain) or cause a heart attack in certain 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
aliskiren and amlodipine 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
- Blurred vision
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- sweating
- unusual tiredness or weakness
- Abdominal or stomach pain
- chills
- clay-colored stools
- dark urine
- dizziness
- fever
- headache
- itching
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- nausea
- rash
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
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:
Incidence not known
- Swelling of the breasts or breast soreness in both females and males
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.
See also: aliskiren and amlodipine side effects (in more detail)
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More aliskiren and amlodipine resources
- Aliskiren and amlodipine Side Effects (in more detail)
- Aliskiren and amlodipine Dosage
- Aliskiren and amlodipine Use in Pregnancy & Breastfeeding
- Aliskiren and amlodipine Drug Interactions
- Aliskiren and amlodipine Support Group
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