aliskiren

a-lis-KYE-ren

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

• Tekturna

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Renin Inhibitor

Uses For aliskiren

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. 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.

aliskiren is available only with your doctor's prescription.

Before Using aliskiren

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, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to aliskiren 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 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 in the elderly.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	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.
3rd Trimester	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, 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 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.

• Cyclosporine


• Itraconazole

Using aliskiren 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.

• Benazepril


• Captopril


• Cilazapril


• Enalapril


• Fosinopril


• Lisinopril


• Moexipril


• Perindopril


• Quinapril


• Ramipril


• Rifampin


• 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 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, 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. Make sure you tell your doctor if you have any other medical problems, especially:

• Airway surgery, history of or


• Angioedema, or history of or


• Hyperkalemia (high potassium in the blood)—Use with caution. May make these conditions worse.

• Dehydration or


• Diarrhea or


• Hyponatremia (low sodium in the blood) or


• Hypovolemia (low blood volume) or


• Vomiting, severe—Use with caution. These conditions may cause the blood pressure to fall too low with aliskiren.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of aliskiren

Your doctor will tell you how much of aliskiren to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

aliskiren may be taken with or without food.

In addition to the use of aliskiren, 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 aliskiren 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.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

You may take aliskiren with or without food. High-fat meals may affect absorption of aliskiren.

Dosing

The dose of aliskiren 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. 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, 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.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of aliskiren, 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

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 tests may be needed to check for unwanted effects.

Using aliskiren while you are pregnant (especially in your second or third trimester) 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 aliskiren, tell your doctor right away.

aliskiren can cause a serious reaction called angioedema. Stop using aliskiren and tell your doctor right away if you start to have swelling on your face, lips, tongue, or throat, or if you are having trouble swallowing or breathing.

Dizziness or lightheadedness may occur while you are using aliskiren, especially if you have been taking a diuretic (water pill). Make sure you know how you react to aliskiren before you drive, use machines, or do anything else that could be dangerous if you are dizzy. 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.

Check with your doctor right away if you become sick while taking aliskiren, especially if you have severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, which can cause low blood pressure. You can also lose water by sweating, so use extra care during exercise or hot weather.

Hyperkalemia (high potassium in the blood) may occur while you are using aliskiren. 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.

Make sure any doctor or dentist who treats you knows that you are using aliskiren. You may need to stop using aliskiren several days before having surgery or medical tests.

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 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


• joint 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 and vomiting


• pain in the groin or genitals


• sharp back pain just below the ribs


• swelling of the feet or lower legs

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


• back pain


• belching


• dizziness


• heartburn


• indigestion


• muscle aches


• rash


• 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.

See also: aliskiren side effects (in more detail)

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More aliskiren resources

• Aliskiren Side Effects (in more detail)
• Aliskiren Dosage
• Aliskiren Use in Pregnancy & Breastfeeding
• Aliskiren Drug Interactions
• Aliskiren Support Group
• 23 Reviews for Aliskiren - Add your own review/rating

• Aliskiren MedFacts Consumer Leaflet (Wolters Kluwer)


• Aliskiren Professional Patient Advice (Wolters Kluwer)


• Aliskiren Hemifumarate Monograph (AHFS DI)


• Tekturna Prescribing Information (FDA)


• Tekturna Consumer Overview

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