Pronunciation:

a-lis-KYE-ren, val-SAR-tan

Brand Names:

• Valturna

Dosage Forms:

• Tablet

Warnings:

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

Classifications:

Therapeutic—

Antihypertensive

Pharmacologic—

Renin Inhibitor

Uses of This Medicine:

Aliskiren and valsartan combination is used 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 decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren and valsartan combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren and valsartan 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.

Other 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 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.

• Aliskiren
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Candesartan
• Captopril
• Enalapril
• Enalaprilat
• Eprosartan
• Fosinopril
• Irbesartan
• Lisinopril
• Losartan
• Moexipril
• Olmesartan Medoxomil
• Perindopril
• Quinapril
• Ramipril
• 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.

• Benazepril
• Captopril
• Cyclosporine
• Eliglustat
• Enalapril
• Enalaprilat
• Fosinopril
• Itraconazole
• Lisinopril
• Lithium
• Lomitapide
• Moexipril
• Nilotinib
• Perindopril
• Quinapril
• Ramipril
• Simeprevir
• Tocophersolan
• Trandolapril
• Trimethoprim

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.

• Diabetes—Should not be used in patients with this condition.

• Electrolyte imbalance (e.g., high or low levels of potassium or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart attack, recent or
• Heart failure or
• Hypotension (low blood pressure) or
• Kidney problems—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Aliskiren and valsartan combination is used when a single medicine to lower your blood pressure is not enough. It is also used as the first medicine to treat your condition if your doctor feels that you need to take more than one blood pressure medicine.

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 changes 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.

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 (film-coated tablets):
  • For high blood pressure:
    • Adults—At first, one tablet containing 150 milligrams (mg) of aliskiren and 160 mg of valsartan once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 300 mg of aliskiren and 320 mg of valsartan once a day.
    • Children—Use and dose must be determined by your doctor.

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—

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 This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood 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 the medicine, tell your doctor right away.

Call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, tongue, or throat, 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®) or itraconazole (Sporanox®).

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 this medicine before you drive, use machines, or do anything else 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 this medicine, 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 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.

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

Drinking alcohol or taking narcotic pain relievers or sleeping pills with this medicine may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless they have been discussed with your doctor. This 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 of This Medicine:

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

Bladder pain

bloody or cloudy urine

body aches or pain

chills

cough

diarrhea

difficult, burning, or painful urination

difficulty breathing

ear congestion

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

joint pain

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

nasal congestion

nausea

runny nose

shivering

sneezing

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Rare

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

sweating

Incidence not known

Abdominal or stomach pain

irregular heartbeat

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

nervousness

numbness or tingling in the hands, feet, or lips

shortness of breath

weakness or heaviness of the 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

Feeling of constant movement of self or surroundings

sensation of spinning

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.