Pronunciation:

val-SAR-tan

Brand Names:

• Diovan
• Prexxartan

Dosage Forms:

• Solution
• Tablet

Warnings:

When pregnancy is detected, discontinue valsartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus .

Classifications:

Therapeutic—

Cardiovascular Agent

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Valsartan 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 can reduce the risk of strokes and heart attacks.

Valsartan is also used to treat heart failure and left ventricular failure after a heart attack. Left ventricular failure occurs when the left side of the heart (the main pumping chamber) becomes stiff and enlarged or swollen. This causes pooling of blood in the lungs because the heart is not pumping properly.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valsartan in children 1 to 16 years of age. However, use is not recommended in children younger than 1 year of age.

Older adults—

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

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
• Sparsentan

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
• Cilazapril
• Enalapril
• Enalaprilat
• Fosinopril
• Furosemide
• Lisinopril
• Lithium
• Moexipril
• Perindopril
• Potassium Citrate
• Potassium Phosphate
• Quinapril
• Ramipril
• Simeprevir
• Spirapril
• Tacrolimus
• Trandolapril
• Trimethoprim
• Zofenopril

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.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Eltrombopag
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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 (an allergic reaction) with other blood pressure medicines (e.g., benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of—Use with caution. Use may cause this condition to reoccur.

• Congestive heart failure, severe—Use may lead to kidney problems.

• Diabetic patients who are also taking aliskiren (Tekturna®)—Should not be used in these patients.

• Electrolyte imbalances (eg, low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Kidney disease, severe—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

In addition to using 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 is most important for you. You should check with your doctor before changing your diet.

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 might 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, strokes, or kidney disease.

You may take this medicine with or without food. Also, take this medicine at the same time each day.

Take all other medicines your doctor has prescribed to treat your condition.

If your child has a liquid form of the medicine, shake the bottle for at least 10 seconds before giving a dose.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 heart failure:
    • Adults—At first, 40 milligrams (mg) two times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 320 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For high blood pressure:
    • Adults—At first, 80 or 160 milligrams (mg) once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 320 mg per day.
    • Children 1 to 16 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 1 milligram (mg) per kilogram (kg) of body weight per day given as a single dose. Your doctor may adjust the dose as needed. However, the dose is usually not more than 4 mg per kg of body weight or 160 mg per day.
    • Children younger than 1 year of age—Use is not recommended.
  • For left ventricular failure after a heart attack:
    • Adults—At first, 20 milligrams (mg) two times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 320 mg per 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—

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.

Store the liquid at room temperature for up to 30 days, or in the refrigerator for up to 75 days.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that 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.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position or 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. 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 if you have severe nausea, vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

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

Bloody urine

cold sweats

confusion

decreased frequency or amount of urine

difficult breathing

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

fainting

increased thirst

irregular heartbeat

loss of appetite

lower back or side pain

nausea

nervousness

numbness or tingling in the hands, feet, or lips

swelling of the face, fingers, or lower legs

unusual tiredness or weakness

vomiting

weakness or heaviness of the legs

weight gain

Rare

Chills

fever

hoarseness

sore throat

swelling of the mouth, hands, or feet

trouble with swallowing or breathing (sudden)

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

dark urine

general tiredness and weakness

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

light-colored stools

pinpoint red spots on the skin

redness, soreness, or itching skin

unusual bleeding or bruising

upper right abdominal or stomach pain

yellow eyes and 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:

Less common

Back pain

blurred vision

cold or flu-like symptoms

coughing

diarrhea

difficulty with moving

headache

muscle pain or stiffness

pain, swelling, or redness in the joints

stomach pain

Incidence not known

Hair loss

thinning of the hair

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.