Prexxartan (Oral)

Valsartan is used on its own or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the strain on the heart and arteries. If it lasts a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure can lower the chances of strokes and heart attacks.

Valsartan is also used to treat heart failure and left ventricular failure after a heart attack. Left ventricular failure happens when the left side of the heart (the main pumping chamber) becomes stiff and larger than normal. This leads to blood pooling in the lungs because the heart is not pumping effectively.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that makes blood vessels narrow. Valsartan relaxes the blood vessels and lowers blood pressure. Lower blood pressure increases the flow of blood and oxygen to the heart.

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

It is very important for your doctor to check your or your child's progress at regular visits to ensure 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 prevent pregnancy. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may happen, especially when you get up suddenly from lying down or sitting, or if you have been taking a diuretic (water pill). Make sure you know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you feel dizzy. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to prevent the dizziness from coming back. If you faint, call your doctor right away.

Check with your doctor immediately if you feel sick while taking this medicine, especially if you have severe nausea, vomiting, or diarrhea that does not stop. These conditions can 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 using any medicines, supplements, or salt substitutes that contain potassium.

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

In deciding to use a medicine, you and your doctor need to think about the risks and the benefits of the medicine. Here are some important points to consider:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare provider if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of valsartan in children aged 1 to 16 years. However, it is not recommended for children younger than 1 year.

Geriatric

Studies have not shown any specific problems that would limit the use of valsartan in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines can be used together, but your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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 increase the 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 adjust the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food, or with certain types of food, due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to 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®)—Use with caution. This condition may happen again.

• Severe congestive heart failure—Using this may cause kidney problems.

• Diabetic patients taking aliskiren (Tekturna®)—This should not be used in these patients.

• Electrolyte imbalances (e.g., low sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Severe kidney disease—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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.

In the U.S.

• Diovan
• Prexxartan

Available Dosage Forms:

• Solution
• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Angiotensin II Receptor Antagonist

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.

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