Prexxartan

Prexxartan is a prescription medication used to treat high blood pressure in adults and children, to treat heart failure in adults, and to improve the chance of living after a heart attack in adults.

Prexxartan belongs to a group of drugs called angiotensin II receptor antagonists. These work by relaxing blood vessels.

This medication comes in oral solution form and is taken two times a day.

Common side effects of Prexxartan include dizziness and low blood pressure. Do not drive or operate heavy machinery until you know how Prexxartan affects you.

Prexxartan is a prescription medication used in adults and children 6 years and older to:

• treat high blood pressure
• treat heart failure in adults
• improve the chance of living longer after a heart attack in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Prexxartan. See the “Prexxartan Precautions” section.

Common side effects of Prexxartan include the following:

• dizziness
• low blood pressure
• diarrhea
• joint pain
• headache
• tiredness
• high potassium in the blood
• stomach pain
• back pain

This is not a complete list of Prexxartan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• angiotensin-converting enzyme (ACE) blockers such as benazepril (Lotensin, Lotensin HCT), captopril (Capoten, Capozide), enalapril (Vasotec, Vaseretic), fosinopril (Monopril, Monopril HCT), lisinopril (Prinivil, Prinzide, Zestril, Zestoretic), moexipril (Univasc, Uniretic), quinapril (Accupril, Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, Tarka)
• angiotensin receptor II blockers such as azilsartan (Edarbi), candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis, Twynsta), and valsartan (Diovan)
• aliskiren
• potassium-sparing diuretics such as spironolactone (Aldactone), triamterene (Dyrenium), amiloride (Midamor)
• potassium supplements. Your doctor may check the amount of potassium in your blood periodically
• a salt substitute. Your doctor may check the amount of potassium in your blood periodically
• nonsteroidal anti-inflammatory drugs (like ibuprofen or naproxen)
• lithium

This is not a complete list of Prexxartan drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Prexxartan including the following:

• harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking valsartan, tell your doctor right away.
• hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure too. Lie down if you feel faint or dizzy. Call your doctor right away.
• a decline in kidney function when used with certain medications. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away if you have any of the symptoms of kidney dysfunction including fatigue, paleness of skin, decreased urination, shortness of breath, change in blood pressure, and swelling of the face, ankles, hands, or feet.
• high potassium in the blood. Your healthcare provider will monitor this with blood tests.

Prexxartan can cause dizziness. Do not drive or operate heavy machinery until you know how Prexxartan affects you.

Do not take Prexxartan if you:

• are allergic to Prexxartan or to any of its ingredients.
• are taking aliskiren and have diabetes.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Prexxartan, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Prexxartan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Prexxartan or to any of its ingredients
• have heart problems
• have kidney problems
• have diabetes
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It has been shown that women taking Prexxartan during pregnancy may have babies born with problems. Prexxartan should be stopped as soon as possible if someone becomes pregnant.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Prexxartan crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Prexxartan.

Take Prexxartan exactly as prescribed.

Prexxartan comes in oral solution form and is taken two times a day.

Prexxartan can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Prexxartan at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Hypertension

The recommended starting dose range of Prexxartan in adults for hypertension is 40 mg to 80 mg twice daily. The maximum dose of Prexxartan is 320 mg daily in divided doses.

The recommended dose of Prexxartan in pediatric patients from age 6 to 16 years is based on weight. The maximum dose in these patients is 40 mg total per day.

Heart Failure

The recommended starting dose of Prexxartan in adults for heart failure is 40 mg twice daily. The maximum dose of Prexxartan is 320 mg daily in divided doses.

Post-Myocardial Infarction

The recommended starting dose of Prexxartan in adults after a heart attack is 20 mg twice daily. The recommended maintenance dose after a heart attack is 160 mg twice daily.

If you take too much Prexxartan, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Prexxartan at room temperature between 68°F to 77°F (20 °C to 25 °C).
• Keep this and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

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