Teveten (Oral)

Eprosartan is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure makes the heart and arteries work harder. If it lasts for a long time, it can cause the heart and arteries to 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 risk of strokes and heart attacks.

Eprosartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that makes the blood vessels tighten. This helps relax the blood vessels. As a result, eprosartan lowers blood pressure and 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 progress during regular visits to ensure that this medicine is working properly. Blood tests may be needed to look 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 might be pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may happen, especially when you get up from lying down or sitting. Make sure you know how this medicine affects you before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down to avoid fainting. Then sit for a few moments before standing to help prevent the dizziness from coming back. If you faint, stop using this medicine and call your doctor right away.

Check with your doctor immediately if you become sick while taking this medicine, especially if you have severe or ongoing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Do not take other medicines unless you have discussed them with your doctor. This includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine versus the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how eprosartan affects children. Its safety and effectiveness in kids have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of eprosartan.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used with caution even if an interaction could happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not be the complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may 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 how often you take one or both medicines.

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

Using this medicine with any of the following medicines may increase the risk of specific side effects, but using both may be necessary for your treatment. If both are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• 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 certain foods, as interactions may occur. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical conditions, especially:

• Congestive heart failure, severe—Using this medicine may lead to kidney problems.

• Diabetic patients taking aliskiren (Tekturna®)—Should not use this medicine.

• Electrolyte imbalances (like low sodium in the body) or
• Fluid imbalances (from dehydration, vomiting, or diarrhea) or
• Heart disease or
• 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 occur, but if they do, you may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Less common

• Burning or painful urination or changes in how often you urinate
• cough
• fever
• sore throat

Rare

• Dizziness, lightheadedness, or fainting
• swollen face, lips, limbs, or tongue

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 how 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 or rare

• Abdominal or stomach pain
• joint pain
• unusual tiredness

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.

• Teveten

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Eprosartan

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 is 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. Therefore, 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.

You may take this medicine with or without food.

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

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 high blood pressure: Adults— 400 to 800 milligrams (mg) per day, taken once a day or divided into two doses. Your doctor may increase your dose as needed. 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.