Eprosartan (Oral)

Eprosartan is used by itself 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, 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 risk of strokes and heart attacks.

Eprosartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. This allows eprosartan to relax the blood vessels. This 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 that your doctor check your progress at regular visits to make sure that Eprosartan (Oral) is working properly. Blood tests may be needed to check for unwanted effects.

Using Eprosartan (Oral) while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent getting pregnant. If you think you have become pregnant while using Eprosartan (Oral), tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Make sure you know how you react to Eprosartan (Oral) 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 so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using Eprosartan (Oral) and call your doctor right away.

Check with your doctor right away if you become sick while taking Eprosartan (Oral), especially with severe or continuing 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 they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

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

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 any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how eprosartan affects children. Its safety and effectiveness have not been proven in the pediatric population.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of eprosartan.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there is a chance of interaction. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are highlighted for their potential significance and may not be a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of the other medicines you take.

• Aliskiren
• Sparsentan

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the 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 certain side effects, but using both drugs may be the best option for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both of the 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 or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor about any other medical issues, especially:

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

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

• Electrolyte imbalances (e.g., low sodium in the body) or
• Fluid imbalances (from dehydration, vomiting, or diarrhea) or
• Heart disease or
• Kidney disease—Use with caution. May worsen these conditions.

Along with its needed effects, Eprosartan (Oral) 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

• Burning or painful urination or changes in urinary frequency
• 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 Eprosartan (Oral). 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 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.