Pronunciation:

ep-roe-SAR-tan MES-i-late, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Teveten HCT

Warnings:

Drugs that act on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. When pregnancy is detected, discontinue treatment immediately .

Classifications:

Pharmacologic—

Eprosartan

Chemical—

Thiazide

Uses of This Medicine:

Eprosartan and hydrochlorothiazide combination 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.

Eprosartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes the blood vessels to tighten. As a result, eprosartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

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 have not been performed on the relationship of age to the effects of eprosartan and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eprosartan and hydrochlorothiazide combination 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
• Dofetilide
• 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.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Cyclosporine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalapril
• Enalaprilat
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Furosemide
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oliceridine
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Spirapril
• Sufentanil
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Tramadol
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Vonoprazan
• 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
• Aminolevulinic Acid
• Amtolmetin Guacil
• Bepridil
• Bromfenac
• Bufexamac
• Carbamazepine
• Celecoxib
• Cholestyramine
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Gossypol
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Licorice
• 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:

• Anuria (not able to pass urine) or
• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Sulfa drug allergy (e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, Septra®)—Should not be used in these patients.

• Asthma, history of—May increase likelihood of having an allergic reaction.

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

• Diabetes or
• Electrolyte imbalances (e.g., high or low potassium, magnesium, or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Hypercalcemia (high calcium in the blood) or
• Kidney problems or
• Liver disease or
• Myopia, acute (changes in the eyeball causing vision problems) or
• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

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 are 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. 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.

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—One tablet once a day. 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 also occur, especially when you get up 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 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 this medicine and call your doctor right away.

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

Check with your doctor immediately if blurred vision, difficulty reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor to check your eyes.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

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.

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:

Rare

Abdominal or stomach pain

ankle, knee, or great toe joint pain

arm, back, or jaw pain

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

chest pain or discomfort

chest tightness or heaviness

confusion

convulsions

decreased urine output

difficulty breathing

difficult, burning, or painful urination

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

dry mouth

fast, pounding, or irregular heartbeat or pulse

feeling of warmth

fever

flushed or dry skin

frequent urination

fruit-like breath odor

headache

increased hunger

increased thirst

increased volume of pale, dilute urine

itching of the skin

joint stiffness or swelling

loss of appetite

loss of bladder control

loss of consciousness

lower back or side pain

muscle pain or cramps

nausea or vomiting

nervousness

numbness and tingling of the face, fingers, or toes

pale, bluish-colored, or cold hands or feet

pinpoint red or purple spots on the skin

rapid weight gain

sudden decrease in the amount of urine

sudden sweating

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

Incidence not known

Back, leg, or stomach pains

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

bloody or cloudy urine

chills

constipation

cough or hoarseness

coughing up blood

darkened urine

decreased frequency or amount of urine

diarrhea

difficulty with swallowing

drowsiness

fever with or without chills

general body swelling

general feeling of tiredness or weakness

hives

indigestion

irritability

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

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

skin rash

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen or painful glands

thickening of bronchial secretions

unusual weight loss

vision changes

weak pulse

weight gain

yellow eyes or 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:

Rare

Acid or sour stomach

belching

body aches or pain

bone pain

burning feeling in the chest or stomach

burning or stinging of the skin

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in hearing

cold or flu-like symptoms

congestion

continuing ringing or buzzing or other unexplained noise in the ears

cough producing mucus

depression

difficulty moving

ear drainage

earache

excess air or gas in the stomach or intestines

fear or nervousness

feeling of constant movement of self or surroundings

feeling unusually cold

full feeling

headache, severe and throbbing

hearing loss

heartburn

increased sweating

irritation in the mouth

itching ears

lack or loss of strength

loose teeth

loss of voice

multiple swollen and inflamed skin lesions

muscle stiffness

pain, inflammation, or swelling in the calves, shoulders, or hands

painful cold sores or blisters on the lips, nose, eyes, or genitals

passing gas

persistent breath odor or bad taste in your mouth

rash with flat lesions or small raised lesions on the skin

redness and swelling of the gums

redness or swelling of the ears

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

runny or stuffy nose

sensation of spinning

shakiness in the legs, arms, hands, or feet

shivering

skin rash, encrusted, scaly, and oozing

sleepiness or unusual drowsiness

sneezing

tender, swollen glands in the neck

tenderness in the stomach area

toothache

trembling or shaking of the hands or feet

trouble sleeping

voice changes

weight loss

Incidence not known

Decreased interest in sexual intercourse

hair loss or thinning of the hair

hives or welts

inability to have or keep an erection

increased sensitivity of the skin to sunlight

loss in sexual ability, desire, drive, or performance

muscle spasm

redness of the skin

redness or other discoloration of the skin

severe sunburn

tenderness of the salivary glands

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.