Teveten HCT

Name: Teveten HCT

What should i avoid while taking hydrochlorothiazide and eprosartan (teveten hct)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of hydrochlorothiazide and eprosartan.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and eprosartan, unless your doctor has told you to.

Teveten HCT Overview

Teveten HCT is a prescription medication used to treat high blood pressure. Teveten HCT is a single product containing 2 medications: eprosartan and hydrochlorothiazide. Eprosartan belongs to a group of drugs called angiotensin II receptor blockers (ARBs) which help lower blood pressure by blocking a natural substance that causes blood vessels to narrow. This allows blood to flow more smoothly and makes the heart more efficient at pumping blood. Hydrochlorothiazide component belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form. It is taken once daily, with or without food.

Common side effects include dizziness, headache, and back pain.

Teveten HCT can also cause drowsiness. Do not drive or operate heavy machinery until you know how Teveten HCT affects you. 

Side Effects of Teveten HCT

Serious side effects have been reported with Teveten HCT. See the "Teveten HCT Precautions" section. 

Common side effects of Teveten HCT include the following:

  • dizziness
  • headache
  • back pain 
  • drowsiness (fatigue)
  • muscle pain (myalgia)
  • an infection that affects the nose, throat, and airways (upper respiratory tract infection)
  • sinus infection (sinusitis)
  • virus infection

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

Tell your doctor if you have any side effect that bothers you or that does 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. 

Teveten HCT Precautions

Serious side effects have been reported with Teveten HCT including the following:

  • Harm to an unborn baby (fetal toxicity). Do not take Teveten HCT if you are pregnant or will become pregnant.
  • Low blood pressure
  • Allergic reactions. More likely with a history of allergic reactions. 
  • A condition in which close objects appear clearly, but far ones don't (myopia) or a buildup of pressure in the eye that can cause blindness (glaucoma). Tell your healthcare provider right away if you experience  visual changes or eye pain.
  • An autoimmune disease in which the body's immune system mistakenly attacks healthy tissue (systemic lupus erythematosus)
  • A condition of excess of uric acid in the blood (hyperuricemia)
  • Painful joint(s) (gout)
  • Imbalances in the levels of salts and fluids in your body (electrolyte and fluid imbalance). Tell your healthcare provider right away if you have some or all of the following symptoms:
    • dry mouth
    • thirst
    • weakness
    • drowsiness
    • restlessness
    • muscle pains or cramps
    • low blood pressure
    • low output of urine
    • fast heart rate
    • nausea
    • vomiting
  • Kidney damage

Do not take Teveten HCT if you:

  • allergic to Teveten HCT or any of its ingredients and sulfonamide-derived drugs. 
  • your kidneys do not produce urine (anuria)
  • are a diabetic patient who is taking aliskiren

Other Requirements

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

Teveten HCT FDA Warning

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Teveten HCT as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. 

Before Using Teveten HCT

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.

Pediatric

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.

Geriatric

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

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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.

Interactions with 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

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.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Amphetamine
  • Amtolmetin Guacil
  • Arsenic Trioxide
  • Aspirin
  • Benazepril
  • Benzphetamine
  • Bromfenac
  • Bufexamac
  • Captopril
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Cyclophosphamide
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Diclofenac
  • Diflunisal
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Droperidol
  • Droxicam
  • Enalapril
  • Enalaprilat
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ibuprofen
  • Indomethacin
  • Ketanserin
  • Ketoprofen
  • Ketorolac
  • Levomethadyl
  • Lisdexamfetamine
  • Lisinopril
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Methamphetamine
  • Methotrexate
  • Metildigoxin
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Ouabain
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sotalol
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Trandolapril
  • Trimethoprim
  • Valdecoxib

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
  • Proglumetacin
  • Propionic Acid
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Topiramate
  • Valdecoxib

Interactions with Food/Tobacco/Alcohol

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.

Teveten HCT Side Effects

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.

Indications and usage

TEVETEN® HCT is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensives such as calcium channel blockers. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

How supplied

TEVETEN® HCT is available as film-coated, capsule-shaped tablets, supplied as bottles of 100 tablets as follows:

600/12.5 mg Butterscotch, capsule-shaped tablets, debossed with “5147”on one side.

600/25 mg Brick red, capsule-shaped tablets, debossed with “5150” on one side.

Eprosartan (mg) HCTZ (mg) Color NDC
600 12.5 Butterscotch 0074-3015-11
600 25 Brick red 0074-3020-11
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