Teveten HCT

DRUG DESCRIPTION

TEVETEN® HCT 600/12.5 mg and TEVETEN® HCT 600/25 mg (eprosartan mesylate-hydrochlorothiazide) combine an angiotensin II receptor (AT1 subtype) antagonist and a diuretic, hydrochlorothiazide. TEVETEN® (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, TEVETEN® is chemically described as the monomethanesulfonate of (E)-2-butyl-1-(pcarboxybenzyl)-?-2-thienylmethylimidazole-5-acrylic acid. Its empirical formula is C23H24N2O4S•ECH4O3S and molecular weight is 520.625. Its structural formula is:

Eprosartan mesylate Structural Formula Illustration

Eprosartan mesylate is a white to off-white free-flowing crystalline powder that is insoluble in water, freely soluble in ethanol, and melts between 248°C and 250°C. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H 1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is:

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. TEVETEN® HCT is available for oral administration in film-coated, non-scored, capsule-shaped tablet combinations of eprosartan mesylate and hydrochlorothiazide. TEVETEN® HCT 600/12.5 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 12.5 mg hydrochlorothiazide in a butterscotch-colored tablet. TEVETEN® HCT 600/25 mg contains 735.8 mg of eprosartan mesylate (equivalent to 600 mg eprosartan) and 25 mg hydrochlorothiazide in a brick-red tablet. Inactive ingredients of both tablets: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, crospovidone, magnesium stearate, and purified water. Ingredients of the OPADRY® 85F27320 butterscotch film coating: polyethylene glycol 3350, talc, polyvinyl alcohol, titanium dioxide, iron oxide black, and iron oxide yellow. Ingredients of the OPADRY® II 85F24297 pink film coating: polyethylene glycol 3350, titanium dioxide, talc, polyvinyl alcohol, iron oxide red, and iron oxide yellow.

What are the possible side effects of eprosartan (Teveten)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any of these other serious side effects, such...

Read All Potential Side Effects and See Pictures of Teveten HCT »

What are the precautions when taking eprosartan mesylate hydrochlorothiazide tablets (Teveten HCT)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to eprosartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g.,...

Read All Potential Precautions of Teveten HCT »


Teveten HCT Consumer (continued)

SIDE EFFECTS: See also How to Use section.

You may experience dizziness, lightheadedness, and blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of loss of too much body water and minerals (e.g., unusual thirst, muscle cramps, weakness, confusion, fast/irregular heartbeat, fainting, seizures), decreased sexual ability, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, muscle pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to eprosartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g., imbalance of sodium/potassium/magnesium/calcium), gout, lupus, high levels of fats in the blood (high cholesterol or triglycerides), asthma.

If you have diabetes, this medication may affect your blood sugar levels. Your doctor may need to adjust the dosage of your medications used to treat diabetes (e.g., insulin, glipizide). Monitor your blood sugar levels as instructed and tell your doctor immediately if you develop signs of high blood sugar (e.g., increased thirst, unusual tiredness, vision changes, fruity breath odor).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Hydrochlorothiazide may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness while using this drug.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

Hydrochlorothiazide passes into breast milk. Consult your doctor before breast-feeding.


Teveten HCT Patient Information Including Side Effects

Brand Names: Teveten HCT

Generic Name: hydrochlorothiazide and eprosartan (Pronunciation: HYE droe KLOR oh THYE a zide and EP roe SAR tan)

  • What are hydrochlorothiazide and eprosartan (Teveten HCT)?
  • What are the possible side effects of hydrochlorothiazide and eprosartan (Teveten HCT)?
  • What is the most important information I should know about eprosartan and hydrochlorothiazide (Teveten HCT)?
  • What should I discuss with my healthcare provider before taking hydrochlorothiazide and eprosartan (Teveten HCT)?
  • How should I take hydrochlorothiazide and eprosartan (Teveten HCT)?
  • What happens if I miss a dose (Teveten HCT)?
  • What happens if I overdose (Teveten HCT)?
  • What should I avoid while taking hydrochlorothiazide and eprosartan (Teveten HCT)?
  • What other drugs will affect hydrochlorothiazide and eprosartan (Teveten HCT)?
  • Where can I get more information?

What are hydrochlorothiazide and eprosartan (Teveten HCT)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Eprosartan is in a group of drugs called angiotensin II receptor antagonists. Eprosartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of hydrochlorothiazide and eprosartan is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and eprosartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and eprosartan (Teveten HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

  • feeling like you might pass out;
  • chest pain, feeling short of breath, even with mild exertion;
  • fever;
  • swelling, rapid weight gain;
  • urinating more or less than usual, or not at all;
  • jaundice (yellowing of the skin or eyes); or
  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects may include:

  • stomach pain;
  • back pain;
  • dizziness, drowsiness;
  • headache;
  • runny or stuffy nose, sore throat; or
  • dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about eprosartan and hydrochlorothiazide (Teveten HCT)?

Do not use this medication without telling your doctor if you are pregnant. Eprosartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Hydrochlorothiazide and eprosartan can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and eprosartan.

In rare cases, hydrochlorothiazide and eprosartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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