Friday, May 18, 2012

Teveten HCT


Generic Name: eprosartan and hydrochlorothiazide (Oral route)


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


Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .



Commonly used brand name(s)

In the U.S.


  • Teveten HCT

Available Dosage Forms:


  • Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination


Pharmacologic Class: Eprosartan


Chemical Class: Thiazide


Uses For Teveten HCT


Eprosartan and hydrochlorothiazide combination is used alone or 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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


Eprosartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes 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 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 CategoryExplanation
1st TrimesterCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd TrimesterDStudies 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.
3rd TrimesterDStudies 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.


  • 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.


  • Acetyldigoxin

  • Arsenic Trioxide

  • Benazepril

  • Deslanoside

  • Digitalis

  • Digitoxin

  • Digoxin

  • Droperidol

  • Enalapril

  • Enalaprilat

  • Flecainide

  • Ketanserin

  • Levomethadyl

  • Lisinopril

  • Lithium

  • Metildigoxin

  • Moexipril

  • Ouabain

  • Perindopril

  • Proscillaridin

  • Quinapril

  • Ramipril

  • Sotalol

  • Trandolapril

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.


  • Alacepril

  • Apazone

  • Aspirin

  • Benazepril

  • Bepridil

  • Bromfenac

  • Captopril

  • Carbamazepine

  • Celecoxib

  • Chlorpropamide

  • Cholestyramine

  • Cilazapril

  • Cyclophosphamide

  • Delapril

  • Diclofenac

  • Diflunisal

  • Enalaprilat

  • Enalapril Maleate

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Fosinopril

  • Ginkgo

  • Glipizide

  • Gossypol

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Moexipril

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Oxaprozin

  • Pentopril

  • Perindopril

  • Piroxicam

  • Quinapril

  • Ramipril

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Sulindac

  • Temocapril

  • Tolmetin

  • Topiramate

  • Trandolapril

  • Zofenopril

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 form urine) or

  • Sulfonamide (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®) allergy—Should not be used in patients with these conditions.

  • Allergies or

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

  • Diabetes or

  • Gout or

  • Kidney problems or

  • Liver problems or

  • Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

  • Electrolyte imbalances (e.g., high calcium or low potassium, magnesium, or sodium in the body) or

  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

Proper Use of Teveten HCT


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 a change 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 or administer twice daily. Usually the dose is not more than 800 mg per day.

      • 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 Teveten HCT


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 (especially in your second or third trimester) 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 occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.


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.


Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of potassium, magnesium, or sodium in the body).


Stop using this medicine and check with your doctor immediately if blurred vision, difficulty in 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 will want you to have your eyes checked by an ophthalmologist (eye doctor).


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.


Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.


Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.


Drinking alcohol or taking narcotic pain relievers or sleeping pills with this medicine may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.


Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.


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

  • coma

  • confusion

  • convulsions

  • cramps in the legs

  • decreased urine output

  • difficult with breathing

  • difficult, burning, or painful urination

  • dizziness

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

  • dry mouth

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • feeling of warmth

  • fever

  • flushed or dry skin

  • frequent urge to urinate

  • frequent urination

  • fruit-like breath odor

  • headache

  • increased hunger

  • increased thirst

  • increased urination

  • increased volume of pale, dilute urine

  • irregular heartbeat

  • itching of the skin

  • joint stiffness or swelling

  • loss of appetite

  • loss of bladder control

  • loss of consciousness

  • lower back or side pain

  • mood changes

  • muscle pain or cramps

  • nausea or vomiting

  • nervousness

  • numbness and tingling of the face, fingers, or toes

  • pain in the arms legs, or lower back, especially pain in the calves and/or heels upon exertion

  • pale skin

  • pale, bluish-colored, or cold hands or feet

  • pinpoint red or purple spots on the skin

  • rapid weight gain

  • redness of the face, neck, arms, and occasionally, upper chest

  • shortness of breath

  • sudden decrease in the amount of urine

  • sudden sweating

  • sugar in the urine

  • sweating

  • swelling of the face, ankles, or hands

  • swelling of the legs and feet

  • swelling or puffiness of the face

  • troubled breathing with exertion

  • unexplained weight loss

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight gain or loss

  • vomiting

  • 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

  • decrease in urine output or decrease in urine-concentrating ability

  • decreased frequency or amount of urine

  • diarrhea

  • difficulty with swallowing

  • drowsiness

  • fever with or without chills

  • general body swelling

  • general feeling of discomfort or illness

  • general feeling of tiredness or weakness

  • greatly decreased frequency of urination or amount of urine

  • hives

  • indigestion

  • irritability

  • joint or muscle pain

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

  • mood changes

  • 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

  • troubled breathing

  • unusual weight loss

  • vision changes

  • weak pulse

  • weight gain

  • wheezing

  • 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

  • degenerative disease of the joint

  • depression

  • difficulty with moving

  • discharge, excessive tearing

  • ear congestion

  • 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 pain or stiffness

  • nasal congestion

  • pain or burning in the throat

  • 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 and unsteady walk

  • shakiness in the legs, arms, hands, or feet

  • shivering

  • skin rash, encrusted, scaly, and oozing

  • sleepiness or unusual drowsiness

  • sleeplessness

  • sneezing

  • stomach discomfort or upset

  • tender, swollen glands in the neck

  • tenderness in the stomach area

  • toothache

  • trembling or shaking of the hands or feet

  • trouble sleeping

  • unable to sleep

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • 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.

See also: Teveten HCT side effects (in more detail)



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More Teveten HCT resources


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