Recommended Topic Related To:

Teveten HCT

"Dec. 14, 2012 -- Drinking a glass of beet juice may have an immediate impact on lowering blood pressure, according to a new study.

The study shows that within hours of drinking it, beet juice lowered systolic blood pressure (the top n"...

Teveten HCT

Teveten HCT

Teveten HCT Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Teveten HCT (eprosartan mesylate/hydrochlorothiazide) is a combination angiotensin II receptor antagonist and a diuretic used to treat high blood pressure (hypertension). Common side effects include dizziness, lightheadedness, and blurred vision as your body adjusts to the medication.

The usual recommended dose of Teveten HCT is 600 mg/12.5 mg once daily when used as combination therapy in patients who are not volume-depleted. Teveten HCT may interact with other blood pressure medications, steroids, lithium, cholestyramine or colestipol, insulin or oral diabetes medications, barbiturates, other diuretics, NSAIDs (nonsteroidal anti-inflammatory drugs), muscle relaxers, or narcotics. Tell your doctor all medications and supplements you use. Teveten HCT is not recommended for use during pregnancy due to the risk for harm to a fetus. Hydrochlorothiazide passes into breast milk. Consult your doctor before breastfeeding.

Our Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Teveten HCT in Detail - Patient Information: Side Effects

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 unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

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

  • eye pain, vision problems;
  • 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.

Read the entire detailed patient monograph for Teveten HCT (Eprosartan Mesylate Hydrochlorothiazide Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Teveten HCT Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Teveten HCT (Eprosartan Mesylate Hydrochlorothiazide Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Teveten HCT FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

TEVETEN® HCT 600/12.5 mg has been evaluated for safety in 268 patients in double-blind, controlled clinical trials. Most of these patients were treated with TEVETEN® HCT 600/12.5 mg for 29 to 60 days. Eprosartan/hydrochlorothiazide combination therapy has been evaluated for safety in 890 patients in open-label, long-term clinical trials. Approximately 50% of these patients were treated with eprosartan/hydrochlorothiazide for over 2 years. Eprosartan/hydrochlorothiazide combination therapy was well tolerated. Most adverse events were of mild or moderate severity and did not require discontinuation of therapy. Adverse experiences were similar in patients regardless of age, gender, or race. In the controlled clinical trials, about 3% of the 268 patients treated with TEVETEN® HCT 600/12.5 mg discontinued therapy due to clinical adverse experiences.

Adverse Events Occurring at an Incidence of Greater Than 3% Among TEVETEN® HCT Treated Patients

The following table lists adverse events that occurred at an incidence of > 3% among TEVETEN® HCT 600/12.5 mg- or monotherapy-treated patients who participated in the controlled clinical trials. Of the 268 patients who received TEVETEN® HCT 600/12.5 mg during the double-blind treatment period in the controlled trials, 110 patients were reported to have adverse events.

Table 1: Incidence of Adverse Events > 3% During the Double-Blind Treatment Period by Preferred Term and Treatment Grouping: Controlled Studies

  Placebo
Eprosartan
600 mg
(N=275)
HCTZ
12.5 mg
(N=117)
HCTZ
25 mg
(N=52)
Eprosartan
600 mg/HCTZ
12.5 mg
(N=268)
Preferred Term n (%) n (%) n (%) n (%) n (%)
Dizziness 4 (1.6) 5 (1.8) 2 (1.7) 2 (3.8) 11 (4.1)
Headache 22 (8.9) 10 (3.6) 4 (3.4) 3 (5.8) 9 (3.4)
Back pain 6 (2.4) 7 (2.5) 2 (1.7) 2 (3.8) 7 (2.6)
Fatigue 6 (2.4) 5 (1.8) 1 (0.9) 2 (3.8) 5 (1.9)
Myalgia 8 (3.3) 2 (0.7) 3 (2.6) 0 (0.0) 1 (0.4)
Upper Respiratory Tract Infection 8 (3.3) 2 (0.7) 0 (0.0) 2 (3.8) 1 (0.4)
Sinusitis 4 (1.6) 1 (0.4) 0 (0.0) 2 (3.8) 0 (0.0)
Viral Infection 4 (1.6) 0 (0.0) 2 (1.7) 2 (3.8) 0 (0.0)

The adverse events reported in over 600 patients that received TEVETEN®/hydrochlorothiazide combination therapy for at least 1 year in the open-label, long-term clinical trials were comparable to those reported in the controlled trials.

Eprosartan Mesylate: In addition to the adverse events above, potentially important adverse events that are included in the current labeling for TEVETEN® monotherapy are listed below. Most of these adverse events occurred in < 1% of patients, or were as frequent or more frequent in the placebo group. It is not known if these events were related to eprosartan usage: Body as a Whole: alcohol intolerance, asthenia, substernal chest pain, dependent edema, peripheral edema, facial edema, fatigue, fever, hot flushes, influenza-like symptoms, injury, malaise, pain, rigors, viral infection; Cardiovascular: angina pectoris, bradycardia, abnormal ECG, specific abnormal ECG, extrasystoles, atrial fibrillation, hypotension (including orthostatic hypotension), tachycardia, palpitations; Gastrointestinal: abdominal pain, anorexia, constipation, diarrhea, dry mouth, dyspepsia, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, nausea, periodontitis, toothache, vomiting; Hematologic: anemia, purpura; Liver and Biliary: increased SGOT, increased SGPT; Metabolic and Nutritional: increased creatine phosphokinase, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hypokalemia, hyponatremia, hypertriglyceridemia; Musculoskeletal: arthralgia, arthritis, aggravated arthritis, arthrosis, skeletal pain, tendinitis; Nervous System/Psychiatric: anxiety, ataxia, depression, dizziness, insomnia, migraine, neuritis, nervousness, paresthesia, somnolence, tremor, vertigo; Resistance Mechanism: herpes simplex, otitis externa, otitis media, upper respiratory tract infection; Respiratory: asthma, bronchitis, coughing, epistaxis, pharyngitis, rhinitis; Skin and Appendages: eczema, furunculosis, pruritus, rash, maculopapular rash, increased sweating; Special Senses: conjunctivitis, abnormal vision, xerophthalmia, tinnitus; Urinary: albuminuria, cystitis, hematuria, micturition frequency, polyuria, renal calculus, urinary incontinence, urinary tract infection; Vascular: leg cramps, peripheral ischemia.

Hydrochlorothiazide: Other adverse events that have been reported for hydrochlorothiazide, without regard to causality, are listed below: Body as a Whole: weakness; Cardiovascular: hypotension (including orthostatic hypotension); Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia; Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia; Hypersensitivity: anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis, and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura; Metabolic: electrolyte imbalance including hyponatremia, hypokalemia, and hypochloremic alkalosis, hyperglycemia, glycosuria, hyperuricemia; Musculoskeletal: muscle spasm; Nervous System/Psychiatric: vertigo, paresthesias, restlessness; Renal: renal failure, renal dysfunction, interstitial nephritis, azotemia; Skin: erythema multiform, including Stevens-Johnson syndrome, exfoliative dermatitis, including toxic epidermal necrolysis, alopecia; Special Senses: transient blurred vision, xanthopsia; Urogenital: impotence.

Laboratory Test Findings

In placebo-controlled studies, clinically important changes in standard laboratory parameters were rarely associated with administration of TEVETEN®. Patients were rarely withdrawn from TEVETEN® because of laboratory test results. Laboratory test findings that have been reported for TEVETEN® are listed below: Creatinine, Blood Urea Nitrogen: Minor elevations in creatinine and in BUN occurred in 0.6% and 1.3%, respectively, of patients taking TEVETEN® and 0.9% and 0.3%, respectively, of patients given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for elevations in serum creatinine and BUN, and three additional patients were withdrawn for increases in serum creatinine. Liver Function Tests: Minor elevations of ALAT, ASAT, and alkaline phosphatase occurred for comparable percentages of patients taking TEVETEN® or placebo in controlled clinical trials. An elevated ALAT of > 3.5 x ULN occurred in 0.1% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Four patients were withdrawn from clinical trials for an elevation in liver function tests. Hemoglobin: A greater than 20% decrease in hemoglobin was observed in 0.1% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Two patients were withdrawn from clinical trials for anemia. Leukopenia: A WBC count of ≤ 3.0 x 103/mm3 occurred in 0.3% of

patients taking TEVETEN® and in 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for leukopenia. Neutropenia: A neutrophil count of ≤ 1.5 x 103/mm3 occurred in 1.3% of patients taking TEVETEN® and in 1.4% of patients given placebo in controlled clinical trials. No patient was withdrawn from any clinical trials for neutropenia. Thrombocytopenia: A platelet count of ≤ 100 x 109/L occurred in 0.3% of patients taking TEVETEN® (one patient) and in no patient given placebo in controlled clinical trials. Four patients receiving TEVETEN® in clinical trials were withdrawn for thrombocytopenia. In one case, thrombocytopenia was present prior to dosing with TEVETEN®. Serum Potassium: A potassium value of ≥ 5.6 mmol/L occurred in 0.9% of patients taking TEVETEN® and 0.3% of patients given placebo in controlled clinical trials. One patient was withdrawn from clinical trials for hyperkalemia and three for hypokalemia.

Additional Information: Among the adverse events reported for patients receiving either TEVETEN® monotherapy or TEVETEN®/hydrochlorothiazide combination therapy in the TEVETEN® HCT clinical trials, some adverse events are not included in the current labeling for either TEVETEN® or hydrochlorothiazide monotherapy. The adverse events which are not currently included in the labeling for TEVETEN® or hydrochlorothiazide monotherapy include the following: angioedema, bilirubinemia, blood urea nitrogen increased, edema periorbital, eosinophilia, and NPN increased. The majority of these adverse events were reported in the open-label, long-term trials and were reported in small numbers of patients receiving TEVETEN® alone or TEVETEN® in combination with hydrochlorothiazide. All of these adverse events were either not reported in patients receiving TEVETEN® monotherapy or combination therapy with hydrochlorothiazide during the double-blind period of the controlled trials, or were reported at an incidence of .1% or in only one patient per treatment group in the controlled trials. The overall safety profile of the TEVETEN®/hydrochlorothiazide combination treatment is as expected based on the safety profile of each of the components and what is generally known about the patient population.

Read the entire FDA prescribing information for Teveten HCT (Eprosartan Mesylate Hydrochlorothiazide Tablets) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Hypertension

Get tips on handling your hypertension.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations