Eprosartan Hydrochlorothiazide Tora

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.

Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) 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 Hydrochlorothiazide Tora 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 Hydrochlorothiazide Tora relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) 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.

Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) is available only with your doctor's prescription.

Applies to the following strengths: 600 mg-12.5 mg; 600 mg-25 mg

Usual Adult Dose for:

• Hypertension

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Precautions
• Dialysis

Usual Adult Dose for Hypertension

Initial Dose: 1 tablet (available as 600 mg-12.5 mg or 600 mg-25 mg) orally once daily.

Maintenance Dose: Initial dosages may be titrated upward as needed and tolerated. The usual range of Eprosartan Hydrochlorothiazide Tora is 400 mg to 800 mg daily, and 12.5 to 50 mg daily for Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora).

Renal Dose Adjustments

The maximum daily dose of Eprosartan Hydrochlorothiazide Tora should not exceed 600 mg in patients with renal impairment.

Liver Dose Adjustments

No adjustment recommended

Precautions

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Limited data is available on the hemodialysis clearance of Eprosartan Hydrochlorothiazide Tora; however, little removal is expected based on the relatively high plasma protein binding of this drug. No data are available on the hemodialysis clearance of Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Eprosartan Hydrochlorothiazide Tora

• Eprosartan Hydrochlorothiazide Tora Side Effects
• During Pregnancy
• Drug Interactions
• Drug class: angiotensin II inhibitors with thiazides

Consumer resources

• Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora)
• Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Advanced Reading)

Other brands: Eprosartan Hydrochlorothiazide Tora

Professional resources

• Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Wolters Kluwer)

Related treatment guides

• High Blood Pressure

See also:
What is the most important information I should know about Eprosartan Hydrochlorothiazide Tora?

Known hypersensitivity to Eprosartan Hydrochlorothiazide Tora, sulphonamide-derived substances (as Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora)) or to any of the excipients; second and third trimesters of pregnancy; severe hepatic impairment; cholestasis and biliary obstructive disorders; severe renal impairment (creatinine clearance <30 mL/min); haemodynamically significant bilateral renovascular disease or severe stenosis of a solitary functioning kidney; therapy resistant hypokalaemia or hypercalcaemia; refractory hyponatraemia; symptomatic hyperuricaemia/gout; the concomitant use of Eprosartan Hydrochlorothiazide Tora + Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Eprosartan Hydrochlorothiazide Tora) with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).

Use Eprosartan Hydrochlorothiazide Tora as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Eprosartan Hydrochlorothiazide Tora by mouth with or without food.
• Drinking extra fluids while you are taking Eprosartan Hydrochlorothiazide Tora is recommended. Check with your doctor for instructions.
• Eprosartan Hydrochlorothiazide Tora may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Eprosartan Hydrochlorothiazide Tora.
• Continue to take Eprosartan Hydrochlorothiazide Tora even if you feel well. Do not miss any doses.
• If you miss a dose of Eprosartan Hydrochlorothiazide Tora, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Eprosartan Hydrochlorothiazide Tora.

Use: Labeled Indications

Hypertension: Management of hypertension

See also:
What other drugs will affect Eprosartan Hydrochlorothiazide Tora?

Potential Interactions Related to Both Eprosartan Hydrochlorothiazide Tora and Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora): Concomitant Use Not Recommended: Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and, rarely, with angiotensin II receptor blockers. In addition, renal clearance of lithium is reduced by thiazides and consequently the risk of lithium toxicity may be increased. Therefore use of Eprosartan Hydrochlorothiazide Tora + Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Eprosartan Hydrochlorothiazide Tora) and lithium in combination is not recommended. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Concomitant Use Requiring Caution: Baclofen: Potentiation of antihypertensive effect may occur.

Non-Steroidal Anti-Inflammatory Medicinal Products: As with ACE inhibitors, concomitant use of angiotensin II receptor blockers and NSAIDs may lead to an increased risk of worsening renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Concomitant use of losartan with the NSAID indometacin led to a decrease in efficacy of the angiotensin II receptor blocker; a class effect cannot be excluded.

Concomitant Use to be Taken Into Account: Amifostine: Potentiation of antihypertensive effect may occur.

Other Antihypertensive Agents: The blood pressure lowering effect of Eprosartan Hydrochlorothiazide Tora + Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Eprosartan Hydrochlorothiazide Tora) can be increased by concomitant use of other antihypertensive medicinal products.

Alcohol, Barbiturates, Narcotics or Antidepressants: Potentiation of orthostatic hypotension may occur.

Potential Interactions Related to Eprosartan Hydrochlorothiazide Tora: Eprosartan Hydrochlorothiazide Tora has been shown not to inhibit human cytochrome P450 isozymes CYP1A, 2A6, 2C9/8, 2C19, 2D6, 2E, and 3A in vitro.

Concomitant Use Not Recommended: Medicinal Products Affecting Potassium Levels: Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin, ACE inhibitors) may lead to increases in serum potassium. If medicinal product which affect potassium levels are to be prescribed in combination with Eprosartan Hydrochlorothiazide Tora + Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Eprosartan Hydrochlorothiazide Tora), monitoring of potassium plasma levels is advised.

Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent.

Potential Interactions Related to Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora): Concomitant Use Not Recommended: Medicinal Products Affecting Potassium Levels: The potassium-depleting effect of Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) may be potentiated by the coadministration of other medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium or salicylic acid derivatives). Such concomitant use is therefore not recommended.

Concomitant Use Requiring Caution: Calcium Salts and Vitamin D: Thiazide diuretics may increase serum calcium levels due to decreased excretion. If calcium supplements or medicinal products affecting serum calcium levels (e.g. Vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.

Cholestyramine and Colestipol Resins: Absorption of Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) is impaired in the presence of anionic exchange resins such as colestyramine or colestipol. However, the interaction might be minimized by graded intake of Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) and the resin in the way that Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) is taken at least 4 hours before or 4-6 hours after the resins.

Digitalis Glycosides: Thiazide-induced hypokalemia or hypomagnesaemia may favor the onset of digitalis-induced cardiac arrhythmias.

Medicinal Products Affected by Serum Potassium Disturbances: Periodic monitoring of serum potassium and ECG is recommended when Eprosartan Hydrochlorothiazide Tora + Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) (Eprosartan Hydrochlorothiazide Tora) is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides and antiarrhythmics) and with the following torsades de pointes (ventricular tachycardia)-inducing medicinal products (including some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes (ventricular tachycardia): Class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide); class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide); some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol); others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV).

Non-Depolarizing Skeletal Muscle Relaxants (e.g. Tubocurarine): The effect of non-depolarizing skeletal muscle relaxants may be potentiated by Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora).

Anticholinergic Agents (e.g. Atropine, Biperiden): Increase of the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.

Antidiabetic Medicinal Products (Oral Agents and Insulin): The treatment with a thiazide may influence the glucose tolerance. Dosage adjustment of the antidiabetic medicinal product may be required.

Metformin: Metformin should be used with caution because of the risk of lactic acidosis induced by possible functional renal failure linked to Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora).

Beta-Blockers and Diazoxide: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.

Pressor Amines (e.g. Noradrenaline): The effect of pressor amines may be decreased.

Medicinal Products Used in the Treatment of Gout (Probenecid, Sulfinpyrazone and Allopurinol): Dosage adjustment of uricosuric medicinal products may be necessary since Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) may raise the level of serum uric acid. Increase in dosage of probenecid or sulfinpyrazone may be necessary.

Co-administration of a thiazide may increase the incidence of hypersensitivity reactions to allopurinol.

Amantadine: Thiazides may increase the risk of adverse effects caused by amantadine.

Cytotoxic Agents (e.g. Cyclophosphamide, Methotrexate): Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.

Tetracyclines: Concomitant administration of tetracyclines and thiazides increases the risk of tetracycline-induced increase in urea. This interaction is probably not applicable to doxycycline.

Medicinal Products Lowering Serum Sodium Level: The hyponatraemic effect of Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) may be intensified by concomitant administration of drugs such as antidepressants, antipsychotics, antiepileptics, etc. Caution is advised in long-term administration of these drugs.

See also:
What are the possible side effects of Eprosartan Hydrochlorothiazide Tora?

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 Tora 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 Tora for over 2 years. Eprosartan Hydrochlorothiazide Tora 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

The adverse events reported in over 600 patients that received TEVETEN®/Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) 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 Hydrochlorothiazide Tora 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 Hydrochlorothiazide Tora 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 (Eprosartan Hydrochlorothiazide Tora): Other adverse events that have been reported for Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora), 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 10/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 (Eprosartan Hydrochlorothiazide Tora) combination therapy in the TEVETEN® HCT clinical trials, some adverse events are not included in the current labeling for either TEVETEN® or Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) monotherapy. The adverse events which are not currently included in the labeling for TEVETEN® or Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) 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 (Eprosartan Hydrochlorothiazide Tora). All of these adverse events were either not reported in patients receiving TEVETEN® monotherapy or combination therapy with Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora) 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 (Eprosartan Hydrochlorothiazide Tora) combination treatment is as expected based on the safety profile of each of the components and what is generally known about the patient population.

Each film-coated tablet contains Eprosartan Hydrochlorothiazide Tora mesylate equivalent to 600 mg Eprosartan Hydrochlorothiazide Tora and 12.5 mg Hydrochlorothiazide (Eprosartan Hydrochlorothiazide Tora).

Excipients/Inactive Ingredients: Tablet Core: Lactose monohydrate, microcrystalline cellulose, pregelatinised starch (from maize), crospovidone, magnesium stearate, purified water. Tablet Coating: Polyvinyl alcohol, macrogol 3350, talcum, titanium dioxide, iron oxide black, iron oxide yellow.