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adverse reactions
ADVERSE REACTIONS 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 (N=246) 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 10 3 /mm 3 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 10 3 /mm 3 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 10 9 /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. OVERDOSAGE Eprosartan Mesylate: Limited data are available regarding overdosage. Appropriate symptomatic and supportive therapy should be given if overdosage should occur. There was no mortality in rats and mice receiving oral doses of up to 3000 mg eprosartan/kg and in dogs receiving oral doses of up to 1000 mg eprosartan/kg. Hydrochlorothiazide: The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, and hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.