VA Class:CV150
Terazosin hydrochloride is a α1-adrenergic blocking agent.1, 2, 3, 4, 5, 6, 8, 9, 10
Terazosin hydrochloride is used alone or in combination with other classes of antihypertensive agents for the management of hypertension.1, 3, 4, 6, 8, 11, 12, 13, 14, 30, 31, 32, 1200 However, because of established clinical benefits (e.g., reductions in overall mortality and in adverse cardiovascular, cerebrovascular, and renal outcomes), current evidence-based practice guidelines for the management of hypertension in adults generally recommend the use of drugs from 4 classes of antihypertensive agents (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics).501, 502, 503, 504, 1200, 1213
In a randomized, double-blind clinical study (the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; [ALLHAT]),50, 56, 57 doxazosin, an α1-blocker, was less effective in lowering mean systolic blood pressure (by about 2-3 mm Hg) than chlorthalidone, a thiazide-like diuretic.50 In order to achieve target blood pressure in hypertensive patients, use of doxazosin required additional hypotensive therapy more frequently than chlorthalidone.50 In addition, interim analysis (median follow-up: 3.3 years) of this study indicated that use of doxazosin in high-risk (at least 2 risk factors for coronary heart disease) hypertensive patients 55 years of age and older was associated with a higher risk of stroke and a higher incidence of combined cardiovascular disease events (including twice the risk of congestive heart failure) than use of chlorthalidone.50, 51 Study investigators concluded that such increased risk of congestive heart failure could not have been caused by the relatively small difference in the mean target systolic blood pressure observed in patients receiving doxazosin compared with those receiving chlorthalidone.50, 51 Therefore, based on these findings, the trial's Data Safety and Monitoring Board recommended that the α-blocker treatment arm be terminated prematurely.50, 51, 57 The remaining antihypertensive arms (e.g., calcium-channel blockers, ACE inhibitors, diuretics) and lipid-lowering (pravastatin vs usual care) components of the study subsequently were completed and reported.56, 57, 58
Current antihypertensive and urology guidelines no longer recommend α1-blockers as preferred first-line therapy for any patients with hypertension, principally because of negative findings observed in ALLHAT.230, 501, 502, 504, 1200 However, α1-blockers are effective antihypertensive drugs and many experts still consider their use appropriate for the management of resistant hypertension as a component of combination therapy.502, 504, 1200 Therapy with an α1-blocker is most effective when used in combination with a diuretic.504 Some experts state that an α1-blocker may be a second-line agent in antihypertensive treatment regimens in men with coexisting benign prostatic hyperplasia (BPH);504, 1200 the American Urology Association (AUA) states that monotherapy with these drugs is not optimal in hypertensive patients with lower urinary tract symptoms (LUTS) or BPH and that such conditions should be managed separately.230
The beneficial effects of α1-blockers on blood glucose and lipid concentrations may mitigate some of the adverse metabolic effects of diuretics,504 and α1-blockers may offer some advantage in patients with underlying lipoprotein disorders (e.g., hypercholesterolemia) or in those with lipoprotein abnormalities induced by other antihypertensive agents (e.g., thiazide diuretics).1, 3, 8, 10, 11, 13, 31, 32, 44 The possibility that geriatric patients may be more susceptible than younger patients to the postural hypotensive effects of α1-blockers should be considered in the selection of therapy.7, 44, 1200 Blood pressure response to α1-blockers appears to be comparable in white and black patients.7, 44
For further information on overall principles and expert recommendations for treatment of hypertension, see Uses: Hypertension in Adults and also see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Terazosin hydrochloride is used to reduce urinary obstruction and relieve associated manifestations in patients with symptomatic benign prostatic hyperplasia (BPH, benign prostatic hypertrophy).1, 5, 9, 17, 18, 21, 23, 25, 33 For patients who can tolerate the potential cardiovascular and other effects of α1-adrenergic blockade, the drug can effectively relieve mild to moderate obstructive manifestations (e.g., hesitancy, terminal dribbling of urine, interrupted stream, impaired size and force of stream, sensation of incomplete bladder emptying or straining) and urinary flow rates in a substantial proportion of patients1, 5, 9, 17, 18, 19, 20, 21, 22, 23, 24, 25 and may be a useful alternative to surgery, particularly in those who are awaiting or are unwilling to undergo surgical correction of the hyperplasia (e.g., via transurethral resection of the prostate [TURP]) or who are not candidates for such surgery.5, 21, 23, 24, 25, 39, 40, 41, 42
Therapy with α1-blockers appears to be less effective in relieving irritative (e.g., nocturia, daytime frequency, urgency, dysuria) than obstructive symptomatology.9, 17, 18 In addition, therapy with the drugs generally can be expected to produce less subjective and objective improvement than prostatectomy,9, 19, 21, 24 and periodic monitoring (e.g., performance of digital rectal examinations, serum creatinine determinations, serum prostate specific antigen [PSA] assays) is indicated in these patients to detect and manage other potential complications of or conditions associated with BPH (e.g., obstructive uropathy, prostatic carcinoma).9, 21, 22, 23, 24, 25, 26, 27, 41, 43 While symptomatic improvement has been maintained for at least up to 2 years of terazosin therapy in some patients,1, 9 the long-term effects of the drug on the need for surgery and on the frequency of developing BPH-associated complications such as acute urinary obstruction remain to be established.1
Combination therapy with an α1-blocker and 5α-reductase inhibitor (e.g., finasteride) has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression; combined therapy also can reduce the risks of long-term acute urinary retention and the need for invasive therapy compared with α-blocker monotherapy.59
Because many of the signs and symptoms of BPH can occur with carcinoma of the prostate1, 9 and with certain genitourinary conditions, including prostatitis and neurologic disorders,9 the possibility of such conditions, particularly this carcinoma, should be ruled out in any patient for whom terazosin therapy for presumed hyperplasia is being considered.1, 9
Terazosin hydrochloride is administered orally.1 Food has little, if any, effect on the extent of absorption of terazosin but may delay achievement of peak plasma concentrations by about 1 hour.1, 28
Dosage of terazosin hydrochloride is expressed in terms of terazosin1 and must be individualized according to the patient's response and tolerance.1, 3
For the management of hypertension, terazosin dosage should be adjusted according to blood pressure response and tolerance.1, 3 The usual initial adult dosage of the drug is 1 mg once daily at bedtime.1, 3 Because of the risk of postural effects (see Cautions: Postural Effects), it is essential that therapy with the drug not be initiated with higher dosages.1
If blood pressure is not adequately controlled at a terazosin dosage of 1 mg daily, the dosage may be increased gradually up to 5 mg once daily in adults, but each incremental increase should be delayed until blood pressure has stabilized at a given dosa 1, 3 some patients may benefit from further titration up to 20 mg daily.1 Maintenance doses of the drug can be administered in the morning rather than at bedtime.1 Blood pressure should be monitored at the end of the dosing interval to ensure maintenance of control, and additional measurements 2-3 hours after dosing may be helpful in determining whether peak and trough responses are similar and in assessing potential manifestations (e.g., dizziness, palpitation) of an excessive response.1 If blood pressure response is diminished substantially 24 hours after a dose, an increased dose may provide adequate control.1 If necessary for optimal blood pressure control, the daily dose can be divided and administered every 12 hours.1
Some experts state the usual adult dosage of terazosin for the management of hypertension ranges from 1-20 mg daily administered as a single dose or in 2 divided doses daily.1200 While higher dosages have been employed, those exceeding 20 mg daily do not appear to be associated with improved hypertensive control and those exceeding 40 mg daily have not been studied systematically.1, 3 If terazosin is discontinued for several days or longer, therapy with drug should be reinstituted at 1 mg daily at bedtime and titrated as usual.1
If terazosin is used for the management of hypertension in children†, some experts have recommended an initial dosage of 1 mg once daily; dosage may be increased as necessary to a maximum dosage of 20 mg once daily.76 (See Cautions: Pediatric Precautions.) For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Blood Pressure Monitoring and Treatment Goals
Blood pressure should be monitored regularly (i.e., monthly) during therapy and dosage of the antihypertensive drug adjusted until blood pressure is controlled.1200 If an adequate blood pressure response is not achieved, the dosage may be increased or another antihypertensive agent with demonstrated benefit and preferably with a complementary mechanism of action (e.g., angiotensin-converting enzyme [ACE] inhibitor, angiotensin II receptor antagonist, calcium-channel blocker, thiazide diuretic) may be added; if target blood pressure is still not achieved with the use of 2 antihypertensive agents, a third drug may be added.1200, 1216 (See Uses: Hypertension.) In patients who develop unacceptable adverse effects with terazosin, the drug should be discontinued and another antihypertensive agent from a different pharmacologic class should be initiated.1216
The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure.1200 However, the optimum blood pressure threshold for initiating antihypertensive drug therapy and specific treatment goals remain controversial.505, 506, 507, 508, 515, 523, 530, 1201, 1207, 1209, 1222 A 2017 multidisciplinary hypertension guideline from the American College of Cardiology (ACC), American Heart Association (AHA), and a number of other professional organizations generally recommends a blood pressure goal of less than 130/80 mm Hg in all adults, regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.1200, 1207 Many patients will require at least 2 drugs from different pharmacologic classes to achieve this blood pressure goal; the potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs also should be considered when deciding a patient's blood pressure treatment goal.1200, 1220
For the management of benign prostatic hyperplasia (BPH), the usual initial adult dosage of terazosin is 1 mg once daily at bedtime.1, 9 Because of the risk of postural effects (see Cautions: Postural Effects), it is essential that therapy with the drug not be initiated with higher dosages.1 To achieve the desired improvement in symptoms and/or urinary flow rates, subsequent dosage may be increased in a stepwise manner to 2, 5, and 10 mg daily as necessary.1, 9 Titration to a dosage of 10 mg once daily generally is required for adequate clinical response.1 A minimum of 4-6 weeks may be needed to adequately assess the response at this dosage, but some patients may not respond despite appropriate titration.1 While additional benefit occasionally may be observed by increasing the dosage to 20 mg daily,1 maximally tolerable and effective dosages have not been established and there currently is insufficient experience with this dosage in the management of BPH to draw definitive conclusions.1, 59 In addition, there currently are insufficient data to support the use of dosages exceeding 20 mg daily in patients with an inadequate or no response at lower dosages.1 If terazosin therapy is discontinued for several days or longer, therapy should be restarted using the recommended initial dosage.1
Dosage in Renal and Hepatic Impairment
Clinically important alterations in the pharmacokinetics of terazosin in patients with impaired renal function have not been observed to date,1, 3, 28, 29 and modification of dosage in such patients generally does not appear to be necessary.3, 28, 29, 33 In addition, administration of supplemental doses of the drug following hemodialysis does not appear to be necessary.1
The effects, if any, of hepatic impairment on the pharmacokinetics of terazosin have not been elucidated,33 and the manufacturer makes no specific recommendations for modification of terazosin dosage in patients with hepatic impairment.1
While the manufacturer makes no specific recommendations for titration of terazosin dosage in geriatric patients,1, 3, 9 patients in this age group generally are less tolerant of the postural hypotensive effects of α1-adrenergic blocking agents because of impaired cardiovascular reflexes, and caution should be exercised.7, 9, 44 Therefore, dosage escalation in elderly patients generally should be slower than in younger adults.7, 9 In addition, the elimination half-life may be prolonged and plasma clearance of the drug decreased in patients 70 years of age and older.1, 3, 9, 28
Adverse effects occurring most frequently during terazosin hydrochloride therapy for hypertension include dizziness, headache, asthenia (weakness, tiredness, lassitude, fatigue), nasal congestion, peripheral edema, somnolence, nausea, and palpitation.1, 3, 4, 6, 7, 13 In patients receiving the drug for benign prostatic hyperplasia (BPH), the most frequent adverse effects are dizziness, asthenia, headache, postural hypotension, and somnolence.1, 9 The frequency of adverse effects in controlled clinical trials generally has been lower in patients receiving terazosin for BPH than in those receiving the drug for hypertension;1, 9 however, dosages employed for this condition also generally have been lower than those for hypertension.1
While adverse effects occur frequently in patients receiving terazosin, most are mild to moderate in severity,1, 3, 9, 13, 30 and discontinuance of the drug secondary to adverse effects was required in only 9% of patients with BPH9, 33 and in only 13-21% of patients with hypertension3, 30, 33 during clinical trials. The principal reasons for discontinuance in patients with hypertension were postural effects1, 3, 30 (e.g., dizziness in about 3% of patients)1 and asthenia, palpitation, headache, and dyspnea1, 3, 30 each in about 1-2% of patients.1 In patients with BPH, the principal reasons for discontinuance were dizziness, headache, and blurred vision/amblyopia in 2,1, 9 1.1,1 and 0.6%,1, 9 respectively, of patients and postural hypotension,1, 9 syncope, vertigo, dyspnea, fever, nausea, and urinary tract infection each in 0.5% of patients.1 In controlled clinical trials in patients with hypertension, only dizziness (including postural effects), asthenia, blurred vision, nasal congestion, nausea, peripheral edema, palpitation, and somnolence occurred at rates significantly greater than those for placebo.1, 3, 30 Only asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence occurred significantly more frequently with the drug than with placebo in controlled clinical trials for BPH.1, 9 The risk of postural hypotension and syncope appears to be higher in geriatric patients (i.e., those 65 years of age and older) than in younger patients.9 Asthenia and postural effects, including dizziness, appear to be dose related.9, 28
Terazosin, like other α1-adrenergic blocking agents, can cause marked hypotension, which may be accompanied by syncope and other postural effects.1, 2, 3, 4, 6, 9, 13, 30 While syncope is the most severe orthostatic effect of the drug, other less severe symptoms, such as dizziness,1, 3, 9, 13, 30 lightheadedness,1 tachycardia,1 palpitation,1, 3, 30 and vertigo,1, 9 also can be associated with terazosin-induced reductions in blood pressure. Syncope is uncommon when terazosin dosage is initiated at low levels and titrated slowly, but dizziness is frequent, occurring in about 20 or 10% of patients receiving the drug for hypertension or BPH, respectively, in controlled trials.1, 9 Palpitation1, 3, 30 has been reported in 4.3% of hypertensive patients receiving terazosin,1 and tachycardia (especially in the standing position) and postural hypotension1, 13 have been reported in 1-2% of such patients.1 Postural hypotension, vertigo, and syncope have been reported in about 4, 1.4, and 0.6% of patients, respectively, receiving the drug for BPH; however, in several clinical trials in such patients, the frequency of postural hypotension ranged from 3.7-5.2%.1, 9
Terazosin-induced postural hypotension is dose related, particularly likely in the upright position following an initial dose, and most likely to develop shortly after dosing (e.g., within 90 minutes), particularly during the initial week of therapy.1, 3, 4, 6 With continued therapy after careful dosage titration, adaptation of reflex mechanisms to α1-blockade develops and the risk of postural effects generally subsides.6 However, marked hypotension also can occur with subsequent dosage increases or after therapy is interrupted for more than a few days.1 Occasionally, syncopal episodes have been preceded by episodes of severe supraventricular tachycardia with heart rates of 120-160 bpm.1 In addition, the possibility exists that hemodilution induced by the drug may contribute to postural hypotension.1 While the adverse effect profiles of terazosin and prazosin generally appear to be similar,3, 6, 12 it has been suggested that postural effects may be less likely with terazosin in part because of the drug's slower onset of action and reduced affinity for α1-receptors;2, 4 however, additional study and experience are needed to elucidate the relative risks of postural effects.
The risk of first-dose syncope with α1-adrenergic blocking agents generally can be minimized by initiating therapy at low doses (i.e., 1 mg of terazosin daily), lessening the level of salt restriction and avoiding diuretics just prior to initiation of α1-blocker therapy, and administering initial doses at bedtime.1, 3, 4, 6, 30 It is essential that terazosin therapy not be initiated at dosages exceeding 1 mg daily and that dosage escalation be slow.1 If syncope develops, the patient should be placed in the recumbent position and treated supportively as necessary.1 Patients should be advised to lie or sit down if they develop any postural symptom (e.g., dizziness, vertigo) and to exercise caution upon standing from a sitting or supine position.1, 2 Patients also should be advised to contact their physician if dizziness, lightheadedness, or palpitations become bothersome since dosage adjustment may be necessary.1 Other antihypertensive therapy, especially verapamil (see Precautions and Contraindications), should be added cautiously in patients receiving terazosin.1, 2, 9
In early trials in which increasing single terazosin doses up to 7.5 mg were administered at 3-day intervals, tolerance to the first-dose phenomenon did not necessarily develop, and first-dose postural effects were observed at all doses.1 In addition, syncope occurred in about 20% of patients at single-dose levels of 2.5, 5, or 7.5 mg, and a few patients developed severe orthostatic hypotension (blood pressure declining to 50/0 mm Hg) at these dosing levels.1 These effects occurred within 90 minutes of dosing in all cases.1
Besides dizziness (see Cautions: Postural Effects), headache is the most common adverse nervous system effect associated with terazosin therapy,1, 3, 9, 13, 30 occurring in about 16 or 5% of patients receiving the drug for hypertension or BPH, respectively.1 Asthenia (weakness, tiredness, lassitude, fatigue)1, 3, 9, 13, 30 occurs in 11.3 or 7.4% of such patients, respectively, and somnolence1, 9, 13 occurs in 5.4 or 3.6%, respectively.1 Paresthesia and nervousness occur in 2-3% of patients receiving the drug for hypertension, and depression occurs in 0.3%.1 Anxiety and insomnia have been reported occasionally, but a causal relationship to the drug has not been established.1
Nausea1, 13 is the most common adverse GI effect of terazosin, occurring in 4.4 or 1.7% of patients receiving the drug for hypertension or BPH, respectively.1 Constipation,1 diarrhea,1, 13 dry mouth,1 dyspepsia,1 flatulence,1 abdominal pain,1, 13 and vomiting have been reported occasionally, but these effects have not been directly attributed to the drug.1
Besides postural effects of the drug (see Cautions: Postural Effects), other cardiovascular effects reported with terazosin include peripheral edema1, 9, 13 in about 6 or 1% of patients receiving the drug for hypertension or BPH, respectively,1 and tachycardia1, 3 and nonperipheral edema in about 1-2% of those receiving the drug for hypertension.1 Arrhythmia,1 chest pain,1, 3, 13 and vasodilation have been reported occasionally, but a causal relationship has not been established.1 While clinically important nonpostural decreases in blood pressure generally are not observed in normotensive patients receiving the drug for BPH, some reduction may occur,1, 9 and hypotension develops in less than 1% of patients.1 Atrial fibrillation has been reported during postmarketing surveillance in patients receiving terazosin.1
Dermatologic and Sensitivity Reactions
Adverse dermatologic effects have been reported occasionally in patients receiving terazosin, but a causal relationship to the drug has not been established.1 Such effects include facial edema, pruritus, and rash.1
Allergic reactions, including anaphylaxis, have been reported rarely in patients receiving terazosin.1
Back pain1 or flu-like syndrome1, 9 occurs in 2.4% of patients receiving terazosin for hypertension or BPH, respectively.1 These effects also have been reported in hypertensive patients,1, 13 but a causal relationship to the drug could not be established.1 Other musculoskeletal effects for which a causal relationship has not been established include neck or shoulder pain, arthralgia, arthritis, joint disorder, and myalgia.1 Pain in the extremities also has been reported.13
Nasal congestion/rhinitis1, 3, 9, 13, 30 occurs in about 6 or 2% of patients receiving terazosin for hypertension or BPH, respectively, and dyspnea1, 3, 13 occurs in about 3.1 and 1.7%, respectively.1 Sinusitis1, 13 occurs in 2.6% of hypertensive patients receiving the drug.1 Occasionally, cold symptoms,1, 13, 30 bronchitis,1 epistaxis,1 cough,1, 13 and pharyngitis1, 13 have been reported, but these effects have not been directly attributed to the drug.1
Impotence1, 9, 30 is the most common adverse genitourinary effect of terazosin, occurring in 1.2 or 1.6% of patients receiving the drug for hypertension or BPH, respectively.1 Priapism (painful penile erection sustained for hours and unrelieved by sexual intercourse or masturbation) has been reported rarely (probably less frequently than 1 per several thousand patients) in patients receiving an α1-adrenergic antagonist (e.g., terazosin).1 Urinary tract infection was reported in 1.3% of patients with BPH receiving the drug, but this frequency was less than that reported with placebo.1 Urinary tract infection also has been reported in hypertensive patients receiving terazosin but could not be directly attributed to the drug.1 Other adverse genitourinary effects for which a causal relationship has not been established include urinary frequency and urinary incontinence (principally in postmenopausal women).1
Blurred vision/amblyopia1, 9 occurs in 1.6 or 1.3% of patients receiving terazosin for hypertension or BPH, respectively.1 Visual abnormalities, conjunctivitis, and tinnitus have been reported occasionally but have not been directly attributed to the drug.1
Small decreases in hemoglobin concentration, hematocrit, leukocyte count, and total protein and albumin concentrations have been observed following administration of terazosin and were suggestive of hemodilution.1, 3, 9, 13, 30, 32 Similar changes have been observed with other α1-adrenergic blocking agents and attributed to hemodilution.1 Thrombocytopenia has been reported during postmarketing surveillance in patients receiving terazosin.1
Weight gain (in both males and females)1, 3, 9, 13, 30, 32 occurs in 0.5% of patients receiving terazosin for hypertension or BPH,1 and decreased libido occurs in 0.6% of those receiving the drug for hypertension.1 Some evidence suggests that the likelihood of weight gain may increase with increasing dosage and/or duration of therapy in some patients.9 Other adverse effects have been reported occasionally with terazosin but have not been directly attributed to the drug.1 Such effects include fever, gout, and sweating.1
Precautions and Contraindications
Patients should be warned of the possibility of terazosin-induced postural dizziness and measures to take if it develops (e.g., sitting, lying down).1 (See Cautions: Postural Effects.) During initiation of terazosin therapy, the patient should be cautioned to avoid, for 12 hours after the first dose, subsequent dosage increases, and resumption of therapy, situations where injury could result (e.g., driving, hazardous tasks) if syncope were to occur.1, 9 If syncope occurs, the patient should be placed in the recumbent position and treated supportively as necessary.1 Patients who engage in potentially hazardous activities such as operating machinery or driving motor vehicles should be warned about possible somnolence, drowsiness, or dizziness.1
While the manufacturer questions the need for caution,33 some clinicians state that α1-adrenergic blocking agents should be avoided in patients with micturition-associated syncope because of the risk of exaggerated postural effects.9
Patients also should be advised that priapism has been reported rarely in patients receiving an α1-adrenergic antagonist (e.g., terazosin).1 Priapism is a medical emergency that could result in penile tissue damage and permanent loss of potency if not treated immediately; therefore, patients should be advised to report promptly to their clinician or, if their clinician is unavailable, to seek alternative immediate medical attention if an erection occurs that persists longer than several (e.g., 4-6) hours or is painful.1, 48, 49
The possibility of carcinoma of the prostate and other conditions associated with manifestations that mimic those of BPH should be excluded in any patient for whom terazosin therapy for presumed BPH is being considered.1, 9
Caution should be exercised when adding terazosin to a preexisting antihypertensive regimen or when adding other hypotensive agents to a terazosin regimen in order to avoid a possible rapid fall in blood pressure and exacerbation of postural effects.1, 9 Dosage reduction and/or retitration of therapy may be necessary.1 Particular caution may be necessary when terazosin and verapamil are used concomitantly because of an added potential pharmacokinetic interaction (i.e., verapamil-induced increases in plasma terazosin concentrations).1
Terazosin is contraindicated in patients with known sensitivity to the drug1 or any other quinazoline derivative (e.g., doxazosin, prazosin).33
The manufacturer states that safety and efficacy of terazosin in patients younger than 21 years of age have not been established.1, 33 Some experts state that use of centrally acting antihypertensive agents (e.g., terazosin) should be reserved for children who are not responsive to 2 or more of the preferred classes of antihypertensive agents (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor antagonists, long-acting calcium-channel blockers, or thiazide diuretics).1150, 1230 For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Geriatric patients (e.g., those 65 years of age and older) may be particularly susceptible to postural as well as certain other adverse effects of terazosin.9 (See Dosage and Administration: Dosage.)
Mutagenicity and Carcinogenicity
There was no evidence of terazosin-induced mutagenicity in in vitro and in vivo test systems (Ames test, in vivo cytogenetics, dominant lethal test in mice, in vivo Chinese hamster chromosome aberration test, V79 forward mutation assay).1
Oral terazosin dosages of 250 mg/kg daily (695 times the maximum recommended human dosage of 20 mg daily adjusted for a 55-kg man) for 2 years were associated with an increase in benign adrenal medullary tumors in male rats; females were unaffected.1 The drug was not oncogenic in mice receiving oral dosages of 32 mg/kg daily for 2 years.1 The absence of mutagenicity in a battery of in vivo and in vitro tests, of tumorigenicity of any cell type in the mouse carcinogenicity assay, of increased total tumor incidence in rats or mice, and of proliferative adrenal lesions in female rats suggests that the observed increase in benign medullary tumors is a male-rat species-specific effect.1 In addition, numerous other drugs and chemicals have been associated with increased benign adrenal medullary tumors in male rats without evidence of carcinogenic effects in humans.1
Pregnancy, Fertility, and Lactation
Terazosin was not teratogenic in rats or rabbits at oral dosages up to 1330 or 165 times the maximum recommended human dosage, respectively.1 Fetal resorptions occurred in rats at an oral dosage of 480 mg/kg daily, which is approximately 1330 times the maximum recommended human dosage.1 Increased fetal resorptions, decreased fetal weight, and increased supernumerary ribs were observed in offspring of rabbits that received 165 times the maximum recommended human dosage.1 These fetal findings were most likely secondary to maternal toxicity.1 There are no adequate and controlled studies in pregnant women, and safety of terazosin during pregnancy has not been established.1 The drug should be used during pregnancy only when potential benefits justify the possible risks to the mother and fetus.1
In a perinatal and postnatal development study in rats, there was an increased frequency of deaths in the offspring during the first 3 weeks postpartum at a maternal oral terazosin dosage of 120 mg/kg daily (more than 300 times the maximum recommended human dosage).1, 33
In reproduction studies in rats receiving oral terazosin dosages of 8, 30, or 120 mg/kg daily, failure to sire litters was observed in males receiving the latter 2 dosages, but testicular weight and morphology were unaffected.1 However, vaginal smears at these latter dosages appeared to contain less sperm than smears from control matings, and a positive correlation between sperm count and subsequent pregnancy was observed.1 An increase in testicular atrophy has been observed in rats receiving terazosin dosages of 40 or 250 mg/kg daily but not in those receiving 8 mg/kg daily (more than 20 times the maximum recommended human dosage).1 Testicular atrophy also was observed in dogs receiving 300 mg/kg daily (more than 800 times the maximum recommended human dosage) for 3 months but not with 1 year of administration at 20 mg/kg daily.1 Such atrophy also has been observed with prazosin.1
Since it is not known whether terazosin is distributed into milk, the drug should be used with caution in nursing women.1
Terazosin hydrochloride is a quinazoline-derivative postsynaptic α1-adrenergic blocking agent.1, 2, 3, 4, 5, 6, 8, 9, 10 The drug is chemically and pharmacologically related to prazosin and doxazosin.1, 2, 3, 4, 6, 8, 9, 10 On a molar basis, the postsynaptic α1-adrenergic receptor affinity of terazosin is one-third that of prazosin when tested in rat liver,3, 9, 10 and the α1-receptor selectivity is 4 times that of doxazosin when tested in human prostate adenoma.9
Terazosin reduces peripheral vascular resistance and blood pressure as a result of its vasodilating effects; the drug produces both arterial and venous dilation.1, 3, 4, 6, 10 Terazosin reduces blood pressure in both supine and standing patients; the effect is most pronounced on standing blood pressure, and postural hypotension can occur.1, 3, 4, 6, 10 Terazosin generally causes no change in heart rate or cardiac output in the supine position.1, 3, 4, 6, 10 Cardiovascular responses to exercise (e.g., increased heart rate and cardiac output) are maintained during terazosin therapy.1, 3, 4, 6, 10
Effects of terazosin on the cardiovascular system are mediated by the drug's activity at α1-receptor sites in vascular smooth muscle.1, 2, 3, 4, 6α1-Adrenergic receptors also are located in nonvascular smooth muscle (e.g., bladder trigone and sphincters, GI tract and sphincters, prostate adenoma and capsule, ureters, uterus)5, 6, 9 and in nonmuscular tissues (e.g., CNS, liver, kidneys).5 Because of the prevalence of α-receptors in the prostate capsule, prostate adenoma, and the bladder trigone and the relative absence of these receptors on the bladder body, α-blockers decrease urinary outflow resistance in men.5, 9
Terazosin may improve to a limited extent the serum lipid profile (e.g., small increases in high-density lipoprotein cholesterol concentrations [HDL]/total cholesterol ratio, small decreases in low-density lipoprotein [LDL] cholesterol, total cholesterol, and triglyceride concentrations).1, 3, 8, 9, 10, 11, 28, 31, 32 In addition, such potential effects of terazosin may counteract the negative effects of thiazide diuretics on serum lipoprotein concentrations.6, 13, 31
Additional Information
SumMon® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for information on the usual cautions, precautions, and contraindications concerning potential drug interactions and/or laboratory test interferences and for information on acute toxicity.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 1 mg (of terazosin)* | Terazosin Hydrochloride Capsules | |
2 mg (of terazosin)* | Terazosin Hydrochloride Capsules | |||
5 mg (of terazosin)* | Terazosin Hydrochloride Capsules | |||
10 mg (of terazosin)* | Terazosin Hydrochloride Capsules |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
1. Abbott Laboratories. Hytrin® (terazosin hydrochloride) capsules prescribing information. North Chicago, IL; 2001 Feb.
2. Babamoto KS, Hirokawa WT. Doxazosin: a new α1-adrenergic antagonist. Clin Pharm . 1992; 11:415-27. [PubMed 1349855]
3. Titmarsh S, Monk JP. Terazosin: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in essential hypertension. Drugs . 1987; 33:461-77. [PubMed 2885169]
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