Generic Name: Terazosin Hydrochloride
Class: alpha-Adrenergic Blocking Agents
VA Class: CV150
Chemical Name: Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-((tetrahydro-2-furanyl-)carbonyl)-, monohydrochloride, dihydrate
CAS Number: 70024-40-7

Introduction

Postsynaptic α1-adrenergic blocking agent; quinazoline derivative.1 2 3 4 5 6 7 8 9 10

Uses for Hytrin

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 3 4 6 7 8 11 12 13 14 30 31 32 44

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Current antihypertensive and urology guidelines (e.g., JNC 7) no longer recommend α1-blockers as preferred first-line therapy for patients with hypertension.62 73 74 75

Benign Prostatic Hyperplasia (BPH)

Reduction of urinary obstruction and relief of associated manifestations in patients with symptomatic BPH.1 5 9 17 18 21 23 25 33

Although drug therapy usually is not as effective as surgical therapy, it may provide adequate symptomatic relief with fewer and less serious adverse effects compared with surgery.59

May consider combined therapy with an α1-adrenergic blocker and 5α-reductase inhibitor for men with bothersome moderate to severe BPH and demonstrable prostatic enlargement.59 Has been more effective than therapy with either drug alone in preventing long-term BPH symptom progression.59 Men at risk for BPH progression are most likely to benefit from combination therapy.59

Hytrin Dosage and Administration

Administration

Oral Administration

Administer orally once daily at bedtime.1

Food may delay time to peak plasma concentrations by about 40 minutes but has little effect on extent of absorption.1 28 Manufacturer makes no specific recommendations regarding administration with meals.1

Dosage

Available as terazosin hydrochloride; dosage expressed in terms of terazosin.1

Individualize dosage according to patient response and tolerance.1 3 7 44 Initiate at low dosage to minimize frequency of postural hypotension and syncope.1

Monitor BP 2–3 hours after dosing and at end of dosing interval to determine whether peak and trough responses are similar and to assess potential manifestations (e.g., dizziness, palpitations) of an excessive response.1

If therapy is interrupted for several days or longer, restart using initial dosage regimen.1

Pediatric Patients

Hypertension
Oral

Initially, 1 mg once daily.76 Increase dosage as necessary up to a maximum of 20 mg once daily.76

Adults

Hypertension
Oral

Initially, 1 mg daily at bedtime.1 3 7 44 62 May increase dosage gradually to 5 mg daily,1 3 7 with further titration up to 20 mg daily if BP is not controlled.1 44 62

Each increase should be delayed until BP has stabilized at a given dosage.1 3 7

BPH
Oral

Initially, 1 mg daily at bedtime.1 9 May increase daily dosage to 2 mg and thereafter to 5 mg and 10 mg, if necessary, to reduce symptoms and/or improve urinary flow rates.1 9

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Maximum 20 mg daily.76

Adults

Hypertension
Oral

Maximum 40 mg daily.1

BPH
Oral

Maximum 20 mg daily.1

Special Populations

Hepatic Impairment

Manufacturer makes no specific dosage recommendations; effects on the pharmacokinetics of terazosin have not been elucidated.1

Renal Impairment

Clinically important alterations in the pharmacokinetics of terazosin not observed to date;1 3 28 29 dosage adjustment not necessary.3 28 29 33

Administration of supplemental doses of the drug following hemodialysis does not appear to be necessary.1

Geriatric Patients

Use with caution; generally, increase dosage more slowly in geriatric patients than in younger adults.7 9

Cautions for Hytrin

Contraindications

  • Known hypersensitivity to terazosin, quinazolines (e.g., doxazosin, prazosin), or any ingredient in the formulation.1 33

Warnings/Precautions

Warnings

Postural Hypotension

Marked hypotension, especially in the upright position, can occur; may be accompanied by syncope, palpitations, and other postural effects (e.g., dizziness, lightheadedness, vertigo).1 2 3 4 6 7 9 13 30

Postural effects are most common after an initial dose, shortly after dosing (e.g., within 90 minutes), when dosage is increased, or when therapy is resumed after an interruption exceeding a few days.1

To decrease risk of excessive hypotension and syncope, initiate therapy at low dose and titrate carefully, lessen level of salt restriction, and avoid diuretics just prior to initiation of terazosin therapy.1 3 4 6 7 30

Priapism

Priapism reported rarely; may lead to permanent impotence if not treated promptly.1 48 49 (See Advice to Patients.)

General Precautions

Prostate Cancer

Exclude possibility of prostate cancer before initiation of therapy for BPH.1 9

Specific Populations

Pregnancy

Category C.1

Lactation

Not known whether terazosin is distributed into milk.1 Caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established in patients <21 years of age.1 33

Geriatric Use

Geriatric patients may be particularly susceptible to postural effects and other adverse effects.7 9 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

In the treatment of hypertension: dizziness, headache, asthenia (weakness, tiredness, lassitude, fatigue), nasal congestion, peripheral edema, somnolence, nausea, palpitation.1 3 4 6 7 13

In the treatment of BPH: dizziness, asthenia, headache, postural hypotension, somnolence.1 9

Interactions for Hytrin

Antihypertensive Agents

Possible rapid fall in BP and exacerbation of postural effects.1 7 9 Use with caution; may need to reduce and/or retitrate dosage.1 7

Specific Drugs

Drug

Interaction

Acetaminophen

No interaction observed1

β-Adrenergic blocking agents (e.g., atenolol, propranolol)

No interaction observed1

Allopurinol

No interaction observed1

Antacids

No interaction observed1

Antihistamines (e.g., chlorpheniramine)

No interaction observed1

Captopril

Increased peak plasma concentrations of terazosin1

Codeine

No interaction observed1

Corticosteroids

No interaction observed1

Co-trimoxazole

No interaction observed1

Diazepam

No interaction observed1

Diuretics, thiazide (e.g., hydrochlorothiazide)

No interaction observed1

Erythromycin

No interaction observed1

Hypoglycemics

No interaction observed1

NSAIAs (e.g., aspirin, ibuprofen, indomethacin)

No interaction observed1

Sympathomimetic (adrenergic) agents (e.g., phenylephrine, pseudoephedrine)

No interaction observed1

Verapamil

Increased AUC of terazosin; decreased time to peak plasma terazosin concentrations1

Hytrin Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from the GI tract following oral administration.1 2 Peak plasma concentration attained in about 1 hour.1

Food

Food has minimal effect on extent of absorption; however, time to peak plasma concentration is delayed by about 40 minutes.1 28

Distribution

Extent

Not known whether terazosin is distributed into breast milk.1

Plasma Protein Binding

90–94%.1 a

Elimination

Metabolism

Extensively metabolized in the liver,a with minimal first-pass metabolism.1

Elimination Route

Excreted in urine (40%) and in feces (60%).1

Half-life

Adults: approximately 12 hours.1

Geriatric patients: approximately 14 hours.1

Special Populations

In geriatric patients, plasma clearance is decreased by about 30%.1

Stability

Storage

Oral

Capsules

20–25°C.1 Protect from light and moisture.1

Actions

  • Reduces peripheral vascular resistance and BP as a result of vasodilating effects; produces both arterial and venous dilation.1 3 4 6 7 10

  • Binds to α1-adrenergic receptors in the prostate and the bladder trigone, resulting in decreased urinary outflow resistance in men.5 9

  • May improve to limited extent the serum lipid profile (e.g., small increases in HDL/total cholesterol ratio; small decreases in LDL, total cholesterol, and triglyceride concentrations).1 3 7 8 9 10 11 28 31 32

Advice to Patients

  • Possible syncopal and orthostatic symptoms, especially at initiation of therapy; importance of avoiding driving or other hazardous tasks for 12 hours after first dose, a dosage increase, or when resumed after therapy interruption.1 9

  • Importance of sitting or lying down when symptoms of lowered BP occur, and of rising carefully from a sitting or lying position.1

  • Importance of informing clinician if bothersome dizziness, lightheadedness, or palpitations occur.1

  • Possible drowsiness or somnolence; use caution when operating machinery or driving a motor vehicle until effects on individual are known.1 9

  • Importance of men seeking medical treatment if painful or sustained (for hours) erection occurs.1 48 49

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Terazosin Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

1 mg (of terazosin)*

Hytrin (with parabens and povidone)

Abbott

2 mg (of terazosin)*

Hytrin (with parabens and povidone)

Abbott

5 mg (of terazosin)*

Hytrin (with parabens and povidone)

Abbott

10 mg (of terazosin)*

Hytrin (with parabens and povidone)

Abbott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Terazosin HCl 1MG Capsules (SANDOZ): 30/$15.99 or 90/$35.97

Terazosin HCl 10MG Capsules (CADISTA): 30/$13.99 or 90/$33.99

Terazosin HCl 2MG Capsules (SANDOZ): 30/$13.99 or 90/$33.99

Terazosin HCl 5MG Capsules (SANDOZ): 30/$13.99 or 90/$33.99

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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a. Sonders RC. Pharmacokinetics of terazosin. Am J Med. 1986; 80:20-24. [PubMed 2872802]

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