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Doxazosin (Systemic)


VA CLASSIFICATION
Primary: CV150
Secondary: CV409; GU900

Commonly used brand name(s): Cardura; Cardura–1; Cardura–2; Cardura–4.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antihypertensive—Doxazosin Mesylate Tablets;

Benign prostatic hyperplasia therapy agent—Doxazosin Mesylate Tablets;

Indications

Accepted

Hypertension (treatment)—Doxazosin is indicated in the treatment of hypertension . {01} {40} {49} {50} {51} {58} {59}
—For additional information on initial therapeutic guidelines related to the treatment of hypertension, see Appendix III.

Benign prostatic hyperplasia (treatment)—Doxazosin is indicated for the treatment of both the urinary outflow obstruction and the obstructive and irritative symptoms associated with benign prostatic hyperplasia (BPH). {43} {44} {45} {52} {53} {54} {55} {56} {58} {59} Obstructive symptoms are hesitation, intermittency, dribbling, weak urinary stream, and incomplete emptying of the bladder; while irritative symptoms include nocturia, daytime frequency, urgency, and burning. {58} {59} Doxazosin may be used in normotensive or hypertensive patients. {58} {59} In normotensive patients with BPH, doxazosin does not appear to significantly lower blood pressure. {56} {58} {59} In hypertensive patients with BPH, both conditions are effectively treated with doxazosin. {56} The long-term effects of doxazosin on the incidence of acute urinary obstruction or other complications of BPH or on the need for surgery have not yet been determined. {59}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    547.59 {03}

Mechanism of action/Effect:

Doxazosin has a selective postsynaptic alpha 1-adrenergic blocking action {59}, which is thought to account primarily for its effects. {01} {08} {09}


Hypertension:

Blockade of alpha 1-adrenergic receptors by doxazosin results in peripheral vasodilation, which produces a fall in blood pressure because of decreased peripheral vascular resistance. {01} {02}



Benign prostatic hyperplasia:

Relaxation of smooth muscle in the bladder neck, prostate, and prostate capsule produced by alpha 1-adrenergic blockade results in a reduction in urethral resistance and pressure, bladder outlet resistance, and urinary symptoms. {52} {53} {54} {58} {59}



Other actions/effects:

Doxazosin slightly lowers the levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. In addition, doxazosin slightly increases high-density lipoprotein (HDL) cholesterol and the HDL/total cholesterol ratio. {07} {10} {11} {17} {18} {19} These lipid effects appear to be the result of doxazosin's effect on lipid metabolism (i.e., increasing LDL receptor activity, decreasing intracellular LDL cholesterol synthesis, decreasing synthesis and secretion of very low-density lipoprotein [VLDL] cholesterol, stimulation of lipoprotein lipase activity, and decreasing the rate of cholesterol absorption). {16} However, the implications of these changes are unclear.

Absorption:

Well-absorbed from gastrointestinal tract {05} {12} {13}; bioavailability is about 65%. {01} {05} {13} {14} {15} {49} {58} {59}

Protein binding:

Very high (98 to 99%). {01} {09} {12}

Biotransformation:

Metabolized extensively in the liver. {01} {05} {13} {58} {59} Although several active and inactive metabolites have been identified (2-piperazinyl, 6´ and 7´-hydroxy, 6´ and 7´- O-desmethyl {01} {12}, and 2-amino {06} {12}), there is no evidence that they are present in substantial amounts. {01} {09} {13}

Half-life:

Elimination—19 to 22 hours; {01} {02} {06} {13} {20} {49} does not appear to be significantly influenced by age {01} {06} {13} {14} {22} or mild to moderate renal impairment. {01} {06} {13} {20} {21} {22} {25} {26}

Onset of action:

Hypertension—1 to 2 hours; {15} {23} {58} {59} there is a slight initial fall in blood pressure within the first hour, but the main hypotensive effect is apparent from 2 hours onwards. {23} {46}

Benign prostatic hyperplasia (BPH)—Within 1 to 2 weeks. {56}

Time to peak concentration:

1.5 to 3.6 hours. {01} {09} {13} {20} {21} {49}

Peak serum concentration

At steady state, there is a positive linear relationship between peak serum concentration and dose of doxazosin. {01} {09} {13} Following an oral dose of 1 mg doxazosin, the standardized peak serum concentration was 9.6 mcg per L. {13}

Time to peak effect

Antihypertensive—Single dose: 2 to 6 hours. {58}

Duration of action:

Antihypertensive—Single dose: 24 hours. {04} {24}

Elimination:
    Fecal—Unchanged drug, about 5%; metabolites, 63 to 65%. {05} {06} {12}
    Renal—9%. {05} {06} {12}
    In dialysis—Doxazosin is not removed by hemodialysis. {06} {21} {58} {59}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other quinazolines (prazosin, terazosin) may also be sensitive to doxazosin. {01} {50} {58} {59}

Carcinogenicity

In one 24-month chronic dietary administration study in rats, doxazosin (given at a dose equivalent to 150 times the maximum recommended human dose) produced no evidence of carcinogenicity. {01} {50} {58} {59} In another similarly conducted study done in mice, up to 18 months of dietary administration produced no evidence of carcinogenicity. The latter study, however, did not use a maximally tolerated dose of doxazosin. {01} {50} {58} {59}

Mutagenicity

There is no evidence of drug- or metabolic-related effects at either chromosomal or subchromosomal levels. {01} {50} {58} {59}

Pregnancy/Reproduction
Fertility—
Studies in rats given oral doses of 20 mg per kg of body weight (mg/kg) per day (equivalent to about 75 times the maximum recommended human dose) have shown that doxazosin reduces fertility in male rats. {01} {50} {58} {59} The effect was reversible after 2 weeks of discontinuation of treatment. {58} {59}

Pregnancy—
Adequate and well-controlled studies in humans have not been done.

Studies in rabbits and rats given daily oral doses of 40 and 20 mg/kg, respectively, have shown no evidence of harm to the fetus. {58} {59} The rabbit study, however, did not use a maximally tolerated dose of doxazosin. {01} {50} Reduced fetal survival was associated with a dosage regimen of 82 mg/kg in rabbits. {50} {58} {59} Following oral administration of labeled doxazosin to pregnant rats, radioactivity was found to cross the placenta. {01}

Studies in perinatal and postnatal rats given 40 or 50 mg/kg per day of doxazosin revealed evidence of delayed postnatal development manifested by slower body weight gain and slightly later appearance of anatomical features and reflexes. {01} {50} {58} {59}

FDA Pregnancy Category C. {50} {58}

Breast-feeding

It is not known whether doxazosin is distributed into breast milk. {58} {59} Problems in humans have not been documented. However, in rats given a single oral dose of 1 mg/kg, doxazosin accumulated in the milk of lactating rats with a maximum concentration about 20 times greater than the maternal plasma concentration. {01} {50} {58}

Pediatrics

No information is available on the relationship of age to the effects of doxazosin in pediatric patients. Safety and efficacy have not been established. {01} {58} {59}


Geriatrics


A study performed in approximately 2000 hypertensive patients older than 65 years of age did not demonstrate geriatrics-specific problems that would limit the usefulness of doxazosin in the elderly. {28} However, the hypotensive effect of doxazosin may be more pronounced in elderly hypertensive individuals, and lower daily maintenance doses may be required. {14} {28}

Experience with use of doxazosin in elderly patients with benign prostatic hyperplasia (BPH) has shown that the safety profile of doxazosin is similar to that in younger patients. {56} {58} {59}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anti-inflammatory drugs, nonsteroidal (NSAIDs), especially indomethacin{35}{36}{37}{42}{58}    (antihypertensive effects of doxazosin may be reduced when the medication is used concurrently with these agents; indomethacin, and possibly other NSAIDs, may antagonize the antihypertensive effect by inhibiting renal prostaglandin synthesis and/or by causing sodium and fluid retention; the patient should be carefully monitored to confirm that the desired effect is being obtained)


Cimetidine{50}{58}{59}    (concurrent use may slightly increase the serum concentration of doxazosin; however, the clinical significance of this increase is not known)


Hypotension-producing medications, other (See Appendix II ){58}{59}    (antihypertensive effects may be potentiated when these medications are used concurrently with doxazosin; although some antihypertensive and/or diuretic combinations are frequently used to therapeutic advantage, dosage adjustments are necessary during concurrent use)


Sympathomimetics{58}{59}    (antihypertensive effects of doxazosin may be reduced when it is used concurrently with these agents; the patient should be carefully monitored to confirm that the desired effect is being obtained)

    (concurrent use of doxazosin antagonizes the peripheral vasoconstriction produced by high doses of dopamine)

    (concurrent use of doxazosin may decrease the pressor response to ephedrine)

    (concurrent use of doxazosin may block the alpha-adrenergic effects of epinephrine, possibly resulting in severe hypotension and tachycardia)

    (concurrent use of doxazosin usually decreases, but does not reverse or completely block, the pressor effect of metaraminol)

    (prior administration of doxazosin may decrease the pressor effect and shorten the duration of action of methoxamine and phenylephrine)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Hepatic function impairment{01}{49}{58}    (although studies in patients with impaired hepatic function have not been done, doxazosin is metabolized primarily in the liver, and, therefore, increased sensitivity or prolonged doxazosin effect may occur)


Renal function impairment{25}{41}{47}    (small incidence of increased risk of first-dose orthostatic hypotensive reaction and prolonged hypotensive effect)


Sensitivity to doxazosin{01}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

» Blood pressure measurements    (recommended at 2 to 6 hours postdose following first dose and with each dosage increase, since postural effects are most likely to occur during this time; dosage to be increased as necessary and tolerated based on individual standing blood pressures taken at 2 to 6 hours and 24 hours postdose {01} {58} {59})




Side/Adverse Effects

Note: A ``first-dose orthostatic hypotensive reaction'' sometimes occurs with the initial dose of doxazosin, especially when the patient is in the upright position. Syncope or other postural symptoms such as dizziness may occur. Subsequent occurrence with dosage increases is also possible. Incidence appears to be dose-related; thus it is important that therapy be initiated with the 1-mg dose. {01} {50} {58} {59} Patients who are volume-depleted or sodium-restricted may be more sensitive to the orthostatic hypotensive effects of doxazosin, and the effect may be exaggerated after exercise. {47}
Hypotensive side effects are more likely to occur in geriatric patients.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Dizziness{01}{11}{28}{29}{30}{33}{34}{58}
    
vertigo (dizziness or lightheadedness){11}{27}{28}{29}{31}{58}

Incidence less frequent
    
Arrhythmias (irregular heartbeat){01}{31}{33}{58}
    
dyspnea (shortness of breath){11}{30}{33}{58}
    
orthostatic hypotension (dizziness or lightheadedness when getting up from a lying or sitting position; sudden fainting){27}{28}{29}{30}
    
palpitations (pounding heartbeat){01}{11}{28}{30}{33}{58}
    
peripheral edema (swelling of feet or lower legs){01}{11}{28}{30}{31}{33}{58}
    
tachycardia (fast heartbeat){01}{11}{28}{30}{33}

Incidence rare
    
Priapism (painful or prolonged erection of the penis){58}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Headache{01}{10}{27}{28}{30}{31}{33}{58}
    
unusual tiredness{01}{10}{11}{27}{28}{30}{33}{58}

Incidence less frequent
    
Nausea{01}{11}{27}{28}{33}{58}
    
nervousness, restlessness, or unusual irritability{01}{27}{31}{33}
    
rhinitis (runny nose){01}{11}{27}{33}
    
somnolence (sleepiness or unusual drowsiness){01}{27}{28}{33}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Treatment of circulatory failure by placing the patient in the supine position and elevating the legs is most important; if shock is present, additional measures are necessary. Volume expanders may be used to treat shock, followed, if necessary, by administration of a vasopressor.

Symptomatic, supportive treatment and monitoring of fluid and electrolyte status.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Doxazosin (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to quinazolines {58} {59}





Use in the elderly—Increased sensitivity to hypotensive effects

Proper use of this medication
Compliance with therapy; taking medication at the same time each day to maintain the therapeutic effect

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses. If not taken for several days, calling doctor before restarting medication {58} {59}

» Proper storage

For use as an antihypertensive
Possible need for control of weight and diet, especially sodium intake {47}

» Patient may not experience symptoms of hypertension; importance of taking medication even if feeling well

» Does not cure, but helps control hypertension; possible need for lifelong therapy; serious consequences of untreated hypertension

For use in benign prostatic hyperplasia (BPH)
Relieves symptoms of BPH but does not change the size of the prostate; may not prevent the need for surgery in the future

May require 1 to 2 weeks of therapy before patient experiences improvement of symptoms {56} {58} {59}

Precautions while using this medication
Making regular visits to physician to check progress, especially elderly patients

» Not taking other medications, especially nonprescription sympathomimetics, unless discussed with physician

» Caution if dizziness, lightheadedness, or sudden fainting occurs, especially after initial dose; taking first dose at bedtime

» Caution when getting up suddenly from a lying or sitting position

» Caution in using alcohol, while standing for long periods or exercising, and during hot weather, because of enhanced orthostatic hypotensive effects

» Possibility of drowsiness

» Caution when driving or doing anything else requiring alertness because of possible drowsiness, dizziness, or lightheadedness

» Possibility of priapism (painful erection of penis), though rare; must be brought to immediate medical attention. {58} {59}


Side/adverse effects
Signs of potential side effects, especially dizziness, vertigo, arrhythmias, dyspnea, orthostatic hypotension, palpitations, peripheral edema, tachycardia, and priapism.


General Dosing Information
In order to minimize the ``first-dose orthostatic hypotensive reaction,'' an initial dose of 1 mg is recommended, with gradual increases in dose every 2 weeks as needed {01}. Administration of the initial dose and of the initial dose of each increment at bedtime is recommended. {01}

If discontinuation occurs for several days or longer, the dose should restart using the initial dosing regimen. {58} {59}

For use as an antihypertensive
Dosage of doxazosin should be adjusted to meet the individual requirements of each patient, on the basis of blood pressure response.

Doxazosin may be used alone or in combination with a thiazide diuretic or beta-adrenergic blocking agent {01}, both of which reduce the tendency for sodium and water retention, although they also produce additive hypotension. If combination therapy is indicated, individual titration is required to ensure the lowest possible therapeutic dose of each medication.

Increases in dose beyond 4 mg increase the likelihood of excessive postural effects including syncope, postural dizziness or vertigo, and postural hypotension. {01} {49}

When a diuretic or another antihypertensive agent is added to doxazosin therapy, the dose of doxazosin may be reduced {48}, followed by slow dosage titration of the combination. When doxazosin is added to existing diuretic or antihypertensive therapy, the dose of the other agent may {48} be reduced and doxazosin started at a dose of 1 mg once a day.

For use in benign prostatic hyperplasia
Prior to initiation of doxazosin therapy, a number of clinical conditions can present with symptoms similar to those associated with BPH and should be ruled out. These conditions may be the presence of prostate carcinoma, stricture of urethra, stricture of bladder neck, urinary bladder stones, neurogenic bladder dysfunction secondary to diabetes, or Parkinson's disease. {59}


Oral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of doxazosin base (not the mesylate salt).

DOXAZOSIN MESYLATE TABLETS

Usual adult dose
Antihypertensive
Initial: Oral, 1 mg (base) once a day. {01} {10} {27} {28} {31} {34} {58}

Maintenance: Oral, the dosage being increased gradually to meet individual requirements; depending on periodic blood pressure measurements, dosage may be increased every two weeks, titrating upwards to 2, 4, 8, and 16 mg (base) once a day as needed and tolerated. {01} {10} {28} {32} {33} {34} {58} {59}

Note: Increases in dose beyond 4 mg (base) increase the likelihood of excessive postural effects including syncope, postural dizziness or vertigo, and postural hypotension. {01} {58}
Geriatric patients may be more sensitive to the effects of the usual adult dose.


Benign prostatic hyperplasia
Initial: Oral, 1 mg (base) once a day, in the morning or in the evening. {58}

Maintenance: Oral, 1 to 8 mg (base) once a day. {44} {45} {56} {58} Dosage increases made to 2 mg and afterwards to 4 mg and 8 mg once daily should be titrated at one- to two-week intervals. {58} {59}


Usual adult prescribing limits
16 mg once a day for hypertension. {58} {59}

8 mg once a day for BPH. {58} {59}

Usual pediatric dose
Safety and efficacy have not been established.

Strength(s) usually available
U.S.—


1 mg (base) (Rx) [Cardura (microcrystalline cellulose)]{58}


2 mg (base) (Rx) [Cardura (microcrystalline cellulose)]{58}


4 mg (base) (Rx) [Cardura (microcrystalline cellulose)]{58}


8 mg (base) (Rx) [Cardura (microcrystalline cellulose)]{58}

Canada—


1 mg (base) (Rx) [Cardura–1]{59}


2 mg (base) (Rx) [Cardura–2]{59}


4 mg (base) (Rx) [Cardura–4]{59}

Packaging and storage:
Store below 30 °C (86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Do not take other medicines without your doctor's advice.
   • May cause dizziness.

Note: Check refill frequency to determine compliance in hypertensive patients.




Revised: 05/21/1999



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