APO-PRAZO TAB 5MG TABLET

Canada - English - Health Canada

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Active ingredient:
PRAZOSIN (PRAZOSIN HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
C02CA01
INN (International Name):
PRAZOSIN
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
PRAZOSIN (PRAZOSIN HYDROCHLORIDE) 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ALPHA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0111527003; AHFS: 24:20.00
Authorization status:
MARKETED
Authorization number:
00882836
Authorization date:
1990-12-31

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Page 1 of 17

PRODUCT MONOGRAPH

APO-PRAZO

Prazosin

H

ydrochloride Tablets

1.0, 2.0, and 5.0 mg

Antihypertensive

APOTEX INC.

150 Signet Drive

Toronto, Ontario

Canada M9L 1T9

Submission Control No.: 217479

DATE OF REVISION:

August 01, 2018

Page 2 of 17

APO-PRAZO

Prazosin Hydrochloride Tablets

1.0, 2.0 and 5.0 mg

THERAPEUTIC CLASSIFICATION

Antihypertensive

ACTIONS AND CLINICAL PHARMACOLOGY

APO-PRAZO is a formulation of prazosin hydrochloride and is a conventional release

formulation. Prazosin causes a decrease in total peripheral resistance. Animal studies suggest

that the vasodilator effect of prazosin is related to selective blockade of post-synaptic alpha

adrenoceptors. The results of dog forelimb experiments demonstrate that the peripheral

vasodilator effect is confined mainly to the level of the resistance vessels (arterioles).

Hemodynamic studies have been carried out in man following acute single dose administration

and during the course of long term maintenance therapy. The results confirm that the therapeutic

effect is a fall in blood pressure unaccompanied by a clinically significant change in heart rate,

renal blood flow and glomerular filtration rate. In patients with hypertension there is little change

in cardiac output. In addition, clinical pharmacology studies have shown that both prazosin and

prazosin GITS antagonize the vasopressor effect of intravenous phenylephrine, an alpha

agonist.

In man blood pressure is lowered in both the supine and standing positions. The hypotensive

effect of prazosin hydrochloride is greater when the patient is standing, and a mild reflex

tachycardia can result. Tolerance has not been observed to develop in long term hypertensive

therapy. Rebound elevation of blood pressure does not seem to occur following abrupt cessation

of therapy with prazosin.

Following oral administration of prazosin in normal volunteers and hypertensive patients, plasma

Page 3 of 17

concentrations reach a peak at about 3 hours with a plasma half-life of 2-3 hours. The drug is

highly bound to plasma protein (97 percent). After chronic administration, no apparent drug

accumulation was observed nor were any obvious decreases in plasma concentrations noted.

Secondary plasma drug peaks and shoulders suggested probable enterohepatic circulation.

Animal studies indicate that prazosin hydrochloride is extensively metabolized, primarily by

demethylation and conjugation, and excreted (primarily as glucuronide conjugates) mainly via bile

and feces. Similar metabolism and excretion has been documented in human studies.

Most clinical studies indicate that chronic therapy with prazosin has little effect on plasma renin

activity. However one report suggests a transient increase in plasma renin activity following the

initial dose, as well as attenuated transient increase with subsequent doses.

Comparative Bioavailability

Comparative bioavailability studies were performed using healthy human volunteers. The rate

and extent of absorption after a single 2 mg dose of APO-PRAZO 1 mg and MINIPRESS 1 mg

tablets was measured and compared. The results are summarized as follows:

Parameter

a-24

(ng.hr/ml)

Apo-Prazo (SO) 1 mg

109 (34.9)

Minipress (SO*) 1 mg

99.8 (32.4)

a-lnf

(ng.hr/ml)

111 (36.1)

102 (33.4)

(ng/ml)

25.4 (7.5)

21.6 (6.4)

(hr)

0.95 (0.40)

1.05 (0.55)

(hr)

3.95 (0.92)

3.88 (0.96)

*SO= Standard Deviation.

*SD =Standard Deviation.

The rate and extent of absorption after a single 2 mg dose of APO-PRAZO 2 mg and

MINIPRESS 2 mg tablets was measured and compared. The results are summarized as follows:

Parameter

a-24

(ng.hr/ml)

Apo-Prazo (SO) 2 mg

84.7 (27.5)

Minipress (SO*) 2 mg

85.4 (20.0)

Page 4 of 17

a-lnf

(ng.hr/ml)

85.9 (27.6)

86.4 (20.3)

(ng/ml)

17.7 (7.9)

18.2 (5.1)

(hr)

1.59 (1.53)

1.21 (0.77)

(hr)

3.69 (0.98)

3.59 (0.89)

*SO= Standard Deviation.

*SO= Standard Deviation.

INDICATIONS AND CLINICAL USE

APO-PRAZO (prazosin hydrochloride) is indicated in the treatment of mild to moderate essential

hypertension. It is employed in a general treatment program in association with a thiazide diuretic

and/or other antihypertensive agents as needed for proper patient response. APO-PRAZO may

be tried as a sole therapy in those patients in whom treatment with other agents caused adverse

effects or is inappropriate.

CONTRAINDICATIONS

APO-PRAZO (prazosin hydrochloride) is contraindicated in patients with a known sensitivity to

quinazolines.

WARNINGS

APO-PRAZO (PRAZOSIN HYDROCHLORIDE) MAY CAUSE SYNCOPE AND/OR EXCESSIVE

HYPOTENSION WITH SUDDEN LOSS OF CONSCIOUSNESS. IN MOST CASES THIS IS

BELIEVED TO BE DUE TO AN EXCESSIVE POSTURAL HYPOTENSIVE EFFECT,

ALTHOUGH OCCASIONALLY THE SYNCOPAL EPISODE HAS BEEN ASSOCIATED WITH A

BOUT OF SEVERE TACHYCARDIA WITH HEART RATES OF 120-160 BEATS PER MINUTE.

THE INCIDENCE OF SYNCOPAL EPISODES IS APPROXIMATELY 0.8% WHEN THE

GRADUAL DOSE BUILD UP DESCRIBED UNDER DOSAGE AND ADMINISTRATION IS

FOLLOWED. THE INCIDENCE IS HIGHER IF THE INITIAL DOSE EXCEEDS 0.5 MG.

SYNCOPAL EPISODES HAVE OCCURRED WITHIN 30 TO 90 MINUTES OF THE INITIAL

Page 5 of 17

DOSE OF THE DRUG. THEY HAVE ALSO BEEN REPORTED IN ASSOCIATION WITH

DOSAGE INCREASES OR THE INTRODUCTION OF APO-PRAZO INTO THE REGIMEN OF A

PATIENT TAKING ANOTHER ANTIHYPERTENSIVE AGENT OR A DIURETIC. PHYSICIANS

ARE THEREFORE ADVISED TO LIMIT THE INITIAL DOSE OF THE DRUG TO 0.5 MG B.I.D.

OR T.I.D., TO SUBSEQUENTLY INCREASE THE DOSAGE SLOWLY, AND TO INTRODUCE

ANY ADDITIONAL ANTIHYPERTENSIVE DRUGS INTO THE PATIENT'S REGIMEN WITH

CAUTION.

PATIENTS WHOSE BLOOD PRESSURE IS NOT ADEQUATELY CONTROLLED BY HIGH

DOSES OF A BETA-ADRENERGIC BLOCKING AGENT SUCH AS PROPRANOLOL MAY

DEVELOP ACUTE HYPOTENSION WHEN PRAZOSIN IS ADDED. TO MINIMIZE THE

INCIDENCE OF ACUTE HYPOTENSION IN SUCH PATIENTS, THE DOSE OF BETA-

ADRENERGIC BLOCKING AGENT SHOULD BE REDUCED BEFORE APO-PRAZO IS

ADMINISTERED. A LOW INITIAL DOSE OF APO-PRAZO IS ALSO STRONGLY

RECOMMENDED (SEE DOSAGE AND ADMINISTRATION).

If syncope occurs, the patient should be placed in the recumbent position and supportive

measures instituted. This adverse effect is self-limiting and in most cases does not recur once a

steady maintenance level is initiated. Patients should be cautioned to avoid situations where

injury could result should syncope occur during APO-PRAZO therapy especially in the initial dose

adjustment period.

More common than loss of consciousness are the symptoms often associated with lowering of

the blood pressure, namely, dizziness and lightheadedness. The patient should be cautioned

about these possible adverse effects and advised what measures to take should they develop.

Use During Pregnancy

Although no teratogenic effects were seen in animal testing, there are no adequate and well

controlled studies which establish the safety of APO-PRAZO in pregnant women. Limited

uncontrolled use in the management of hypertension in the later stages of pregnancy suggests

that prazosin hydrochloride in combination with a beta-blocker can lower blood pressure in

pregnant patients. The drug appears to be less effective in patients with proteinuria in whom the

addition of i.v. hydralazine was usually required. Accordingly APO-PRAZO should be used during

Page 6 of 17

pregnancy only if in the opinion of the physician the potential benefit outweighs potential risk to

mother and child.

Use During Lactation

Prazosin has been shown to be excreted in small amounts in human milk. Caution should be

exercised when APO-PRAZO is administered to nursing mothers.

Use For Children

APO-PRAZO is not recommended for the treatment of children under the age of twelve years

since safe conditions for its use have not been established in this group.

PRECAUTIONS

Use in Patients with Moderate to Severe Grades of Renal Impairment

Because some patients with moderate to severe grades of renal impairment have responded to

smaller than usual doses of prazosin hydrochloride, it is recommended that therapy be initiated

with APO-PRAZO (prazosin hydrochloride) at 0.5 mg and that dose increases be instituted

cautiously.

Drug Interactions

Prazosin has been administered without any adverse drug interaction in limited clinical

experience to date with the following: (1) cardiac glycosides - digitalis and digoxin; (2)

hypoglycemics - insulin, chlorpropamide, tolazamide and tolbutamide; (3) tranquilizers and

sedatives - chlordiazepoxide, diazepam and phenobarbital; (4) antigout - allopurinol, colchicine

and probenecid; (5) antiarrhythmics -procainamide, propranolol (see WARNINGS however), and

quinidine; and (6) analgesics, antipyretics and anti-inflammatories - propoxyphene, ASA,

indomethacin and phenylbutazone.

Addition of a diuretic or other antihypertensive agent to prazosin hydrochloride has been

shown to cause an additive hypotensive effect. (See WARNINGS and DOSAGE AND

ADMINISTRATION sections.) An exaggerated hypotensive response has also been observed.

Page 7 of 17

Drug/Laboratory Test Interactions

False positive results may occur in screening tests for pheochromocytoma (urinary

vanillylmandelic acid [VMA] and methoxyhydroxyphenyl glysol (MHPG) urinary metabolites of

norepinephrine in patients who are being treated with prazosin hydrochloride. If an elevated VMA

is found, APO-PRAZO should be discontinued and the patient retested after a month.

ADVERSE REACTIONS

The most common reactions associated with prazosin hydrochloride therapy are postural

dizziness (11%), nausea (9.5%), drowsiness (8.7%), headache (8.4%), palpitations (6.6%), dry

mouth (5.6%), weakness (4.6%), and fatigue/malaise (4.5%). In most instances side effects have

disappeared with continued therapy or have been tolerated with no decrease in dose of drug. The

following reactions have also been observed during prazosin hydrochloride administration.

Gastrointestinal:

vomiting, diarrhea, constipation, abdominal discomfort and/or pain.

Cardiovascular:

syncope (See WARNINGS), orthostatic hypotension, edema,

dyspnea, tachycardia, faintness.

Central Nervous System:

nervousness, vertigo, depression, paresthesia, hallucinations.

Dermatologic:

rash, pruritus, alopecia, lichen planus.

Genitourinary:

urinary frequency, incontinence, impotence, priapism.

EENT:

blurred vision, reddened sclera, epistaxis, tinnitus, nasal

congestion.

Hepatic:

liver function abnormalities, pancreatitis.

Hematologic:

decreased hematocrit/hemoglobin.

Page 8 of 17

Other:

diaphoresis, fever, arthralgia, positive ANA titer.

Single reports of pigmentary mottling and serous retinopathy have been reported. In these

instances, the exact causal relationship has not been established because the baseline

observations were frequently inadequate.

In more specific slit-lamp and funduscopic studies, which included adequate baseline

examinations, no drug-related abnormal ophthalmological findings have been reported.

Literature reports exist associating prazosin hydrochloride therapy with a worsening of pre-

existing narcolepsy. A causal relationship is uncertain in these cases.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms

A few reports of prazosin hydrochloride overdose have been documented with prazosin

hydrochloride. The most frequently observed symptoms of overdose include hypotension and

somnolence.

Accidental ingestion of at least 50 mg of prazosin in a two-year-old child resulted in profound

drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was

uneventful.

Treatment

Should overdosage lead to hypotension, support of the cardiovascular system is of first

importance. Restoration of blood pressure and normalization of heart rate may be accomplished

by keeping the patient in the supine position. If necessary, vasopressors should be used. If this

measure is inadequate, shock should then be treated with volume expanders. Renal function

should be monitored and supported as needed. Laboratory data indicate prazosin is not

dialysable because it is protein bound.

DOSAGE AND ADMINISTRATION

Page 9 of 17

APO-PRAZO CONVENTIONAL RELEASE TABLETS (prazosin hydrochloride)

NOTE:

When titration is to be undertaken using the tablet formulation it will be necessary to

split the 1 mg scored tablet to obtain the 0.5 mg starting dose.

It is recommended that the starting dose of 0.5 mg be given with food preferably with the evening

meal, at least two or three hours before retiring. The dose should be built up gradually with 0.5

mg being given b.i.d. or t.i.d. for at least three days. Unless adverse effects occur and subject to

the blood pressure lowering effect this dose should be increased to 1 mg given b.i.d. or t.i.d. for

at least a further three days.

Thereafter, as determined by the patient's response to the blood pressure lowering effect, the

dose should be increased gradually. Response to APO-PRAZO (prazosin hydrochloride) is

usually seen within one to fourteen days if it is to occur at any particular dose. When a response

is seen, therapy should be continued at that dose until the degree of response has reached the

optimum before the next dose increment is added.

Incremental increases should be continued until a desired effect is achieved or a maximum daily

dose of 20 mg is reached.

The maintenance dose of APO-PRAZO may be given as a twice or three times daily dosage

regimen.

In patients with moderate to severe grades of renal impairment, it is recommended that therapy

be initiated at 0.5 mg daily and that dose increases be instituted gradually.

Use With Other Drugs

Patients Receiving Diuretic Therapy

The diuretic should be reduced to a maintenance dose level for the particular agent and APO-

PRAZO initiated at 0.5 mg h.s. then proceeding to 0.5 mg b.i.d. or t.i.d. After the initial period of

observation, the dose of APO-PRAZO should be gradually increased as determined by the

patient's response.

Patients Receiving Other Antihypertensive Agents

Page 10 of 17

Because some additive effect is anticipated, the other agent (e.g., propranolol* or other beta-

adrenergic blocking agents*, alpha methyldopa, reserpine, clonidine*, etc.) should be reduced

and APO-PRAZO initiated at 0.5 mg h.s. then proceeding to 0.5 mg b.i.d. or t.i.d. Subsequent

dosage increase should be made depending upon the patient's response.

Patients on APO-PRAZO to Whom Other Antihypertensive Agents Are Added

When adding a diuretic or other antihypertensive agent, the dose of APO-PRAZO should be

reduced to 1 mg or 2 mg b.i.d. or t.i.d. and retitration then carried out.

*Appropriate precautions should be observed when the dosage of these other antihypertensive

agents is reduced.

Page 11 of 17

PHARMACEUTICAL INFORMATION

CHEMISTRY

Trade Name:

APO-PRAZO

Proper Name:

Prazosin hydrochloride

Chemical Name:

1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(2-furoyl}-piperazine

hydrochloride.

Structural Formula:

Molecular Formula:

Molecular Weight:

419.9 g/mol

Description:

Prazosin hydrochloride is a white, crystalline substance, slightly

soluble in water and isotonic saline.

Composition:

APO-PRAZO tablets contain prazosin hydrochloride equivalent to

1.0, 2.0 and 5.0 mg of prazosin. The tablets also contain

croscarmellose sodium, lactose, magnesium stearate,

microcrystalline cellulose and polysorbate. The 1 mg tablets also

contain the dyes D&C yellow #10 and FD&C yellow #6.

Stability and Storage Recommendations

Store at room temperature (15°C to 30°C).

Page 12 of 17

DOSAGE FORMS

AVAILABILITY

1 mg:

Each capsule-shaped, peach, flat-faced with bevelled edge tablet, scored and engraved

APO P1 on one side contains prazosin hydrochloride equivalent to 1.0 mg prazosin.

Available in bottles of 100 and 500.

2 mg:

Each round, white, biconvex tablet, scored and engraved APO over P2 on one side,

contains prazosin hydrochloride equivalent to 2.0 mg prazosin. Available in bottles of 100

and 500.

5 mg:

Each diamond shaped, white, biconvex tablet, scored and engraved APO over P5 on one

side, contains prazosin hydrochloride equivalent to 5.0 mg of prazosin. Available in bottles

of 100.

Page 13 of 17

PHARMACOLOGY

Hypotensive Action

The nature of the hypotensive action of prazosin hydrochloride was studied both by in vitro and in

vivo methodology. Intravenously administered prazosin hydrochloride in dogs caused prolonged

hypotension and reduction in total peripheral resistance. Cardiac output, heart rate, and blood

flow in the femoral, renal, and splanchnic vascular beds were increased transiently. Cardiac

responses to electrical stimulation of cardioaccelerator nerves were not depressed, nor was there

sympathetic ganglion or adrenergic neurone blockade. Although prazosin hydrochloride reversed

the epinephrine pressor response in intact animals, vasodilator activity was only slightly

diminished when the vessels were deprived of sympathetic tone by ganglionic blockade.

Physiologic and direct radioligand binding data from studies in experimental animals indicates

that the hypotensive effect of prazosin hydrochloride ascribed to peripheral vasodilation is

achieved primarily by competitive blockade of the vascular postsynaptic alpha

-adrenergic

receptors. As prazosin acts preferentially on postsynaptic alpha

-adrenergic receptors, the

feedback control of neuronal norepinephrine release by presynaptic alpha

-receptors remains

unchanged.

In the dog, the hypotensive effect of prazosin hydrochloride intravenously was reversed by

metaraminol and norephinephrine given by intravenous infusion.

Miscellaneous Actions

At doses considerably higher than those required for antihypertensive activity, prazosin

hydrochloride has mild CNS depressant activity, decreases heart norepinephrine and adrenal

epinephrine in rats, causes diuresis in anesthetized dogs, but fluid retention in conscious dogs

and mice, and is hyperglycemic in rats.

In clinical studies in which lipid profiles were followed, there were generally no adverse changes

noted between pre- and post-treatment lipids levels.

Page 14 of 17

TOXICOLOGY

Acute Toxicity

The results of single-dose acute toxicity studies on prazosin hydrochloride are presented in

Table 1.

TABLE 1

Acute Toxicity of Prazosin Hydrochloride

SPECIES

ORAL

INTRAPERITONEAL

mg/kg

(95% Confidence limits)mg/kg

Mouse

M & F

>5000

84 (62-113)

M & F

>2000

141 (121-165)

The signs of toxicity observed following the administration of this compound were, for the most

part, common to both mice and rats by both routes and included blanching, depression,

decreased respiration, ptosis, writhing, ataxia, tremors and convulsions.

Mongrel dogs given 250 and 500 mg/kg as a single oral dose showed ataxia, depression,

occasional diarrhea, relaxed nictitating membrane, ptosis, and occasional tremors. Tachycardia

was also noted in the three dogs at 250 mg/kg. Anorexia was noted 48 hours post dose in one

dog receiving 500 mg/kg.

Chronic Toxicity

Prazosin hydrochloride was administered to dogs in doses of 2, 10 and 25 mg/kg/day seven days

per week for one year. Testicular atrophy and degeneration accompanied by prostatic atrophy

and fibrosis occurred in male dogs receiving doses of 25 mg/kg/day.

(Urinary 17-ketosteroid excretion in human clinical studies was monitored in 105 patients for any

possible effect on testicular function for periods ranging from 3 to 33 months. A trend analysis of

the 17-ketosteroid data disclosed a seasonal variation, but did not suggest a drug effect. Routine

semen analysis in 27 male patients on prazosin hydrochloride alone for up to 51 months revealed

no semen abnormalities.)

Page 15 of 17

Rats received prazosin hydrochloride in doses of 5, 25, 75 and 150 mg/kg/day for 18 months.

During the first 18 weeks of study, drug-induced hepatocellular degeneration and/or necrosis and

renal corticomedullary necrosis occurred at the dose level of 150 mg/kg; mild hepatocellular

degenerative changes and/or necrosis were found at the dose level of 75 mg/kg.

Between 19 and 53 weeks, the following pathologic changes were observed at dose levels of 150

and 75 mg/kg: testicular necrosis with accompanying inguinal and/or scrotal adhesions; chronic

nephrotoxic nephritis; degenerative folding and contracture of the retina (retinitis proliferans);

adrenal plethora; gastric necrosis and hepatic necrosis. At the dose level of 25 mg/kg, there was

a low percent incidence of testicular, renal and gastric alterations; since these same changes

occurred in larger numbers of animals at the two higher dose levels, they appear drug-related.

Between 54 weeks and 18 months, the following changes occurred at dose levels of 150, 75 and

25 mg/kg: testicular atrophy and/or degeneration with accompanying inguinal and/or scrotal

adhesions; retinitis proliferans (150 and 75 mg/kg levels only) and hepatic degeneration and/or

necrosis. Additionally, bilateral cataracts (not observed previously) occurred at the dose levels of

150 and 75 mg/kg. Chronic nephritis and adrenal plethora (cystic degeneration) which previously

(19 - 53 weeks) had a higher percent incidence at the dose levels of 150, 75 and 25 mg/kg, and

150 and 75 mg/kg respectively, appeared with approximately the same frequency at all dose

levels including the controls.

Carcinogenicity

In a chronic study with rats, prazosin hydrochloride fed at levels up to 75 mg/kg/day for 18

months showed no evidence of carcinogenicity.

Reproductive and Teratologic Studies

Reproductive and teratologic studies were carried out at dose levels of 25 and 75 mg/kg/day in

rats and rabbits. No drug-induced changes were observed.

Page 16 of 17

REFERENCES

1. Awan NA, Miller RR, Maxwell K, Mason DT. Effects of prazosin on forearm resistance and

capacitance vessels. Clin Pharmacol Ther 1977;22( 1):79-84.

2. Brogden RN, Heel RC, Speight TM, Avery GS. Prazosin: a review of its pharmacological

properties and therapeutic efficacy in hypertension. Drugs 1977; 14: 163-97.

3. Cambridge D, Davey MJ, Massingham R. Prazosin, a selective antagonist of post-synaptic

alpha-adrenoceptors. Brit J Pharmacol 1977;59:514P-5P.

4. Colluci WS. Alpha-adrenergic receptor blockade with prazosin. Ann Intern Med 1982;97:67-

5. Curtis JR. Prazosin in patients with chronic renal failure. Br Med J 1974;3:742-43.

6. Davey MJ. The pharmacology of prazosin, an alpha

-adrenoceptor antagonist and the basis

for its use in the treatment of essential hypertension. Clin and Exper Hyper-Theory and

Practice 1982;A4(1-2):47-59.

7. Graham RM, Mulvihil-Wilson J. Clinical pharmacology of prazosin used alone or in

combination in the therapy of hypertension. J Cardiovasc Pharmacol 1980;2(Suppl.3):S387-

S398.

8. Graham RM, Pettinger WA. Prazosin. N Engl J Med 1979;300(5):232-36.

9. Grahnen A, Seideman P, Lindstrom B, Haglund K, von Bahr C. Prazosin kinetics in

hypertension. Clin Pharmacol Ther 1981;30(4):439-46.

10. Hobbs DC, Twomey TM, Palmer RF. Pharmacokinetics of prazosin in man. J Clin Pharmacol

1978; 18(8):402-406.

11. Johnson BF, Romero L, Johnson J, Marwaha R. Comparative effects of propranolol and

prazosin upon serum lipids in thiazide-treated hypertensive patients. Am J Med

1984;76(2A):109-112.

12. Karlberg BE, Thulin T, Fageerberg SE, Scherten B, Tolagen K, Vikesdal O, Malmberg L.

Effects of prazosin on plasma renin activity and blood pressure. J Clin Pharmacol

1979;19(7):357-65.

13. Kincaid-Smith P, Fang P, Laver MC. A new look at the treatment of severe hypertension. Clin

Sci Molec Med 1973;45:75s-87s.

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14. Kincaid-Smith P. Vasodilators in the treatment of hypertension. Med J Aust 1975;1(Spec

Suppl):7-9.

15. Kwan CM, Shepard AMM, Johnson J, Taylor F, Brockway B. Forearm and finger

hemodynamics, blood pressure control, and lipid changes in diabetic hypertensive patients

treated with atenolol and prazosin: a brief report. Am J Med 1989;86:55-58.

16. Leren P, Helgeland A, Holme I, Foss PO, Hjermann I, Lund-Larsen PG. Effect of propranolol

and prazosin on blood lipids: the Oslo Study. Lancet 1984;2(8184):4-6.

17. Lowenstein J, Neusy AJ. Effects of prazosin and propranolol on serum lipids in patients with

essential hypertension. Am J. Med 1984;76:79-84.

18. McAreavey D, Cumming AMM, Sood VP, Leckie BJ, Morton JJ, Murray GD, Robertson JIS.

The effect of oral prazosin on blood pressure and plasma concentrations of renin and

angiotensin II in man. Clin Sci 1981;61:457s-460s.

19. Meredith P, Elliott MH, Vincent J, Reid JA. A clinical pharmacological assessment of a new

osmotic pump formulation of prazosin. Br J Clin Pharmacol 1986;22:235P.

20. Rouffy J, Jaillard J. Comparative effects of prazosin and atenolol on plasma lipids in

hypertensive patients. Am J Med 1984; 76(2A):105-108.

21. Richardson DW, Ramaswamy D, Ramirez A. Effect of prazosin on arterial pressure and

cardiac output in human hypertension. Circulation 1968;38(suppl 6): 164.

22. Symposium. Prazosin: clinical symposium proceedings. Proceedings of a prazosin

symposium, San Francisco, 1974. Postgrad Med 1978 5 Nov; (Spec Suppl). (128 pages).

23. Weber MA, Stokes GS. Treatment of hypertension with an antihypertensive agent possessing

vasodilator activity. Med J Aust 1975;1(Spec Suppl):9-11.

24. Product Monograph – MINIPRESS (prazosin hydrochloride) Tablets, 1.0 mg, 2.0 mg and 5.0

Aspri Pharma Canada Inc.. Date of Revision:

November 2, 2016, Control No.

198268.

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