Back Matter

Once-
i
Triamterene 75 mg/Hydrochlorothiazide SO mg/Lederle
THE FIRST AND ONLY
REPLACEMENT FOR THE LESS
BtOAVAILABLE TRIAMTERENE/
HYDROCHLOROTHIAZIDE
FORMULATION... PROVEN
SUPERIOR IN BIOAVAILABIUTY
Once-a-day
Triamterene 75 mg/Hydrochbrothiazide 50 mg/Lederie
SUPERIOR DRUG DELIVERY AND ABSORPTION —
TABLET TO TABLET, PATIENT TO PATIENT
MAXZIDE is optimally bioavailable and consistently delivers the
prescribed dose of 75 mg triamterene and 50 mg hydrochlorothiazide.
Dyazide®,* on the other nand, exhibits poor bioavailability. When given in
equivalent doses, Dyazide delivers approximately half the amount of
hydrochlorothiazide as MAXZIDE. Similarly, two Dyazide capsules deliver
less than half the amount of triamterene as one MAXZIDE tablet.1
Percent dose of hydrochlorothiazide
recovered from urine over 72 hours In subjects'
given single oral doses
mm M
Percent dose of triamterene recovered from urine
over 72 hours In subjects3 given single oral doses
Mean
Standard
Deviation
D
J
Data from a study of 24 subjects.
HydroDIURIL is the registered trademark of Merck & Co , Inc., for
hydrochlorothiazide.
b
*Data from two studies of 24 subjects each
Once-a-day
Triamterene 75 mg/Hydrochlorothiazide 50 mg/Lederie
ECONOMICAL, ONCE-A-DAY POTASSIUM-SPARING
ANTIHYPERTENSIVE THERAPY
BRIEF SUMMARY
Please see package insert for full prescribing information.
INDICATIONS AND USAGE: MAXZIDE is indicated for the treatment of hypertension
or edema in patients who develop hypokalemia on hydrochlorothtazide alone. It is
also indicated for those patients who require a thiazide diuretic and in whom the
development of hypokalemia cannot be risked {e.g., patients on digitalis preparations or with a history of cardiac arrhythmias, etc.). This fixed combination drug Is
not Indicated for the Initial therapy of edema or hypertension except In Individuals
In whom the development of hypokalemia cannot be risked. MAXZIDE may be used
alone or in combination with other antihypertensive drugs such as beta-blockers.
Since MAXZIDE may enhance the actions of these drugs, dosage adjustments may
be necessary Usage m Pregnancy The routine use of diuretics in an otherwise
healthy woman is inappropriate and exposes mother and fetus to unnecessary hazards Diuretics do not prevent development of toxemia in pregnancy, and there is no
satisfactory evidence that they are useful in the treatment of developed toxemia.
CONTRAINDICATIONS: Hyperkalemia: MAXZIDE should not be used in the presence
of elevated serum potassium levels (greater than 5.5 mEo/liter). If hyperkalemia
develops, this drug should be discontinued and a thiazide alone should be substituted. Concomitant use with other potassium conserving agents such as spironolactone. amiloride HCI or other formulations containing triamterene. Concomitant
potassium supplementation in the form of medication, potassium-containing salt
substitute or potassium-enriched diets should also not be used. Contraindicated
m patients with anuria, acute and chronic renal insufficiency or significant renal
impairment- Hypersensitivity to either component separately or other sulfonamidederived drugs.
WARNINGS: Hyperkalemia.
Abnormal elevation of serum potassium levels (greater than or equal to 5.5
mEcj/liter) can occur with all potassium conserving agents including MAXZIDE.
Hyperkalemia is more likely to occur in patients with renal impairment, diabetes (even without evidence of renal impairment), or elderly or severely ill
patients. Since uncorrected hyperkalemia maybe fatal, serum potassium levels must be monitored at frequent intervals especially in patients first receiving MAXZIDE, when dosages are changed, or with any illness that may
influence renal function
If hyperkalemia is suspected, (warning signs include paresthesias, muscular
weakness, fatigue, flaccid paralysis of the extremities, oradycardia and shock) an
electrocardiogram (ECG) should be obtained Monitor serum potassium levels
because mild hyperkalemia may not be associated with ECG changes. If hyperkalemia is present, MAXZIDE should be discontinued immediately and a thiazide alone
should be substituted If the serum potassium level exceeds 6.5mEQ/liter. more
vigorous therapy is required. The clinical situation dictates the procedurea0b$)
employed These include the intravenous administration of calcn^g^pfgf
solution, sodium bicarbonate solution ant"
"
glucose with a rapid acting insulin pn
sodium polystyrene sulfonate may be
hyperkalemia may require dialysis, li
with potassium-sparing diuretics is a\
a/ impaironal impairment
nt (see CONTRAINDICATIONS). Pat
finued monitoring of serum
should not receive this drug without ft
electrolytes.
. . _ , _ _ Cumulative
__ . _ _ _ drug
_ _ „ _effects _,
,d in patients with impaired
renal function. The renal clearances of hydrochlorothiazide. the pharmacologically
active metabolite of triamterene, and the sulfate ester of hydroxytriamterene have
been shown to be reduced and the plasma levels increased following MAXZIDE
administration to elderly patients and patients with impaired renal function Hyperkalemia has been reported in diabetic patients with the use of potassium conserving agents even in the absence of apparent renal impairment Avoid MAXZIDE in
diabetic patients If it is employed, serum electrolytes must be frequently monitored Metabolic or Respiratory Acidosis: Potassium conserving therapy should also
be avoided in severely ill patients In whom respiratory or metabolic acidosis may
occur, since acidosis may be associated with rapid elevations in serum potassium
levels. If MAXZIDE" triamterene 75mg/hydrochkxothiazide SOmg is employed,
frequent evaluations of acid/base balance wd serum electrolytes are necessary
PRECAUTIONS: Electrolyte Imbalance and BUN Increases Patients receiving
MAXZIDE should be carefully monitored for fluid or electrolyte imbalances, i.e.,
hyponatremia. hypochforemic alkatosis. hypokalemia and hypomagnesemia.
Serum and urine electrolyte determinations should be frequently performed and
are especially important when the patient is vomiting or receiving parenteral fluids.
Warning signs or symptoms of fluid and electrolyte imbalance include, dryness of
mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or
cramps, muscular fatigue, hypotension, oliguha. tachycardia and gastrointestinal
disturbances such as nausea and vomiting
Any chloride deficit during thiazide therapy is generally mild and usually does not
require any specific treatment except under extraordinary circumstances (as in
liver disease or renal disease) DHutional hyponatremia may occur in edematous
patients in hot weather: appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life threatening In actual salt depletion, appropriate replacement is the therapy of choice.
Hypokalemia may develop with thiazide therapy, especially with brisk diuresis,
when severe cirrhosis is present, or during concomitant use of corticosteroids.
ACTH, amphotericm B or after prolonged thiazide therapy However, hypokalemia of
this type is usually prevented by the triamterene component of MAXZIDE
Interference with adequate oral electrolyte intake will also contribute to hypokalemia Hypokalemia can sensitize or exaggerate the response of the heart to the
toxic effects of digitalis (e.g.. increased ventricular irritability).
MAXZIDE may produce an elevated blood urea nitrogen level (BUN), creatinine
level or both. This is probably not the result of renal toxicity but is secondary to a
reversible reduction of the glomerular filtration rate or a depletion of the intravascular fluid volume Periodic BUN and creatinine determinations should be made
especially in elderly patients, patients with suspected or confirmed hepatic disease
or renal insufficiencies. If azotemia increases. MAXZIDE should be discontinued
Hepatic Coma: MAXZIDE should be used with caution in patients with impaired
hepatic function or progressive liver disease, since minor alterations of fluid and
electrolyte balance may precipitate hepatic coma Renal Stones Triamterene has
been reported in renal stones in association with other calculus components.
MAXZIDE should be used with caution in patients with histories of renal lithiasis.
Folic Add Deficiency: Triamterene is a weak folic acid antagonist and may contribute to the appearance of megaloblastosis in instances where folic acid stores are
decreased In such patients, periodic blood evaluations are recommended. Hyperuricemia Hyperuncemia may occur or acute gout may be precipitated in certain
patients receiving thiazide therapy Metabolic and Endocrine Effects: The thiazides
may decrease serum PBI levels without signs oHhyroid disturbance.
Calcium excretion is decreased by thiazides. Pathological changes in the parathyroid gland with hypercalcemia and hypophosphatemia have been observed in a
few patients on prolonged thiazide therapy. The common complications ofhyperpara thyroid ism such as renal lithiasis, bone resorption, and peptic ulceration have
not been seen. Thiazides should be discontinued before carrying out tests for parathyroid function.
Insulin requirements in diabetic patients may be increased, decreased or
unchanged Latent diabetes mellitus may become manifest during thiazide administration Hypersensitivity: Sensitivity reactions to thiazides may occur in patients
with or without a history of allergy or bronchial asthma.
Possible exacerbation or activation of systemic lupus erythematosus by thiazides
has been reported Drug Interactions: Thiazides may add to or potentiate the action
of other antihypertensive drugs.
The thiazides may decrease arterial responsiveness to norepinephnne. This
diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase responsiveness to
tubocurarine.
Lithium, when given with diuretics, reduces renal clearance and increases the
risk of lithium toxicity. Refer to the package insert on lithium before use of such
concomitant therapyAcute renal failure has been reported in a few patients receiving indomethacin
and other formulations containing triamterene and hydrochlorothiazide Caution is
therefore advised when administering nonsteroidal anti-inflammatory agents with
MAXZIDE.
Drug/Laboratory Test (Qteractions Tnawtertne and quinidine have similar
fluorescence spectra: trwm MAXZS^, may interfere with the measurement of
=£- —
— _
^
ZIDE in pregnancy has not been
e not been conducted with
roWiazioe 50mg. It is also not known if
nmtstered to a pregnant woman or can
ilazides cross the placental barrier and appear in
Tiiazides in pregnant women requires that the anticipated
eighed against possible hazards to the fetus. These hazards include
_ __ Jr neonatal jaundice, thrombocytopenia. pancreatitis, and possibly other
adverse reactions which have occurred in the adult. MAXZIDE should be given to a
pregnant woman only if clearly needed
Nursing Mothers Thiazides appear in breast milk. If the use of MAXZIDE is
deemed essential the patient should stop nursing. PediatricUse: Thesafetyand
effectiveness of MAXZIDE in children has not been established.
ADVERSE REACTIONS: Side effects observed in association with the use of
MAXZIDE include drowsiness and fatigue, insomnia, muscle cramps and weakness, headache, nausea, appetite disturbance, vomiting, diarrhea, constipation,
dizziness, decreased sexual performance, shortness ofbreath and chest pain, dry
mouth, depression and anxiety. These adverse reactions are common to other
triamterene and hydrochlorothiazide containing products. Other adverse reactions
include.
Hydrqchloroth iazide
Gastrointestinal: anorexia, gastric irritation, cramping, jaundice (intrahepatic
cholestatic jaundice), pancreatitis, sialadenitis Central Nervous System: vertigo,
paresthesias. xanthopsia. H^n^tojpgic leukopenia. agranuhcytosls. thrombocytopenia. aplastic anemia, hemofytic anemia, megaloblastosis Cardiovascular
orthostatic hypotension (may be aggravated by alcohol, barbiturates, or narcotics).
Hypersensitivity anaphytaxis. purpura, photosensitivity, rash, urticaria, necrotizing angntisfvasculitis. cutaneous vasculitis). fever, respiratory distress including
pneumomtis Other hyperglycemia. glycosuna. hyperuncemia. restlessness, transient blurred vision.
Triamterene:
Hypersensitivity: anaphyiaxis, photosensitivity and rash. Other: Triamterene has
been reported in renal stones in association with other calculus materials. Triamterene has been associated with blood dyscrasias. Whenever adverse reactions
are moderate to severe, therapy should be reduced or withdrawn.
DOSAGE AND ADMINISTRATION: The recommended dosage of MAXZIDE is one tablet daily with appropriate monitoring of serum potassium levels (see WARNINGS).
Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be
transferred to MAXZIDE directly. In patients requiring 50 mg of hydrochlorothiazide
in whom hypokalemia cannot be risked, therapy may be initiated with MAXZIDE
There is no clinical experience with doses exceeding one tablet daily
Clinical studies have shown that patients already taking less bioavailabfe formulations of triamterene and hydrochlorothiazide (totaling 50100 mg of hydrochlorqthiazide and 100-200 mg of triamterene) may be safely changed to one MAXZIDE"
triamterene 75mg/hydrochlorothtazide 50mg tablet per day: these patients should
be monitoredcUnicany and with serum potassium after the transfer.
LEDERLE LABORATORIES
\ A Division of American Cyanamid Company
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BEHIND THE FACE Catapres
OF HYPERTENSION (clonidineHCI)
Hypertension
New evidencefor central control
Catapres®
(clonidine hydrochloride)
Tablets of 0.1, 0.2, 0.3 mg
Indication: The drug is indicated in the treatment of hypertension. As an antihypertensive drug, Catapres (clonidine hydrochloride) is mild to moderate in potency. It may be employed in a general treatment program with a diuretic and/or
other antihypertensive agents as needed for proper patient response.
Warnings: Tolerance may develop in some patients necessitating a reevaluation of therapy.
Usage in Pregnancy: In view of embryotoxic findings in animals, and since
information on possible adverse effects in pregnant women is limited to uncontrolled clinical data, the drug is not recommended in women who are or may
become pregnant unless the potential benefits outweigh the potential risk to
mother and fetus.
Usage in Children: No clinical experience is available with the use of Catapres
(clonidine hydrochloride) in children.
Precautions: When discontinuing Catapres (clonidine hydrochloride), reduce
the dose gradually over 2 to 4 days to avoid a possible rapid rise in blood
pressure and associated subjective symptoms such as nervousness, agitation,
and headache. Patients should be instructed not to discontinue therapy without
consulting their physician. Rare instances of hypertensive encephalopathy and
death have been recorded after cessation of clonidine hydrochloride therapy. A
causal relationship has not been established in these cases. It has been
demonstrated that an excessive rise in blood pressure, should it occur, can be
reversed by resumption of clonidine hydrochloride therapy or by intravenous
phentqlamine. Patients who engage in potentially hazardous activities, such as
operating machinery or driving, should be advised of the sedative effect. This
drug may enhance the CNS-depressive effects of alcohol, barbiturates and
other sedatives. Like any other agent lowering blood pressure, clonidine hydrochloride should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease or chronic renal
failure.
As an integral part of their overall long-term care, patients treated with
Catapres (clonidine hydrochloride) should receive periodic eye examinations.
While, except for some dryness of the eyes, no drug-related abnormal
ophthalmologic findings have been recorded with Catapres (clonidine hydrochloride), in several studies the drug produced a dose-dependent increase in the
incidence and severity of spontaneously occurring retinal degeneration in albino rats treated for 6 months or longer.
Adverse Reactions: The most common reactions are dry mouth, drowsiness
and sedation. Constipation, dizziness, headache, and fatigue have been reported. Generally these effects tend to diminish with continued therapy. The
following reactions have been associated with the drug, some of them rarely. (In
some instances an exact causal relationship has not been established.) These
include: Anorexia, malaise, nausea, vomiting, parotid pain, mild transient abnormalities in liver function tests; one report of possible drug-induced hepatitis
without icterus and hyperbilirubinemia in a patient receiving clonidine hydrochloride, chlorthalidone and papaverine hydrochloride. Weight gain, transient
elevation of blood glucose, or serum creatine phosphokinase; congestive heart
failure, Raynaud's phenomenon; vivid dreams or nightmares, insomnia, other
behavioral changes, nervousness, restlessness, anxiety and mental depression. Also rash, angioneurotic edema, hives, urticaria, thinning of the hair,
pruritus not associated with a rash, impotence, urinary retention, increased
sensitivity to alcohol, dryness, itching or burning of the eyes, dryness of the
nasal mucosa, pallor, gynecomastia, weakly positive Coombs' test, asymptomatic electrocardiographic abnormalities manifested as Wenckebach period or
ventricular trigeminy.
Overdosage: Profound hypotension, weakness, somnolence, diminished or
absent reflexes and vomiting followed the accidental ingestion of Catapres
(clonidine hydrochloride) by several children from 19 months to 5 years of age.
Gastric lavage and administration of an analeptic and vasopressor led to
complete recovery within 24 hours. Tolazoline in intravenous doses of 10 mg at
30-minute intervals usually abolishes all effects of Catapres (clonidine hydrochloride) overdosage.
How Supplied: Catapres, brand of clonidine hydrochloride, is available as 0.1
mg (tan) and 0.2 mg (orange) oval, single-scored tablets in bottles of 100 and
1000 and unit dose package of 100. Also available as 0.3 mg (peach) oval,
single-scored tablets in bottles of 100.
For complete details, please see full prescribing information.
Under license from Boehringer Ingelheim International GmbH
Reference:
1. Pioneering Research in Hypertension: The Role of the Sympathetic Nervous System, film and monograph, Boehringer Ingelheim Ltd., 1982.
mum )
VBOEHRINGER/
Boehringer
Innolhoim
Boehringer Ingelheim Ltd.
Ridgefield, CT 06877
Initial therapy should
start hypertensive patients
offright
Brief Summary
MINIPRESS • (prazosin hydrochloride) Capsules
For Oral Use
INDICATIONS: MINIPRESS (prazosin hydrochloride) is indicated in the treatment of hypertension. As an antihypertensive drug, it is mild to moderate in activity. II can be used as the initial agent or it may be employed in a general treatment
program in conjunction with a diuretic and/or other anlihypertensive drugs as
needed for proper patient response.
WARNINGS: Minipress may cause syncope 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
preceded by a bout of severe tachycardia with heart rates of 120-160
beats per minute. Syncopal episodes have usually occurred within 30 to
90 minutes of the initial dose of the drug; occasionally they have been reported in association with rapid dosage increases or the introduction of
another antihypertensive drug into the regimen of a patient taking high
doses of MINIPRESS. The incidence of syncopal episodes is approximately 1 % in patients given an initial dose of 2 mg or greater. Clinical
trials conducted during the investigational phase of this drug suggest that
syncopal episodes can be minimized by limiting the initial dose ot the
drug to 1 mg, by subsequently increasing the dosage slowly, and by introducing any additional antihypertensive drugs into the patient's regimen
with caution. (See DOSAGE AND ADMINISTRATION.) Hypotension may
develop in patients given MINIPRESS who are also receiving a betablocker such as propranolol.
If syncope occurs, the patient should be placed in the recumbent position and
treated supportively as necessary. Tfiis adverse effect is self-limiting and in most
cases does not recur after the initial period of therapy or during subsequent dose
ti (ration
• Patients'should always be started on the 1 mg capsule o! MINIPRESS. The 2
and 5 mg capsules are not indicated for initial therapy.
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 eftectsand advised what
measures to take should they develop. The patient should also be cautioned to
avoid situations where injury could result should syncope occur during the initiation of MINIPRESS therapy.
Usage in Pregnancy: Although no teratogenic ellects were seen in animal
testing, the safety of MINIPRESS in pregnancy has not been established.
MINIPRESS is not recommended in pregnant women unless the potential benefit
outweighs potential risk to mother and fetus.
Usage in Children: No clinical experience is available with the use ol
MINIPRESS in children.
ADVERSE REACTIONS: The most common reactions associated with
MINIPRESS therapy are: dizziness 10.3%. headache 7.8%. drowsiness 7.6%, lack
of energy 6.9%. weakness 6.5%, palpitations 5.3%, and nausea 4.9%. 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 been associated with MINIPRESS some of (hem
rarely. (In some instances exact causal relationships have not been established.)
Gastrointestinal: vomiting, diarrhea, constipation, abdominal discomfort and/
or pain.
Cardiovascular: edema, dyspnea, syncope, tachycardia.
Central Nervous System: nervousness, vertigo, depression, paresthesia.
Dermatoiogic: rash, pruritus, alopecia, lichen planus.
Genitourinary: urinary frequency, incontinence, impotence, priapism.
EENT: blurred vision, reddened sclera, epistaxis. tinnitus, dry mouth, nasal
congestion.
Other: diaphoresis.
Single reports of pigmentary mottling and serous retinopalhy, and a lew reports
of cataract development or disappearance 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 lunduscopic studies, which included adequate
baseline examinations, no drug-related abnormal ophthalmological findings have
been reported.
DOSAGE AND ADMINISTRATION: The dose ol MINIPRESS should beadjusted
according to the patient's individual blood pressure response. The following is a
guide to its administration:
Initial Dose: 1 mg two or three limes a day. (See WARNINGS.)
Maintenance pose: Dosage may be slowly increased to a total daily dose ol
20 mg given in divided doses. The therapeutic dosages most commonly employed
have ranged Irom 6 mg to 15 mg daily given in divided doses. Doses higher than
20 mg usually do nol increase efficacy: however a few patients may benefit Irqm
further increases up to a daily dose o! 40 mg given in divided doses. Alter initial
tilration some patients can be maintained adequately on a twice daily dosage
regimen.
Use With Other Drugs: When adding a diuretic or other antihypertensive
agent, the dose of MINIPRESS should be reduced to 1 mg or 2 mg three times a
day and retitration then carried out.
OVERDOSAGE: Accidental ingestion ol at least 50 mg ol MINIPRESS in a two
year old child resulted in profound drowsiness and depressed reflexes. No decrease in blood pressure was noted. Recovery was unevenilul.
Should overdosage lead to hypotension, support of the cardiovascular system
is ol first importance. Restoration of blood pressure and normalization of heart
rale may be accomplished by keeping the patient in the supine position. II this
measure is inadequate, shock should first be treated with volume expanders. II
necessary, vasopressors should then be used. Renal function should be monitored
and supported as needed. Laboratory data indicate MINIPRESS is not dialysable
because it is protein bound.
TOXICOLOGY: Testicular changes, necrosis and atrophy have occurred at 25 mg/
kg/day (60 times the usual maximum recommended dose ol 20 mg per day in humans) in long term (one year or more) studies in rats and dogs. No testicular
changes were seen in rats or dogs at the 10 mg/kg/day level (24 times the usual
maximum recommended dose of 20 mg per day in humans). In view of the testicular changes observed in animals. 105 patients on long term MINIPRESS
(prazosin hydrochloride) therapy were monitored lor 17-ketosteroid excretion and
<s 1983, Pfizer Inc.
no changes indicating a drug effect were observed. In addition, 27 males on
MINIPRESS (prazosin hydrochloride) alone for up to 51 months did not demonstrate changes in sperm morphology suggestive of drug effect.
HOW SUPPLIED: MINIPRESS isavaitable in 1 mg (white #431). 2 mg (pink and
white #437) capsules in bottles of 250,1000, and unit dose institutional packages ol 100 (10 x 10's); and 5 mg (blue and white #438} capsules in bottles ol
250, 500 and unit dose institutional packages of 100 (10 x 10's).
More detailed information available on request.
References: 1. Pitts NE: The clinical evaluation ol prazosin, a new anlihypertensive agenl, in Prazosin Clinical Symposium Proceedings. Published as a special
report by Postgraduate Medicine, New York, McGraw-Hill Book and Education
Services Group, 1975, pp 117-127.2. Adapted from Kaplan NM: Summary: J CardiovascPharmacol 4 (suppl 2): S265,1982. 3 . Lund-JohansenP:Hemodynamic
changes at rest and during exercise in long-term prazosin therapy for essential hypertension, in Prazosin Clinical Symposium Proceedings. Published as a special
report by Postgraduate Medicine, New York, McGraw-Hill Book and Education
Services Group, 1975. pp 45-52.
Minipress
nra7f)Pin up|\MCapsules1mg2mg,5mg
or Initial Therapy
in Hypertension
Pfizer
LABORATORIES DIVISION
PFIZER INC.