A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Inderal Indications, Dosage, Storage, Stability - Propranolol
Inderal Indications, Dosage, Storage, Stability - Propranolol
INDICATIONS
Hypertension
Propranolol HCl is indicated in the management of hypertension.
It may be used alone or used in combination with other antihypertensive
agents, particularly a thiazide diuretic. Propranolol HCl is not
indicated in the management of hypertensive
emergencies.
Angina Pectoris Due to Coronary Atherosclerosisa
Propranolol HCl is indicated for the long-term management of patients
with angina pectoris.
Cardiac Arrhythmias
Supraventricular arrhythmias:
a) Paroxysmal atrial
tachycardias, particularly those arrhythmias induced by catecholamines
or digitalis or associated
with the Wolff-Parkinson-White syndrome. (See WARNINGS)
b) Persistent sinus
tachycardia which
is noncompensatory and impairs the well-being of the patient.
c) Tachycardias and arrhythmias due to thyrotoxicosis
when causing distress or increased hazard and when immediate
effect is necessary as
adjunctive, short-term (2 to 4 weeks) therapy. May be used with,
but not in place of, specific
therapy. (See WARNINGS)
d) Persistent atrial
extrasystoles which impair the well-being of the patient
and do not respond to conventional measures.
e) Atrial flutter
and fibrillation
when ventricular
rate cannot be controlled
by digitalis alone,
or when digitalis
is contraindicated.
Ventricular tachycardias:
Ventricular arrhythmias do not respond to propranolol as predictably
as do the supraventricular
arrhythmias.
a) Ventricular tachycardias: With the exception of
those induced by catecholamines or digitalis, Propranolol HCl is
not the drug of first choice. In
critical situations
when cardioversion
techniques or other drugs are not indicated or are not effective,
Propranolol HCl may be considered. If, after consideration of the
risks involved, Propranolol HCl is used, it should be given intravenously
in low dosage and very
slowly. (See DOSAGE AND ADMINISTRATION
.)
Care in the administration of Propranolol HCl with constant
electrocardiographic monitoring is essential
as the failing heart requires
some sympathetic
drive for maintenance
of myocardial tone.
b) Persistent premature
ventricular extrasystoles
which do not respond to conventional measures and impair the well-being
of the patient.
Tachyarrhythmias of digitalis
intoxication: If digitalis-induced tachyarrhythmias persist
following discontinuance of digitalis
and correction of electrolyte
abnormalities, they are usually reversible
with oral Propranolol HCl. Severe bradycardia
may occur. (See OVERDOSAGE)
Intravenous propranolol hydrochloride
is reserved for life-threatening arrhythmias. Temporary maintenance
with oral therapy may be
indicated. (See DOSAGE AND ADMINISTRATION
.)
Resistant tachyarrhythmias due to excessive catecholamine
action during anesthesia: Tachyarrhythmias due to excessive
catecholamine action during anesthesia
may sometimes arise because of release
of endogenous catecholamines or administration
of catecholamines. When usual measures fail in such arrhythmias,
Propranolol HCl may be given intravenously to abolish them. All
general inhalation
anesthetics produce some degree
of myocardial depression. Therefore, when Propranolol HCl is used
to treat arrhythmias during anesthesia, it should be used with extreme
caution and constant ECG
and central venous
pressure monitoring.
(See WARNINGS)
Myocardial Infarction
Propranolol HCl is indicated to reduce
cardiovascular
mortality in patients who have survived the acute
phase of myocardial
infarction and are
clinically stable.
Migraine
Propranolol HCl is indicated for the prophylaxis
of common migraine headache. The efficacy of propranolol in the
treatment of a migraine
attack that has started has not been established, and propranolol
is not indicated for such use.
Essential Tremor
Propranolol HCl is indicated in the management of familial
or hereditary essential tremor. Familial or essential
tremor consists of involuntary,
rhythmic, oscillatory movements, usually limited to the upper limbs.
It is absent at rest but
occurs when the limb is
held in a fixed posture
or position against gravity and during active movement. Propranolol
HCl causes a reduction
in the tremor amplitude
but not in the tremor
frequency. Propranolol HCl is not indicated for the treatment
of tremor associated
with Parkinsonism.
Hypertrophic Subaortic Stenosis
Propranolol HCl is useful in the management of hypertrophic subaortic
stenosis, especially for treatment
of exertional or other stress-induced angina, palpitations, and
syncope. Propranolol HCl also improves exercise performance. The
effectiveness
of propranolol hydrochloride
in this disease appears to be due to a reduction
of the elevated outflow
pressure gradient,
which is exacerbated by beta-receptor stimulation. Clinical improvement
may be temporary.
Pheochromocytoma
After primary treatment
with an alpha-adrenergic blocking
agent has been instituted,
Propranolol HCl may be useful as adjunctive therapy if the
control of tachycardia
becomes necessary before of during surgery.
It is hazardous to use Propranolol HCl unless alpha-adrenergic
blocking drugs are already in use, since this would predispose to
serious blood pressure elevation. Blocking only the peripheral
dilator (beta) action
of epinephrine leaves
its constrictor
(alpha) action unopposed.
In the event of hemorrhage
or shock, there is a disadvantage in having both beta and alpha
blockade since the
combination prevents the increase in heart rate and peripheral
vasoconstriction
needed to maintain blood
pressure.
With inoperable
or metastatic pheochromocytoma, Propranolol HCl may be useful as
an adjunct to the management
of symptoms due to excessive beta-receptor stimulation.
DOSAGE AND ADMINISTRATION
Oral
The dosage range
for Propranolol HCl is different for each indication.
Hypertension: Dosage must be individualized.
The usual initial dosage
is 40 mg Propranolol HCl
twice daily, whether used alone or added to a diuretic. Dosage may
be increased gradually until adequate blood pressure
control is achieved.
The usual maintenance dosage
is 120 mg to 240 mg per
day. In some instances a
dosage of 640 mg
a day may be required. The time
needed for full antihypertensive
response to a given
dosage is variable
and may range from a few
days to several weeks.
While twice-daily dosing is effective and can maintain a reduction
in blood pressure throughout
the day, some patients, especially when lower doses are used, may
experience a modest
rise in blood pressure
toward the end of the 12-hour dosing interval. This can be evaluated
by measuring blood pressure
near the end of the dosing
interval to determine
whether satisfactory control
is being maintained throughout the day. If control is not adequate,
a larger dose, or 3-times-daily therapy may achieve better control.
Angina Pectoris: Dosage must be individualized.
Total daily doses of 80 mg
to 320 mg, when administered orally, twice a day, three times a
day, or four times a day, have been shown to increase exercise tolerance
and to reduce ischemic
changes in the ECG. If treatment is to be discontinued, reduce
dosage gradually over
a period of several weeks.
(See WARNINGS)
Arrhythmias: 10 mg
to 30 mg three or four times
daily, before meals and at bedtime.
Myocardial Infarction: The recommended daily dosage
is 180 mg to 240 mg
per day in divided doses.
Although a t.i.d. regimen
was used in the Beta-Blocker Heart Attack Trial and a q.i.d. regimen
in the Norwegian Multicenter Trial, there is a reasonable basis
for the use of either a t.i.d. or b.i.d. regimen
(see CLINICAL PHARMACOLOGY.)
The effectiveness
and safety of daily dosages greater than 240 mg
for prevention of
cardiac mortality have
not been established. However, higher dosages may be needed to effectively
treat coexisting diseases such as angina
or hypertension
(See DOSAGE AND ADMINISTRATION
).
Migraine: Dosage must be individualized.
The initial oral
dose is 80 mg
Propranolol HCl daily in divided doses. The usual effective dose
range is 160 mg
to 240 mg per
day. The dosage may be increased gradually to achieve optimum
migraine prophylaxis.
If a satisfactory response
is not obtained within four to six weeks after reaching the maximum
dose, Propranolol HCl therapy should be discontinued. It may be
advisable to withdraw the drug
gradually over a period
of several weeks.
Essential Tremor: Dosage must be individualized.
The initial dosage
is 40 mg Propranolol HCl
twice daily. Optimum reduction of essential
tremor is usually achieved
with a dose of 120 mg
per day. Occasionally, it
may be necessary to administer 240 mg
to 320 mg per
day.
Hypertrophic Subaortic Stenosis: 20 mg
to 40 mg three or four times
daily, before meals and at bedtime.
Pheochromocytoma: Preoperatively¾60
mg daily in divided doses for three days prior to surgery, concomitantly
with an alpha-adrenergic blocking
agent.
Management of inoperable
tumor: 30 mg daily
in divided doses.
Use in Children: Intravenous administration
of Propranolol HCl is not recommended in children. Oral dosage
for treating hypertension requires individual titration, beginning
with a 1.0 mg per
kg (body weight) per day
dosage regimen
(i.e., 0.5 mg per
kg b.i.d.).
The usual pediatric
dosage range
is 2 mg to 4 mg
per kg
per day in two equally divided
doses (i.e., 1.0 mg
per kg
b.i.d. to 2.0 mg per kg b.i.d.).
Pediatric dosage calculated
by weight (recommended)
generally produces propranolol plasma
levels in a therapeutic
range similar to that
in adults. On the other hand, pediatric
doses calculated on the basis
of body surface area
(not recommended) usually result in plasma
levels above the mean adult
therapeutic range.
Doses above 16 mg per
kg per
day should not be used in children. If treatment
with Propranolol HCl is to be discontinued, a gradually decreasing
dose titration
over a 7- to 14-day period is necessary.
Intravenous
Parenteral drug products
should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution
and container permit. Intravenous administration
is reserved for life-threatening arrhythmias or those occurring
under anesthesia. The usual dose
is from 1 mg to 3 mg
administered under careful monitoring, (e.g., electrocardiographic,
central venous pressure).
The rate of administration
should not exceed 1 mg (1
ml) per minute to diminish
the possibility of lowering blood
pressure and causing cardiac
standstill. Sufficient time
should be allowed for the drug to reach the site
of action even when a
circulation
is present. If necessary, a second dose
may be given after two minutes. Thereafter, additional drug
should not be given in less than four hours. Additional Propranolol
HCl should not be given when the desired alteration in rate and/or
rhythm is achieved.
Transference to oral therapy
should be made as soon as possible.
The intravenous
administration
of Propranolol HCl has not been evaluated adequately in the management
of hypertensive
emergencies.
Store at room temperature
(approximately 25° C). Dispense in well-closed, light-resistant
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