Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3126
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Inderal (Tablet)
|
| dailymed-instance:dosage |
General: Because of the variable bioavailability of propranolol,
the dose should be individualized based on response.<br/>Hypertension: The usual initial dosage is 40 mg Inderal 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.<br/>Angina Pectoris: Total daily doses of 80 mg to 320 mg Inderal,
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.<br/>Atrial Fibrillation: The recommended dose is 10 mg to 30 mg Inderal
three or four times daily before meals and at bedtime.<br/>Myocardial Infarction: In the Beta-Blocker Heart Attack Trial (BHAT), the
initial dose was 40 mg t.i.d., with titration after 1 month to 60
mg to 80 mg t.i.d. as tolerated. The recommended daily dosage is 180 mg
to 240 mg Inderal per day in divided doses. Although a t.i.d.
regimen was used in the BHAT 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 . 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 above).<br/>Migraine: The initial dose is 80 mg Inderal 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, Inderal therapy
should be discontinued. It may be advisable to withdraw the drug gradually
over a period of several weeks.<br/>Essential Tremor: The initial dosage is 40 mg Inderal 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.<br/>Hypertrophic Subaortic Stenosis: The usual dosage is 20 mg to 40 mg Inderal
three or four times daily before meals and at bedtime.<br/>Pheochromocytoma: The usual dosage is 60 mg Inderal daily in divided
doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic
blockade. For the management of inoperable tumors, the usual dosage
is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic
blockade.
|
| dailymed-instance:descripti... |
Inderal (propranolol hydrochloride)
is a synthetic beta-adrenergic receptor blocking agent chemically
described as 2-Propanol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-,
hydrochloride,(��)-. Its molecular and structural formulae are: Propranolol hydrochloride is a stable, white, crystalline
solid which is readily soluble in water and ethanol. Its molecular
weight is 295.80. Inderal is available as 10 mg,
20 mg, 40 mg, 60 mg, and 80 mg tablets for oral
administration. The inactive ingredients contained
in Inderal Tablets are: lactose, magnesium stearate, microcrystalline
cellulose, and stearic acid. In addition, Inderal 10 mg and 80 mg
Tablets contain FD&C Yellow No. 6 and D&C Yellow No. 10; Inderal
20 mg Tablets contain FD&C Blue No. 1; Inderal 40 mg
Tablets contain FD&C Blue No. 1, FD&C Yellow No. 6, and D&C
Yellow No. 10; Inderal 60 mg Tablets contain D&C Red
No. 30.
|
| dailymed-instance:clinicalP... |
General: Propranolol is a nonselective beta-adrenergic receptor
blocking agent possessing no other autonomic nervous system activity.
It specifically competes with beta-adrenergic receptor agonist agents
for available receptor sites. When access to beta-receptor sites is
blocked by propranolol, the chronotropic, inotropic, and vasodilator
responses to beta-adrenergic stimulation are decreased proportionately.
At dosages greater than required for beta blockade, propranolol also
exerts a quinidine-like or anesthetic-like membrane action, which
affects the cardiac action potential. The significance of the membrane
action in the treatment of arrhythmias is uncertain.<br/>Mechanism of Action: The mechanism of the antihypertensive effect of propranolol
has not been established. Factors that may contribute to the antihypertensive
action include: (1) decreased cardiac output, (2) inhibition of renin
release by the kidneys, and (3) diminution of tonic sympathetic nerve
outflow from vasomotor centers in the brain. Although total peripheral
resistance may increase initially, it readjusts to or below the pretreatment
level with chronic use of propranolol. Effects of propranolol on plasma
volume appear to be minor and somewhat variable. In angina pectoris, propranolol generally reduces the oxygen requirement
of the heart at any given level of effort by blocking the catecholamine-induced
increases in the heart rate, systolic blood pressure, and the velocity
and extent of myocardial contraction. Propranolol may increase oxygen
requirements by increasing left ventricular fiber length, end diastolic
pressure, and systolic ejection period. The net physiologic effect
of beta-adrenergic blockade is usually advantageous and is manifested
during exercise by delayed onset of pain and increased work capacity. Propranolol exerts its antiarrhythmic effects in concentrations
associated with beta-adrenergic blockade, and this appears to be its
principal antiarrhythmic mechanism of action. In dosages greater than
required for beta blockade, propranolol also exerts a quinidine-like
or anesthetic-like membrane action, which affects the cardiac action
potential. The significance of the membrane action in the treatment
of arrhythmias is uncertain. The mechanism
of the antimigraine effect of propranolol has not been established.
Beta-adrenergic receptors have been demonstrated in the pial vessels
of the brain. The specific mechanism of propranolol's
antitremor effects has not been established, but beta-2 (noncardiac)
receptors may be involved. A central effect is also possible. Clinical
studies have demonstrated that Inderal is of benefit in exaggerated
physiological and essential (familial) tremor.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Propranolol is contraindicated in 1) cardiogenic
shock; 2) sinus bradycardia and greater than first degree block; 3)
bronchial asthma; and 4) in patients with known hypersensitivity to
propranolol hydrochloride.
|
| dailymed-instance:supply |
Inderal(propranolol hydrochloride)<br/>Tablets: INDERAL 10���Each
hexagonal-shaped, orange, scored tablet, embossed with an���I���and imprinted with���INDERAL 10,���contains 10 mg
propranolol hydrochloride, in bottles of 100 (NDC 0046-0421-81)
and 5,000 (NDC 0046-0421-95). Store at controlled room temperature 20��to
25��C (68��to 77��F); excursions permitted to 15��to 30��C (59��to 86��F). Dispense in a well-closed container as
defined in the USP. INDERAL 20���Each hexagonal-shaped,
blue, scored tablet, embossed with an���I���and imprinted
with���INDERAL 20,���contains 20 mg propranolol hydrochloride,
in bottles of 100 (NDC 0046-0422-81). Store at controlled room temperature 20��to
25��C (68��to 77��F); excursions permitted to 15��to 30��C (59��to 86��F). Dispense in a well-closed, light-resistant
container as defined in the USP. Protect from light. Use carton to protect contents from light. INDERAL 40���Each hexagonal-shaped, green, scored tablet, embossed with
an���I���and imprinted with���INDERAL 40,���contains 40 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0424-81)
and 5,000 (NDC 0046-0424-95). Store at controlled room temperature 20��to
25��C (68��to 77��F); excursions permitted to 15��to 30��C (59��to 86��F). Dispense in a well-closed, light-resistant
container as defined in the USP. Protect from light. Use carton to protect contents from light. INDERAL 60���Each hexagonal-shaped, pink, scored tablet, embossed with
an���I���and imprinted with���INDERAL 60,���contains 60 mg propranolol hydrochloride, in bottles of 100 (NDC 0046-0426-81). Store at controlled room temperature
20��to 25��C (68��to 77��F); excursions permitted
to 15��to 30��C (59��to 86��F). Dispense in a well-closed container
as defined in the USP. INDERAL 80���Each hexagonal-shaped,
yellow, scored tablet, embossed with an���I���and imprinted
with���INDERAL 80,���contains 80 mg propranolol hydrochloride,
in bottles of 100 (NDC 0046-0428-81). Store at 20��to 25��C (68��to 77��F); excursions permitted to 15��to 30��C (59��to 86��F). [See USP Controlled Room Temperature] Dispense in a well-closed container as
defined in the USP. The appearance
of these tablets is a registered trademark of Wyeth Pharmaceuticals. Wyeth Wyeth Pharmaceuticals Inc.Philadelphia,
PA 19101 W10486C007ET01Rev 12/07
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Propranolol should be used with caution in patients
with impaired hepatic or renal function. Inderal is not indicated
for the treatment of hypertensive emergencies. Beta-adrenergic receptor blockade can cause reduction of intraocular
pressure. Patients should be told that Inderal may interfere with
the glaucoma screening test. Withdrawal may lead to a return of increased
intraocular pressure. While taking beta blockers,
patients with a history of severe anaphylactic reaction to a variety
of allergens may be more reactive to repeated challenge, either accidental,
diagnostic, or therapeutic. Such patients may be unresponsive to the
usual doses of epinephrine used to treat allergic reaction.<br/>Clinical Laboratory Tests: In patients with hypertension, use of propranolol
has been associated with elevated levels of serum potassium, serum
transaminases and alkaline phosphatase. In severe heart failure, the
use of propranolol has been associated with increases in Blood Urea
Nitrogen.<br/>Drug Interactions: Caution should be exercised when Inderal is administered
with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways.
Co-administration of such drugs with propranolol may lead to clinically
relevant drug interactions and changes on its efficacy and/or toxicity
(see Drug Interactions in PHARMACOKINETICS
AND DRUG METABOLISM).<br/>Cardiovascular Drugs:<br/>Non-Cardiovascular Drugs:<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: In dietary administration studies in which mice and
rats were treated with propranolol hydrochloride for up to 18 months
at doses of up to 150 mg/kg/day, there was no evidence of drug-related
tumorigenesis. On a body surface area basis, this dose in the mouse
and rat is, respectively, about equal to and about twice the maximum
recommended human oral dailydose (MRHD) of 640 mg propranolol hydrochloride.
In a study in which both male and female rats were exposed to propranolol
hydrochloride in their diets at concentrations of up to 0.05% (about
50 mg/kg body weight and less than the MRHD), from 60 days prior to
mating and throughout pregnancy and lactation for two generations,
there were no effects on fertility. Based on differing results from
Ames Tests performed by different laboratories, there is equivocal
evidence for a genotoxic effect of propranolol hydrochloride in bacteria
(S. typhimurium strain TA 1538).<br/>Pregnancy: Pregnancy Category C: In a series of reproductive and developmental toxicology
studies, propranolol hydrochloride was given to rats by gavage or
in the diet throughout pregnancy and lactation. At doses of 150 mg/kg/day,
but not at doses of 80 mg/kg/day (equivalent to the MRHD on a
body surface area basis), treatment was associated with embryotoxicity
(reduced litter size and increased resorption rates) as well as neonatal
toxicity (deaths). Propranolol hydrochloride also was administered
(in the feed) to rabbits (throughout pregnancy and lactation) at doses
as high as 150 mg/kg/day (about 5 times the maximum recommended
human oral daily dose). No evidence of embryo or neonatal toxicity
was noted. There are no adequate and well-controlled
studies in pregnant women. Intrauterine growth retardation, small
placentas, and congenital abnormalities have been reported in neonates
whose mothers received propranolol during pregnancy. Neonates whose
mothers received propranolol at parturition have exhibited bradycardia,
hypoglycemia, and/or respiratory depression. Adequate facilities for
monitoring such infants at birth should be available. Inderal should
be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.<br/>Nursing Mothers: Propranolol is excreted in human milk. Caution should
be exercised when Inderal is administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness of propranolol in pediatric
patients have not been established. Bronchospasm
and congestive heart failure have been reported coincident with the
administration of propranolol therapy in pediatric patients.<br/>Geriatric Use: Clinical studies of Inderal did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and
younger patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing
range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy.
|
| dailymed-instance:overdosag... |
Propranolol is not significantly dialyzable. In the
event of overdosage or exaggerated response, the following measures
should be employed: General: If ingestion is
or may have been recent, evacuate gastric contents, taking care to
prevent pulmonary aspiration. Supportive Therapy:
Hypotension and bradycardia have been reported following propranolol
overdose and should be treated appropriately. Glucagon can exert potent
inotropic and chronotropic effects and may be particularly useful
for the treatment of hypotension or depressed myocardial function
after a propranolol overdose. Glucagon should be administered as 50-150 mcg/kg
intravenously followed by continuous drip of 1-5 mg/hour for positive
chronotropic effect. Isoproterenol, dopamine or phosphodiesterase
inhibitors may also be useful. Epinephrine, however, may provoke uncontrolled
hypertension. Bradycardia can be treated with atropine or isoproterenol.
Serious bradycardia may require temporary cardiac pacing. The electrocardiogram, pulse, blood pressure, neurobehavioral
status and intake and output balance must be monitored. Isoproterenol
and aminophylline may be used for bronchospasm.
|
| dailymed-instance:genericMe... |
propranolol hydrochloride
|
| dailymed-instance:fullName |
Inderal (Tablet)
|
| dailymed-instance:adverseRe... |
The following adverse events were observed and have
been reported in patients using propranolol. Cardiovascular: Bradycardia;
congestive heart failure; intensification of AV block; hypotension;
paresthesia of hands; thrombocytopenic purpura; arterial insufficiency,
usually of the Raynaud type. Central Nervous System: Light-headedness,
mental depression manifested by insomnia, lassitude, weakness, fatigue;
catatonia; visual disturbances; hallucinations; vivid dreams; an acute
reversible syndrome characterized by disorientation for time and place,
short-term memory loss, emotional lability, slightly clouded sensorium,
and decreased performance on neuropsychometrics. For immediate-release
formulations, fatigue, lethargy, and vivid dreams appear dose-related. Gastrointestinal: Nausea,
vomiting, epigastric distress, abdominal cramping, diarrhea, constipation,
mesenteric arterial thrombosis, ischemic colitis. Allergic: Hypersensitivity
reactions, including anaphylactic/anaphylactoid reactions, pharyngitis
and agranulocytosis; erythematous rash, fever combined with aching
and sore throat; laryngospasm, and respiratory distress. Respiratory: Bronchospasm. Hematologic: Agranulocytosis,
nonthrombocytopenic purpura, thrombocytopenic purpura. Autoimmune: Systemic
lupus erythematosus (SLE). Skin and mucous membranes: Stevens-Johnson
Syndrome, toxic epidermal necrolysis, dry eyes, exfoliative dermatitis,
erythema multiforme, urticaria, alopecia, SLE-like reactions, and
psoriasiform rashes. Oculomucocutaneous syndrome involving the skin,
serous membranes and conjunctivae reported for a beta blocker (practolol)
have not been associated with propranolol. Genitourinary: Male impotence;
Peyronie's disease.
|
| dailymed-instance:warning |
Angina Pectoris: There have been reports
of exacerbation of angina and, in some cases, myocardial infarction,
following abrupt discontinuance of propranolol therapy. Therefore,
when discontinuance of propranolol is planned, the dosage should be
gradually reduced over at least a few weeks and the patient should
be cautioned against interruption or cessation of therapy without
the physician's advice. If propranolol therapy is interrupted
and exacerbation of angina occurs, it usually is advisable to reinstitute
propranolol therapy and take other measures appropriate for the management
of angina pectoris. Since coronary artery disease may be unrecognized,
it may be prudent to follow the above advice in patients considered
at risk of having occult atherosclerotic heart disease who are given
propranolol for other indications.<br/>Hypersensitivity and Skin Reactions: Hypersensitivity reactions, including anaphylactic/anaphylactoid
reactions, have been associated with the administration of propranolol
. Cutaneous reactions, including
Stevens-Johnson Syndrome, toxic epidermal necrolysis, exfoliative
dermatitis, erythema multiforme, and urticaria, have been reported
with use of propranolol .<br/>Cardiac Failure: Sympathetic stimulation may be a vital component
supporting circulatory function in patients with congestive heart
failure, and its inhibition by beta blockade may precipitate more
severe failure. Although beta blockers should be avoided in overt
congestive heart failure, some have been shown to be highly beneficial
when used with close follow-up in patients with a history of failure
who are well compensated and are receiving additional therapies, including
diuretics as needed. Beta-adrenergic blocking agents do not abolish
the inotropic action of digitalis on heart muscle. In Patients without a History
of Heart Failure, continued use of beta blockers can, in
some cases, lead to cardiac failure.<br/>Nonallergic Bronchospasm (e.g., Chronic Bronchitis, Emphysema): In general, patients with bronchospastic lung disease
should not receive beta blockers. Propranolol should be administered
with caution in this setting since it may provoke a bronchial asthmatic
attack by blocking bronchodilation produced by endogenous and exogenous
catecholamine stimulation of beta-receptors.<br/>Major Surgery: The necessity or desirability of withdrawal of beta-blocking
therapy prior to major surgery is controversial. It should be noted,
however, that the impaired ability of the heart to respond to reflex
adrenergic stimuli in propranolol-treated patients may augment the
risks of general anesthesia and surgical procedures. Propranolol is a competitive inhibitor of beta-receptor agonists,
and its effects can be reversed by administration of such agents,
e.g., dobutamine or isoproterenol. However, such patients may be subject
to protracted severe hypotension.<br/>Diabetes and Hypoglycemia: Beta-adrenergic blockade may prevent the appearance
of certain premonitory signs and symptoms (pulse rate and pressure
changes) of acute hypoglycemia, especially in labile insulin-dependent
diabetics. In these patients, it may be more difficult to adjust the
dosage of insulin. Propranolol therapy, particularly
when given to infants and children, diabetic or not, has been associated
with hypoglycemia, especially during fasting as in preparation for
surgery. Hypoglycemia has been reported in patients taking propranolol
after prolonged physical exertion and in patients with renal insufficiency.<br/>Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical
signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol
may be followed by an exacerbation of symptoms of hyperthyroidism,
including thyroid storm. Propranolol may change thyroid-function tests,
increasing Tand reverse Tand decreasing
T.<br/>Wolff-Parkinson-White Syndrome: Beta-adrenergic blockade in patients with Wolf-Parkinson-White
Syndrome and tachycardia has been associated with severe bradycardia
requiring treatment with a pacemaker. In one case, this result was
reported after an initial dose of 5 mg propranolol.<br/>Pheochromocytoma: Blocking only the peripheral dilator (beta) action
of epinephrine with propranolol 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.
|
| dailymed-instance:indicatio... |
Hypertension: Inderal is indicated in the management of hypertension.
It may be used alone or used in combination with other antihypertensive
agents, particularly a thiazide diuretic. Inderal is not indicatedin the management of hypertensive emergencies.<br/>Angina Pectoris Due to Coronary Atherosclerosis: Inderal is indicated to decrease angina frequency
and increase exercise tolerance in patients with angina pectoris.<br/>Atrial Fibrillation: Inderal is indicated to control ventricular rate
in patients with atrial fibrillation and a rapid ventricular response.<br/>Myocardial Infarction: Inderal is indicated to reduce cardiovascular mortality
in patients who have survived the acute phase of myocardial infarction
and are clinically stable.<br/>Migraine: Inderal 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.<br/>Essential Tremor: Inderal 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. Inderal causes a reduction in the tremor amplitude, but
not in the tremor frequency. Inderal is not indicated for the treatment
of tremor associated with Parkinsonism.<br/>Hypertrophic Subaortic Stenosis: Inderal improves NYHA functional class in symptomatic
patients with hypertrophic subaortic stenosis.<br/>Pheochromocytoma: Inderal is indicated as an adjunct to alpha-adrenergic
blockade to control blood pressure and reduce symptoms of catecholamine-secreting
tumors.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Inderal
|