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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Propranolol
Inderal Warnings, Precautions, Pregnancy, Nursing, Abuse - Propranolol
WARNINGS
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, if
necessary, they can be used with close follow-up
in patients with a history of failure
who are well compensated and are receiving digitalis and diuretics.
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. Therefore,
at the first sign or symptom
of heart failure, the
patient should be digitalized
and/or treated with diuretics, and the response
observed closely, or Propranolol HCl should be discontinued (gradually,
if possible).
| In Patients With Angina Pectoris: There have
been reports of exacerbation
of angina and,
in some cases, myocardial
infarction, following abrupt discontinuance of Propranolol
HCl therapy. Therefore, when discontinuance of Propranolol
HCl 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 HCl therapy
is interrupted and exacerbation
of angina occurs,
it usually is advisable to reinstitute Propranolol HCl therapy
and take other measures appropriate
for the management of unstable 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. |
Nonallergic Bronchospasm: (e.g. chronic
bronchitis, emphysema) PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD
IN GENERAL NOT RECEIVE BETA BLOCKERS. Propranolol HCl should be
administered with caution since it may block
bronchodilation produced by endogenous
and exogenous catecholamine stimulation
of beta receptors.
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 may augment the risks of general anesthesia
and surgical procedures.
Propranolol HCl, like other beta
blockers, 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. Difficulty in starting and maintaining the heartbeat
has also been reported with beta blockers.
Diabetes and Hypoglycemia: Beta blockers should be
used with caution in diabetic
patients if a beta-blocking agent
is required. Beta blockers may mask
tachycardia occurring
with hypoglycemia, but other manifestations such as dizziness
and sweating may not
be significantly affected. Following insulin-induced hypoglycemia,
propranolol may cause a delay in the recovery of blood
glucose to normal
levels.
Thyrotoxicosis: Beta 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 T4 and
reverse T3 and decreasing T3.
In Patients with Wolf-Parkinson-White Syndrome: Several
cases have been reported in which, after propranolol, the tachycardia
was replaced by a severe bradycardia
requiring a demand pacemaker.
In one case this resulted
after an initial dose
of 5 mg propranolol.
PRECAUTIONS
General: Propranolol should be used with caution
in patients with impaired hepatic
or renal function. Propranolol
HCl is not indicated for the treatment
of hypertensive
emergencies.
Beta-adrenoreceptor blockade
can cause reduction
of intraocular pressure.
Patients should be told that Propranolol HCl may interfere with
the glaucoma screening test. Withdrawal may lead
to a return of increased intraocular pressure.
Clinical Laboratory Test: Elevated blood
urea levels in patients
with severe heart disease,
elevated serum transaminase,
alkaline phosphatase, lactate
dehydrogenase.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Long-term studies in animals have been conducted to evaluate toxic
effects and carcinogenic
potential. In 18-month studies,
in both rats and mice, employing doses up to 150 mg/kg/day, there
was no evidence of
significant drug-induced toxicity. There were no drug-related tumorigenic
effects at any of the dosage
levels. Reproductive studies in animals did not show any impairment
of fertility that was attributable to the drug.
Pregnancy Category C: In
a series of reproduction
and developmental toxicology studies, propranolol was given to rats
at doses up to 150 mg/kg/day by gavage
or in the diet throughout
pregnancy and through lactation. In
rats given 150 mg/kg/day (about 10 times the maximum
recommended human dose) propranolol was embryotoxic (reduced litter
sizes and increased resorption sites). In
addition, an unexplained increase in neonatal
toxicity (death) was noted at all dosage
groups in some of the studies. Maternal toxicity (decreased body
weight) was evident at 150 mg/kg/day. Propranolol also was given
to rabbits at dosages up to 250 mg/kg/day (approximately 20 times
the maximum recommended
human dose) throughout
pregnancy. No evidence of embryotoxicity was noted.
Teratogenicity was not noted in either species.
There are no adequate and well-controlled studies in pregnant
women. Intertwine growth
retardation has
been reported in neonates whose mothers received propranolol during
pregnancy. Neonates whose mothers are receiving propranolol at parturition
have exhibited bradycardia, hypoglycemia
and respiratory depression. Adequate facilities for monitoring these
infants at birth should
be available. Propranolol HCl should be used during pregnancy only
if the potential benefit
justifies the potential
risk to the fetus.
Nursing Mothers: Propranolol HCl is excreted in human
milk. Caution should be exercised when Propranolol HCl is administered
to a nursing woman.
Pediatric Use: High serum
propranolol levels have been noted in patients with Down's syndrome
(trisomy 21), suggesting that the bioavailability of propranolol
may be increased in patients with this condition. Evaluation of
the effects of propranolol in children, relative to the drug's efficacy
and safety, has not been as systematically performed as in adults.
Information is available in the medical
literature to allow fair estimates, and specific
dosing information has been reasonably studied.
Cardiovascular diseases that are common to adults and children
are generally as responsive to propranolol intervention
in children as they are in adults.
Adverse reactions are also similar: for example, bronchospasm
and congestive heart failure
related to propranolol therapy have been reported in children and
occur through the same mechanisms as previously described in adults.
The normal echocardiogram
evolves through a series
of changes as the heart matures during growth
and development
in children. Should echocardiography be used to monitor
propranolol therapy in children, the age-related changes in the
echocardiogram
need to be borne in mind.
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