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
Glucagon Warnings, Precautions, Pregnancy, Nursing, Abuse - Glucagon
Glucagon Warnings, Precautions, Pregnancy, Nursing, Abuse - Glucagon
WARNINGS
Glucagon should be administered cautiously to patients with a history
suggestive of insulinoma,
pheochromocytoma, or both. In
patients with insulinoma, intravenous
administration
of glucagon may produce an initial
increase in blood glucose;
however, because of glucagon's hyperglycemic effect
the insulinoma may
release insulin
and cause subsequent hypoglycemia.
A patient developing
symptoms of hypoglycemia
after a dose of glucagon
should be given glucose
orally, intravenously, or by gavage, whichever is most appropriate.
Exogenous glucagon
also stimulates the release of catecholamines. In
the presence of pheochromocytoma,
glucagon can cause
the tumor to release
catecholamines, which may result in a sudden and marked increase
in blood pressure. If
a patient develops a
sudden increase in blood pressure,
5 to 10 mg of phentolamine
mesylate may be administered intravenously in an attempt to control
the blood pressure.
Generalized allergic
reactions, including urticaria, respiratory
distress, and hypotension,
have been reported in patients who received glucagon
by injection.
PRECAUTIONS
General
Glucagon is effective in treating hypoglycemia
only if sufficient liver glycogen is present. Because glucagon
is of little or no help in
states of starvation, adrenal
insufficiency, or chronic
hypoglycemia, hypoglycemia
in these conditions should be treated with glucose.
Geriatric Use
Clinical studies of glucagon 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.
Information for Patients
See PATIENT INFORMATION section.
Laboratory Tests
Blood glucose determinations
should be obtained to follow the patient with hypoglycemia
until patient is asymptomatic.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Because glucagon is
usually given in a single dose
and has a very short half- life, no
studies have been done regarding carcinogenesis. In
a series of studies examining effects on the bacterial mutagenesis
(Ames) assay, it was determined that an increase in colony
counts was related to technical difficulties in running this assay
with peptides and was not due to mutagenic activities of the glucagon.
Reproduction studies have been performed in rats at doses up to
2 mg/ kg glucagon
administered two times a day (up to 40 times the human
dose based on body
surface area, mg/ m2
) and have revealed no evidence
of impaired fertility.
Pregnancy
Pregnancy Category B: Reproduction studies have not
been performed with recombinant
glucagon. However, studies with animal- sourced glucagon
were performed in rats at doses up to 2 mg/ kg glucagon administered
two times a day (up to 40 times the human
dose based on body
surface area, mg/ m2),
and have revealed no evidence
of impaired fertility or harm to the fetus
due to glucagon. There are, however, no
adequate and well-controlled studies in pregnant women. Because
animal reproduction
studies are not always predictive of human
response, this drug should
be used during pregnancy
only if clearly needed.
Nursing Mothers
It is not known whether this drug
is excreted in human milk.
Because many drugs are excreted in human
milk, caution should be exercised when glucagon is administered
to a nursing woman.
If the drug is excreted
in human milk during its
short half-life, it will
be hydrolyzed and absorbed like any other polypeptide. Glucagon
is not active when taken orally because it is destroyed in the gastrointestinal
tract before it can be
absorbed.
Pediatric Use
For the treatment
of hypoglycemia: The use of glucagon
in pediatric patients
has been reported to be safe and effective. For use as a diagnostic
aid: Effectiveness has not been established in pediatric
patients.
top
