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
Nebupent Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentamidine Isethionate
Nebupent Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentamidine Isethionate
WARNINGS
Fatalities due to severe hypotension,
hypoglycemia, acute
pancreatitis and cardiac
arrhythmias have been reported in patients treated with pentamidine
isethionate, both by the I.M.
and I.V. routes. Severe hypotension
may result after a single dose
(see PRECAUTIONS
). The administration of
the drug should, therefore,
be limited to the patients in whom Pneumocystis carinii has
been demonstrated. Patients should be closely monitored for the
development of serious
adverse reactions (see PRECAUTIONS
and ADVERSE
REACTIONS).
Extravasations have been reported which, in some instances, proceeded
to ulceration, tissue
necrosis and
or sloughing at the
injection site. While
not common, surgical
debridement and
skin grafting
has been necessary in some of these cases; long- term
sequelae have been reported. Prevention is the most effective means
of limiting the severity of extravasation. The intravenous
needle or catheter
must be properly positioned and closely observed throughout the
period of pentamidine
isethionate administration. If extravasation
occurs, the injection
should be discontinued immediately and restarted in another vein.
Because there are no known
local treatment measures
which have proven to be useful, management of the extravasation
should be symptomatic.
PRECAUTIONS
General
Pentamidine isethionate should be used with caution in patients
with hypertension, hypotension,
hypoglycemia, hyperglycemia,
hypocalcemia, leukopenia, thrombocytopenia, anemia,
and hepatic or renal
dysfunction.
Patients may develop sudden, severe hypotension
after a single dose of pentamidine
isethionate, whether given I.V. or I.M.
Therefore, patients receiving the drug
should be lying down and
the blood pressure
should be monitored closely during administration
of the drug and several
times thereafter until the blood
pressure is stable.
Equipment for emergency
resuscitation should be readily available. If pentamidine
isethionate is administered I.V., it should be infused over a period
of 60 minutes.
Pentamidine isethionate- induced
hypoglycemia has
been associated with pancreatic islet
cell necrosis
and inappropriately high plasma
insulin concentrations. Hyperglycemia and diabetes
mellitus, with or without preceding hypoglycemia, have also occurred,
sometimes several months after therapy with pentamidine
isethionate. Therefore, blood
glucose levels should
be monitored daily during therapy
with pentamidine
isethionate, and several times thereafter.
Laboratory Tests
The following tests should be carried out before, during and after
therapy:
- a) Daily blood urea
nitrogen and serum
creatinine determinations.
- b) Daily blood glucose
determinations.
- c) Complete blood
count and platelet
count .
- d) Liver function
tests, including bilirubin,
alkaline phosphatase,
AST (SGOT, and ALT (SGPT).
- e) Serum calcium
determinations.
- f) Electrocardiograms at regular
intervals.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted to evaluate the potential
of pentamidine isethionate as a carcinogen, mutagen, or cause
of impaired fertility.
Pregnancy Category C
Animal reproduction
studies have not been conducted with pentamidine isethionate. It
is also not known whether pentamidine
isethionate can cause fetal harm when administered to a pregnant
woman or can affect
reproduction capacity. Pentamidine isethionate should be given to
a pregnant woman
only if clearly needed.
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