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
Celestone Warnings, Precautions, Pregnancy, Nursing, Abuse - Betamethasone (Injectable Suspension)
Celestone Warnings, Precautions, Pregnancy, Nursing, Abuse - Betamethasone (Injectable Suspension)
WARNINGS
CELESTONE SOLUSPAN Injectable Suspension should not be administered intravenously.
In patients on corticosteroid therapy subjected to any unusual stress,
increased dosage of rapidly acting corticosteroids before, during, and
after the stressful situation is indicated.
Corticosteroids may mask some signs of infection, and new infections
may appear during their use. There may be decreased resistance and inability
to localize infection when corticosteroids are used.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts,
glaucoma with possible damage to the optic nerves, and may enhance the
establishment of secondary ocular infections due to fungi or viruses.
CELESTONE SOLUSPAN Injectable Suspension contains two betamethasone esters
one of which, betamethasone sodium phosphate, disappears rapidly from
the injection site. The potential for systemic effect produced by the
soluble portion of CELESTONE SOLUSPAN Injectable Suspension should therefore
be taken into account by the physician when using the drug.
Average and large doses of cortisone or hydrocortisone can cause elevation
of blood pressure, salt and water retention, and increased excretion of
potassium. These effects are less likely to occur with the synthetic derivatives
except when used in large doses. Dietary salt restriction and potassium
supplementation may be necessary. All corticosteroids increase calcium
excretion.
While on corticosteroid therapy patients should not be vaccinated
against smallpox. Other immunization procedures should not be undertaken
in patients who are on corticosteroids, especially in high doses, because
of possible hazards of neurological complications and lack of antibody
response.
Persons who are on drugs which suppress the immune system are more susceptible
to infections than healthy individuals. Chickenpox and measles, for example,
can have a more serious or even fatal course in non-immune children or
adults on corticosteroids. In such children, or adults who have not had
these diseases, particular care should be taken to avoid exposure. How
the dose, route, and duration of corticosteroid administration affects
the risk of developing a disseminated infection is not known. The contribution
of the underlying disease and/or prior corticosteroid treatment to the
risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster
immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis
with pooled intramuscular immunoglobulin (IG) may be indicated. (See the
respective package inserts for complete VZIG and IG prescribing information.)
If chickenpox develops, treatment with antiviral agents may be considered.
Similarly, corticosteroids should be used with great care in patients
with known or suspected Strongyloides (thread-worm) infestation. In such
patients, corticosteroid-induced immunosuppression may lead to Strongyloides
hyperinfection and dissemination with widespread larval migration, often
accompanied by severe enterocolitis and potentially fatal gram-negative
septicemia.
The use of CELESTONE SOLUSPAN Injectable Suspension in active tuberculosis
should be restricted to those cases of fulminating or disseminated tuberculosis
in which the corticosteroid is used for the management of the disease
in conjunction with appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis
or tuberculin reactivity, close observation is necessary as reactivation
of the disease may occur. During prolonged corticosteroid therapy, these
patients should receive chemoprophylaxis.
Because rare instances of anaphylactoid reactions have occurred in patients
receiving parenteral corticosteroid therapy, appropriate precautionary
measures should be taken prior to administration, especially when the
patient has a history of allergy to any drug.
Usage in pregnancy Since adequate human reproduction studies have not
been done with corticosteroids, the use of these drugs in pregnancy, nursing
mothers, or women of childbearing potential requires that the possible
benefits of the drug be weighed against the potential hazards to the mother
and embryo or fetus. Infants born of mothers who have received substantial
doses of corticosteroids during pregnancy should be carefully observed
for signs of hypoadrenalism.
PRECAUTIONS
General
Drug-induced secondary adrenocortical insufficiency may be minimized
by gradual reduction of dosage. This type of relative insufficiency may
persist for months after discontinuation of therapy; therefore, in any
situation of stress occurring during that period, hormone therapy should
be reinstituted. Since mineralocorticoid secretion may be impaired, salt
and/or a mineralocorticoid should be administered concurrently.
There is an enhanced effect of corticosteroids in patients with hypothyroidism
and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes
simplex for fear of corneal perforation.
The lowest possible dose of corticosteroid should be used to control
the condition under treatment, and when reduction in dosage is possible,
the reduction must be gradual.
Psychic derangements may appear when corticosteroids are used, ranging
from euphoria, insomnia, mood swings, personality changes, and severe
depression to frank psychotic manifestations. Also, existing emotional
instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids
in hypoprothrombinemia.
Steroids should be used with caution in nonspecific ulcerative colitis,
if there is a probability of impending perforation, abscess, or other
pyogenic infection; also in diverticulitis, fresh intestinal anastomoses,
active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis,
and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid
therapy should be carefully followed.
The following additional precautions also apply for parenteral
corticosteroids: Intra-articular injection of a corticosteroid
may produce systemic as well as local effects.
Appropriate examination of any joint fluid present is necessary to exclude
a septic process.
A marked increase in pain accompanied by local swelling, further restriction
of joint motion, fever, and malaise are suggestive of septic arthritis.
If this complication occurs and the diagnosis of sepsis is confirmed,
appropriate antimicrobial therapy should be instituted.
Local injection of a steroid into a previously infected joint is to be
avoided.
Corticosteroids should not be injected into unstable joints.
The slower rate of absorption by intramuscular administration should
be recognized.
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