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
Prelone Warnings, Precautions, Pregnancy, Nursing, Abuse - Prednisolone (syrup)
Prelone Warnings, Precautions, Pregnancy, Nursing, Abuse - Prednisolone (syrup)
WARNINGS
In patients on corticosteroid
therapy subjected to
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.
Use in Pregnancy
Since adequate human
reproduction studies
have not been done with corticosteroids, the use of these drugs
in pregnancies, 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.
Average and large doses of hydrocortisone
or cortisone 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
corticosteroid
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 on high dose, because of possible hazards of neurological
complications and a lack of antibody
response.
Children who are on drugs which suppress the immune
system are more susceptible
to infections than healthy
children. 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 intravenous
immunoglobulin
(IVIG) may be indicated. (See the respective package inserts for
complete VZIG and IVIG
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
(threadworm) infestation. In
such patients, corticosteroid-induced immunosuppression
may lead to Strongy-loides
hyperinfection and dissemination with widespread larval migration,
often accompanied by severe enterocolitis
and potentially fatal
gram-negative septicemia.
The use of PRELONE Syrup 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 an 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.
PRECAUTIONS
Information for Patients
Patients who are on immunosuppressant doses of corticosteroids
should be warned to avoid exposure
to chickenpox or
measles. Patients should also be advised that if they are exposed,
medical advice should
be sought without delay.
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 on patients with hypothyroidism and in those
with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular
herpes simplex because of possible 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 should 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
infections, 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 observed.
Pediatric Use
In the treatment
of endocrine disorders
such as primary
and secondary adrenocortical insufficiency
in infancy, mineralocorticoid
supplementation is of particular importance. Infants born to mothers
who have received substantial doses of corticosteroids during pregnancy
should be carefully obsewed for signs of hypoadrenalism. Immunization
procedures should not be undertaken in patients who are on corticosteroids.
Pediatric patients who are on drugs which suppress the immune
system are more susceptible
to infections than healthy
pediatric patients.
Chickenpox and measles, for example, can have a more serious or
even fatal course in non-immune
patients on corticosteroids. Growth and development
in the pediatric population
on prolonged corticosteroid
therapy should be carefully
observed. (See CONTRAINDICATIONS
and WARNINGS
for complete information.)
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