When multidose vials are used, special care to prevent contamination of the contents is essential. A
povidone-iodine solution or similar product is recommended to cleanse the vial top prior to aspiration
of contents. (See WARNINGS.)
This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be
autoclaved when it is desirable to sterilize the outside of the vial.
The lowest possible dose of corticosteroid should be used to control the condition under treatment.
When reduction in dosage is possible, the reduction should be gradual.
Since complications of treatment with glucocorticoids are dependent on the size of the dose and
duration of treatment, a risk/benefit decision must be made in each individual case as to dose and
duration of treatment and as to whether daily or intermittent therapy should be used.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for
chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.
As sodium retention with resultant edema and potassium loss may occur in patients receiving
corticosteroids, these agents should be used with caution in patients with congestive heart failure,
hypertension, or renal insufficiency.
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.
Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in
hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.
Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal
anastomoses, and non-specific ulcerative colitis, since they may increase the risk of a perforation.
Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids
may be minimal or absent.
There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis.
Intra-articular injected corticosteroids may be systemically absorbed.
Appropriate examination of any joint fluid is necessary to exclude a septic process.
A marked increase in pain associated 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.
Injection of a steroid into an infected site is to be avoided. Local injection of a steroid into a previously
infected joint is not usually recommended.
Corticosteroids decrease bone formation and increase bone resorption both through their effect on
calcium regulation (e.g., decreasing absorption and increasing excretion) and inhibition of osteoblast
function. This, together with a decrease in the protein matrix of the bone secondary to an increase in
protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in
pediatric patients and the development of osteoporosis at any age. Special consideration should be
given to patients at increased risk of osteoporosis (i.e., postmenopausal women) before initiating
Although controlled clinical trials have shown corticosteroids to be effective in speeding the
resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the
ultimate outcome or natural history of the disease. The studies do show that relatively high doses of
corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)
An acute myopathy has been observed with the use of high doses of corticosteroids, most often
occurring in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis), or in
patients receiving concomitant therapy with neuromuscular blocking drugs (e.g., pancuronium). This
acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in
quadriparesis. Elevation of creatine kinase may occur. Clinical improvement or recovery after stopping
corticosteroids may require weeks to years.
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.
Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more
than 6 weeks, intraocular pressure should be monitored.
Corticosteroids should be used cautiously in patients with ocular herpes simplex for fear of corneal
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No adequate studies have been conducted in animals to determine whether corticosteroids have a
potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of
spermatozoa in some patients.
Pregnancy Category C
Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to
the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and
rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and
well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received
corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
This product contains benzyl alcohol as a preservative.
Benzyl alcohol can cross the placenta. See PRECAUTIONS: Pediatric use.
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere
with endogenous corticosteroid production, or cause other untoward effects. Because of the potential
for serious adverse reactions in nursing infants from corticosteroids, a decision should be made
whether to continue nursing or discontinue the drug, taking into account the importance of the drug to
This product contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product,
has been associated with serious adverse events and death, particularly in pediatric patients. The
"gasping syndrome" (characterized by central nervous system depression, metabolic acidosis, gasping
respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been
associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.
Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage,
hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and
cardiovascular collapse. Although normal therapeutic doses of this product ordinarily delivers amounts
of benzyl alcohol that are substantially lower than those reported in association with the "gasping
syndrome", the minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of
benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the
chemical. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be
more likely to develop toxicity. Practitioners administering this and other medications containing benzyl
alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.
The efficacy and safety of corticosteroids in the pediatric population are based on the well-established
course of effect of corticosteroids, which is similar in pediatric and adult populations. Published
studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephritic
syndrome (patients >2 years of age) and aggressive lymphomas and leukemias (patients >1 month of
age). Other indications for pediatric use of corticosteroids (e.g., severe asthma and wheezing) are
based on adequate and well-controlled clinical trials conducted in adults, on the premises that the course
of the diseases and their pathophysiology are considered to be substantially similar in both populations.
The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent
measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the
presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and
osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including
systemically administered corticosteroids, may experience a decrease in their growth velocity. This
negative impact of corticosteroids on growth has been observed at low systemic doses and in the
absence of laboratory evidence of HPA axis suppression (i.e., cosyntropin stimulation and basal
cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic
corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The
linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential
growth effects of prolonged treatment should be weighed against clinical benefits obtained and the
availability of treatment alternatives. In order to minimize the potential growth effects of
corticosteroids, pediatric patients should be titrated to the lowest effective dose.
Clinical studies 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