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
Aclovate Warnings, Precautions, Pregnancy, Nursing, Abuse - Alclometasone Dipropionate
Aclovate Warnings, Precautions, Pregnancy, Nursing, Abuse - Alclometasone Dipropionate
WARNINGS
No information provided
PRECAUTIONS
General
Systemic absorption of topical corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential
for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations
of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced
in some patients by systemic absorption of topical corticosteroids while
on treatment.
Patients applying a topical steroid to a large surface area or to areas
under occlusion should be evaluated periodically for evidence of HPA axis
suppression. This may be done by using the ACTH stimulation, A. M. plasma
cortisol, and urinary free cortisol tests.
The effects of ACLOVATE Cream and Ointment on the HPA axis have been
evaluated. In one study, ACLOVATE Cream and Ointment were applied to 30%
of the body twice daily for 7 days, and occlusive dressings were used
in selected patients either 12 hours or 24 hours daily. In another study,
ACLOVATE Cream was applied to 80% of the body surface of normal subjects
twice daily for 21 days with daily 12-hour periods of whole body occlusion.
Average plasma and urinary free cortisol levels and urinary levels of
17-hydroxysteroids were decreased (about 10%), suggesting suppression
of the HPA axis under these conditions. Plasma cortisol levels have also
been demonstrated to decrease in pediatric patients treated twice daily
for 3 weeks without occlusion.
If HPA axis suppression is noted, an attempt should be made to withdraw
the drug, to reduce the frequency of application, or to substitute a less
potent corticosteroid. Recovery of HPA axis function is generally prompt
upon discontinuation of topical corticosteroids. Infrequently, signs and
symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental
systemic corticosteroids. For information on systemic supplementation,
see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from
equivalent doses due to their larger skin surface area to body mass ratios
(see Pediatric Use below).
If irritation develops, ACLOVATE Cream or Ointment should be discontinued
and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids
is usually diagnosed by observing a failure to heal rather than
noting a clinical exacerbation, as with most topical products not containing
corticosteroids. Such an observation should be corroborated with appropriate
diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate
antifungal or antibacterial agent should be used. If a favorable response
does not occur promptly, use of ACLOVATE Cream or Ointment should be discontinued
until the infection has been adequately controlled.
Information for Patients
See PATIENT INFORMATION
section.
Laboratory Tests
The following tests may be helpful in evaluating patients for HPA axis
suppression:
ACTH stimulation test
A. M. plasma cortisol test
Urinary free cortisol test
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of topical corticosteroids.
Pregnancy
Teratogenic Effects
Pregnancy Category C: Corticosteroids have been shown to
be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. Some corticosteroids have been shown to
be teratogenic after dermal application in laboratory animals. There are
no adequate and well-controlled studies in pregnant women. ACLOVATE Cream
or Ointment should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing Mothers
Systemically administered corticosteroids appear in human milk and could
suppress growth, interfere with endogenous corticosteroid production,
or cause other untoward effects. It is not known whether topical administration
of topical corticosteroids could result in sufficient systemic absorption
to produce detectable quantities in human milk. Because many drugs are
excreted in human milk, caution should be exercised when ACLOVATE Cream
or Ointment is administered to a nursing woman.
Pediatric Use
ACLOVATE Cream and Ointment may be used with caution in pediatric patients
1 year of age or older, although the safety and efficacy of drug use for
longer than 3 weeks have not been established. Use of ACLOVATE Cream and
Ointment is supported by results from adequate and well-controlled studies
in pediatric patients with corticosteroid-responsive dermatoses. Since
the safety and efficacy of ACLOVATE Cream and Ointment have not been established
in pediatric patients below 1 year of age, its use in this age-group is
not recommended. Because of a higher ratio of skin surface area to body
mass, pediatric patients are at a greater risk than adults of HPA axis
suppression and Cushing's syndrome when they are treated with topical
corticosteroids. They are therefore also at greater risk of adrenal insufficiency
during and/or after withdrawal of treatment. Adverse effects, including
striae, have been reported with inappropriate use of topical corticosteroids
in infants and children. Pediatric patients applying ACLOVATE Cream or
Ointment to >20% of the body surface area are at higher risk for HPA axis
suppression.
HPA axis suppression, Cushing's syndrome, linear growth retardation,
delayed weight gain, and intracranial hypertension have been reported
in pediatric patients receiving topical corticosteroids. Manifestations
of adrenal suppression in pediatric patients include low plasma cortisol
levels and absence of response to ACTH stimulation. Manifestations of
intracranial hypertension include bulging fontanelles, headaches, and
bilateral papilledema.
ACLOVATE Cream or Ointment should not be used in the treatment of diaper
dermatitis.
Geriatric Use:
A limited number of patients at or above 65 years of age have been treated with
ACLOVATE Cream and Ointment in US clinical trials. The number of patients is too small to
permit separate analysis of efficacy and safety. No adverse events were reported with
ACLOVATE Ointment in geriatric patients, and the single adverse reaction reported with
ACLOVATE Cream in this population was similar to those reactions reported by younger
patients. Based on available data, no adjustment of dosage of ACLOVATE Cream and Ointment
in geriatric patients is warranted.
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