HALCINONIDE
DESCRIPTION:
The topical corticosteroids constitute a class of primarily synthetic steroids
used as anti- inflammatory and antipruritic agents. The steroids in this class
include halcinonide. Halcinonide is designated chemically as 21-Chloro-9-fluoro-
11beta,16alpha,17-trihydroxypregn-4-ene- 3,20-dione cyclic 16,17-acetal with
acetone.
Each gram of 0.1% HALOG Cream (Halcinonide Cream) contains 1 mg halcinonide in a
specially formulated cream base consisting of glyceryl monostearate NF XII,
cetyl alcohol, isopropyl palmitate, dimethicone 350, polysorbate 60, titanium
dioxide, propylene glycol, and purified water.
ACTIONS/CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is
unclear. Various laboratory methods, including vasoconstrictor assays, are used
to compare and predict potencies and/or clinical efficacies of the topical
corticosteroids. There is some evidence to suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic efficacy in
man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is determined
by many factors including the vehicle, the integrity of the epidermal barrier,
and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation
and/or other disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of
topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic
adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled through
pharmacokinetic pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids
are metabolized primarily in the liver and are then excreted by the kidneys.
Some of the topical corticosteroids and their metabolites are also excreted into
the bile.
INDICATIONS AND USAGE:
HALOG (Halcinonide) preparations are indicated for the relief of the
inflammatory and pruritic manifestations of corticosteroid-responsive
dermatoses.
CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in those patients with a history of
hypersensitivity to any of the components of the preparations.
PRECAUTIONS:
GENERAL
Systemic absorption of topical corticosteroids has produced reversible
hypothalamic-pituitary- adrenal (HPA) axis suppression, manifestations of
Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more
potent steroids, use over large surface areas, prolonged use, and the addition
of occlusive dressings.
Therefore, patients receiving a large dose of any potent topical steroid applied
to a large surface area or under an occlusive dressing should be evaluated
periodically for evidence of HPA axis suppression by using the urinary free
cortisol and ACTH stimulation tests, and for impairment of thermal homeostasis.
If HPA axis suppression or elevation of the body temperature occurs, an attempt
should be made to withdraw the drug, to reduce the frequency of application,
substitute a less potent steroid, or use a sequential approach when utilizing
the occlusive technique.
Recovery of HPA axis function and thermal homeostasis are generally prompt and
complete upon discontinuation of the drug. Infrequently, signs and symptoms of
steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Occasionally, a patient may develop a sensitivity reaction to a particular
occlusive dressing material or adhesive and a substitute material may be
necessary.
Children may absorb proportionally larger amounts of topical corticosteroids and
thus be more susceptible to systemic toxicity (see PRECAUTIONS, Pediatric Use).
If irritation develops, topical corticosteroids should be discontinued and
appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate
antifungal or antibacterial agent should be instituted. If a favorable response
does not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.
These preparations are not for ophthalmic use.
INFORMATION FOR THE PATIENT
Patients using topical corticosteroids should receive the following information
and instructions:
1. These medications are to be used as directed by the physician. They are for
dermatologic use only. Avoid contact with the eyes.
2. Patients should be advised not to use these medications for any disorder
other than for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped
as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under
occlusive dressing.
5. Parents of pediatric patients should be advised not to use tight-fitting
diapers or plastic pants on a child being treated in the diaper area, as these
garments may constitute occlusive dressings.
LABORATORY TESTS
A urinary free cortisol test and ACTH stimulation test may be helpful in
evaluating HPA axis suppression.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Long-term animal studies have not been performed to evaluate the carcinogenic
potential or the effect on fertility of topical corticosteroids. Studies to
determine mutagenicity with prednisolone and hydrocortisone showed negative
results.
PREGNANCY: TERATOGENIC EFFECTS
Category C. Corticosteroids are generally teratogenic in laboratory animals when
administered systemically at relatively low dosage levels. The more potent
corticosteroids have been shown to be teratogenic after dermal application in
laboratory animals. There are no adequate and well-controlled studies in
pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus. Drugs of this class
should not be used extensively on pregnant patients, in large amounts, or for
prolonged periods of time.
NURSING MOTHERS
It is not known whether topical administration of corticosteroids could result
in sufficient systemic absorption to produce detectable quantities in breast
milk. Systemically administered corticosteroids are secreted into breast milk in
quantities NOT likely to have a deleterious effect on the infant. Nevertheless,
caution should be exercised when topical corticosteroids are administered to a
nursing woman.
PEDIATRIC USE
PEDIATRIC PATIENTS MAY DEMONSTRATE GREATER SUSCEPTIBILITY TO TOPICAL
CORTICOSTEROID-INDUCED HPA AXIS SUPPRESSION AND CUSHING'S SYNDROME THAN MATURE
PATIENTS BECAUSE OF A LARGER SKIN SURFACE AREA TO BODY WEIGHT RATIO.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have
been reported in children receiving topical corticosteroids. Manifestations of
adrenal suppression in children include linear growth retardation, delayed
weight gain, low plasma cortisol levels, and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to children should be limited to the
least amount compatible with an effective therapeutic regimen. Chronic
corticosteroid therapy may interfere with the growth and development of
children.
ADVERSE REACTIONS:
The following local adverse reactions are reported infrequently with topical
corticosteroids, but may occur more frequently with the use of occlusive
dressings (reactions are listed in an approximate decreasing order of
occurrence): burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis,
allergic contact dermatitis, maceration of the skin, secondary infection, skin
atrophy, striae, and miliaria.
OVERDOSAGE:
Topically applied corticosteroids can be absorbed in sufficient amounts to
produce systemic effects (see PRECAUTIONS, General).
DOSAGE AND ADMINISTRATION:
HALOG CREAMS (HALCINONIDE CREAM): Apply the 0.1% HALOG Cream (Halcinonide Cream)
to the affected area two to three times daily. Rub in gently.
HALOG OINTMENT (HALCINONIDE OINTMENT): Apply a thin film of 0.1% HALOG Ointment
(Halcinonide Ointment) to the affected area two to three times daily.
HALOG SOLUTION (HALCINONIDE TOPICAL SOLUTION): Apply HALOG Solution (Halcinonide
Topical Solution) 0.1% to the affected area two to three times daily.
HALOG-E CREAM (HALCINONIDE CREAM): Apply HALOG-E Cream (Halcinonide Cream) 0.1%
to the affected area one to three times daily. Rub in gently.
OCCLUSIVE DRESSING TECHNIQUE
Occlusive dressings may be used for the management of psoriasis or other
recalcitrant conditions.
HALOG Cream (Halcinonide Cream) 0.1% and HALOG-E Cream (Halcinonide Cream) 0.1%:
Gently rub a small amount of the cream into the lesion until it disappears.
Reapply the preparation leaving a thin coating on the lesion, cover with a
pliable nonporous film, and seal the edges. If needed, additional moisture may
be provided by covering the lesion with a dampened clean cotton cloth before the
nonporous film is applied or by briefly wetting the affected area with water
immediately prior to applying the medication. The frequency of changing
dressings is best determined on an individual basis. It may be convenient to
apply HALOG/HALOG-E Cream under an occlusive dressing in the evening and to
remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the
12-hour occlusion regimen, additional cream should be applied, without
occlusion, during the day. Reapplication is essential at each dressing change.
If an infection develops, the use of occlusive dressings should be discontinued
and appropriate antimicrobial therapy instituted.
HALOG Ointment (Halcinonide Ointment) 0.1%: Apply a thin film of the ointment to
the lesion, cover with a pliable nonporous film, and seal the edges. If needed,
additional moisture may be provided by covering the lesion with a dampened clean
cotton cloth before the nonporous film is applied or by briefly wetting the
affected area with water immediately prior to applying the medication. The
frequency of changing dressings is best determined on an individual basis. It
may be convenient to apply HALOG Ointment under an occlusive dressing in the
evening and to remove the dressing in the morning (i.e., 12-hour occlusion).
When utilizing the 12-hour occlusion regimen, additional ointment should be
applied, without occlusion, during the day. Reapplication is essential at each
dressing change.
If an infection develops, the use of occlusive dressings should be discontinued
and appropriate antimicrobial therapy instituted.
HALOG Solution (Halcinonide Topical Solution) 0.1%: Apply the solution to the
lesion, cover with a pliable nonporous film, and seal the edges. If needed,
additional moisture may be provided by covering the lesion with a dampened clean
cotton cloth before the nonporous film is applied or by briefly wetting the
affected area with water immediately prior to applying the medication. The
frequency of changing dressings is best determined on an individual basis. It
may be convenient to apply HALOG solution under an occlusive dressing in the
evening and to remove the dressing in the morning (i.e., 12-hour occlusion).
When utilizing the 12-hour occlusion regimen, additional solution should be
applied, without occlusion, during the day. Reapplication is essential at each
dressing change.
If an infection develops, the use of occlusive dressings should be discontinued
and appropriate antimicrobial therapy instituted.
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