CYCLOCORT
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amcinonide ointment
DPT Laboratories, Ltd.
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DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.
TOPICAL LOTION 0.1%
Each gram of CYCLOCORT (amcinonide) Topical Lotion contains 1 mg of the active steroid amcinonide in AQUATAIN,* a white, smooth, homogeneous, opaque emulsion composed of Benzyl Alcohol 1% (wt/wt) as preservative, Emulsifying Wax, Glycerin, Isopropyl Palmitate, Lactic Acid, Purified Water and Sorbitol Solution. In addition, contains Polyethylene Glycol 400.
Sodium hydroxide may be used to adjust pH to approximately 4.4 during manufacture.
TOPICAL CREAM 0.1%
Each gram of CYCLOCORT (amcinonide) Topical Cream contains 1 mg of the active steroid amcinonide in AQUATAIN,* a white, smooth, homogeneous, opaque emulsion composed of Benzyl Alcohol 2% (wt/wt) as preservative, Emulsifying Wax, Glycerin, Isopropyl Palmitate, Lactic Acid, Purified Water and Sorbitol Solution.
*AQUATAIN(TM) is non-staining, water-washable, paraben-free, spermaceti-free, and has a light texture and consistency.
TOPICAL OINTMENT 0.1%
Each gram of CYCLOCORT (amcinonide) Topical Ointment contains 1 mg of the active steroid amcinonide in a specially formulated base composed of Benzyl Alcohol 2% (wt/wt),
White Petrolatum, Emulsifying Wax, and Tenox II (Butylated Hydroxyanisole, Propyl Gallate, Citric Acid, Propylene Glycol).
Chemically, amcinonide is:
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-,(11β, 16α).
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 (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
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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 that
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 a
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. If HPA axis suppression is noted, an attempt should
be made to withdraw the drug, to reduce the frequency of application,
or to substitute with a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Pediatric patients 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.
The products are not for ophthalmic use.
Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
- This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
- Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
- The
treated skin area should not be bandaged or otherwise covered or
wrapped as to be occlusive unless directed by the physician.
- Patients should report any signs of local adverse reactions especially under occlusive dressing.
- 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
since these garments may constitute occlusive dressings.
Laboratory Tests
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
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 have revealed negative results.
Pregnancy 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, a decision should be
made whether to discontinue nursing or to discontinue the drug, taking
into account the importance of the drug to the mother.
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.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s
syndrome, and intracranial hypertension have been reported in pediatric
patients receiving topical corticosteroids. Manifestations of adrenal
suppression in pediatric patients 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
pediatric patients should be limited to the least amount compatible
with an effective therapeutic regimen. Chronic corticosteroid therapy
may interfere with the growth and development of pediatric patients.
ADVERSE REACTIONS
In the clinical trials with CYCLOCORT Lotion, the investigators
reported a 4.7% incidence of side effects. In a weekly acceptability
evaluation, approximately 20% of the patients treated with CYCLOCORT
Lotion or placebo reported itching, stinging, soreness, or burning at
one or more of the visits.
The following local adverse
reactions are reported infrequently with topical corticosteroids, but
may occur more frequently with the use of occlusive dressings. These
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
Miliaria
OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see
PRECAUTIONS).
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as a
thin film from two to three times daily depending on the severity of
the condition.
The lotion may be applied topically to the
specified lesions, particularly to those in hairy areas, two times per
day. The lotion should be rubbed into the affected area completely, and
the area should be protected from washing, clothing, rubbing, etc.
until the lotion has dried.
Occlusive dressings may be a valuable therapeutic adjunct for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be
discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
CYCLOCORT (amcinonide) Topical Lotion 0.1% (1 mg/g) with AQUATAIN hydrophilic base
NDC 0469-7404-20 Product Code 740420
20 mL (19.6 g) bottle
NDC 0469-7404-60 Product Code 740460
60 mL (58.8 g) bottle
CYCLOCORT (amcinonide) Topical Cream 0.1% (1mg/g) with AQUATAIN hydrophilic base
NDC 0469-7054-15 Product Code 705415
15 g tube
NDC 0469-7054-30 Product Code 705430
30 g tube
NDC 0469-7054-60 Product Code 705460
60 g tube
CYCLOCORT (amcinonide) Topical Ointment 0.1% (1 mg/g)
NDC 0469-7115-15 Product Code 711515
15 g tube
NDC 0469-7115-30 Product Code 711530
30 g tube
NDC 0469-7115-60 Product Code 711560
60 g tube
Store at Controlled Room Temperature 15°-30°C (59°-86°F).
DO NOT FREEZE.
Rx only
Manufactured for
Fujisawa Healthcare, Inc.,
Deerfield, IL 60015
Revised: 127918
December 2002
Principal Display Panel
Cyclocort
(amcinonide)
0.1% Ointment
60 grams
NDC 0469-7115-60
CYCLOCORT
amcinonide
ointment |
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Revised: 07/2010DPT Laboratories, Ltd.