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Fluocinonide
Overview
What is Fluocinonide?
The topical corticosteroids constitute a class of primarily synthetic steroids
used as anti-inflammatory and antipruritic agents. The topical corticosteroids
are intended for topical administration. The active component is the
corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone
acetonide and has the chemical name
pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)
bis(oxy)]-,(6α, 11β, 16α)-. It has the following structural formula:
CHF0 M.W. 494.54
Each gram of Fluocinonide Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg
fluocinonide in a water-washable aqueous emollient base of stearyl alcohol,
cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate
60, citric acid (hydrous) and purified water.
Each gram of Fluocinonide Cream USP, 0.05% contains: 0.5 mg fluocinonide in a
specially formulated cream base consisting of stearyl alcohol, polyethylene
glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid (hydrous). This
white cream vehicle is greaseless, non-staining, anhydrous and completely water
miscible. The base provides emollient and hydrophilic properties.
In this formulation, the active ingredient is totally in solution.
Each gram of Fluocinonide Gel USP, 0.05% contains: 0.5 mg fluocinonide in a
specifically formulated gel base consisting of purified water, propylene glycol,
edetate disodium, carbomer 934P, and sodium hydroxide. Hydrochloric acid is
added to adjust the pH. This clear, colorless thixotropic vehicle is greaseless,
non-staining and completely water miscible.
In this formulation, the active ingredient is totally in solution.
Each gram of Fluocinonide Ointment USP, 0.05% contains: 0.5 mg fluocinonide
in an ointment base consisting of white petrolatum, castor oil, and sorbitan
sesquioleate. It provides the occlusive and emollient effects desirable in an
ointment.
In this formulation, the active ingredient is totally in solution.
What does Fluocinonide look like?
What are the available doses of Fluocinonide?
Sorry No records found.
What should I talk to my health care provider before I take Fluocinonide?
Sorry No records found
How should I use Fluocinonide?
The topical corticosteriods are indicated for the relief of the inflammatory and
pruritic manifestations of corticosteroid-responsive dermatoses.
The topical corticosteroids are generally applied to the affected
area as a thin film from two to four times daily depending on the severity of
the condition.
Occlusive dressings may be used 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.
What interacts with Fluocinonide?
The topical corticosteriods are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
What are the warnings of Fluocinonide?
Sorry No Records found
What are the precautions of Fluocinonide?
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 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 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.
Children may absorb proportionally larger amounts of topical corticosteroids
and thus be more susceptible to systemic toxicity. (See ). If irritation develops, topical
corticosteroids should be discontinued and appropriate therapy instituted.
As with any topical corticosteroid product, prolonged use may produce atrophy
of the skin and subcutaneous tissues. When used on intertriginous or flexor
areas, or on the face, this may occur even with short-term use.
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.
Patients using topical corticosteroids should receive the
following information and instructions:
The following tests may be helpful in evaluating the HPA axis
suppression:
Urinary free cortisol test
ACTH stimulation test
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.
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.
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 likely to have a
deleterious effect on the infant. Nevertheless, caution should be exercised when
topical corticosteroids are administered to a nursing woman.
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.
- 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, as these garments may constitute occlusive dressings.
What are the side effects of Fluocinonide?
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 | Perioral dermatitis |
| Itching | Allergic contact dermatitis |
| Irritation | Maceration of the skin |
| Dryness | Secondary infection |
| Folliculitis | Skin atrophy |
| Hypertrichosis | Striae |
| Acneiform eruptions | Miliaria |
What should I look out for while using Fluocinonide?
The topical corticosteriods are contraindicated in those patients with a history
of hypersensitivity to any of the components of the preparation.
What might happen if I take too much Fluocinonide?
Topically applied corticosteroids can be absorbed in sufficient amounts to
produce systemic effects. (See ).
How should I store and handle Fluocinonide?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960Fluocinonide Cream USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-0431-2, 30 gram - NDC 54868-0431-3, 60 gram - NDC 54868-0431-1.Fluocinonide Gel USP, 0.05% is supplied in tubes of:60 gram - NDC 54868-3023-0 Fluocinonide Ointment USP, 0.05% is supplied in tubes of:15 gram - NDC 54868-3435-2, 30 gram - NDC 54868-3435-0, 60 gram - NDC 54868-3435-1.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Avoid excessive heat, above 40°C (104°F).Rev. K 3/2005Manufactured By: Sellersville, PA 18960
Clinical Information
Chemical Structure
No Image foundClinical 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.
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 ).
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.
Non-Clinical Toxicology
The topical corticosteriods are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
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 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 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.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.
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.
Patients using topical corticosteroids should receive the following information and instructions:
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
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.
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.
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 likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
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.
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:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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