Fluocinolone Acetonide Topical

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Overview

What is Fluocinolone Acetonide Topical?

Fluocinolone acetonide topical solution, USP 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, USP, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure:

Fluocinolone acetonide topical solution, USP contains fluocinolone acetonide, USP (anhydrous) 0.1 mg/mL in a water-washable base of citric acid anhydrous and propylene glycol.

What does Fluocinolone Acetonide Topical look like?

What are the available doses of Fluocinolone Acetonide Topical?

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What should I talk to my health care provider before I take Fluocinolone Acetonide Topical?

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How should I use Fluocinolone Acetonide Topical?

Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

Fluocinolone acetonide topical solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.

Occlusive dressing 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 Fluocinolone Acetonide Topical?

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

What are the warnings of Fluocinolone Acetonide Topical?

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What are the precautions of Fluocinolone Acetonide Topical?

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 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 .

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.

Information for 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.

Patients using topical corticosteroids should receive the following information and instructions:

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 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 hypothalmic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalmic-pituitary-adrenal (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.

What are the side effects of Fluocinolone Acetonide Topical?

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:

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

	Burning		Perioral dermatitis
Itching	Allergic contact dermatitis
Irritation	Maceration of the skin
Dryness	Secondary infection
Folliculitis	Skin atrophy
	Hypertrichosis	Striae
Acneiform eruptions	Miliaria
Hypopigmentation

What should I look out for while using Fluocinolone Acetonide Topical?

Topical corticosteroids 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 Fluocinolone Acetonide Topical?

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

How should I store and handle Fluocinolone Acetonide Topical?

Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.Storage:[See USP controlled room temperature]Protect from moisture.Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Manufactured by: Actavis Laboratories UT, Inc.Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA234192-00 Revised – August 2016

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic 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.

Non-Clinical Toxicology

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe persistent hypertension or cerebrovascular accidents.

Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

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 .

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.

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:

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

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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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Professional

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. 315.72

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Interactions

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