Flurandrenolide Cream

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Overview

What is Flurandrenolide Cream?

Flurandrenolide, USP is a potent corticosteroid intended for topical use. Flurandrenolide occurs as white to off-white, fluffy, crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One g dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52.

The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione,6-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 16α)-; its empirical formula is C H FO .

The structure is as follows:

Each gram of Flurandrenolide Cream USP, 0.05% contains 0.5 mg (1.145 μmol; 0.05%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water.

What does Flurandrenolide Cream look like?

What are the available doses of Flurandrenolide Cream?

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What should I talk to my health care provider before I take Flurandrenolide Cream?

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How should I use Flurandrenolide Cream?

Flurandrenolide USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Flurandrenolide Cream USP, 0.05% should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.

What interacts with Flurandrenolide Cream?

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

What are the warnings of Flurandrenolide Cream?

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What are the precautions of Flurandrenolide Cream?

General

Conditions that augment systemic absorption include 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 using 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, so that supplemental systemic corticosteroids are required.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See Pediatric Use under PRECAUTIONS).

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, Flurandrenolide Cream should be discontinued until the infection has been adequately controlled.

Information for the Patient

Laboratory tests

Urinary-free cortisol test ACTH stimulation test

Carcinogenesis, Mutagenesis and Impairment of Fertility

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Usage in Pregnancy - Pregnancy Category C

Nursing Mothers

Pediatric Use

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 for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped in order to be occlusive unless the patient is directed to do so 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 patient being treated in the diaper area, because these garments may constitute occlusive dressings.
Do not use flurandrenolide cream on the face, underarms, or groin areas unless directed by your physician.
If no improvement is seen within 2 weeks, contact your physician.
Do not use other corticosteroid-containing products while using flurandrenolide cream without first consulting your physician.

What are the side effects of Flurandrenolide Cream?

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

The following may occur more frequently with occlusive dressings: Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

To report , contact Cintex Services, LLC at 1-855-899-4237, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Call your doctor for medical advice about side effects.

Postmarketing Adverse Reactions

The following adverse reactions have been identified during post approval use of flurandrenolide, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin:

What should I look out for while using Flurandrenolide Cream?

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

What might happen if I take too much Flurandrenolide Cream?

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

How should I store and handle Flurandrenolide Cream?

Storage:Protect from moisture.Storage:Protect from moisture.Flurandrenolide Cream USP, 0.05%, a white cream is available as follows: NDC 24470-919-60 60g tube NDC 24470-919-12 120g (2 x 60g tubes) Store at 20° to 25° C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep tightly closed and protect from light.Manufactured by:Manufactured for:Flurandrenolide Cream USP, 0.05%, a white cream is available as follows: NDC 24470-919-60 60g tube NDC 24470-919-12 120g (2 x 60g tubes) Store at 20° to 25° C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep tightly closed and protect from light.Manufactured by:Manufactured for:Flurandrenolide Cream USP, 0.05%, a white cream is available as follows: NDC 24470-919-60 60g tube NDC 24470-919-12 120g (2 x 60g tubes) Store at 20° to 25° C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep tightly closed and protect from light.Manufactured by:Manufactured for:Flurandrenolide Cream USP, 0.05%, a white cream is available as follows: NDC 24470-919-60 60g tube NDC 24470-919-12 120g (2 x 60g tubes) Store at 20° to 25° C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Keep tightly closed and protect from light.Manufactured by:Manufactured for:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Flurandrenolide is primarily effective because of its anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of the anti-inflammatory effect of the topical corticosteroids is not completely understood. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation.

Pharmacokinetics

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

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. They are metabolized primarily in the liver and then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Non-Clinical Toxicology

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

When administered concurrently, the following drugs may interact with adrenal corticosteroids.

Digitalis glycosides

Oral anticoagulants

Antidiabetic drugs

Barbiturates, phenytoin, or rifampin—

Anabolic steroids

Estrogen

General

Conditions that augment systemic absorption include 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 using 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, so that supplemental systemic corticosteroids are required.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See Pediatric Use under PRECAUTIONS).

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, Flurandrenolide Cream should be discontinued until the infection has been adequately controlled.

Information for the Patient

Laboratory tests

Urinary-free cortisol test ACTH stimulation test

Carcinogenesis, Mutagenesis and Impairment of Fertility

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Usage in Pregnancy - Pregnancy Category C

Nursing Mothers

Pediatric Use

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:

Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis

The following may occur more frequently with occlusive dressings: Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

To report , contact Cintex Services, LLC at 1-855-899-4237, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Call your doctor for medical advice about side effects.

Postmarketing Adverse Reactions

The following adverse reactions have been identified during post approval use of flurandrenolide, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin:

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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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Review

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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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