Flurandrenolide

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Overview

What is Flurandrenolide?

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.

Each mL of Flurandrenolide Lotion, USP 0.05% contains 0.5 mg (1.145 μmol) (0.05%) flurandrenolide in an oil-in-water emulsion base composed of glycerin, cetyl alcohol, stearic acid, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl alcohol, and purified water.

What does Flurandrenolide look like?

What are the available doses of Flurandrenolide?

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

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How should I use Flurandrenolide?

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

Shake well before using. A small quantity of Flurandrenolide Lotion should be rubbed gently into the affected area 2 or 3 times daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Flurandrenolide Lotion 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?

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What are the warnings of Flurandrenolide?

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What are the precautions of Flurandrenolide?

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What are the side effects of Flurandrenolide?

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What should I look out for while using Flurandrenolide?

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

What might happen if I take too much Flurandrenolide?

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

How should I store and handle Flurandrenolide?

Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] . Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows:15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) Keep out of reach of children.Storage: Avoid freezing. Keep tightly closed. Protect from light. 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] Manufactured by:Manufactured for:

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Flurandrenolide

The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood.

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. Corticosteroids with antiinflammatory 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. Evaporation of water from the lotion vehicle produces a cooling effect, which is often desirable in the treatment of acutely inflamed or weeping lesions.

Pharmacokinetics -

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

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to those of systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. They are metabolized primarily in the liver and then excreted in the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Non-Clinical Toxicology

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

The concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.

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 Lotion should be discontinued until the infection has been adequately controlled.

Information for the Patient –

Laboratory Tests –

Carcinogenesis, Mutagenesis, Impairment of Fertility –

Pregnancy Category C.

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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

SUSPECTED ADVERSE REACTIONS

www.fda.gov/medwatch.

Postmarketing Adverse Reactions

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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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