Clobetasol Propionate Emulsion

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Overview

What is Clobetasol Propionate Emulsion?

Clobetasol Propionate Emulsion Foam, 0.05% is a white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient clobetasol propionate USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula CHClFOand a molecular weight of 466.97.

The following is the chemical structure:

Clobetasol propionate is a white to cream-colored crystalline powder, practically insoluble in water.

Each gram of Clobetasol Propionate Emulsion Foam contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl 20 cetostearyl ether, potassium citrate monohydrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative.

Clobetasol Propionate Emulsion Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.

What does Clobetasol Propionate Emulsion look like?

What are the available doses of Clobetasol Propionate Emulsion?

Foam, 0.05%. ()

What should I talk to my health care provider before I take Clobetasol Propionate Emulsion?

How should I use Clobetasol Propionate Emulsion?

Clobetasol Propionate Emulsion Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

Clobetasol Propionate Emulsion Foam is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of Clobetasol Propionate Emulsion Foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.

What interacts with Clobetasol Propionate Emulsion?

Sorry No Records found

What are the warnings of Clobetasol Propionate Emulsion?

Sorry No Records found

What are the precautions of Clobetasol Propionate Emulsion?

Sorry No Records found

What are the side effects of Clobetasol Propionate Emulsion?

Sorry No records found

What should I look out for while using Clobetasol Propionate Emulsion?

None.

What might happen if I take too much Clobetasol Propionate Emulsion?

Topically applied Clobetasol Propionate Emulsion Foam can be absorbed in sufficient amounts to produce systemic effects.

How should I store and handle Clobetasol Propionate Emulsion?

Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Protect from light and moisture. [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Store the unit-dose blister packages in the carton until contents have been used.Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540Lorazepam Tablets, USP are available as:0.5 mg: NDC 0781-5371-01 bottles of 100NDC 0781-5371-05 bottles of 5001 mg: NDC 0781-5377-01 bottles of 100NDC 0781-5377-05 bottles of 5002 mg:NDC 0781-5379-01 bottles of 100NDC 0781-5379-05 bottles of 500Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).10-2013M7446Sandoz Inc.Princeton, NJ 08540

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Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in corticosteroid-responsive dermatoses is unknown.

The contribution to efficacy by individual components of the vehicle has not been established.

Non-Clinical Toxicology

None.

The benzodiazepines, including lorazepam, produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.

Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.

The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

Clobetasol Propionate Emulsion Foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic absorption of Clobetasol Propionate Emulsion has caused reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Use of Clobetasol Propionate Emulsion Foam for longer than 2 weeks may suppress the immune system.

In a trial including 37 subjects aged 12 and older with at least 30% body surface area (BSA), adrenal suppression was identified in 6 out of 37 subjects (16.2%) after 2 weeks of treatment with Clobetasol Propionate Emulsion.

Because of the potential for systemic absorption, use of Clobetasol Propionate Emulsion may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An adrenocorticotrophic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than 1 corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface- to-body mass ratios.

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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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