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clobetasol propionate
Overview
What is OLUX-E?
OLUX-E (clobetasol propionate) 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 OLUX-E 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.
OLUX-E Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.
What does OLUX-E look like?
What are the available doses of OLUX-E?
Foam, 0.05%. ()
What should I talk to my health care provider before I take OLUX-E?
How should I use OLUX-E?
OLUX-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.
OLUX-E Foam is not for oral, ophthalmic, or intravaginal use.
Apply a thin layer of OLUX-E 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 OLUX-E?
Sorry No Records found
What are the warnings of OLUX-E?
Sorry No Records found
What are the precautions of OLUX-E?
Sorry No Records found
What are the side effects of OLUX-E?
Sorry No records found
What should I look out for while using OLUX-E?
None.
What might happen if I take too much OLUX-E?
Topically applied OLUX-E Foam can be absorbed in sufficient amounts to produce systemic effects.
How should I store and handle OLUX-E?
StorageStore at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.StorageStore at 25°C (77°F); excursions permitted 15–30°C (59–86°F) (see USP Controlled Room Temperature). Protect from excessive heat and humidity.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.Tramadol Hydrochloride Extended-Release Capsules are supplied as opaque white hard gelatin capsules, imprinted as follows:150 mg Capsules: White capsule imprinted with gold ink “G 322” on cap and “150” between lines on the bodyBottle of 500 capsules: NDC 69467-1001-1StorageDispense in a tight container. Store at 25°C; excursions permitted to 15°C to 30°C (59°F to 86°F). Keep out of reach of children.Distributed by:STA3, LLCLos Angeles, CA 90064 USATo report SUSPECTED ADVERSE REACTIONS, contact STA3, LLC at Vertical (877) 958-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Clinical Information
Chemical Structure
No Image foundClinical 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.There has been a report of a patient who passed an orange rubbery precipitate in his stool the day after ingesting carbamazepine suspension immediately followed by Thorazine* solution. Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril, resulted in the occurrence of this precipitate. Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (See ).
Clinically meaningful drug interactions have occurred with concomitant medications and include (but are not limited to) the following:
OLUX-E Foam has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Systemic absorption of OLUX-E 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 OLUX-E Foam for longer than 2 weeks may suppress the immune system. )
In a trial including 37 subjects aged 12 years 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 OLUX-E.
Because of the potential for systemic absorption, use of OLUX-E 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. see
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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