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HYDROCORTISONE PROBUTATE
Overview
What is PANDEL?
PANDEL(hydrocortisone probutate) Cream, 0.1% contains hydrocortisone probutate, a synthetic corticosteroid. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.
Hydrocortisone probutate is a tasteless and odorless white crystalline powder practically insoluble in hexane or water, slightly soluble in ether, and very soluble in dichloromethane, methanol and acetone. Chemically, it is 11β,17,21-trihydroxypregn-4-ene-3,20-dione 17-butyrate 21-propionate. The structural formula is:
Molecular Formula: CHO
Molecular Weight: 488.62
Each gram of PANDEL (hydrocortisone probutate) Cream, 0.1% contains: 1 mg of hydrocortisone probutate in a cream base of propylene glycol, white petrolatum, light mineral oil, stearyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl monostearate, PEG-20 stearate, glyceryl stearate SE, methylparaben, butylparaben, citric acid, sodium citrate anhydrous, and purified water.
What does PANDEL look like?
What are the available doses of PANDEL?
Cream, 0.1%.
What should I talk to my health care provider before I take PANDEL?
How should I use PANDEL?
PANDEL (hydrocortisone probutate) Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.
Apply a thin film of PANDEL to the affected area once or twice a day depending on the severity of the condition. Massage gently until the medication disappears.
Occlusive dressings may be used for the management of refractory lesions of psoriasis and other deep-seated dermatoses, such as localized neurodermatitis (lichen simplex chronicus).
Discontinue PANDEL when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Do not use PANDEL with occlusive dressings unless directed by the physician. Do not apply PANDEL in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
What interacts with PANDEL?
Sorry No Records found
What are the warnings of PANDEL?
Sorry No Records found
What are the precautions of PANDEL?
Sorry No Records found
What are the side effects of PANDEL?
Sorry No records found
What should I look out for while using PANDEL?
None.
What might happen if I take too much PANDEL?
Sorry No Records found
How should I store and handle PANDEL?
Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time. Busulfan Injection diluted in 0.9% Sodium Chloride Injection, USP is stable at refrigerated conditions (2°C to 8°C) for up to 12 hours but the infusion must be completed within that time. Busulfan Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F). Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.PANDEL, a white to off-white opaque cream is supplied as follows:45 g tubes NDC 10337-153-4680 g tubes NDC 10337-153-80Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].PANDEL, a white to off-white opaque cream is supplied as follows:45 g tubes NDC 10337-153-4680 g tubes NDC 10337-153-80Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].PANDEL, a white to off-white opaque cream is supplied as follows:45 g tubes NDC 10337-153-4680 g tubes NDC 10337-153-80Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].PANDEL, a white to off-white opaque cream is supplied as follows:45 g tubes NDC 10337-153-4680 g tubes NDC 10337-153-80Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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
Non-Clinical Toxicology
None.Cabergoline should not be administered concurrently with D-antagonists, such as phenothiazines, butyrophenones, thioxanthenes, or metoclopramide.
PANDEL can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age.
Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.
If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. If signs and symptoms of steroid withdrawal occur, supplemental systemic corticosteroids may be required. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
In a trial including 15 evaluable subjects 18 years of age or older with psoriasis or atopic dermatitis affecting more than 20% of body surface area, 1 subject (6.7%) had ACTH stimulation test results suggestive of adrenal suppression after treatment with PANDEL twice daily for 21 days. Recovery of HPA axis suppression for this subject is unknown [].
Systemic effects of topical corticosteroids may also manifest as Cushing’s syndrome, hyperglycemia, and unmasking latent diabetes mellitus.
Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA-axis suppression.
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios .
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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