Drug Catalog - Product Detail
HYDROCORTISONE BUTYRATE CREAM CRM 0.001 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0464-65 | GLENMARK PHARMACEUTICALS | 60 | 0.1% | CREAM |
PACKAGE FILES
Generic Name
HYDROCORTISONE BUTYRATE
Substance Name
HYDROCORTISONE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202145
Description
11 DESCRIPTION Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains hydrocortisone butyrate, USP, a non-fluorinated hydrocortisone ester, for topical use. Hydrocortisone butyrate is a corticosteroid. The chemical name of hydrocortisone butyrate is [Pregn-4-ene-3, 20-dione, 11, 21-dihydroxy-17- [(1-oxobutyl) oxy (11β)-] It has the following structural formula: Hydrocortisone butyrate, USP is a white to practically white powder with a molecular weight of 432.56, and a molecular formula of C 25 H 36 O 6 . It is practically insoluble in water, slightly soluble in ether, soluble in methanol, in alcohol, and in acetone, and freely soluble in chloroform. Each gram of Hydrocortisone Butyrate Cream, 0.1% (lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a hydrophilic base consisting of anhydrous citric acid, arlacel 165 (glyceryl stearate and PEG 100 stearate), butylparaben, cetostearyl alcohol, mineral oil, propylparaben, purified water, sodium citrate anhydrous, sorbitan monostearate, and white petrolatum. C:\Users\90400190\Desktop\structure.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is white to off-white in color, and supplied in: • tubes of 15 g: NDC 68462-464-17 • tubes of 45 g: NDC 68462-464-47 • tubes of 60 g: NDC 68462-464-65 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
1 INDICATIONS AND USAGE Hydrocortisone butyrate cream, 0.1% (lipophilic) is indicated for: • Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. • The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. Hydrocortisone butyrate cream, 0.1% (lipophilic) is a corticosteroid indicated for: • Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. ( 1 ) • The topical treatment of mild to moderate atopic dermatitis in pediatric • patients 3 months of age and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage for Corticosteroid-Responsive Dermatoses For corticosteroid-responsive dermatoses in adults, apply a thin layer to the affected skin areas 2 or 3 times daily, depending on the severity of the condition, and rub in gently. Recommended Dosage for Atopic Dermatitis For atopic dermatitis in patients 3 months of age and older, apply a thin layer to the affected skin areas 2 times daily and rub in gently. Administration Instructions • Discontinue therapy when control is achieved. • If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, weigh any additional benefits of extending treatment to 4 weeks against the risk of HPA-axis suppression and local adverse events [see Warnings and Precautions ( 5.1 )] . • Hydrocortisone butyrate cream, 0.1% (lipophilic) is not for oral, ophthalmic, or intravaginal use. • Do not use hydrocortisone butyrate cream, 0.1% (lipophilic) o With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. o On the face, underarms, or groin areas unless directed by a healthcare provider. • Corticosteroid-Responsive Dermatoses : Apply a thin layer to the affected skin areas 2 or 3 times daily for corticosteroid-responsive dermatoses in adults. Rub in gently. ( 2 ) • Atopic Dermatitis : Apply a thin layer to the affected skin areas 2 times daily for atopic dermatitis in pediatric patients 3 months of age and older. Rub in gently. ( 2 ) • Discontinue hydrocortisone butyrate cream, 0.1% (lipophilic) when control is achieved. ( 2 ) • Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, weigh any additional benefits of extending treatment up to 4 weeks against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression and local adverse reactions. ( 2 ) • Avoid use under occlusion or in the diaper area. ( 2 ) • Hydrocortisone butyrate cream, 0.1% (lipophilic) is not for oral, ophthalmic, or intravaginal use. ( 2 )