Hydrocortisone Valerate
Hydrocortisone Valerate is an FDA drug label for the active ingredient HYDROCORTISONE VALERATE manufactured by Cosette Pharmaceuticals, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231129.
- Generic name
- HYDROCORTISONE VALERATE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0713-0560
- Application
- ANDA211764
- Label effective
- 20231129
Indications & Usage
INDICATIONS AND USAGE Hydrocortisone valerate ointment USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
Dosage & Administration
DOSAGE AND ADMINISTRATION Hydrocortisone valerate ointment USP, 0.2% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Hydrocortisone valerate ointment USP, 0.2% should not be used with occlusive dressings unless directed by a physician. Hydrocortisone valerate ointment USP, 0.2% should not be applied in the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.
Contraindications
CONTRAINDICATIONS Hydrocortisone valerate ointment USP, 0.2% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of hydrocortisone valerate ointment USP, 0.2% was approximately 12%. These included worsening of condition (2%), transient itching (2%), irritation (1%) and redness (1%). In controlled clinical studies involving pediatric atopic dermatitis patients 2 through 12 years of age (n=64), the incidence of adverse experiences was approximately 28.1%, which is higher than that seen in adult patients. Reported reactions included eczema (12.5%), pruritis (6%), stinging (2%), and dry skin (2%). Patients were not specifically evaluated for signs of atrophy (thinning, telangiectasia, erythema). No studies were performed to assess adrenal suppression and/or growth suppression. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .