Hydrocortisone Butyrate
Generic: HYDROCORTISONE BUTYRATE
Basic Information
Manufacturer
Oceanside Pharmaceuticals
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1
Indications & Usage
1 INDICATIONS AND USAGE Hydrocortisone Butyrate Cream (lipid), 0.1% 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 (lipid), 0.1% 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 )
The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older.
Hydrocortisone Butyrate Cream (lipid), 0.1% 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 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Endocrine system adverse reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] Ophthalmic adverse reactions [see Warnings and Precautions ( 5.2 )] Skin infections [see Warnings and Precautions ( 5.3 )] Allergic contact dermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥1%) are application site reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis.
Table 1.
Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133) Application site folliculitis 1% 0.0% Application site irritation 1% 0.0% Acne 1% 0.0% 6.2 Postmarketing Experience The following adverse reactions have been reported during post approval use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local Adverse Reactions: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis.
Table 1.
Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133) Application site folliculitis 1% 0.0% Application site irritation 1% 0.0% Acne 1% 0.0%
6.2 Postmarketing Experience The following adverse reactions have been reported during post approval use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local Adverse Reactions: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis.
Table 1.
Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133) Application site folliculitis 1% 0.0% Application site irritation 1% 0.0% Acne 1% 0.0% 6.2 Postmarketing Experience The following adverse reactions have been reported during post approval use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local Adverse Reactions: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis.
Table 1.
Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133) Application site folliculitis 1% 0.0% Application site irritation 1% 0.0% Acne 1% 0.0%
6.2 Postmarketing Experience The following adverse reactions have been reported during post approval use of topical corticosteroids, including Hydrocortisone Butyrate Cream (lipid), 0.1%.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Local Adverse Reactions: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.
Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.