Hydrocortisone Butyrate

HYDROCORTISONE BUTYRATE- hydrocortisone butyrate cream
Actavis Pharma, Inc.

1 INDICATIONS AND USAGE

Hydrocortisone Butyrate Cream USP, 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 to 18 years of age.

2 DOSAGE AND ADMINISTRATION

For corticosteroid-responsive dermatoses in adults, apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition, and rub in gently.

For atopic dermatitis in patients 3 months to 18 years of age, apply a thin film to the affected skin areas two times daily, and rub in gently. Do not apply Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) in the diaper area unless directed by a physician.

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, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) has not been established beyond 4 weeks of use [see Warnings and Precautions (5.1)].

Do not use Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) with occlusive dressings unless directed by a physician.

Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1%. Each gram of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) contains 1 mg of hydrocortisone butyrate, USP in a white to off white hydrophilic cream base. Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) is supplied in tubes of 15 g, 45 g, and 60 g.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic). Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) due to their larger skin surface-to-body-mass ratios [see Use in Specific Populations (8.4)].

Patients applying a topical corticosteroid to a large surface area or to areas under occlusion should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH1-24 ) stimulation testing (CST).

Minimize systemic corticosteroid effects by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) as recommended [see Dosage and Administration (2)].

If HPA axis suppression is noted, the frequency of application should be reduced or the drug should be withdrawn, or a less potent corticosteroid should be substituted. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see Adverse Reactions (6)].

5.2 Concomitant Skin Infections

If skin infections are present or develop, an appropriate antifungal, antibacterial or antiviral agent should be used. If a favorable response does not occur promptly, use of Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) should be discontinued until the infection has been adequately controlled [see Adverse Reactions (6)].

5.3 Allergic Contact Dermatitis

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noticing a clinical exacerbation. Such an observation should be corroborated with appropriate patch testing. Discontinue Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) if the diagnosis is established [see Adverse Reactions (6)].

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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 USP, 0.1% (Lipophilic) clinical trials reflect exposure to Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic) twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis. Adverse reactions shown in the table below include those for which there is some basis to believe there is a causal relationship to Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic).

TABLE 1. Frequency of adverse reactions in pediatric subjects with mild to moderate atopic dermatitis

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic)


Vehicle

(N=131)

(N=133)

Application site reactions, including application

site folliculitis, irritation, dermatitis, erythema

1.5%

1.5%

Acne

0.8%

0.0%

Telangiectasia

0.0%

0.8%


6.2 Postmarketing Experience

Because adverse 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.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, drying, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

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