Hydrocortisone Butyrate

HYDROCORTISONE BUTYRATE — hydrocortisone butyrate lotion
Teligent Pharma, Inc.

structural formula2 oz carton PDP

1 INDICATIONS AND USAGE

Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

2 DOSAGE AND ADMINISTRATION

Apply a thin layer to the affected skin areas two times daily, and rub in gently. Do not apply Hydrocortisone Butyrate Lotion 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 Lotion has not been established beyond 4 weeks of use [see Warnings and Precautions (5.1)].

Do not use Hydrocortisone Butyrate Lotion 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 Lotion is not for oral, ophthalmic, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

Lotion, 0.1%. Each gram of Hydrocortisone Butyrate Lotion contains 1 mg of hydrocortisone butyrate in a white to off white lotion base.Hydrocortisone Butyrate Lotion is supplied in bottles of 2 fl. oz. and 4 fl. oz.

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. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Hydrocortisone Butyrate Lotion 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 Lotion 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 Lotion 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 Lotion 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:

HPA axis suppression. This has been observed in pediatric subjects using Hydrocortisone Butyrate Lotion [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.4 )]
Concomitant skin infections [see Warnings and Precautions ( 5.2 )]
Allergic contact dermatitis [see Warnings and Precautions ( 5.3 )]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The safety data derived from Hydrocortisone Butyrate Lotion clinical trials reflect exposure to Hydrocortisone Butyrate Lotion twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age and adult subjects 18 years of age and older with mild to moderate atopic dermatitis.

Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Hydrocortisone Butyrate Lotion. Although the rates of application site reactions in the vehicle group were greater than those in the Hydrocortisone Butyrate group in both studies, these rates are included in the tables (Table 1 and Table 2) because skin irritation is a known adverse reaction of topical corticosteroids.

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

Hydrocortisone Butyrate Lotion

(n=139) n (%)

Vehicle

(n=145) n (%)

Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation

2 (1)

20 (14)

Infantile acne

1 (1)

0 (0)

Skin depigmentation

1 (1)

0 (0)

TABLE 2. Frequency of adverse reactions in adult subjects with mild to moderate atopic dermatitis

Hydrocortisone Butyrate Lotion

(n=151) n (%)

Vehicle

(n=150) n (%)

Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus

5 (3)

7 (5)

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