Hydrocortisone Butyrate

HYDROCORTISONE BUTYRATE- hydrocortisone cream
Glenmark Generics Inc.,USA

1 INDICATIONS AND USAGE

Hydrocortisone butyrate cream, 0.1% (lipophilic) is a topical corticosteroid indicated for:

1.%2
Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults.
2.%2
The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months to 18 years of age.

2 DOSAGE AND ADMINISTRATION

Hydrocortisone butyrate cream, 0.1% (lipophilic) is not for oral, ophthalmic, or intravaginal use. Therapy should be discontinued 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, 0.1% (lipophilic) has not been established beyond 4 weeks of use.

2.1 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. Rub in gently.

2.2 Atopic Dermatitis in Patients From 3 Month to 18 Years

Apply a thin film to the affected skin areas two times daily. Rub in gently.

Hydrocortisone butyrate cream, 0.1% (lipophilic) should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

3 DOSAGE FORMS AND STRENGTHS

Cream, 0.1% (1 mg/g), 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. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of hydrocortisone butyrate 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).

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.

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 should be discontinued until the infection has been adequately controlled.

5.3 Skin Irritation

Hydrocortisone butyrate may cause local skin adverse reactions [see Adverse Reactions (6)].

If irritation develops, hydrocortisone butyrate should be discontinued and appropriate therapy instituted. 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.

6 ADVERSE REACTIONS

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

1
HPA axis suppression. This has been observed in pediatric subjects using hydrocortisone butyrate [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)]
2
Concomitant skin infections [see Warnings and Precautions (5.2)]
3
Skin irritation [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience: Adults

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, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

6.2 Clinical Trials Experience: Pediatrics

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 clinical trials reflect exposure to hydrocortisone butyrate 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 tables below include those for which there is some basis to believe there is a causal relationship to hydrocortisone butyrate.

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

Hydrocortisone

butyrate (N=131)

Vehicle (N=133)

Application site reactions, including application site folliculitis, irritation, dermatitis, or erythema

1.5%

1.5%

Acne

0.8%

0.0%

Telangiectasia

0.0%

0.8%

6.3 Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydrocortisone butyrate. 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.

Skin: Erythema, rash and application site irritation.

7 DRUG INTERACTIONS

There are no known drug interactions with hydrocortisone butyrate.

8 USE IN SPECIFIC POPULATIONS

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