HYDROCORTISONE BUTYRATE

HYDROCORTISONE BUTYRATE- hydrocortisone butyrate lotion
Oceanside Pharmaceuticals

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 Hydrocortisone Butyrate Lotion for up to 2 weeks as a thin layer to the affected skin two times daily and rub in gently.
  • Discontinue Hydrocortisone Butyrate Lotion when control is achieved.
  • If no improvement is seen within 2 weeks, consider reassessment of the diagnosis. Before prescribing for more than 2 weeks, the additional benefits of extending treatment up to 4 weeks should be weighed against the risk of endocrine system adverse reactions and local adverse reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1, 6.2)].
  • Hydrocortisone Butyrate Lotion is not for oral, ophthalmic, or intravaginal use.
  • Do not use Hydrocortisone Butyrate Lotion [see Warnings and Precautions (5.1)] :
  • With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.
  • On the face, underarms, or groin areas unless directed by a healthcare provider.

3 DOSAGE FORMS AND STRENGTHS

Lotion: Each gram contains 1 mg of hydrocortisone butyrate (0.1%) in a white to off-white lotion base.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Endocrine System Adverse Reactions

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause systemic adverse reactions including reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Such patients should be considered for periodic evaluation of the HPA axis. This may be done by using cosyntropin (ACTH 1-24 ) stimulation testing (CST). If HPA axis suppression is noted, reduce the frequency of application or discontinue Hydrocortisone Butyrate Lotion, or substitute with a less potent corticosteroid. Signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids [see Adverse Reactions (6)] .

Studies conducted in pediatric subjects demonstrated reversible HPA axis suppression after use of Hydrocortisone Butyrate Lotion. 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)].

Cushing’s Syndrome, Hyperglycemia, and Glucosuria

Systemic adverse reactions of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may also include manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria.

Additional Considerations for Endocrine Adverse Reactions

Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

Minimize systemic corticosteroid adverse reactions by mitigating the risk factors for increased systemic absorption and using Hydrocortisone Butyrate Lotion as recommended [see Dosage and Administration (2) ].

5.2 Ophthalmic Adverse Reactions

Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in post-marketing experience with the use of topical corticosteroid products [see Adverse Reactions (6.2)] .

Avoid contact of Hydrocortisone Butyrate Lotion with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

5.3 Skin Infections

Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, may delay healing or worsen concomitant skin infections. If skin infections are present or develop, an appropriate antimicrobial 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)].

5.4 Allergic Contact Dermatitis

Use of topical corticosteroids, including Hydrocortisone Butyrate Lotion, can cause allergic contact dermatitis [see Adverse Reactions (6)] . 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 .

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 practice.

The safety data described below reflect exposure to Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis [see Clinical Studies (14)] .

The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2.

Table 1. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated Pediatric Subjects 3 Months to 18 Years of Age 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. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated 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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