LOCOID Lotion, 0.1% (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

16781-392

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1. Indications and Usage

LOCOID 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 LOCOID Lotion in the diaper area unless directed by a physician. Discontinue therapy when control is achieved. ...

3. Dosage Forms and Strengths

Lotion, 0.1%. Each gram of LOCOID Lotion contains 1 mg of hydrocortisone butyrate in a white to off-white lotion base. LOCOID 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 Cushings syndrome, hyperglycemia, and ...

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 LOCOID Lotion <em>[see Warnings ...

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 ...

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. ...

8.1. Pregnancy

<b>Pregnancy Category C.</b> There are no adequate and well-controlled studies in pregnant women. Therefore, LOCOID Lotion should be used during pregnancy only if the potential benefit justifies the potential ...

8.3. Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical ...

8.4. Pediatric Use

Safety and efficacy in pediatric patients below 3 months of age have not been established. Because of higher skin-surface-to-body-mass ratios, pediatric patients are at a greater risk than adults of HPA ...

8.5. Geriatric Use

Clinical studies of LOCOID Lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

11. Description

LOCOID (hydrocortisone butyrate) Lotion, 0.1% contains hydrocortisone butyrate, a non-fluorinated hydrocortisone ester, for topical use. The chemical name of hydrocortisone butyrate is Pregn-4-ene-3,20-dione, ...

12.1. Mechanism of Action

Topical corticosteroids share anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical corticosteroids is unclear. However, corticosteroids ...

12.3. Pharmacokinetics

No studies were conducted to determine the pharmacokinetics of LOCOID Lotion. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 2-year dermal rat carcinogenicity study with LOCOID Lotion, hydrocortisone butyrate was administered to Sprague-Dawley rats at topical doses of 0.05, 0.15, and 0.3 mg/kg/day in males and 0.1, 0.25, ...

14. Clinical Studies

In a multicenter, randomized, vehicle-controlled trial of 284 pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis, LOCOID Lotion or vehicle was applied twice daily for ...

16.1. How Supplied

LOCOID Lotion, 0.1% is white to off-white in color and supplied in bottles of 2 fl. oz. (NDC 16781-392-02) and 4 fl. oz. (NDC 16781-392-04). Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 ...

16.2. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

17. Patient Counseling Information

Patients using LOCOID Lotion should receive the following information and instructions: Apply a thin layer to the affected skin two times daily and rub in gently. Discontinue LOCOID Lotion when control ...