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brand eucrisa 2% ointment

In stock Manufacturer PFIZER US PHARM 55724021121
$669.60 / 60 Grams Tube

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Uses

Atopic Dermatitis

Crisaborole 2% ointment is used for the topical treatment of mild to moderate atopic dermatitis (eczema) in adults and children 2 years of age and older.

Clinical Experience

Efficacy and safety of crisaborole 2% ointment for the topical treatment of atopic dermatitis were established in 2 identical, randomized, double-blind, vehicle-controlled, multicenter phase 3 studies that included 1522 individuals 2-79 years of age (about 86% were 2-17 years of age) who had mild to moderate atopic dermatitis (as defined by the Investigator's Static Global Assessment [ISGA] score) involving 5-95% of body surface area. According to ISGA scoring (severity scale of 0-4 based on erythema, induration/papulation, and oozing/crusting), 39% of study patients had an ISGA score of 2 (mild) and 62% had a score of 3 (moderate). Patients were randomized to receive crisaborole 2% ointment or vehicle applied to atopic dermatitis lesions twice daily for 28 days. The primary efficacy end point in both studies was the proportion of patients achieving a successful ISGA score on day 29, defined as an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. A successful ISGA score was achieved on day 29 in 31 and 33% of patients treated with crisaborole 2% ointment compared with 18 and 25% of those treated with vehicle control. A greater proportion of crisaborole-treated patients had clinical improvement in signs and symptoms of atopic dermatitis (e.g., pruritus, erythema, exudation, excoriation, induration/papulation, lichenification) than placebo-treated patients. Beneficial effects were evident as early as 8 days after topical crisaborole treatment was initiated.

Dosage and Administration

Administration

Crisaborole is applied topically to the skin as a 2% ointment.

Crisaborole ointment is for external use only and should not be used orally or vaginally; contact with the eyes should be avoided.

A thin layer of crisaborole ointment should be applied to affected areas of skin.

Hands should be washed after applying the ointment, unless the hands are being treated.

Dosage

For the topical treatment of mild to moderate atopic dermatitis in adults and children 2 years of age and older, a thin layer of crisaborole 2% ointment should be applied to affected areas of skin twice daily.

Special Populations

The manufacturer makes no special population dosage recommendations.

Cautions

Contraindications

Crisaborole 2% ointment is contraindicated in individuals with known hypersensitivity to crisaborole or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions (e.g., urticaria) have occurred in patients receiving topical crisaborole.

Hypersensitivity should be suspected if severe pruritus, swelling, and erythema occur at the site of application or at a distant site.

If signs and symptoms of hypersensitivity occur, crisaborole should be discontinued immediately and appropriate therapy initiated.

Specific Populations

Pregnancy

Data are inadequate regarding use of topical crisaborole in pregnant women.

Animal reproduction studies using oral crisaborole have not revealed evidence of fetal harm at exposures greater than those attained with the maximum recommended human topical dosage.

Lactation

It is not known whether systemically absorbed crisaborole is distributed into human milk, affects human milk production, or affects breast-fed infants.

The benefits of breast-feeding and the importance of topical crisaborole to the woman should be considered along with potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy of topical crisaborole have not been established in pediatric patients younger than 2 years of age.

Safety and efficacy of crisaborole for the topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 years of age and older is supported by evidence from 2 multicenter, randomized, double-blind, parallel-group, vehicle-controlled trials that included 1313 pediatric patients in this age group.

Geriatric Use

Clinical studies of topical crisaborole did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients.

Common Adverse Effects

Adverse effects occurring in 1% or more of patients receiving topical crisaborole for the treatment of atopic dermatitis include application site pain (burning or stinging).

Drug Interactions

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

In vitro studies indicate that crisaborole and its initial metabolite (AN7602) are not expected to inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4. In vitro studies also indicate that the subsequent metabolite (AN8323) does not inhibit CYP2C19, 2D6, or 3A4, but is a weak inhibitor of CYP1A2 and 2B6 and a moderate inhibitor of CYP2C8 and 2C9. Crisaborole and its metabolites are not expected to induce CYP isoenzymes.

Warfarin

Drug interactions are not expected if topical crisaborole is used in patients receiving warfarin.

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