CUTIVATE Lotion (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

PharmaDerm a division of Fougera Pharmaceuticals Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

CUTIVATE Lotion is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients 3 months of age or older.

2. Dosage and Administration

Apply a thin film of CUTIVATE Lotion to the affected skin areas once daily. Rub in gently. Discontinue use when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis ...

3. Dosage Forms and Strengths

Lotion, 0.05%. Each gram of CUTIVATE Lotion USP contains 0.5 mg fluticasone propionate, USP in a white to off-white lotion base. CUTIVATE Lotion USP is supplied in 120 mL bottles.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression and Other Adverse Endocrine Effects Topical corticosteroids, including CUTIVATE Lotion, can produce reversible HPA axis suppression with the potential ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: HPA Axis Suppression and Other Adverse Endocrine Effects [see Warnings and Precautions (5.1)] ...

6.3. Postmarketing Experience

The following local adverse reactions have been identified during post-approval use of CUTIVATE Lotion: erythema, edema/swelling, and bleeding. The following systemic adverse reactions have been identified ...

8.1. Pregnancy

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

8.3. Nursing Mothers

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

8.4. Pediatric Use

CUTIVATE Lotion may be used in pediatric patients as young as 3 months of age. The safety and effectiveness of CUTIVATE Lotion in pediatric patients below 3 months of age have not been established. Because ...

8.5. Geriatric Use

A limited number of patients above 65 years of age have been treated with CUTIVATE Lotion in US and non-US clinical trials. Specifically only 8 patients above 65 years of age were treated with CUTIVATE ...

11. Description

CUTIVATE (fluticasone propionate) Lotion USP, 0.05% contains fluticasone propionate, USP [S-Fluoromethyl 6α, 9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxyandrosta-1,4-diene-17β-carbothioate], ...

12.1. Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of CUTIVATE Lotion in atopic dermatitis is unknown.

12.2. Pharmacodynamics

Vasoconstrictor Assay Trials performed with CUTIVATE Lotion indicate that it is in the medium range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical ...

12.3. Pharmacokinetics

Absorption The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressing enhances ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral (gavage) mouse carcinogenicity study, doses of 0.1, 0.3 and 1 mg/kg/day fluticasone propionate were administered to mice for 18 months. Fluticasone propionate demonstrated no tumorigenic potential ...

14. Clinical Studies

CUTIVATE Lotion applied once daily was superior to vehicle in the treatment of atopic dermatitis in two clinical trials. The two trials enrolled 438 subjects with atopic dermatitis aged 3 months and older, ...

16.1. How Supplied

CUTIVATE (fluticasone propionate) Lotion USP, 0.05% is white to off-white in color, and supplied as follows: 120 mL bottle NDC 10337-434-04

16.2. Storage and Handling

Store between 15° and 30°C (59° and 86°F). Do not refrigerate, and keep container tightly closed.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Administration Instructions Advise the patient of appropriate CUTIVATE Lotion administration instructions, including ...