Cutivate Cream (Fluticasone Propionate Cream) Drug Information: Side Effects and Drug Interactions

Pill Identifier Search

May 27, 2012

Cutivate

Dry Skin »

Dry skin facts

Dry skin is a very common condition that causes small fine flakes and dry patches.
Itching is one of the most common symptoms of dry skin.
Scratching may be hard to resist.
Dry skin is more common in colder winter months and drier climates.
The elderly are more prone to dry skin than younger people.
Dry skin is more common in individuals with a history of eczema, atopic dermatitis, allergies, or asthma.
Dry skin may rarely be a side effect of medications.
Dry skin is more common in those with hypothyroidism and hyperthyroidism.
Repeat itch-scratch cycles may lead to skin thickening and darkening.
Possible complications include rashes, eczema, and bacterial infections.
Extremely dry skin can cause cracks and breaks on the skin.
Medications including topical corticosteroids and oral antihistamines can help ease itching.
Secondary ...

Read the Dry Skin article »

« Previous
1
2
3
4
5
6
7
8
9
10
Next »

Cutivate Cream

Adult Skin Problems Slideshow Pictures

Quiz: Can You Identify These Skin Conditions?

Gallery of Skin Problems and Image Collection

font size

SIDE EFFECTS

Clinical Trial Experience

In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® (fluticasone propionate cream) Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.

Two clinical studies compared once- to twice-daily administration of CUTIVATE® (fluticasone propionate cream) Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1. In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.

Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. CUTIVATE® (fluticasone propionate cream) Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤ 18 μg/dL, indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of CUTIVATE® (fluticasone propionate cream) Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® (fluticasone propionate cream) Cream.

Table 1: Drug-Related Adverse Events—Skin

Adverse Events	Fluticasone Once Daily (n = 210)	Fluticasone Twice Daily (n = 203)	Vehicle Twice Daily (n = 78)
Skin infection	1 (0.5%)	0	0
Infected eczema	1 (0.5%)	2 (1.0%)	0
Viral warts	0	1 (0.5%)	0
Herpes simplex	0	1 (0.5%)	0
Impetigo	1 (0.5%)	0	0
Atopic dermatitis	1 (0.5%)	0	0
Eczema	1 (0.5%)	0	0
Exacerbation of	4 (1.9%)	1 (0.5%)	1 (1.3%)
eczema
Erythema	0	2 (1.0%)	0
Burning	2 (1.0%)	2 (1.0%)	2 (2.6%)
Stinging	0	2 (1.0%)	1 (1.3%)
Skin irritation	6 (2.9%)	2 (1.0%)	0
Pruritus	2 (1.0%)	4 (1.9%)	4 (5.1%)
Exacerbation of
pruritus	4 (1.9%)	1 (0.5%)	1 (1.3%)
Folliculitis	1 (0.5%)	1 (0.5%)	0
Blisters	0	1 (0.5%)	0
Dryness of skin	3 (1.4%)	1 (0.5%)	0

Table 2: Adverse Events* From Pediatric Open-Label Trial (n = 51)

Adverse Events	Fluticasone Twice Daily
Burning	1 (2.0%)
Dusky erythema	1 (2.0%)
Erythematous rash	1 (2.0%)
Facial telangiectasia†	2 (4.9%)
Non-facial telangiectasia	1 (2.0%)
Urticaria	1 (2.0%)
*See text for additional detail. † n = 41.

Post Marketing Experience

Systemic adverse events with CUTIVATE® (fluticasone propionate cream) Cream and CUTIVATE® (fluticasone propionate cream) Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following localized adverse reactions have been reported during post approval use of CUTIVATE® (fluticasone propionate cream) Cream: skin discoloration, erythema, irritation, edema/swelling, atrophy, contusion, dermatitis, pain, sepsis, hemorrhage, acneiform eruptions.

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.