Crema

Prescribing Information

EUMOVATE Cream
(clobetasone butyrate, 0.05%)

EUMOVATE Ointment
(clobetasone butyrate, 0.05%)

Topical Corticosteroid

Prescribing Information

EUMOVATE Cream
(clobetasone butyrate, 0.05%)

EUMOVATE Ointment
(clobetasone butyrate, 0.05%)

THERAPEUTIC CLASSIFICATION

Topical corticosteroid

ACTIONS AND CLINICAL PHARMACOLOGY
The corticosteroids are aclass of compounds comprising steroid hormones secreted by the
adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used
primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids
such as clobetasone 17-butyrate are effective in the treatment of corticosteroid-responsive
dermatoses primarily because of theiranti-inflammatory, anti-pruritic, and vasoconstrictive
actions. However, while the physiologic, pharmacologic and clinical effects of the
corticosteroids are well known, the exact mechanisms of their actions in each disease are
uncertain.
Clobetasone butyrate has been shown to have topical and systemic pharmacologic and
metabolic effects characteristic of the corticosteroid class of drugs.EUMOVATEPRESCRIBINGINFO

Indications and Clinical Use
EUMOVATE (clobetasone butyrate) Cream and Ointment are indicated in the treatment of
milder forms of eczema, seborrheic dermatitis, and other corticosteroid-responsive skin
conditions, which do not require the use of a more potent topical corticosteroid.

Contraindications
Clobetasone butyrate cream and ointment are not indicated for the treatmentof primarily
infected skin lesions caused by infection with fungi or bacteria if no anti-infective agent is used
simultaneously, primary cutaneous viral infections (i.e., herpes simplex, vaccinia and varicella)
or tuberculous skin lesions. Clobetasone butyrate cream and ointment are also contraindicated
in patients with a hypersensitivity to any of the components of the preparation.Warnings
EUMOVATE (clobetasone butyrate) Cream and Ointment should not be used in the eye and
should be used with caution in lesions close to the eye as glaucoma may result. Posterior
subcapsular cataracts have been reported following systemic use of corticosteroids.
If clobetasone butyrate is used under occlusive dressing over extensive areas for prolonged
periods, it is possible that sufficientabsorption may take place to give rise to transient adrenal
suppression. Long-term continuous topical corticosteroid therapy should be avoided where
possible as adrenal suppression can occur even without occlusion.
Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
EUMOVATEPRESCRIBINGINFO

Precautions
Significant systemic absorption may resultwhen corticosteroids are applied over large areas of
the body. To minimise this possibility, treatment should be interrupted periodically or one area
of the body should be treated at a time when long-term therapy is anticipated. In infants, the
diaper may act as an occlusive dressing and increase absorption.
As with all corticosteroids, prolonged application of EUMOVATE (clobetasone butyrate)Cream
and Ointment to the face is undesirable.
Prolonged or extensive use of topycal corticosteroid products may product atrophy of the skin
and subcutaneous tissue, particularly on flexor surfaces and on the face. If this is noted, the
use of EUMOVATE should be discontinued.
EUMOVATE should be used with caution in patients with stasis dermatitis and other skin
diseases associated withimpaired circulation.
If a symptomatic response is not noted within a few days to a week, the local application of
EUMOVATE should be discontinued and the patient re-evaluated.
In case of bacterial infections of the skin, appropriate anti-bacterial agents should be used as
primary therapy. If it is considered necessary, the topical corticosteroid may be used as an
adjunct to control inflammation,...