Desonide

Physicians Total Care, Inc.

Desonide Lotion 0.05%

FULL PRESCRIBING INFORMATION: CONTENTS*

• DESONIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• Pharmacokinetics
• INDICATION AND USAGE
• DESONIDE CONTRAINDICATIONS
• PRECAUTIONS
• Information for patients
• Laboratory tests
• Carcinogenesis, mutagenesis, and impairment or fertility
• Pregnancy
• Nursing mothers
• Pediatric use
• DESONIDE ADVERSE REACTIONS
• OVERDOSAGE
• DESONIDE DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• Storage Conditions
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

DESONIDE DESCRIPTION

CLINICAL PHARMACOLOGY

Pharmacokinetics

INDICATION AND USAGE

DESONIDE CONTRAINDICATIONS

PRECAUTIONS

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See   PRECAUTIONS: Pediatric Use).
If irritation develops, Desonide Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide Lotion should be discontinued until the infection has been adequately controlled.

Information for patients

Laboratory tests

Carcinogenesis, mutagenesis, and impairment or fertility

Pregnancy

Nursing mothers

Pediatric use

DESONIDE ADVERSE REACTIONS

OVERDOSAGE

PRECAUTIONS

DESONIDE DOSAGE AND ADMINISTRATION

HOW SUPPLIED

Storage Conditions

Store between 2° and 30°C (36° and 86°F).

Distributed by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

Manufactured by
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA

325097-0209     Revised: February 2009

Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK         74146

PRINCIPAL DISPLAY PANEL

Desonide Lotion 0.05%