Desonide description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Desonide

Physicians Total Care, Inc.

Desonide Lotion 0.05%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


Rx Only
For Dermatologic Use Only
Not for Ophthalmic Use

DESONIDE DESCRIPTION


24326
Desonide

CLINICAL PHARMACOLOGY

22.

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

Teratogenic effects: Pregnancy category C:

Nursing mothers

Pediatric use


DESONIDE ADVERSE REACTIONS


OVERDOSAGE

PRECAUTIONS

DESONIDE DOSAGE AND ADMINISTRATION



HOW SUPPLIED



2 fl oz / 59 mL
NDC 54868-5050-1
4 fl oz / 118 mL
NDC 54868-5050-0


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


Desonide Lotion 0.05%

Desonide

Desonide LOTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:54868-5050(NDC:0472-0803)
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DESONIDE desonide 0.5 mg

Inactive Ingredients

Ingredient Name Strength
CETYL ALCOHOL
EDETATE SODIUM
GLYCERYL MONOSTEARATE
LIGHT MINERAL OIL
METHYLPARABEN
propylene glycol
PROPYLPARABEN
SODIUM LAURYL SULFATE
SORBITAN MONOSTEARATE
stearyl alcohol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-5050-0 120 in 1 BOTTLE, PLASTIC
2 NDC:54868-5050-1 60 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072354 2004-05-17


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.