DIFLORASONE DIACETATE OINT- diflorasone diacetate ointment ointment

Diflorasone Diacetate Oint by

Drug Labeling and Warnings

Diflorasone Diacetate Oint by is a Prescription medication manufactured, distributed, or labeled by Sola Pharmaceuticals, Teligent Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base.
Chemically, diflorasone diacetate is 6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-
3,20-dione 17,21-diacetate. The structural formula is represented below:

Each gram of diflorasone diacetate ointment contains 0.5 mg diflorasone diacetate in an ointment base of
glyceryl monostearate, propylene glycol and white petrolatum.

Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.
The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various
laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or
clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a
recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics
The extent of percutaneous absorption of topical corticosteroids is determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease
processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the
percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.)

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in
varying degrees. They are metabolized primarily in the liver and are then excreted by the kidneys. Some
of the topical corticosteroids and their metabolites are also excreted into the bile.

Indication and Usage

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses.

Contraindications

Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the
components of the preparation.

Warnings

Use of topical corticosteroids, including diflorasone diactate dintment may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products. Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids.

Avoid contact of Diflorasone Diacetate Ointment with eyes. Advise patients to report any visual symptoms.

Precautions

General
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal
(HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some
patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use
over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or
under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by
using the urinary free cortisol and ACTH stimulation tests. 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 steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug.
Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic
corticosteroids.
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more
susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use.)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent
should be instituted. If a favorable response does not occur promptly, the corticosteroid should be
discontinued until the infection has been adequately controlled.

Information for the Patient
Patients using topical corticosteroids should receive the following information and instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact
with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was
prescribed.
3. Contact your healthcare provider if you experience blurred vision or other visual disturbances (see
WARNINGS).
4. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive
unless directed by the physician.
5. Patients should report any signs of local adverse reactions especially under occlusive dressing.
6. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on an
infant or child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests
The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect
on fertility of topical corticosteroids.
Diflorasone diacetate was not mutagenic in a micronucleus test in rats at intraperitoneal doses up to
2400 mg/kg.

Pregnancy
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after
dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant
women on teratogenic effects from topically applied corticosteroids. Therefore, topical
corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk
to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or
for prolonged periods of time.

Nursing Mothers
It is not known whether topical administration of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human
milk, caution should be exercised when Diflorasone Diacetate Ointment is administered to a nursing
woman.

Pediatric Use
Safety and effectiveness of diflorasone diacetate ointment in pediatric patients have not been
established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a
greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids.
They are, therefore, also at greater risk of glucocorticosteroid insufficiency after withdrawal of
treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been
reported with inappropriate use of topical corticosteroids in pediatric patients.
HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in
pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric
patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence
of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging
fontanelles, headaches, and bilateral papilledema.

Geriatric Use
Clinical studies of diflorasone diacetate topical formulations did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond differently from younger subjects.

Adverse Reactions

The following local adverse reactions have been identified from clinical trials or postmarketing
surveillance. Because they are reported from a population from unknown size, it is not always possible
to reliably estimate their frequency or establish a causal relationship to topical corticosteroids
exposure.

These adverse reactions may occur more frequently with the use of occlusive dressings or prolonged
use of topical corticosteroids.

Skin and Subcutaneous Tissue Disorders: burning, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis,
maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.

Vision Disorders: cataract, glaucoma, central serous chorioretinopathy

To report SUSPECTED ADVERSE REACTIONS, contact Teligent Pharma, Inc. at 1-856-697-1441,
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
(See PRECAUTIONS.)

Dosage and Administration

Diflorasone diacetate ointment should be applied to the affected area as a thin film from one to three
times daily depending on the severity or resistant nature of the condition.

For topical us only. Avoid contact with eyes.

Wash hands after each application.

Do not use with occlusive dressings, unless directed by a physician (see PRECAUTIONS).

If an infection develops, the use of occlusive dressings should be discontinued and appropriate
antimicrobial therapy initiated.

How Supplied

Diflorasone Diacetate Ointment USP, 0.05% is available in 60 gram (NDC: 70512-031-60) tubes.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
Sola Pharmaceuticals
Baton Rouge, LA 70809
Revised: 01/2019

Principal Display Panel

60 g Tube Carton
NDC: 70512-031-60

Diflorasone Diacetate
Ointment USP, 0.05%

For Topical Use Only
Not For Ophthalmic Use
Net Wt. 60 g Rx only

Keep this and all medications out of the reach of children.

Sola Pharmaceuticals

INGREDIENTS AND APPEARANCE

DIFLORASONE DIACETATE OINT 
diflorasone diacetate ointment ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70512-031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIFLORASONE DIACETATE (UNII: 7W2J09SCWX) (DIFLORASONE - UNII:T2DHJ9645W)	DIFLORASONE DIACETATE	0.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-031-60	1 in 1 CARTON	02/04/2019
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA210753	02/04/2019

Labeler - Sola Pharmaceuticals (080121345)

Establishment
Name	Address	ID/FEI	Business Operations
Teligent Pharma, Inc.		011036910	manufacture(70512-031)