19 . July , 2018 - Thursday
Check todays hot topics or new products

Find a Drug: Advanced

Please Sign in or Register

All about: Florone

Big Image
Generic Name: diflorasone diacetate
Dosage Form: Cream, usp 0.05%

Not For Ophthalmic Use

Florone Description

Each gram of Florone Cream contains 0.5 mg diflorasone diacetate in a cream 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:

Florone Cream contains diflorasone diacetate in an emulsified and hydrophilic cream base of propylene glycol, stearic acid, polysorbate 60, sorbitan monostearate and monooleate, sorbic acid, citric acid and water. The corticosteroid is formulated as a solution in the vehicle using 15 percent propylene glycol to optimize drug delivery.

Florone - 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.

Indications and Usage for Florone

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.

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. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
  4. Patients should report any signs of local adverse reactions especially under occlusive dressing.
  5. 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, And Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect of topical corticosteroids on fertility.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

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. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Florone in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at 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 reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

  1. Burning
  2. Itching
  3. Irritation
  4. Dryness
  5. Folliculitis
  6. Hypertrichosis
  7. Acneiform eruptions
  8. Hypopigmentation
  9. Perioral dermatitis
  10. Allergic contact dermatitis
  11. Maceration of the skin
  12. Secondary infection
  13. Skin atrophy
  14. Striae
  15. Miliaria

Overdosage

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

Florone Dosage and Administration

Topical corticosteroids are generally applied to the affected area as a thin film from one to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

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

How is Florone Supplied

Florone Cream is available in 30 gram and 60 gram collapsible tubes

Store at controlled room temperature, 20° to 25° C (68° to 77° F) [see USP].

Rx only

DAW123C

January 2004


Florone (diflorasone diacetate)
PRODUCT INFO
Product Code 0009-0199 Dosage Form CREAM
Route Of Administration TOPICAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
diflorasone diacetate (diflorasone) Active 0.5 MILLIGRAM  In 1 GRAM
propylene glycol Inactive  
stearic acid Inactive  
polysorbate 60 Inactive  
sorbitan monostearate Inactive  
monooleate Inactive  
sorbic acid Inactive  
citric acid Inactive  
water Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color Score
Shape Symbol
Imprint Code Coating
Size
PACKAGING
# NDC Package Description Multilevel Packaging
1 0009-0199-31 30 GRAM In 1 TUBE None
2 0009-0199-60 60 GRAM In 1 TUBE None

Revised: 02/2006

Recent Drug Updates at DrugIndexOnline:





Acular PF Drops Acular PF Drops
Generic Name: Ketorolac Eye Drops and PF Eye Drops (kee-TOE-role-ak) Brand Name: Acular and Acular PFAcular PF Drops is used for:Treating itchy eyes and swelling caused by seasonal allergies. It may be used to relieve eye swelling following cataract surgery. It may also be used to reduce eye pa more...

Alumina, Magnesia, and Magnesium Carbonate or Alumina, Magnesia, and Simethicone Alumina, Magnesia, and Magnesium Carbonate or Alumina, Magnesia, and Simethicone
Some commonly used brand names are: In the U.S.— Advanced Formula Di-Gel 29 Alamag 2 Alamag Plus 9 Alenic Alka 15 Alenic Alka Extra Strength 18 Alka-Mints 27 Alkets 27 Alkets Extra Strength 27 Almacone 9 Almacone II 9 AlternaGEL 21 Alu-Cap 25 Aludrox 9 Alu-Tab 25 Amitone 27 Amphojel 25 An more...

Carbetapentane/Pseudoephedrine Suspension Carbetapentane/Pseudoephedrine Suspension
Generic Name: Carbetapentane/Pseudoephedrine Suspension (car-beta-PEN-tane/soo-doe-e-FED-rin) Brand Name: Respi-TannCarbetapentane/Pseudoephedrine Suspension is used for:Relieving symptoms of sinus congestion and cough due to colds, upper respiratory infections, and allergies. It may also be use more...

chaparral chaparral
Generic Name: chaparral (SHAH peh rel) Brand Names: What is chaparral? The use of chaparral in cultural and traditional settings may differ from concepts accepted by current Western medicine. When considering the use of herbal supplements, consultation with a primary health care profess more...

Delsym Delsym
Some commonly used brand names are: In the U.S.— Benylin Adult Formula Cough Syrup Benylin Pediatric Cough Suppressant Cough-X Creo-Terpin Delsym Cough Formula Diabe-TUSS DM Syrup Hold DM Pertussin CS Children's Strength Pertussin DM Extra Strength Robitussin Maximum Strength Cough Suppre more...

Fluticasone Propionate/Salmeterol Fluticasone Propionate/Salmeterol
Pronouncation: (flew-TICK-ah-SONE PRO-pee-oh-nate/sal-MEET-ah-rahl) Class: Respiratory inhalant combination Trade Names: Advair Diskus - Powder for inhalation 100 mcg fluticasone propionate, 50 mcg salmeterol - Powder for inhalation 250 mcg fluticasone propionate, 50 mcg salmeterol - Powder for inh more...

Mol-Iron Mol-Iron
Generic Name: ferrous sulfate (FEHR russ SULL fate) Brand Names: Chem-Sol, Fe 50, Feosol, Fer-Gen-Sol, Fer-in-Sol, Fero-Gradumet Filmtab, FeroSul, Ferra T.D. Caps, Ferra-TD, Ferratab, Ferro-Bob, Ferro-Time, Ferrospace, Mol-Iron, Slow Fe, Yieronia What is Mol-Iron (ferrous sulfate)? Ferr more...

Nicorette Plus Nicorette Plus
Some commonly used brand names are: In the U.S.— Commit NicoDerm CQ Nicorette Nicotrol In Canada— Habitrol Nicoderm Nicorette Nicorette Plus Nicotrol Prostep Generic name product may be available in the U.S. Category Smoking cessation adjunct Description Nicotine (NIK-o-t more...