Dosing & Uses
Dosage Forms & Strengths
cream/ointment
- 0.05%
Dermatoses
Apply sparingly to affected area(s) qDay-q8hr; discontinue therapy when; discontinue therapy if control achieved and reassess diagnosis if no improvement within 4 weeks
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Skin atrophy
Arthralgia
Dryness
Folliculitis
Secondary infection
Striae
Pigmentation changes
HPA suppression (with higher potency used >2 wk)
Burning
Itching
Irritation
Hypertrichosis
Acneiform eruptions
Hypopigmentation
Perioral dermatitis
Allergic contact dermatitis
Maceration of the skin,
Miliaria
Postmarketing Reports
Vision Disorders: Cataract, glaucoma, central serous chorioretinopathy
Warnings
Contraindications
Underlying infection
Hypersensitivity
Ophthalmic use
Cautions
Chronic topical corticosteroid therapy may interfere with growth and development in children
Use med to very high potency for <2 wk to reduce local and systemic side effects
Use low potency for chronic therapy
Kaposi's sarcoma reported with prolonged corticosteroid therapy
Avoid medium to very high potency on face, folds, groin because can increase steroid absorption
Use lower potency for children (ie, increase BSA/kg, therefore increase systemic absorption)
Use of topical corticosteroids may increase risk of posterior subcapsular cataracts and glaucoma; cataracts reported in postmarketing experience with use of topical diflorasone diacetate products; glaucoma, with possible damage to optic nerve, and increased intraocular pressure reported in postmarketing experience with use of topical dermal corticosteroids
Avoid contact with eyes; advise patients to report any visual symptoms
Some patients, including children may exhibit susceptibility to corticosteroid-induced HPA axis suppression and Cushing's syndrome due to prolonged use, or addition of occlusive dressings
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity
If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted
In presence of dermatological infections, institute appropriate antifungal or antibacterial; if a favorable response does not occur promptly, the discontinue corticosteroid therapy until infection has been adequately controlled
Pregnancy & Lactation
Pregnancy
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels; more potent corticosteroids 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; topical corticosteroids should be used during pregnancy only if potential benefit justifies potential risk to fetus; drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time
Lactation
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, exercise caution should when administering product to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Absorption: yes
Potency
Very high: diflorasone ointment 0.05%
High: diflorasone emollient 0.05%
Relative potency: ointment >cream >lotion >solution
Mechanism of Action
Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation
Pharmacokinetics
Absorption: Minimal (~1%); nature of skin at application; occlusion and inflammation may increase absorption
Metabolism: Liver
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| diflorasone topical - | 0.05 % ointment |  | |
| diflorasone topical - | 0.05 % cream |  | |
| diflorasone topical - | 0.05 % ointment |  | |
| diflorasone topical - | 0.05 % cream |  | |
| diflorasone topical - | 0.05 % ointment |  | |
| diflorasone topical - | 0.05 % ointment |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
diflorasone topical
DIFLORASONE - TOPICAL
(dye-FLOR-a-sone)
COMMON BRAND NAME(S): Florone
USES: Diflorasone is used to treat a variety of skin conditions (such as eczema, dermatitis, allergies, rash). Diflorasone reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a strong (high-potency) corticosteroid.
HOW TO USE: Use this medication only on the skin. However, do not use it on the face, groin or underarms unless directed to do so by your doctor.Wash and dry your hands before applying. Clean and dry the affected area. Apply a thin film of the medication to the affected area and gently rub in as directed by your doctor, usually 1 to 3 times daily. Do not bandage, wrap or cover the area unless directed to do so by your doctor.After applying the medication, wash your hands, unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water.Use this medication only for the condition prescribed. Inform your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Burning, stinging, itching, irritation, dryness, or redness may occur when this medication is first applied to the skin. This should disappear in a few days as your body adjusts to the medication. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: stretch marks (striae), skin thinning/discoloration, excessive hair growth, acne, small red bumps on the skin (folliculitis).Skin infections can become worse when using this medication. Notify your doctor if redness, swelling or irritation does not improve.Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using diflorasone, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (such as hydrocortisone, dexamethasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, other skin conditions (such as rosacea, perioral dermatitis), immune system problems.Do not use if there is an infection or sore in the area to be treated.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medication can be harmful if swallowed.
NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases.Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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