Diflorasone Diacetate 0.05% Crm 15g
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jun 1976
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone diacetate cream is a strong medicine (a corticosteroid) that you put on your skin to help reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down your body's inflammatory response in the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Wash your hands before and after applying the medication. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature with the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Wash your hands before and after applying the medication. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storage and Disposal
Store the medication at room temperature with the lid tightly closed.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in drug take-back programs in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer of cream only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the cream.
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- Do not use for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas one to two times daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
Psoriasis:
Apply a thin film to the affected skin areas one to two times daily.
Eczema:
Apply a thin film to the affected skin areas one to two times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (increased risk of systemic absorption due to higher surface area to body weight ratio; use with extreme caution if at all, for shortest duration possible)
Child:
Not established (increased risk of systemic absorption due to higher surface area to body weight ratio; use with extreme caution if at all, for shortest duration possible)
Adolescent:
Apply a thin film to the affected skin areas one to two times daily, with caution regarding systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Severe:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Dialysis:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Severe:
No specific adjustment recommended for topical use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Diflorasone diacetate is a high-potency synthetic corticosteroid. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Thus, corticosteroids exert anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Not quantifiable (topical)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not well-defined (topical)
ProteinBinding:
Not well-defined (topical)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined (topical)
Clearance:
Not well-defined (topical)
ExcretionRoute:
Renal (metabolites)
Unchanged:
Not well-defined (topical)
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effects)
PeakEffect:
Not well-defined
DurationOfAction:
Varies, typically requires once or twice daily application
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Thinning of the skin
Skin irritation
Changes in vision, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Itching
* Burning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Thinning of the skin
Skin irritation
Changes in vision, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dry skin
Itching
* Burning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased skin irritation, burning, stinging, or itching at the application site.
- Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks (striae).
- Development of new skin infections (e.g., pus, redness, warmth, fever).
- Acne-like breakouts or increased hair growth in the treated area.
- Changes in skin color (lightening).
- If used extensively or for prolonged periods, watch for signs of systemic absorption such as unusual weight gain, swelling in the face (moon face), fatigue, or muscle weakness (signs of Cushing's syndrome or adrenal suppression).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Avoid using it for these conditions.
When applying this medication to the diaper area, do not use tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not apply this medication to cuts, scrapes, or damaged skin, as this can cause further irritation.
If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor. Additionally, do not use this medication for longer than prescribed by your doctor.
Using this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication.
When using this medication in children, it is essential to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to you and your baby.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Avoid using it for these conditions.
When applying this medication to the diaper area, do not use tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
Do not apply this medication to cuts, scrapes, or damaged skin, as this can cause further irritation.
If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor. Additionally, do not use this medication for longer than prescribed by your doctor.
Using this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
If you have diabetes (high blood sugar), it is crucial to monitor your blood sugar levels closely while taking this medication.
When using this medication in children, it is essential to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged and excessive use of topical corticosteroids can lead to systemic effects due to absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Local overdose may result in increased local adverse effects such as skin atrophy, striae, or telangiectasias.
What to Do:
If systemic effects are suspected, gradually withdraw the drug under medical supervision. Symptomatic and supportive treatment should be initiated. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (e.g., erythema, scaling, pruritus, lesion size)
Rationale: To assess the severity of the dermatosis and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Area of involvement
Rationale: To determine the extent of skin surface requiring treatment and estimate potential for systemic absorption.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, lesion size)
Frequency: Regularly, typically at follow-up visits (e.g., weekly for acute conditions, less frequently for chronic)
Target: Significant improvement or resolution of symptoms
Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks; consider alternative therapy or re-evaluation of diagnosis.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, acneiform eruptions, hypopigmentation)
Frequency: At each follow-up visit, especially with prolonged use or on sensitive areas
Target: Absence of new or worsening local adverse effects
Action Threshold: Development of significant local adverse effects; reduce frequency, switch to lower potency, or discontinue.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)
Frequency: Periodically, especially if used extensively, under occlusion, or in pediatric patients
Target: Absence of systemic signs/symptoms
Action Threshold: Presence of systemic signs/symptoms; discontinue or gradually withdraw therapy and manage symptoms.
Symptom Monitoring
- Reduction in skin redness
- Decrease in itching
- Improvement in scaling or dryness
- Healing of skin lesions
- Development of new skin irritation or rash
- Skin thinning or bruising
- Stretch marks (striae)
- Increased hair growth at application site
- Signs of infection (pus, fever, increased pain)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Diflorasone diacetate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should generally be avoided or used with extreme caution during pregnancy due to potential for systemic absorption.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, use only if clearly needed.
Second Trimester:
Potential for fetal harm, use only if clearly needed.
Third Trimester:
Potential for fetal harm, use only if clearly needed.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when diflorasone diacetate is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper use, but potential for systemic effects in infant if significant absorption occurs or applied to breast.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Prolonged use of topical corticosteroids in pediatric patients should be avoided. Adrenal suppression, growth retardation, and intracranial hypertension have been reported in children receiving topical corticosteroids. Use the least potent effective corticosteroid for the shortest duration possible.
Geriatric Use
No specific dosage adjustments are recommended. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy or purpura. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Diflorasone diacetate is a high-potency topical corticosteroid; use it sparingly and for short durations to minimize local and systemic side effects.
- Avoid using this cream on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to adverse effects like skin thinning and stretch marks.
- Occlusive dressings (e.g., bandages, plastic wrap) can significantly increase systemic absorption and should only be used if explicitly prescribed by a healthcare provider.
- Patients should be advised to report any signs of local irritation, infection, or systemic effects (e.g., unusual weight gain, swelling, fatigue) to their doctor.
- Not for ophthalmic use.
Alternative Therapies
- Other topical corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate, Fluocinonide, Triamcinolone acetonide, Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for eczema
- Topical vitamin D analogs (e.g., Calcipotriene) for psoriasis
- Topical retinoids (e.g., Tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases of psoriasis or eczema
Cost & Coverage
Average Cost:
Varies, typically $20-$100+ per 15g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.