Diflorasone Diacetate 0.05% Crm 60g
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
Sep 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone Diacetate cream is a strong medicine (a corticosteroid) used on the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Unless instructed to do so by your doctor, do not apply the medication to your face, underarms, or groin area.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so. If you need to apply the medication to a sensitive area, consult with your doctor for specific guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping the lid tightly closed. Keep all medications in a safe place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Unless instructed to do so by your doctor, do not apply the medication to your face, underarms, or groin area.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Instructions
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so. If you need to apply the medication to a sensitive area, consult with your doctor for specific guidance.
Storing and Disposing of Your Medication
Store your medication at room temperature, keeping the lid tightly closed. Keep all medications in a safe place, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and ask about any local drug take-back programs.
Missing a Dose
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer of cream to the affected area and rub it in gently.
- Wash your hands thoroughly before and after applying the cream.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid getting the cream in your eyes, mouth, or nose.
- Do not use this cream on your face, groin, or armpits unless your doctor tells you to, as these areas are more sensitive to side effects.
- Use only for the prescribed duration; prolonged use can lead to skin thinning or other side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin area one to three times daily.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
psoriasis:
Apply one to two times daily.
eczema:
Apply one to three times daily.
Pediatric Dosing
Neonatal:
Not established (increased risk of systemic absorption and adrenal suppression)
Infant:
Not established (increased risk of systemic absorption and adrenal suppression)
Child:
Use with caution, limited to small areas and short duration (e.g., <2 weeks) due to increased risk of systemic absorption and adrenal suppression.
Adolescent:
Similar to adult dosing, but monitor closely for systemic effects if used on large areas or for prolonged periods.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations for topical use
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Diflorasone diacetate is a potent synthetic corticosteroid. It exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated through the induction of phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Generally low.
Tmax:
Not applicable for topical application in a systemic sense.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not precisely quantified for topical application; if absorbed, distributed throughout the body.
ProteinBinding:
High (similar to other corticosteroids, typically >90%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life of absorbed corticosteroids varies.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted due to extensive hepatic metabolism.
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (local effect).
PeakEffect:
Within 1-2 weeks of consistent application (local effect).
DurationOfAction:
Effects persist as long as applied; local effects dissipate upon discontinuation.
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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Skin irritation
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. 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 all 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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Skin irritation
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug may cause side effects in some people. While many individuals do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. 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 all 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 irritation, burning, or itching at the application site
- Signs of a skin infection (e.g., pus, fever, worsening redness)
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like rash or unusual hair growth
- Any signs of systemic side effects like unusual weight gain, swelling in the face, or fatigue (especially with prolonged or extensive use)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
- Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about your health problems
You must verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
- An allergy to this medication or any of its components
- An allergy to other medications, foods, or substances
When discussing your allergy, be sure to describe the symptoms you experienced.
This medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
- Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
- Share information about your health problems
You must verify that it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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 using 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 age group. 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, planning 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 using 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 age group. 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, planning 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 or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including moon face, central obesity, striae, and hypertension.
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure) can also occur.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin damage or infection.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: At each follow-up visit, or as symptoms arise.
Target: N/A
Action Threshold: Discontinue or reduce frequency if severe or persistent.
Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia, glucosuria)
Frequency: Periodically, especially with prolonged use, large surface areas, or in pediatric patients.
Target: N/A
Action Threshold: Perform appropriate diagnostic tests (e.g., ACTH stimulation test, plasma cortisol) if suspected; discontinue or taper therapy.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain (signs of infection)
- Skin thinning or fragility
- Development of stretch marks (striae)
- Easy bruising
- Acne-like rash
- Unusual hair growth (hypertrichosis)
- Fatigue, weakness, weight gain (potential signs of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of corticosteroids, though topical absorption is generally low.
Second Trimester:
Monitor for fetal growth restriction with extensive use.
Third Trimester:
Monitor for fetal growth restriction and adrenal suppression in the neonate if used extensively near term.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is generally low. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use, but monitor infant for any unusual effects.
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity (adrenal suppression, Cushing's syndrome, intracranial hypertension) due to a larger skin surface area to body weight ratio. Not recommended for prolonged use or on large areas. Use the least potent effective corticosteroid for the shortest duration possible.
Geriatric Use
No specific dosage adjustments are typically needed. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like atrophy and purpura. Monitor closely.
Clinical Information
Clinical Pearls
- Diflorasone diacetate is a high-potency (Class I) topical corticosteroid, generally reserved for severe inflammatory dermatoses.
- Due to its potency, it should typically be used for short-term treatment (e.g., 2-4 weeks) to minimize the risk of local and systemic side effects.
- Avoid prolonged use on sensitive areas such as the face, groin, axillae, or in intertriginous areas, as these sites are more prone to atrophy, striae, and telangiectasias.
- Occlusive dressings significantly enhance percutaneous absorption and should be avoided unless specifically directed by a physician.
- Tapering the frequency of application (e.g., every other day) may be considered for chronic conditions to reduce the risk of rebound flares upon discontinuation.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate) for less severe conditions or maintenance.
- Calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for sensitive areas or long-term management, especially in atopic dermatitis.
- Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread, or refractory conditions.
Cost & Coverage
Average Cost:
$50 - $200 per 60g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.