Diflorasone Diacetate 0.05% Crm 30g
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Anti-inflammatory Agent
Pharmacologic Class
Topical Corticosteroid; Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone diacetate is a strong (high-potency) steroid cream used on the skin to reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema, psoriasis, and severe dermatitis. It works by calming down the 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 instructed to do so by your doctor.
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.
If you have questions about disposing of medications, consult your pharmacist. You may also have access to 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 instructed to do so by your doctor.
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.
If you have questions about disposing of medications, consult your pharmacist. You may also have access to 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 very thin layer of cream to the affected skin area(s) as directed by your doctor, usually once to three times a day.
- Wash your hands before and after applying the cream.
- Do not use more cream than prescribed or apply it more often than directed.
- Do not use this cream on your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to steroid side effects.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially on large areas of the body or in children, due to the risk of systemic side effects.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas one to three times daily.
Dose Range:
1 - 3 mg
Condition-Specific Dosing:
generalUse:
Apply sparingly to affected areas.
Pediatric Dosing
Neonatal:
Not established; generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established; generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Child:
Use with caution, for the shortest duration possible, and the least amount necessary to achieve therapeutic effect. Generally once daily for limited periods. Not recommended for children under 12 years without specialist advice.
Adolescent:
Apply a thin film to the affected skin areas one to three times daily, similar to adults, but with caution regarding duration and area of application.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (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. Corticosteroids also possess vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly; minimal systemic absorption through intact skin. Increased absorption with inflammation, skin barrier disruption, occlusion, prolonged use, and large surface areas.
Tmax:
Not well-defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed drug is distributed throughout the body.
ProteinBinding:
High (for systemically absorbed portion, typically >90%).
CnssPenetration:
Limited (for systemically absorbed portion).
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed drug has a variable half-life.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Varies with frequency of application and individual response.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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 can cause side effects. While many people may not experience any side effects or only have mild ones, it's 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 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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 can cause side effects. While many people may not experience any side effects or only have mild ones, it's 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 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:
- Worsening of your skin condition or development of new skin problems (e.g., new rash, infection, severe irritation).
- Signs of skin thinning, such as easy bruising, stretch marks (striae), or visible blood vessels (telangiectasias).
- Signs of a skin infection (e.g., pus, fever, increased pain or redness).
- Signs of systemic absorption, which are rare but serious: unusual weight gain, swelling (especially in the face or neck), muscle weakness, fatigue, increased thirst or urination (signs of high blood sugar).
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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. Use it only for its prescribed purpose.
When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Before using any other skin products or medications, 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 or complications.
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 the duration prescribed by your doctor.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Therefore, it is crucial to discuss this potential risk with your doctor.
If you have diabetes (high blood sugar), it is essential to monitor your blood sugar levels closely while using this medication.
When using this medication in children, it is crucial to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may 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 it is necessary to weigh the benefits and risks of using this medication to both you and your baby.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Use it only for its prescribed purpose.
When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Before using any other skin products or medications, 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 or complications.
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 the duration prescribed by your doctor.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Therefore, it is crucial to discuss this potential risk with your doctor.
If you have diabetes (high blood sugar), it is essential to monitor your blood sugar levels closely while using this medication.
When using this medication in children, it is crucial to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may 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 it is necessary to weigh the benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (characterized by moon face, central obesity, buffalo hump, skin thinning, easy bruising) and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to fatigue, weakness, nausea, vomiting, low blood pressure).
What to Do:
If you suspect an overdose or experience systemic symptoms, contact your doctor immediately or call a poison control center (1-800-222-1222). Treatment is supportive and may involve gradual withdrawal of the corticosteroid.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Area of body surface involved
Rationale: To estimate potential for systemic absorption, especially in children or with extensive use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, lesions)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms and skin appearance.
Action Threshold: Lack of improvement or worsening of condition may indicate need for re-evaluation or alternative therapy.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit.
Target: Absence of or minimal local adverse effects.
Action Threshold: Presence of significant local adverse effects may require dose reduction, discontinuation, or change in therapy.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome, hyperglycemia, glucosuria)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Normal adrenal function and metabolic parameters.
Action Threshold: Symptoms or laboratory findings suggestive of systemic absorption (e.g., low morning cortisol, elevated blood glucose) require immediate medical attention and discontinuation of therapy.
Symptom Monitoring
- Worsening of skin condition
- Development of new skin lesions or infections
- Increased redness, swelling, or pain at application site
- Skin thinning, easy bruising, or stretch marks
- Unusual weight gain or swelling (especially in face/neck)
- Increased thirst or urination
- Fatigue or weakness
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from topical application is minimal, high-potency corticosteroids should be used with caution, for the shortest duration, and on the smallest area possible.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of teratogenicity with high systemic exposure, but unlikely with appropriate topical use.
Second Trimester:
Minimal risk with appropriate topical use.
Third Trimester:
Minimal risk with appropriate topical use; theoretical risk of HPA axis suppression in the neonate with extensive maternal use near term.
Lactation
Use with caution. It is not known whether topical diflorasone diacetate is excreted in human milk. Systemic absorption is minimal, making infant exposure unlikely. However, avoid applying to areas that may come into direct contact with the infant's skin or mouth (e.g., breasts).
Infant Risk:
Low risk due to minimal systemic absorption, but caution advised.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Not recommended for children under 12 years without specialist consultation.
Geriatric Use
No specific dose adjustments are generally required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Diflorasone diacetate is a high-potency topical corticosteroid; use it judiciously and for limited durations to minimize local and systemic side effects.
- Educate patients on proper application technique: apply a very thin layer, rub in gently, and do not use more than prescribed.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to steroid-induced atrophy and other side effects.
- Warn patients against abrupt discontinuation after prolonged use on large areas, as this can lead to a rebound flare of the underlying skin condition.
- Consider step-down therapy to a lower-potency corticosteroid or non-steroidal agent once the acute inflammation is controlled.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
- Low-potency topical corticosteroids (e.g., Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy
- Vitamin D analogs (e.g., Calcipotriene) for psoriasis
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
Cost & Coverage
Average Cost:
$30 - $100 per 30g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 is a good idea to check with your pharmacist for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.