Diflorasone Diacetate 0.05% Ont 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
Aug 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone diacetate is a strong steroid cream or ointment used on the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response.
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 to do so 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. 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 extra doses to make up for a missed dose.
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 to do so 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. 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 extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the medication.
- 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 using this medication on your face, groin, or underarms unless your doctor tells you to, as these areas are more sensitive to side effects.
- Do not use for longer than prescribed, typically 2-4 weeks, to minimize the risk of side effects.
- Avoid contact with eyes, nose, and mouth. 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 three times daily.
Condition-Specific Dosing:
Psoriasis:
Apply a thin film to the affected skin areas one to three times daily. Limit treatment to 4 weeks.
Atopic Dermatitis:
Apply a thin film to the affected skin areas one to three times daily. Limit treatment to 2 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with extreme caution due to increased systemic absorption risk.
Child:
Not established, use with extreme caution due to increased systemic absorption risk. Limit treatment to shortest duration possible.
Adolescent:
Similar to adult dosing, but monitor closely for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific adjustment needed for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Diflorasone diacetate is a high-potency synthetic corticosteroid. It induces 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. It also possesses vasoconstrictive, antipruritic, and antimitotic actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on vehicle, integrity of epidermal barrier, site of application, and use of occlusive dressings)
Tmax:
Not precisely quantified for topical application, systemic absorption is minimal but can occur.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; once absorbed, corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding:
Not precisely quantified for topical application.
CnssPenetration:
Limited (systemic absorption is minimal)
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life of absorbed corticosteroids varies.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Excreted primarily by the kidneys, with some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Days to weeks for full therapeutic effect, depending on condition severity.
DurationOfAction:
Varies with application frequency and individual response.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 minor 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 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.
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 medical help right away:
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 minor 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 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:
- Worsening of your skin condition or new skin problems (e.g., thinning skin, stretch marks, acne, increased hair growth).
- Signs of skin infection (redness, swelling, pus, warmth).
- Signs that too much medicine has been absorbed into your body, such as unusual weight gain, swelling in your face (moon face), increased thirst or urination, or feeling tired and weak.
- Any severe burning, itching, or irritation at the application site.
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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose 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.
Do not use this medication to treat acne, rosacea, or a rash around the mouth.
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 medications or products on your skin, including soaps, consult with your doctor.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Exercise caution when using this medication on a large area of skin and consult with your doctor. Do not use this medication for a longer period than prescribed by your doctor.
This medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this with your doctor.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels 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 population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary; consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Do not use this medication to treat acne, rosacea, or a rash around the mouth.
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 medications or products on your skin, including soaps, consult with your doctor.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Exercise caution when using this medication on a large area of skin and consult with your doctor. Do not use this medication for a longer period than prescribed by your doctor.
This medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this with your doctor.
If you have diabetes (high blood sugar), it is crucial to closely monitor your blood sugar levels 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 population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary; consult with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia, muscle weakness).
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure).
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management is supportive and may involve gradual withdrawal of the corticosteroid under medical supervision.
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.
Extent of affected body surface area
Rationale: To assess potential for systemic absorption and guide appropriate use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Weekly or as clinically indicated
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit
Target: Absence of or minimal local reactions
Action Threshold: Presence of significant local reactions may require discontinuation or reduction in frequency/potency.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome, hyperglycemia, growth retardation in children)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Normal HPA axis function, normal blood glucose
Action Threshold: Symptoms or signs of systemic absorption (e.g., moon face, central obesity, increased thirst/urination, fatigue) warrant immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Development of new skin lesions
- Signs of skin infection (pus, increased redness, warmth)
- Excessive skin thinning or bruising
- Development of stretch marks (striae)
- Increased hair growth in treated areas
- Increased thirst or urination (signs of hyperglycemia)
- Unusual weight gain or changes in body fat distribution (e.g., moon face, buffalo hump)
- Fatigue or weakness (signs of HPA axis suppression)
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, though data for topical corticosteroids are limited and generally suggest low risk with appropriate use.
Second Trimester:
Risk of fetal growth restriction or adrenal suppression with extensive or prolonged use of potent corticosteroids.
Third Trimester:
Risk of fetal growth restriction or adrenal suppression with extensive or prolonged use of potent corticosteroids.
Lactation
Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, appropriate use. Monitor infant for any unusual effects.
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and growth retardation have been reported. Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dose adjustments are generally needed. However, geriatric patients may have thinner skin, which could increase susceptibility to local adverse effects such as atrophy, purpura, and telangiectasias. Monitor closely for skin integrity.
Clinical Information
Clinical Pearls
- Diflorasone diacetate is a high-potency topical corticosteroid; it should be used judiciously and for limited durations (typically 2-4 weeks) to minimize the risk of local and systemic side effects.
- Educate patients on proper application technique: apply a thin film, do not use excessive amounts, and avoid occlusive dressings unless specifically instructed by a physician.
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to corticosteroid-induced atrophy, striae, and telangiectasias.
- Not for ophthalmic use. Avoid contact with eyes.
- If no improvement is seen after 2 weeks of treatment, re-evaluate the diagnosis and treatment plan.
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 atopic dermatitis, especially on sensitive areas.
- Emollients and moisturizers for barrier repair.
- Phototherapy (UVB, PUVA) for widespread or severe psoriasis/eczema.
- Systemic immunomodulators or biologics for severe, refractory dermatoses.
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 60g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic formulations; Tier 3 or higher for brand names.
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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.