Diflorasone Diacetate 0.05% Ont 30g
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid, Synthetic; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Sep 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone diacetate is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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 completely 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 a drug take-back program 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 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 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 completely 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 a drug take-back program 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 make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the ointment.
- Apply a thin layer of ointment to the affected skin area, gently rubbing it in until it disappears. Do not use more than directed.
- 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 applying the ointment to your face, groin, or armpits unless directed by your doctor.
- Do not get the ointment in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Use for the shortest time necessary to control your symptoms.
- Do not use this medicine for diaper rash.
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 once or twice daily.
eczema:
Apply once or twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with extreme caution due to increased systemic absorption risk.
Child:
Apply a thin film to the affected skin areas once or twice daily. Use for shortest duration possible and smallest amount to achieve desired effect. Avoid occlusive dressings.
Adolescent:
Apply a thin film to the affected skin areas one to three times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Dialysis:
No specific considerations for topical use, systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Diflorasone diacetate is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism of action involves binding to cytoplasmic glucocorticoid receptors, which then translocate to the nucleus and modulate gene expression. This leads to the inhibition of prostaglandin and leukotriene synthesis by inducing phospholipase A2 inhibitory proteins (lipocortins), thereby reducing the release of arachidonic acid. It also suppresses the migration of neutrophils and macrophages, reverses increased capillary permeability, and inhibits the release of vasoactive kinins.
Pharmacokinetics
Absorption:
Bioavailability:
Not typically quantified for topical application; systemic absorption is minimal but can increase with inflammation, skin barrier disruption, prolonged use, large surface area application, or occlusive dressings.
Tmax:
Not applicable for topical use; systemic levels are generally undetectable.
FoodEffect:
Not applicable.
Distribution:
Vd:
Not typically quantified for topical use.
ProteinBinding:
Approximately 90% bound to plasma proteins (for systemically absorbed portion).
CnssPenetration:
Limited, if any, with topical application.
Elimination:
HalfLife:
Not typically quantified for topical use; systemic half-life of corticosteroids varies.
Clearance:
Not typically quantified for topical use.
ExcretionRoute:
Metabolites are primarily excreted in the urine and bile.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days to 1-2 weeks of consistent application.
DurationOfAction:
Varies with application frequency and individual response; effects persist as long as treatment continues.
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 medical attention immediately:
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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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 medical attention immediately:
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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
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 no improvement after 1-2 weeks.
- Signs of a skin infection (e.g., increased redness, swelling, pain, pus, fever).
- Severe burning, itching, or irritation where the ointment is applied.
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
- Acne-like breakouts or increased hair growth in the treated area.
- Changes in skin color (e.g., lightening of the skin).
- Unusual fatigue, weakness, weight gain, swelling in your ankles or feet, or increased thirst/urination (signs of systemic absorption).
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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage 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 identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust 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. Use it only as directed by your doctor for its approved 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 medications or skin products, including soaps, consult with your doctor to ensure safe use.
Do not apply this medication to cuts, scrapes, or damaged skin, as this can increase the risk of adverse effects.
If you need to use this medication on a large area of skin, discuss this with your doctor, as it may require special precautions.
Use this medication for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Regular monitoring by your doctor is recommended.
If you have diabetes, it is crucial to closely monitor your blood sugar levels while using this medication, as it may affect your blood sugar control.
When using this medication in children, it is essential to follow the doctor's instructions carefully, as the risk of certain side effects may be higher in this age group. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, and your doctor will discuss this with you.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the health of your baby.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. Use it only as directed by your doctor for its approved 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 medications or skin products, including soaps, consult with your doctor to ensure safe use.
Do not apply this medication to cuts, scrapes, or damaged skin, as this can increase the risk of adverse effects.
If you need to use this medication on a large area of skin, discuss this with your doctor, as it may require special precautions.
Use this medication for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Regular monitoring by your doctor is recommended.
If you have diabetes, it is crucial to closely monitor your blood sugar levels while using this medication, as it may affect your blood sugar control.
When using this medication in children, it is essential to follow the doctor's instructions carefully, as the risk of certain side effects may be higher in this age group. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, and your doctor will discuss this with you.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you, considering both your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy of treatment (reduction in inflammation, pruritus)
Frequency: Weekly to bi-weekly during initial treatment, then as needed.
Target: Significant improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, acneiform eruptions, hypopigmentation)
Frequency: At each follow-up visit, or if patient reports new symptoms.
Target: Absence of significant adverse effects.
Action Threshold: Presence of significant or worsening local adverse effects warrants discontinuation or reduction in frequency/potency.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients. Consider morning cortisol levels or ACTH stimulation test if HPA axis suppression is suspected.
Target: Normal adrenal function.
Action Threshold: Abnormal findings warrant immediate discontinuation and medical evaluation.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, warmth, pus, fever)
- Severe burning, itching, or irritation at application site
- Thinning of skin, easy bruising, stretch marks (striae)
- Acne-like breakouts
- Increased hair growth in treated areas
- Changes in skin color (lightening)
- Unusual fatigue, weight gain, swelling in ankles/feet (signs of systemic absorption)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is low.
Second Trimester:
Risk of HPA axis suppression in the fetus with extensive or prolonged use.
Third Trimester:
Risk of HPA axis suppression in the fetus with extensive or prolonged use; potential for low birth weight.
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 appropriate use due to minimal systemic absorption, but monitor infant for potential adverse effects (e.g., growth suppression).
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults because of a larger skin surface area to body weight ratio. Use the smallest amount for the shortest duration possible. Avoid occlusive dressings. Not recommended for infants under 1 year of age.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor closely for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Diflorasone diacetate is a high-potency topical corticosteroid; use it judiciously to minimize the risk of local and systemic side effects.
- Educate patients on the 'less is more' principle: a thin film is sufficient. Over-application does not increase efficacy but increases risk of side effects.
- Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or in pediatric patients, due to increased risk of skin atrophy, telangiectasias, and HPA axis suppression.
- If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
- Patients should be advised to report any signs of infection or worsening of their skin condition immediately.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids for certain dermatoses
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, recalcitrant conditions
Cost & Coverage
Average Cost:
$50 - $150 per 30g tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred generic or non-preferred 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'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.