Diflorasone Diacetate 0.05% Ont 15g
It is used to treat skin irritation.It is used to treat skin rashes.
Drug Class
Topical corticosteroid
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Category C
FDA Approved
Sep 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diflorasone diacetate ointment is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the skin's immune 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 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 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. 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
- Wash your hands before and after applying the ointment.
- Apply a thin layer of the ointment to the affected skin area(s) as directed by your doctor. Do not use more than prescribed.
- Gently rub it in until it disappears.
- 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 the face, groin, or armpits unless specifically told to do so by your doctor, as these areas are more sensitive to side effects.
- Do not use this medication for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or broken skin.
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:
psoriasis:
Apply a thin film to the affected skin areas one to three times daily.
eczema:
Apply a thin film to the affected skin areas one to three times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (increased risk of systemic absorption)
Child:
Not established for routine use; use with caution and for shortest duration possible if prescribed (increased risk of systemic absorption and HPA axis suppression). Generally not recommended for children under 12 years unless directed by a physician.
Adolescent:
Apply a thin film to the affected skin areas one to three times daily, with caution regarding duration and area of application due to potential for systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Diflorasone diacetate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids diffuse across cell membranes and bind with high affinity to specific cytoplasmic receptors. This complex then enters the nucleus, binds to DNA (chromatin), and stimulates the transcription of mRNA, which leads to the synthesis of various enzymes responsible for the anti-inflammatory effects. These effects include inhibition of prostaglandin and leukotriene synthesis by inducing phospholipase A2 inhibitory proteins (lipocortins), stabilization of lysosomal membranes, and suppression of migration of polymorphonuclear leukocytes and fibroblasts.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; systemic absorption is generally minimal but can increase with prolonged use, large surface area application, occlusive dressings, or compromised skin barrier. Percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Tmax:
Not well-defined for topical application due to variable absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not well-quantified for topical application due to minimal systemic absorption.
ProteinBinding:
Not well-quantified for topical application; systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical application.
Clearance:
Not well-quantified for topical application.
ExcretionRoute:
Primarily renal (for systemically absorbed drug).
Unchanged:
Not well-quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Varies; effects persist as long as applied, with residual effects for a period after discontinuation.
Confidence:
Medium
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 fainting
+ 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
Most people experience few or no side effects when taking this medication. However, some individuals may encounter mild side effects. If you experience any of the following symptoms or if they persist or bother you, contact your doctor or seek medical attention:
Dry skin
Itching
* Burning
This is not an exhaustive list of potential 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 fainting
+ 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
Most people experience few or no side effects when taking this medication. However, some individuals may encounter mild side effects. If you experience any of the following symptoms or if they persist or bother you, contact your doctor or seek medical attention:
Dry skin
Itching
* Burning
This is not an exhaustive list of potential 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 redness, burning, itching, or irritation at the application site
- Development of new skin rash or worsening of existing condition
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like breakouts or increased hair growth where applied
- Signs of infection (pus, fever, increased pain, spreading redness)
- Unusual fatigue, weakness, or weight gain (signs of systemic absorption, rare but serious)
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 allergic reaction you experienced, including any symptoms that occurred.
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 you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current 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 allergic reaction you experienced, including any symptoms that occurred.
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 you have, as this medication may interact with certain conditions.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your current 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.
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 to ensure safe use.
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 duration than prescribed by your doctor.
This medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk 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 to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks of using this medication 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 to ensure safe use.
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 duration than prescribed by your doctor.
This medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk 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 to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor 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 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 (adrenal insufficiency upon withdrawal).
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.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin damage.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection)
Frequency: Regularly during therapy, especially with prolonged use or occlusive dressings.
Target: Absence of new or worsening reactions.
Action Threshold: If reactions occur, reduce frequency, discontinue use, or consider alternative therapy.
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.
Target: Normal adrenal function, normal glucose levels.
Action Threshold: If suspected, perform HPA axis suppression tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol) and consider gradual withdrawal or alternative therapy.
Symptom Monitoring
- Worsening of skin condition
- New skin irritation, redness, burning, itching
- Skin thinning or fragility
- Development of stretch marks (striae)
- Increased hair growth at application site
- Acne-like breakouts
- Changes in skin color (lightening)
- Signs of infection (pus, fever, increased pain)
- Unusual fatigue or weakness
- Weight gain, especially in the face or trunk
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, especially on large surface areas or for prolonged periods.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution is advised.
Second Trimester:
Use with caution; minimal systemic absorption expected.
Third Trimester:
Use with caution; minimal systemic absorption expected. Risk of HPA axis suppression in the neonate is theoretical but low with appropriate topical use.
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. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The benefits of breastfeeding should be weighed against the potential risks. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate topical use due to minimal systemic absorption, but monitor infant for any unusual effects.
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. Use in children under 12 years is generally not recommended unless specifically directed by a physician. If used, limit to the smallest amount compatible with an effective therapeutic regimen and for the shortest duration possible. Monitor for signs of systemic toxicity.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have thinner, more fragile skin, which could increase the risk of local side effects such as skin atrophy, purpura, and striae. Monitor skin integrity closely.
Clinical Information
Clinical Pearls
- Diflorasone diacetate 0.05% ointment is a high-potency topical corticosteroid; use it judiciously and for the shortest effective duration.
- Avoid prolonged use, especially on the face, groin, or axillae, as these areas are more prone to side effects like skin atrophy and telangiectasias.
- Occlusive dressings significantly increase systemic absorption and local side effects; use only if specifically instructed by a physician.
- Educate patients on proper application technique: apply a thin film, rub in gently, and wash hands after use.
- Monitor for signs of secondary infection, as corticosteroids can mask symptoms of infection or worsen fungal/bacterial infections.
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)
- Calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for certain inflammatory skin conditions
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions
Cost & Coverage
Average Cost:
$30 - $100+ per 15g 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's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.