Diprosone 0.05% Ointment 15gm
It is used to treat psoriasis.It is used to treat skin irritation.It is used to treat skin rashes.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical corticosteroid
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Category C
FDA Approved
Jun 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diprosone Ointment contains a strong medicine called a corticosteroid that helps 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
Using Your Medication Correctly
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Restrictions
Do not apply the medication to your face, underarms, or groin area unless your doctor has specifically instructed you to do so.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and freezing temperatures. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Restrictions
Do not apply the medication to your face, underarms, or groin area unless your doctor has specifically instructed you to do so.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and freezing temperatures. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you forget to apply a dose of your medication, apply it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular application 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 very thin layer of the ointment only to the affected skin areas, as directed by your doctor.
- Do not cover the treated area with bandages or tight dressings unless specifically told to by your doctor, as this can increase absorption.
- Avoid applying the ointment to your face, groin, or armpits unless your doctor has specifically instructed you to do so.
- Do not get the ointment in your eyes, nose, or mouth. If it does, rinse thoroughly with water.
- Do not use this ointment for longer than prescribed, especially in children, as prolonged use can lead to side effects.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas once or twice daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
general:
Apply sparingly to affected areas. Do not use for more than 2 weeks continuously or on large body areas without physician supervision. Avoid use on face, groin, or axillae unless directed by a physician.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic absorption and adrenal suppression.
Infant:
Not established. Use with extreme caution due to increased risk of systemic absorption and adrenal suppression. Limit to smallest amount for shortest duration.
Child:
Apply a thin film to the affected skin areas once daily. Limit to smallest amount for shortest duration (e.g., 5-7 days) due to increased risk of systemic absorption and adrenal suppression. Avoid occlusive dressings.
Adolescent:
Apply a thin film to the affected skin areas once or twice daily. Use with caution, similar to adults but monitor for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Betamethasone dipropionate is a synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. It also suppresses the immune response by reducing the activity and volume of the lymphatic system, decreasing immunoglobulin and complement concentrations, and inhibiting the migration of macrophages and leukocytes.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (intact skin); significantly increased with damaged skin, inflammation, occlusion, or large surface area application.
Tmax:
Not applicable (primarily local action); systemic absorption is minimal and variable.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not well-defined for topical absorption; if absorbed systemically, widely distributed.
ProteinBinding:
Approximately 64% (systemically absorbed betamethasone).
CnssPenetration:
Limited (if systemically absorbed).
Elimination:
HalfLife:
Approximately 5 hours (systemic, if absorbed).
Clearance:
Not well-defined for topical absorption.
ExcretionRoute:
Renal (primarily) and biliary (if systemically absorbed).
Unchanged:
Minimal (if systemically absorbed).
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects).
PeakEffect:
Days to weeks (for maximal therapeutic effect).
DurationOfAction:
Varies; effects may persist for some time after discontinuation.
Safety & Warnings
Side Effects
Urgent 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 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Skin irritation
Thinning of the skin
Changes in eyesight
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:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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 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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Skin irritation
Thinning of the skin
Changes in eyesight
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:
Burning or stinging
Dry skin
* Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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 a few days.
- Signs of a skin infection (e.g., pus, spreading redness, fever).
- Severe burning, itching, or irritation where you applied the ointment.
- Skin thinning, easy bruising, stretch marks (striae), or changes in skin color in the treated area.
- Signs that the medicine is being absorbed into your body, especially in children (e.g., unusual weight gain, rounded face, fatigue, slow growth).
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.
If you have thinning skin at the site where you will be applying this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you have thinning skin at the site where you will be applying this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of use, and do not exceed the recommended treatment period.
When applying this medication to a large skin area, exercise caution and consult your doctor. Additionally, this medication is not intended for treating diaper rash or redness, and it is crucial to avoid applying it to the diaper area.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population. Note that different brands of this medication may be suitable for different age groups, so consult your doctor before giving it to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
When applying this medication to a large skin area, exercise caution and consult your doctor. Additionally, this medication is not intended for treating diaper rash or redness, and it is crucial to avoid applying it to the diaper area.
Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population. Note that different brands of this medication may be suitable for different age groups, so consult your doctor before giving it to a child.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of this medication with you. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic effects of corticosteroids, including Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising, muscle weakness), hyperglycemia, and adrenal suppression (fatigue, weakness, 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 gradual withdrawal of the medication may be necessary under medical supervision.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis, identify signs of infection, and determine appropriate treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Regularly during treatment (e.g., weekly or bi-weekly).
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of diagnosis or treatment.
Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: Regularly during treatment.
Target: Absence or minimal signs.
Action Threshold: Presence of significant adverse effects may require discontinuation or change in therapy.
Signs of systemic absorption (especially in children or with extensive/occlusive use)
Frequency: Periodically, particularly with prolonged or extensive use.
Target: Absence of signs of Cushing's syndrome or adrenal suppression.
Action Threshold: Presence of systemic effects (e.g., weight gain, moon face, growth retardation in children, fatigue) requires immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, muscle weakness, mood changes, delayed wound healing)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts, prolonged use, or application to large surface areas.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester:
Minimal systemic absorption, but still use with caution.
Third Trimester:
Minimal systemic absorption, but still use with caution. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Higher risk with extensive, prolonged use due to potential for systemic absorption and excretion into breast milk, leading to potential adverse effects in the infant (e.g., growth suppression, adrenal suppression).
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 the lowest effective potency for the shortest duration possible. Avoid occlusive dressings. Monitor for signs of systemic toxicity and growth retardation.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Diprosone 0.05% Ointment is a high-potency topical corticosteroid. It should be used for short-term treatment of severe inflammatory dermatoses.
- Ointments are generally more potent and occlusive than creams or lotions, making them suitable for dry, scaly lesions.
- Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound flares.
- Educate patients on the 'less is more' principle: a very thin layer is sufficient. Overuse increases the risk of local and systemic side effects.
- Not indicated for rosacea, perioral dermatitis, or fungal/bacterial infections without concomitant antimicrobial therapy.
- Consider step-down therapy to a lower potency corticosteroid or non-steroidal options once acute inflammation is controlled.
Alternative Therapies
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for maintenance or steroid-sparing therapy.
- Emollients and moisturizers for barrier repair and symptom relief.
- Systemic therapies (e.g., methotrexate, biologics) for severe, widespread dermatoses not controlled by topical agents.
- Antihistamines (oral) for associated pruritus.
- Phototherapy (UVB, PUVA) for conditions like psoriasis.
Cost & Coverage
Average Cost:
$10 - $50 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 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.