Diprosone 0.05% Ointment 45gm

Manufacturer SCHERING Active Ingredient Betamethasone Cream, Gel, and Ointment(bay ta METH a sone) Pronunciation bay ta METH a sone
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.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Synthetic Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diprosone 0.05% Ointment contains a strong medicine called betamethasone, which is a type of steroid. It works by reducing swelling, redness, and itching caused by certain skin conditions like eczema or psoriasis. It should only be used on the skin and exactly as prescribed by your doctor.
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How to Use This Medicine

Using Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, which means it should be applied directly to the affected area of your skin. Do not take it by mouth. 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 and after applying the medication, wash your hands thoroughly. If the affected area is on your hand, do not wash your hand after applying the medication.

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 place, out of the reach of children and pets.

What to Do If You Miss a Dose

If you forget to apply a dose, do so 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.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area(s) only, as directed by your doctor.
  • 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 to the face, groin, or armpits unless specifically directed by your doctor.
  • Do not use for longer than prescribed, especially in children.
  • Avoid contact with eyes, nose, mouth, or other mucous membranes.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily.

Condition-Specific Dosing:

psoriasis: Apply once or twice daily, generally for up to 2 weeks. Re-evaluate if no improvement.
eczema: Apply once or twice daily, generally for up to 2 weeks. Re-evaluate if no improvement.
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Pediatric Dosing

Neonatal: Not established (use generally avoided due to high risk of systemic absorption)
Infant: Not established (use generally avoided due to high risk of systemic absorption)
Child: Apply a thin film to the affected skin areas once daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid use on face, groin, or axillae. Limit duration to 2 weeks. Monitor for HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Limit duration to 2 weeks if possible.
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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 (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Betamethasone dipropionate is a potent synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (variable, depends on skin integrity, vehicle, duration, and area of application)
Tmax: Not clinically relevant for topical application unless significant systemic absorption occurs
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not clinically relevant for topical application unless significant systemic absorption occurs
ProteinBinding: If absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant for topical application unless significant systemic absorption occurs
Clearance: Not clinically relevant for topical application unless significant systemic absorption occurs
ExcretionRoute: Renal (if absorbed systemically)
Unchanged: Not quantifiable for topical application
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory effect)
PeakEffect: Days to weeks (with consistent application)
DurationOfAction: Variable, depends on application frequency and condition

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 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 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
+ Frequent urination
+ 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Burning or stinging
Dry skin
* Itching

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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, itching, or irritation at the application site
  • Signs of skin infection (pus, spreading redness, fever)
  • Thinning of the skin, easy bruising, or stretch marks where the ointment is applied
  • Acne-like breakouts
  • Excessive hair growth in treated areas
  • Unusual fatigue or weakness
  • Swelling in ankles or feet
  • Blurred vision or other eye problems (rare, with prolonged or extensive use)
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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 and its symptoms.
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 you 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.
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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, as directed by your doctor, and avoid using it for an extended period.

When applying this medication to a large skin area, exercise caution and consult with your doctor. Additionally, do not use this medication to treat diaper rash or redness, and avoid applying it to the diaper area.

Be aware that this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. Furthermore, in some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult with your doctor to discuss this potential effect.

When administering this medication to a child, use it with caution, as the risk of certain side effects may be higher in children. Note that different brands of this medication may be suitable for different age groups of children, so consult with your doctor before giving it to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to both you and your baby. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar, and growth retardation in children.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection or skin breakdown.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: Lack of improvement after 2 weeks, or worsening of condition, warrants re-evaluation.

Local skin adverse effects (atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit

Target: Absence of new or worsening adverse effects

Action Threshold: Development of significant adverse effects warrants discontinuation or change in therapy.

Signs of HPA axis suppression (especially with extensive/prolonged use, occlusive dressings, or in children)

Frequency: Consider periodically with high-risk use (e.g., plasma cortisol levels, ACTH stimulation test)

Target: Normal HPA axis function

Action Threshold: Signs of suppression (e.g., fatigue, weakness, hypotension) require immediate medical attention and gradual withdrawal of therapy.

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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., Cushing's syndrome, hyperglycemia, glucosuria, growth retardation in children)

Special Patient Groups

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Pregnancy

Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids is limited and generally low risk.
Second Trimester: Risk of fetal growth restriction with high-dose systemic corticosteroids; topical risk is lower but still present with extensive use.
Third Trimester: Risk of fetal growth restriction and adrenal suppression in the neonate with high-dose systemic corticosteroids; topical risk is lower but still present with extensive use.
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Lactation

Caution should be exercised when administered to a nursing woman. 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 the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use (minimal systemic absorption), but monitor infant for potential adverse effects if used extensively by mother.
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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 least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Not recommended for infants or neonates.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local side effects.

Clinical Information

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Clinical Pearls

  • Diprosone 0.05% Ointment is a high-potency topical corticosteroid; use with caution and for limited durations, especially on sensitive areas or in children.
  • Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically directed by a physician.
  • Patients should be advised to apply a very thin layer and rub it in gently until it disappears.
  • Long-term use, especially on the face, can lead to irreversible skin atrophy, telangiectasias, and perioral dermatitis.
  • If no improvement is seen after 2 weeks, the diagnosis and treatment plan should be re-evaluated.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone) of varying potencies.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema.
  • Systemic therapies (e.g., oral corticosteroids, biologics, immunosuppressants) for severe dermatoses.
  • Emollients and moisturizers for dry skin conditions.
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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.