Diprosone 0.05% Cream 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
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% Cream contains betamethasone, a strong medicine that helps reduce redness, swelling, and itching caused by skin conditions like eczema and psoriasis. It works by calming down your body's immune response in the skin.
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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. Then, apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Restrictions

Do not apply this 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 miss a dose, 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 resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Apply a very thin layer of cream to the affected skin area(s) as directed by your doctor, usually once or twice a day.
  • Wash your hands thoroughly before and after applying the cream.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to your face, groin, or armpits unless specifically told to by your doctor, as these areas are more sensitive to side effects.
  • Do not use the cream for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
  • Keep the cream away from your eyes, nose, and mouth. If it gets into these areas, rinse thoroughly with water.
  • Do not share your medication with others.

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:

dermatoses: Apply a thin film to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
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Pediatric Dosing

Neonatal: Not established (use generally not recommended due to increased risk of systemic absorption and adrenal suppression)
Infant: Not established (use generally not recommended due to increased risk of systemic absorption and adrenal suppression)
Child: Apply a thin film to the affected skin areas once or twice daily. Use with caution and for the shortest duration possible 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 with awareness of potential for higher systemic absorption.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption from topical application.
Moderate: No adjustment needed due to minimal systemic absorption from topical application.
Severe: No adjustment needed due to minimal systemic absorption from topical application.
Dialysis: No specific considerations due to minimal systemic absorption from topical application.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption from topical application.
Moderate: No adjustment needed due to minimal systemic absorption from topical application.
Severe: No adjustment needed due to minimal systemic absorption from topical application.

Pharmacology

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Mechanism of Action

Betamethasone 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 (typically <5% but varies with skin integrity, vehicle, and site of application); can be increased by inflammation, occlusion, or large surface area application.
Tmax: Not typically defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not precisely quantified for topical application due to minimal systemic absorption.
ProteinBinding: Approximately 64% (for systemically absorbed betamethasone, primarily to albumin).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Approximately 5-6 hours (for systemically absorbed betamethasone, but highly variable and not clinically relevant for typical topical use).
Clearance: Not precisely quantified for topical application.
ExcretionRoute: Primarily renal excretion if systemically absorbed.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for local anti-inflammatory effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Varies with individual and condition, typically requires once or twice daily application.

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
+ 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. 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 if they bother you or do not go away:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of your skin condition or no improvement after 2 weeks.
  • Increased redness, burning, stinging, or irritation at the application site.
  • Development of new skin problems like pimples, boils, or pus-filled bumps.
  • Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks.
  • Any signs of infection (e.g., fever, spreading redness, warmth, pus).
  • Unusual fatigue, weight gain, or swelling in your face (rare, but can indicate systemic absorption).
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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 you experienced, including any symptoms that occurred.
If you have thinning skin in the area 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 with your other medications and health conditions.

Remember, do not start, stop, or change 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 to discuss any potential risks. Additionally, this medication is not intended to treat diaper rash or redness, and you should avoid applying it to the diaper area.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will help determine the best course of action.

When using this medication in children, it is vital to exercise caution, as the risk of certain side effects may be higher in this population. Different brands of this medication may be suitable for different age groups, so consult with your doctor before administering 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 using this medication with you. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to minimize potential exposure to the baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic effects of corticosteroids, including:
  • Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
  • Adrenal suppression (fatigue, weakness, low blood pressure)
  • Hyperglycemia (high blood sugar)
  • Growth retardation in children
  • Increased intracranial pressure in children

What to Do:

If you suspect an overdose or experience systemic symptoms, contact your doctor or a poison control center immediately. In the US, call 1-800-222-1222. Treatment is symptomatic and supportive; gradual withdrawal of the corticosteroid may be necessary.

Drug Interactions

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Contraindicated Interactions

  • None known for topical application due to minimal systemic absorption.
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Major Interactions

  • None known for topical application due to minimal systemic absorption.
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Moderate Interactions

  • None known for topical application due to minimal systemic absorption.
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Minor Interactions

  • None known for topical application due to minimal systemic absorption.

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, extent of dermatosis)

Rationale: To establish baseline for treatment efficacy and identify contraindications.

Timing: Prior to initiation of therapy.

Patient history (age, comorbidities, concurrent medications, previous corticosteroid use)

Rationale: To identify risk factors for adverse effects (e.g., adrenal suppression in children, skin atrophy in elderly).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, erythema)

Frequency: Daily to weekly, depending on severity.

Target: Significant improvement in symptoms.

Action Threshold: If no improvement within 2 weeks, reassess diagnosis and treatment plan.

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, allergic contact dermatitis, secondary infection)

Frequency: Weekly to monthly, or as symptoms arise.

Target: Absence of new or worsening local adverse effects.

Action Threshold: Discontinue or reduce frequency/potency if severe local reactions occur; treat secondary infections appropriately.

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression, hyperglycemia, glycosuria) - rare but possible with extensive/prolonged use, especially in children or with occlusion.

Frequency: Periodically, especially with prolonged use over large surface areas or in pediatric patients.

Target: Absence of systemic signs/symptoms.

Action Threshold: If suspected, discontinue drug gradually and refer for endocrine evaluation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that does not improve
  • Development of new skin lesions (e.g., pustules, blisters)
  • Signs of skin thinning (e.g., bruising, transparency)
  • Stretch marks (striae)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Signs of infection (e.g., pus, fever, spreading redness)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoid high-potency corticosteroids on large areas.
Second Trimester: Use with caution, consider lowest effective dose and shortest duration.
Third Trimester: Use with caution, consider lowest effective dose and shortest duration. Potential for fetal growth restriction or adrenal suppression with extensive use.
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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 the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use (minimal systemic absorption), but potential for adverse effects if significant amounts are ingested by the infant.
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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 that achieves the desired effect for the shortest duration possible. Avoid occlusive dressings.

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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 for these effects.

Clinical Information

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Clinical Pearls

  • Betamethasone 0.05% cream is a high-potency topical corticosteroid. Use it sparingly and only on affected areas.
  • Avoid prolonged use, especially on the face, groin, or axillae, as these areas are more susceptible to corticosteroid-induced skin atrophy and other side effects.
  • Do not use occlusive dressings unless specifically instructed by a healthcare professional, as this significantly increases systemic absorption.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and wash hands after use.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan. Prolonged use without benefit is not recommended.
  • Be aware of the potential for rebound flares or worsening of the condition upon abrupt discontinuation after prolonged use.
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Alternative Therapies

  • Other topical corticosteroids (e.g., Clobetasol propionate for very high potency, Triamcinolone acetonide for medium potency, Hydrocortisone for low potency)
  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus - for eczema, steroid-sparing)
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., Crisaborole - for eczema)
  • Emollients and moisturizers (for dry skin conditions)
  • Systemic therapies (for severe or widespread conditions, e.g., oral corticosteroids, biologics, immunosuppressants)
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Cost & Coverage

Average Cost: Varies widely, typically $20 - $100+ per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations); Tier 3 or higher (for brand-name formulations).
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.