Diprosone 0.05% Cream 15gm

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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Mar 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diprosone 0.05% Cream 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 body's inflammatory response in the skin.
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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 to do so, do not cover the treated area with bandages or dressings.
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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, avoid applying the medication to your face, underarms, or groin area.

Storage and Disposal

Store this medication at room temperature, away from freezing temperatures.
Protect the medication from light.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose Instructions

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 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 cream.
  • Apply a thin layer of cream only to the affected skin area, 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 and side effects.
  • Avoid applying the cream to your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive.
  • Do not use the cream for longer than prescribed, especially in children.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • 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.
Dose Range: 1 - 2 mg

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 4 weeks. Re-evaluate if no improvement.
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Pediatric Dosing

Neonatal: Not established (increased risk of systemic absorption and adrenal suppression)
Infant: Not established (increased risk of systemic absorption and adrenal suppression)
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, or under occlusive dressings. Monitor for signs of systemic toxicity.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Limit treatment duration.
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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 synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1% to 5% depending on skin integrity, site, and vehicle)
Tmax: Not typically applicable for topical application due to minimal systemic absorption; local effect is rapid.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Approximately 64% (if systemically absorbed)
CnssPenetration: Limited (if systemically absorbed)
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Pharmacodynamics

OnsetOfAction: Within hours of application (local anti-inflammatory effect)
PeakEffect: Within days of consistent application
DurationOfAction: Varies with condition and frequency of application; local effects persist for several hours.

Safety & Warnings

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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 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 experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Burning or stinging
Dry skin
* Itching

This is not an exhaustive list of 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:

  • Increased irritation, burning, or stinging where the cream is applied.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Thinning of the skin, stretch marks, or changes in skin color.
  • Acne-like breakouts or increased hair growth in the treated area.
  • If used extensively or for prolonged periods, watch for signs of systemic effects like unusual weight gain, swelling in the face, or extreme tiredness (rare).
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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 at the site where you will be applying this medication.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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, and do not exceed the recommended treatment period.

When applying this medication to a large skin area, exercise caution and consult with your doctor to discuss potential risks and benefits. 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, it is vital to discuss this potential risk with your doctor. In children and teenagers, this medication may affect growth in some cases, necessitating regular growth checks. Your doctor will determine the need for these checks and monitor your child's growth accordingly.

When administering this medication to a child, it is crucial to exercise caution, as the risk of certain side effects may be higher in pediatric patients. Different brands of this medication may be suitable for various age groups, so it is essential to consult with your doctor before giving this medication to a child.

If you are pregnant, planning to become pregnant, or 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 prevent potential exposure to the baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose with topical application is unlikely due to minimal systemic absorption.
  • Chronic overuse or misuse (e.g., applying to large surface areas, under occlusion, or for prolonged periods) can lead to systemic effects such as Cushing's syndrome, hyperglycemia, and adrenal suppression.

What to Do:

If chronic overuse is suspected, consult a healthcare professional. Management involves gradual withdrawal of the corticosteroid and symptomatic treatment. Call 1-800-222-1222 (Poison Control) for advice if accidental ingestion or significant misuse occurs.

Drug Interactions

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Contraindicated Interactions

  • None known for topical use
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Major Interactions

  • None known for topical use
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Moderate Interactions

  • None known for topical use
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Minor Interactions

  • None known for topical use

Monitoring

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Baseline Monitoring

Skin condition (type, severity, location of lesion)

Rationale: To establish baseline for efficacy assessment and identify contraindications (e.g., active infection).

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, lesion size)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: If no improvement after 2-4 weeks (or 2 weeks for psoriasis), re-evaluate diagnosis and treatment.

Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection)

Frequency: At each follow-up visit

Target: Absence of new or worsening reactions

Action Threshold: If severe or persistent reactions occur, discontinue use and manage appropriately.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings, and in pediatric patients.

Target: Absence of systemic effects

Action Threshold: If suspected, perform appropriate diagnostic tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol). Discontinue or gradually withdraw the drug.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that worsens
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like breakouts
  • Increased hair growth at application site
  • Changes in skin color (lightening)
  • Signs of infection (pus, fever, spreading redness)
  • Unusual fatigue or weakness (rare, systemic absorption)
  • Weight gain, moon face, buffalo hump (rare, systemic absorption)

Special Patient Groups

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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 is advised.
Second Trimester: Generally considered safer than first trimester, but still use with caution and limit exposure.
Third Trimester: Risk of fetal adrenal suppression with prolonged or extensive use of potent corticosteroids.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Potential for adverse effects if significant systemic absorption occurs in mother or if applied to breast and ingested by infant.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Increased risk of adrenal suppression, Cushing's syndrome, and intracranial hypertension. Limit use to the least effective amount and shortest duration. Avoid occlusive dressings. Not recommended for infants or very young children unless specifically directed by a specialist.

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Geriatric Use

Generally safe. Elderly patients may have thinner skin, which could increase the risk of local adverse effects such as atrophy, purpura, and skin tears. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Diprosone 0.05% Cream is a high-potency topical corticosteroid. Use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • Educate patients on proper application technique: a thin film, gently rubbed in, only to affected areas.
  • Warn patients against using this cream on the face, groin, or axillae unless specifically instructed by a physician, due to increased risk of side effects in these sensitive areas.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flare of the skin condition or signs of adrenal insufficiency (rare).
  • Always consider the underlying cause of the skin condition; corticosteroids treat symptoms, not the root cause.
  • For children, emphasize the increased risk of systemic absorption and the need for careful monitoring and limited use.
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Alternative Therapies

  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
  • Phototherapy
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Cost & Coverage

Average Cost: $20 - $60 per 15gm tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 your 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 taken, the amount, and the time it happened.