Diprosone 0.05% Lotion 60ml

Manufacturer SCHERING Active Ingredient Betamethasone Lotion(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 Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Jun 1974
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diprosone 0.05% Lotion contains betamethasone, a strong steroid medicine. It works by reducing redness, swelling, and itching caused by various skin conditions like eczema and psoriasis. It helps to calm down the skin's immune response.
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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 to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it 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.
Unless directed to do so by your doctor, avoid applying the medication to your face, underarms, or groin area.

Important Preparation Instructions

Some formulations of this medication require shaking before use. Be sure to check if this is necessary for your specific product before applying it.

Storage and Disposal

Store the medication at room temperature, avoiding 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

  • Apply a thin layer of the lotion to the affected skin area(s) as directed by your doctor, usually once or twice a day. Do not use more than prescribed.
  • Gently rub it in completely. Wash your hands thoroughly before and after applying the lotion, unless your hands are the treated area.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the lotion to your face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use this lotion for longer than prescribed, typically no more than 2 weeks for continuous use, especially on the face or in skin folds.
  • Do not use this lotion for diaper rash in infants.
  • Inform your doctor if your condition does not improve after 1-2 weeks of treatment or if it worsens.

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 not exceeding 2 weeks of continuous treatment.
eczema: Apply once or twice daily, generally not exceeding 2 weeks of continuous treatment.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (increased risk of systemic absorption)
Child: Apply a thin film to the affected skin areas once daily. Use with caution and for the shortest duration possible, especially in children under 12 years due to increased risk of systemic absorption and HPA axis suppression. Not recommended for prolonged use.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Use with caution for prolonged periods.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed for topical use.
Moderate: No adjustment typically needed for topical use.
Severe: No adjustment typically needed for topical use.
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment typically needed for topical use.
Moderate: No adjustment typically needed for topical use.
Severe: No adjustment typically needed for topical use.

Pharmacology

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Mechanism of Action

Betamethasone dipropionate is a high-potency synthetic corticosteroid. It induces phospholipase A2 inhibitory proteins, collectively called 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. Thus, betamethasone dipropionate exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
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Pharmacokinetics

Absorption:

Bioavailability: Low (systemic absorption varies)
Tmax: Not applicable for topical use (systemic absorption is minimal and variable)
FoodEffect: Not applicable for topical use

Distribution:

Vd: Not available (systemic distribution if absorbed)
ProteinBinding: Not available (systemic protein binding if absorbed)
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not precisely defined for topical use (systemic half-life of corticosteroids varies)
Clearance: Not precisely defined for topical use
ExcretionRoute: Renal (primarily metabolites, if systemically absorbed)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within days for symptomatic relief
PeakEffect: Within 1-2 weeks of consistent application
DurationOfAction: Effects persist as long as applied, and for some time after discontinuation

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. 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, 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, swelling, or pus, which could indicate a skin infection.
  • Severe burning, stinging, or irritation at the application site.
  • Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks (striae).
  • Changes in skin color (lightening or darkening).
  • Acne-like breakouts or increased hair growth in the treated area.
  • If used extensively or for prolonged periods, watch for signs of systemic absorption like unusual weight gain, swelling in the face ('moon face'), increased thirst or urination, or muscle weakness. Contact your doctor immediately if these occur.
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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 symptoms you experienced as a result of the allergy.
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 in conjunction with your other medications and health issues. Never start, stop, or adjust 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 to minimize potential risks.

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

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

  • Prolonged or excessive use, especially over large surface areas, under occlusion, or in children, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: weight gain, moon face, central obesity, thinning skin, easy bruising, striae, muscle weakness, high blood pressure, high blood sugar, and adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or emergency services immediately. For general poison control, call 1-800-222-1222. Treatment is supportive and may involve gradual withdrawal of the corticosteroid under medical supervision.

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 contraindications.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly for initial 2 weeks)

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of condition after 1-2 weeks may indicate need for re-evaluation or alternative therapy.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation, hypopigmentation)

Frequency: Regularly during treatment and at follow-up

Target: Absence of new or worsening adverse effects

Action Threshold: Presence of significant local adverse effects warrants discontinuation or reduction in potency/frequency.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusion

Target: Normal HPA axis function, normal blood glucose

Action Threshold: Symptoms or laboratory findings suggestive of systemic absorption require immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin rash or symptoms
  • Signs of skin infection (redness, warmth, swelling, pus, fever)
  • Severe burning, stinging, or itching at application site
  • New skin changes such as thinning, easy bruising, stretch marks (striae), or changes in skin color (hypopigmentation)
  • Unusual hair growth
  • Acne-like eruptions
  • Perioral dermatitis (rash around the mouth)

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. Systemic absorption of topical corticosteroids can occur, and animal studies have shown teratogenic effects with high doses of corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk with topical use is low due to minimal systemic absorption.
Second Trimester: Use with caution; monitor for signs of systemic absorption.
Third Trimester: Use with caution; monitor for signs of systemic absorption. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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Lactation

Use with caution. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic corticosteroids are excreted into breast milk. Avoid applying the lotion to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with proper topical use due to minimal systemic absorption, but potential for adverse effects if significant absorption occurs or if applied to areas where infant can ingest.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Prolonged use should be avoided, and the smallest effective amount should be used for the shortest duration. Not recommended for children under 12 years for prolonged use.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and increased susceptibility to local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity and adverse reactions.

Clinical Information

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Clinical Pearls

  • Diprosone 0.05% Lotion is a high-potency topical corticosteroid. It should be used judiciously and for short durations (typically 2 weeks) to minimize the risk of local and systemic side effects.
  • Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to adverse effects like skin atrophy and striae.
  • Patients should be instructed on the proper application technique: apply a thin film and rub in gently. Excessive application or use under occlusion significantly increases systemic absorption.
  • If long-term therapy is required, consider intermittent therapy (e.g., 2 days on, 5 days off) or switching to a lower potency corticosteroid to reduce side effects.
  • Rebound flares of the dermatosis can occur upon abrupt discontinuation after prolonged use; gradual tapering may be necessary.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole)
  • Topical Janus kinase (JAK) inhibitors (e.g., ruxolitinib)
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants, biologics) for severe or widespread dermatoses.
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 60ml lotion
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 taken, the amount, and the time it happened.