Betamethasone Dip 0.05% Crm 15gm

Manufacturer TARO Active Ingredient Betamethasone Cream, Gel, and Ointment(bay ta METH a sone) Pronunciation bay ta METH a sone dye PRO pee oh nate
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
Aug 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone dipropionate cream is a strong medicine used on the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It belongs to a group of medicines called corticosteroids.
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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 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 applying the medication. 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 Precautions

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 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 extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Apply a thin layer of cream to the affected skin area(s) as directed by your doctor, usually once or twice a day.
  • Gently rub the cream into the skin until it disappears.
  • Wash your hands thoroughly before and after applying the cream, unless your hands are the treated area.
  • Do not use more cream than prescribed or apply it more often than directed.
  • 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 cream to your face, groin, or armpits unless specifically told to do so by your doctor, as these areas are more sensitive to side effects.
  • Avoid getting the cream in your eyes, nose, or mouth. If it gets into these areas, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, typically no more than 2 weeks for most conditions, to minimize the risk of side effects.

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 for up to 2 weeks, or until lesion clears. Do not exceed 50g per week.
eczema: Apply once or twice daily for up to 2 weeks, or until lesion clears. Do not exceed 50g per week.
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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. Not recommended for children under 12 years for prolonged use or on large surface areas due to increased risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Use with caution and for the shortest duration 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 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: Variable (depends on skin integrity, vehicle, occlusion, site of application, and duration of exposure); generally low systemic absorption.
Tmax: Not applicable for topical use (systemic levels are typically very low).
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not applicable for topical use (minimal systemic distribution). If absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding: Not applicable for topical use (minimal systemic distribution). If absorbed systemically, typically high (e.g., >90%).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not precisely determined for topical use due to minimal systemic absorption. Systemically absorbed corticosteroids are primarily excreted renally.
Clearance: Not precisely determined for topical use.
ExcretionRoute: Renal (if systemically absorbed).
Unchanged: Not precisely determined for topical use.
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Pharmacodynamics

OnsetOfAction: Local anti-inflammatory effects typically within hours to days.
PeakEffect: Within days of consistent application.
DurationOfAction: Depends on frequency of application; local effects persist for several hours after application.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention 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. 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 unusual symptoms, contact your doctor or seek medical help:

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, 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 burning, itching, or irritation where the cream is applied
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of skin infection (redness, swelling, pus, fever)
  • Unusual tiredness, weakness, nausea, or dizziness (rare, but can indicate systemic absorption, especially in children or with 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 symptoms you experienced as a result of the allergy.
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 treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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.

If the patient is a child, use this medication with 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 of children, 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 you will need to discuss the benefits and risks of using this medication to both you and your baby. While 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, potentially causing Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising, high blood pressure, high blood sugar)
  • Adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged high-dose use
  • Growth retardation in children

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin thinning, atrophy, or infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria)

Frequency: Regularly during treatment, especially during prolonged use.

Target: Absence of new or worsening reactions.

Action Threshold: If severe irritation or sensitization develops, discontinue use and institute appropriate therapy. If signs of infection develop, discontinue use and initiate appropriate antimicrobial therapy.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)

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

Target: Absence of symptoms.

Action Threshold: If suspected, perform appropriate laboratory tests (e.g., plasma cortisol, ACTH stimulation test) and gradually withdraw the drug or substitute a less potent corticosteroid.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Skin thinning or bruising
  • Development of stretch marks (striae)
  • Increased hair growth in treated areas
  • Acne-like breakouts
  • Signs of infection (pus, fever, worsening pain)
  • Unusual fatigue or weakness
  • Weight gain (especially in children with prolonged use)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption of topical corticosteroids is low, but can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption is minimal.
Second Trimester: Minimal risk with appropriate use.
Third Trimester: Minimal risk with appropriate 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. Systemic corticosteroids are excreted into breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use (avoiding application to breast and large areas), but monitor infant for potential systemic 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. Not recommended for children under 12 years for prolonged use or on large surface areas.

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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 or local side effects like skin atrophy. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% cream is a high-potency topical corticosteroid. Use it sparingly and for short durations (typically no more than 2 weeks) to minimize 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 side effects like skin thinning and perioral dermatitis.
  • Occlusive dressings (e.g., bandages, plastic wrap) significantly increase the absorption of topical corticosteroids and should only be used if explicitly instructed by a healthcare provider.
  • Patients should be advised to wash their hands thoroughly after applying the cream to avoid accidental transfer to eyes or other sensitive areas.
  • Monitor for signs of skin atrophy (thinning, bruising, telangiectasias) with prolonged use.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids for certain dermatoses
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: $15 - $40 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 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.