Betamethasone Dip 0.05% Aug Crm 15g

Manufacturer TARO 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 receptor agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone dipropionate augmented cream is a strong corticosteroid medicine used on the skin to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis or eczema. It works by calming down the body's inflammatory 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. 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 to do so by your doctor, avoid applying the medication to your face, underarms, or groin area.

Storage and Disposal

Store the medication at room temperature, avoiding freezing.
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 schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer of cream to the affected skin area(s) as directed by your doctor, usually once or twice a day.
  • Rub in gently until it disappears.
  • Do not use more than the prescribed amount or for longer than directed, as this can increase the risk of side effects.
  • Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid applying to the face, groin, or armpits unless specifically directed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash.
  • 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 for up to 2 weeks. Do not exceed 45g per week.
eczema: Apply once or twice daily for up to 2 weeks. Do not exceed 45g per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established; use with extreme caution if considered due to higher risk of systemic absorption.
Child: Not recommended for children under 12 years of age. If used, apply a thin film to affected areas once daily for up to 2 weeks. Limit treatment area and duration due to higher risk of systemic absorption and adrenal suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Do not exceed 45g per week.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Betamethasone dipropionate is a high-potency 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: Varies; systemic absorption can occur, especially with augmented formulations, prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Percutaneous absorption of betamethasone dipropionate augmented cream is approximately 0.6% to 0.8% of the applied dose.
Tmax: Not precisely defined for topical application due to variable absorption; systemic effects may be observed within hours to days of significant absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not available for topical application; systemically absorbed corticosteroids are extensively distributed to all body tissues.
ProteinBinding: Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily albumin and corticosteroid-binding globulin.
CnssPenetration: Limited for topical application; systemic absorption can lead to CNS penetration.

Elimination:

HalfLife: Systemic half-life of betamethasone is approximately 300-360 minutes (5-6 hours).
Clearance: Not available for topical application; systemically absorbed corticosteroids are cleared primarily by hepatic metabolism.
ExcretionRoute: Metabolites are excreted primarily in the urine, with some biliary excretion.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours of application for anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as applied; systemic effects can last for days after discontinuation if significant absorption occurred.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while 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. While many people may not experience any side effects or only have mild ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Burning or stinging
Dry skin
* Itching

These are not all the possible side effects that may occur. 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, itching, or redness at the application site.
  • Signs of skin infection (pus, spreading redness, fever).
  • Thinning of the skin, easy bruising, or stretch marks.
  • Acne-like breakouts.
  • Increased hair growth on the treated area.
  • Any signs of systemic effects like unusual weight gain, swelling in the face, or fatigue (signs of Cushing's syndrome or adrenal suppression).
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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 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.

Remember, do not start, stop, or modify 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 to discuss any potential risks. Additionally, do not use this medication to treat diaper rash or redness, and avoid applying it to the diaper area to minimize potential irritation.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, it is crucial to 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 determine the best course of action.

When administering this medication to a child, exercise caution, as the risk of certain side effects may be higher in this population. It is also important to note that different brands of this medication may be suitable for different age groups of children; therefore, consult with your doctor before giving this medication to a child.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you. When breast-feeding, 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 can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, hyperglycemia, and adrenal suppression.

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (type, severity, extent of lesion)

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

Timing: Prior to initiation of therapy.

Adrenal function (e.g., plasma cortisol levels, ACTH stimulation test)

Rationale: Consider for patients at high risk of systemic absorption (e.g., large surface area, prolonged use, occlusive dressings, pediatric patients).

Timing: Prior to initiation if high risk, or if signs of systemic toxicity develop.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, lesion size)

Frequency: Weekly or bi-weekly during treatment period.

Target: Improvement in symptoms and lesion appearance.

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

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

Frequency: At each follow-up visit.

Target: Absence of or minimal local adverse effects.

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

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

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

Target: Absence of systemic signs.

Action Threshold: Any signs of systemic absorption require immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site (signs of infection)
  • Thinning of skin
  • Stretch marks (striae)
  • Easy bruising
  • Acne-like eruptions
  • Excessive hair growth
  • Moon face
  • Weight gain (especially around the trunk)
  • Fatigue
  • Muscle weakness
  • Blurred vision (cataracts, glaucoma)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C.

Trimester-Specific Risks:

First Trimester: Animal studies have shown teratogenic effects with corticosteroids. Human data are limited.
Second Trimester: Limited human data; systemic absorption can occur. Monitor for signs of fetal growth restriction.
Third Trimester: Limited human data; systemic absorption can occur. Monitor for signs of fetal growth restriction and adrenal suppression in the neonate if used extensively.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited topical use; higher risk with extensive or prolonged use due to potential for systemic absorption.
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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. Not recommended for children under 12 years of age. If used, limit to the smallest amount compatible with an effective therapeutic regimen and for the shortest duration possible. Monitor closely for signs of adrenal suppression (e.g., growth retardation, delayed weight gain).

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy or purpura.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate augmented cream is a high-potency topical corticosteroid. Use it sparingly and for short durations (typically no more than 2 weeks) to minimize the risk of local and systemic side effects.
  • The 'augmented' formulation means it's designed for enhanced penetration and potency compared to standard betamethasone dipropionate creams.
  • Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to corticosteroid-induced side effects (e.g., atrophy, telangiectasias).
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
  • Patients should be advised to report any signs of local irritation, infection, or systemic side effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Retinoids (e.g., tazarotene) for psoriasis
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 15g tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic; Tier 3 or 4 for brand.
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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 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.