Betamethasone Dip 0.05% Aug Crm 50g

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
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Pregnancy Category
Category C
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FDA Approved
Aug 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone Dipropionate Augmented 0.05% Cream is a strong (high-potency) corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or psoriasis. The 'augmented' part means it's formulated to penetrate the skin more effectively.
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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, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. If you are treating a skin condition 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, do not apply the medication to your face, underarms, or groin area.

Storage and Disposal

Store the 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

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

  • Apply a thin layer to the affected skin area(s) as directed by your doctor, usually once or twice daily.
  • Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor.
  • Wash your hands before and after applying the cream.
  • 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.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use this cream for diaper rash in infants.

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:

generalUse: Limit treatment to 2 weeks. Do not use more than 50g per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years due to increased risk of systemic absorption and adverse effects (e.g., HPA axis suppression, Cushing's syndrome). If used, limit to the smallest amount for the shortest duration.
Adolescent: For adolescents 12 years and older, use as per adult dosing, but with caution and for limited duration.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed for typical topical use.
Moderate: No specific adjustment needed for typical topical use.
Severe: No specific adjustment needed for typical 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.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable (systemic absorption can range from <1% to >10% depending on skin integrity, vehicle, site of application, and occlusion). Augmented formulation increases penetration.
Tmax: Not typically reported for topical application; systemic absorption is gradual.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not specifically quantified for topical absorption; systemically absorbed corticosteroids are widely distributed.
ProteinBinding: Systemically absorbed corticosteroids are bound to plasma proteins, primarily transcortin and albumin.
CnssPenetration: Limited (systemic absorption is generally low).

Elimination:

HalfLife: Not well-defined for topical absorption; systemic half-life of betamethasone is approximately 5-7 hours.
Clearance: Not specifically quantified for topical absorption.
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some biliary excretion.
Unchanged: <5% (systemically absorbed drug)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as applied; residual effects may last for hours 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Burning or stinging
Dry skin
* Itching

This is not a comprehensive 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:

  • Increased redness, itching, burning, or irritation at the application site.
  • Thinning of the skin, easy bruising, or stretch marks (striae).
  • Acne-like breakouts or increased hair growth where the cream is applied.
  • Signs of skin infection (pus, worsening pain, fever).
  • Signs of systemic absorption (rare with proper use): unusual weight gain, swelling in the face (moon face), fatigue, muscle weakness, increased thirst or urination.
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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 of the 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have to ensure safe use of this medication.

To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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 it without consulting your doctor.

When applying this medication to a large skin area, exercise caution and discuss it with your doctor. Additionally, avoid using this medication to treat diaper rash or redness, and refrain from applying it to the diaper area.

Be aware that this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk. In children and teenagers, this medication may affect growth in some cases, necessitating regular growth checks. Consult your doctor to 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. Note that different brands of this medication may be suitable for different age groups, so consult your doctor before giving it to a child.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby. If you are 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, especially over large areas or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome) or adrenal suppression.
  • Symptoms may include: moon face, central obesity, thinning skin, easy bruising, striae, muscle weakness, fatigue, hyperglycemia, hypertension, and growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Contraindicated Interactions

  • Not significant with typical topical use.
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Major Interactions

  • Not significant with typical topical use.
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Moderate Interactions

  • Not significant with typical topical use.
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Minor Interactions

  • Not significant with typical topical use.

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine severity, extent of affected area, and suitability for treatment.

Timing: Prior to initiation of therapy.

Patient age and medical history

Rationale: To identify risk factors for systemic absorption (e.g., pediatric patients, pre-existing adrenal suppression, diabetes).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Daily to weekly

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks; consider alternative therapy or re-evaluation.

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

Frequency: Daily to weekly

Target: Absence of new or worsening local effects

Action Threshold: Development of significant local adverse effects; discontinue or reduce frequency/potency.

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

Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.

Target: Absence of systemic signs/symptoms

Action Threshold: Development of symptoms like weight gain, moon face, fatigue, hyperglycemia; consider HPA axis testing (e.g., ACTH stimulation test) and discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • New skin lesions or infections
  • Excessive burning, itching, or irritation at application site
  • Thinning of skin, easy bruising, or stretch marks (striae)
  • Increased hair growth at application site
  • Signs of systemic effects: unusual weight gain, facial puffiness (moon face), fatigue, muscle weakness, increased thirst/urination (hyperglycemia).

Special Patient Groups

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Pregnancy

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Corticosteroids have been shown to be teratogenic in animals. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies with systemic corticosteroids. Risk with topical use is low due to minimal systemic absorption, but caution is advised.
Second Trimester: Similar considerations as first trimester. Minimal systemic absorption expected.
Third Trimester: Similar considerations as first trimester. Minimal systemic absorption expected. Avoid large areas or prolonged use.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when Betamethasone Dipropionate Augmented Cream is administered to a nursing woman.

Infant Risk: L3 (Moderately Safe). Risk is generally low due to minimal systemic absorption. Avoid applying to areas that may come into direct contact with the infant's mouth or skin (e.g., breasts).
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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. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Not recommended for children under 12 years of age. If used, limit to the smallest amount for the shortest duration.

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Geriatric Use

No specific dose adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or increase the risk of local adverse effects like skin atrophy. Monitor for skin fragility.

Clinical Information

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Clinical Pearls

  • Betamethasone Dipropionate Augmented 0.05% Cream is a high-potency topical corticosteroid. Use it sparingly and for short durations (typically up to 2 weeks) to minimize side effects.
  • Avoid using this cream on the face, groin, or axillae unless specifically instructed by a dermatologist, as these areas are more prone to skin thinning and other adverse effects.
  • Do not use occlusive dressings (e.g., bandages, plastic wrap) over the treated area unless directed by your healthcare provider, as this significantly increases systemic absorption.
  • Educate patients on the signs of skin atrophy (thinning, bruising, striae) and systemic absorption (e.g., moon face, weight gain) and to report these to their doctor.
  • This formulation is 'augmented' for enhanced penetration, making it more potent than non-augmented betamethasone dipropionate creams.
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Alternative Therapies

  • Medium-potency topical corticosteroids (e.g., Triamcinolone Acetonide 0.1% Cream/Ointment)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone 1% Cream/Ointment)
  • Topical calcineurin inhibitors (e.g., Tacrolimus ointment, Pimecrolimus cream) for steroid-sparing therapy, especially on sensitive areas.
  • Vitamin D analogs (e.g., Calcipotriene) for psoriasis.
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $20 - $50 per 50g tube
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 is essential to contact your doctor promptly. 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. 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.