Betamethasone Dip Aug 0.05% Gel50gm

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
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
Aug 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone gel is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by 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

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 irritation or 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 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.

Important Application Restrictions

Do not apply this 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, avoiding freezing temperatures. Protect the medication from light to preserve its effectiveness. Keep all medications in a safe and secure location, out of the reach of children and pets.

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

  • Apply a thin layer of the gel to the affected skin area(s) exactly as directed by your doctor, usually once or twice a day.
  • Gently rub it in until it disappears.
  • Wash your hands before and after applying the gel, unless your hands are the area being treated.
  • Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the gel to the face, groin, or armpits unless directed by your doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than the prescribed duration (typically 2 weeks) or on large areas of the body without consulting your doctor.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

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 a thin film to the affected skin areas once or twice daily for up to 2 weeks. Do not exceed 50g per week.
eczema: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Do not exceed 50g per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established, use with extreme caution and for shortest duration possible due to increased risk of systemic absorption and HPA axis suppression.
Child: Apply a thin film to the affected skin areas once daily for up to 2 weeks. Use with caution, for shortest duration possible, and on smallest area due to increased risk of systemic absorption and HPA axis suppression. Not recommended for children under 13 years.
Adolescent: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Use with caution, for shortest duration possible, and on smallest area due to increased risk of systemic absorption and HPA axis suppression.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.
Dialysis: No specific adjustment needed due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Betamethasone dipropionate, an augmented topical corticosteroid, 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: Minimal systemic absorption; varies with vehicle, skin integrity, and use of occlusive dressings. Percutaneous absorption of topical corticosteroids is in the range of 1% to 5% of the applied dose, but can be higher.
Tmax: Not applicable for systemic peak due to minimal absorption; local effect onset is rapid.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Not applicable (minimal systemic distribution)
CnssPenetration: No

Elimination:

HalfLife: Not precisely determined for topical application due to minimal systemic absorption; systemic corticosteroids have variable half-lives.
Clearance: Not precisely determined for topical application.
ExcretionRoute: Primarily renal excretion of metabolites, but minimal systemic excretion for topical.
Unchanged: Not applicable (minimal systemic absorption).
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in pruritus, erythema).
PeakEffect: Within days of consistent application.
DurationOfAction: Varies; typically requires once or twice daily application.

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 have mild 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 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, 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:

  • Worsening of your skin condition or no improvement after 1-2 weeks of use.
  • Signs of a skin infection (e.g., increased redness, swelling, pus, fever).
  • Severe burning, itching, irritation, or dryness at the application site.
  • Development of new skin problems like thinning skin, stretch marks, acne, or changes in skin color.
  • Unusual fatigue, weakness, nausea, vomiting, or dizziness (rare, but could indicate systemic absorption).
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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 medications and health issues.

Remember, do not initiate, discontinue, or modify 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 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. Furthermore, in some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Your doctor will monitor this and provide guidance.

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 ranges, 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:

  • Local skin atrophy (thinning, stretch marks)
  • Acne-like eruptions
  • Increased hair growth
  • Perioral dermatitis
  • Hypothalamic-pituitary-adrenal (HPA) axis suppression (rare with topical use, but possible with extensive or prolonged use, especially in children, leading to symptoms like fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

Discontinue use and consult a healthcare professional. For suspected HPA axis suppression, medical evaluation and management are required. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (erythema, scaling, pruritus, lesion size)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated during treatment period.

Target: Improvement in symptoms and lesion appearance.

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

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

Frequency: At each follow-up visit.

Target: Absence or minimal local reactions.

Action Threshold: Presence of significant local adverse reactions may require discontinuation or change in therapy.

Signs of HPA axis suppression (if extensive use, large surface area, or prolonged use, especially in children)

Frequency: Consider baseline and periodic morning cortisol levels or ACTH stimulation test if risk factors are present.

Target: Normal cortisol levels.

Action Threshold: Suppressed cortisol levels may require discontinuation or tapering of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site (signs of infection)
  • Severe burning, itching, or irritation
  • Development of new skin changes (e.g., thinning skin, stretch marks, acne-like eruptions)
  • Systemic symptoms (e.g., fatigue, weakness, weight loss, nausea, vomiting) which could indicate HPA axis suppression, though rare with topical use.

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 areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption is minimal. Use with caution.
Second Trimester: Use with caution; minimal systemic absorption expected.
Third Trimester: Use with caution; minimal systemic absorption expected. Risk of HPA axis suppression in the neonate is theoretical but low with appropriate topical use.
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Lactation

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

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption by the mother. Monitor infant for any unusual symptoms.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the least potent effective corticosteroid for the shortest duration possible. Not recommended for children under 13 years for augmented formulations unless specifically directed by a specialist.

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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. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate augmented 0.05% gel is a high-potency topical corticosteroid. It should be used for short-term treatment (typically up to 2 weeks) of moderate to severe inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
  • Avoid prolonged use, especially on the face, groin, or axillae, as this can lead to skin atrophy, telangiectasias, and striae.
  • Occlusive dressings significantly increase the absorption of topical corticosteroids and should only be used if specifically instructed by a healthcare provider.
  • Patients should be advised to apply a thin film and rub it in gently until it disappears. Excessive application does not improve efficacy and increases the risk of side effects.
  • HPA axis suppression is a rare but serious systemic side effect, particularly in children or with extensive/prolonged use. Monitor for signs and symptoms if risk factors are present.
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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 (e.g., tazarotene) for psoriasis
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread disease
  • Phototherapy
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Cost & Coverage

Average Cost: $50 - $150 per 50gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (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 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 occurred.