Betamethasone Dip Aug 0.05% Oin 15g

Manufacturer LUPIN Active Ingredient Betamethasone Cream, Gel, and Ointment(bay ta METH a sone) Pronunciation bay-ta-METH-a-sone dye-PRO-pee-oh-nate AWG-men-ted
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
Synthetic Adrenocorticosteroid; Anti-inflammatory
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone Dipropionate Augmented Ointment is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It's a type of steroid medicine.
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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 the treated area is on your hand, do not wash your 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.
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 light and freezing temperatures.
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 take extra doses.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area and rub it in gently. Do not use more than directed.
  • 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 contact with eyes, nose, mouth, and genital areas. If contact occurs, rinse thoroughly with water.
  • Do not use on 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 prescribed, typically no more than 2 weeks for adults, due to the risk of skin thinning and other side effects.
  • 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 a thin film to the affected skin areas once or twice daily for up to 2 weeks. Do not exceed 45 g per week.
eczema: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Do not exceed 45 g per week.
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Pediatric Dosing

Neonatal: Not established (use generally not recommended due to increased systemic absorption and HPA axis suppression risk)
Infant: Not established (use generally not recommended due to increased systemic absorption and HPA axis suppression risk)
Child: Not established (use generally not recommended due to increased systemic absorption and HPA axis suppression risk; if used, limit to smallest effective amount for shortest duration)
Adolescent: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Use with caution and limit duration due to potential for systemic absorption and HPA axis suppression.
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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, an augmented topical corticosteroid, exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions through induction of 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; however, the augmented formulation enhances percutaneous absorption. Absorption is increased by occlusive dressings, prolonged use, application to large surface areas, and compromised skin barrier.
Tmax: Not precisely quantifiable for topical application due to variable systemic absorption.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not precisely quantifiable for topical application; systemically absorbed corticosteroids are bound to plasma proteins.
ProteinBinding: High (systemically absorbed portion)
CnssPenetration: Limited (systemically absorbed portion)

Elimination:

HalfLife: Not precisely quantifiable for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance: Not precisely quantifiable for topical application.
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days to a week of consistent application.
DurationOfAction: Varies; effects persist as long as applied, but prolonged use can lead to tachyphylaxis and adverse effects.

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 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 a complete 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:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that was not present before
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of systemic absorption, especially in children: weight gain, rounding of the face (moon face), delayed growth, fatigue, weakness.
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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, 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 with your other medications and health conditions.

Remember, do not start, stop, or change the dose 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.

Be aware that this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. In some cases, this medication may affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss this potential effect.

When using this medication in children, exercise 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, 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.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects of corticosteroid excess, including Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia)
  • Adrenal insufficiency upon abrupt withdrawal after prolonged high-dose use (e.g., fatigue, weakness, nausea, vomiting, hypotension)

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek immediate 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 damage or infection.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (e.g., reduction in erythema, pruritus, scaling)

Frequency: Regularly during treatment (e.g., weekly)

Target: Improvement in symptoms

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

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

Frequency: Regularly during treatment

Target: Absence of significant adverse effects

Action Threshold: Development of significant local adverse effects; consider reducing frequency, potency, or discontinuing.

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

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

Target: Normal HPA axis function

Action Threshold: Suspicion of HPA axis suppression; consider ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw if confirmed.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of Cushing's syndrome (e.g., moon face, central obesity, striae)
  • Signs of adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, hypotension)

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. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic doses; topical absorption is generally low but augmented formulation increases risk.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with prolonged or high-dose systemic exposure.
Third Trimester: Risk of fetal growth restriction or adrenal suppression with prolonged or high-dose systemic exposure.
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Lactation

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

Infant Risk: Low risk with appropriate use (limited area, short duration), but potential for systemic effects in infant if significant absorption occurs.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the smallest effective amount for the shortest duration. Avoid occlusive dressings. Not recommended for infants and young children unless specifically directed by a specialist.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., atrophy, purpura) and potentially systemic absorption. Monitor closely for skin integrity and adverse effects.

Clinical Information

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Clinical Pearls

  • Betamethasone Dipropionate Augmented 0.05% Ointment is a high-potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 weeks for adults).
  • The 'augmented' formulation means it's designed for enhanced penetration and potency, increasing the risk of both local and systemic side effects compared to non-augmented formulations.
  • Avoid using this ointment on the face, groin, or axillae unless specifically instructed by a dermatologist, as these areas are more prone to corticosteroid-induced side effects like atrophy and striae.
  • Do not use occlusive dressings (e.g., plastic wrap) over the treated area unless directed by a healthcare professional, as this significantly increases systemic absorption and the risk of HPA axis suppression.
  • Educate patients on the signs of skin atrophy (thinning, shiny skin, visible blood vessels) and HPA axis suppression (fatigue, weight gain, moon face) and to report them immediately.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone, desonide - varying potencies)
  • 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 dermatoses
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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 (generic), Tier 3 or 4 (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.