Betamethasone Dip Aug 0.05% Oin 50g

Manufacturer LUPIN PHARMACEUTICALS 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
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 0.05% Ointment is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It's a type of corticosteroid, which works by calming down the body's inflammatory response in the skin.
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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 make sure it is dry.
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

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 film of the ointment to the affected skin area(s) exactly as directed by your doctor, usually once or twice a day.
  • Do not use more than the prescribed amount or for longer than recommended, as this can increase the risk of side effects.
  • Wash your hands before and after applying the ointment.
  • 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 ointment to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash in infants.
  • Inform your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.

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.
eczema: Apply a thin film to the affected skin areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased risk of systemic effects)
Infant: Not established (use with extreme caution, increased risk of systemic effects)
Child: Apply a thin film to the affected skin areas once daily for up to 2 weeks. Not recommended for prolonged use or on large body surface areas. Increased risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Limit duration of treatment to 2 weeks and total dose to 50g per week.
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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 augmented 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: Variable (depends on skin integrity, vehicle, occlusion, duration of exposure, and body site; generally minimal systemic absorption)
Tmax: Not precisely quantifiable due to variable topical absorption
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not precisely quantifiable (minimal systemic absorption)
ProteinBinding: High (to plasma proteins, if systemically absorbed)
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not precisely quantifiable (variable systemic absorption and metabolism)
Clearance: Not precisely quantifiable
ExcretionRoute: Renal (primarily, if systemically absorbed)
Unchanged: Minimal (if systemically absorbed)
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Pharmacodynamics

OnsetOfAction: Hours to days (for clinical effect)
PeakEffect: Days to weeks (with consistent application)
DurationOfAction: Varies with application frequency and condition

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 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:

  • Increased redness, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of skin infection (e.g., pus, fever, spreading redness)
  • Blurred vision or other eye problems (if applied near eyes)
  • Signs of systemic absorption (rare with proper use, but can include: unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes)
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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, and do not exceed the recommended treatment period.

When applying this medication to a large skin area, exercise caution and consult your doctor to discuss potential risks and benefits. Additionally, this medication is not intended for treating diaper rash or redness; avoid applying it to the diaper area to prevent unnecessary exposure.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult your doctor to discuss this potential risk and undergo regular eye examinations as recommended. Furthermore, in some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Your doctor will monitor your child's growth and adjust treatment as needed.

When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. Different brands of this medication may be suitable for various age groups, so consult your doctor before giving it to a child to ensure the correct formulation is used.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. While breastfeeding, avoid applying this medication directly to the nipple or surrounding area to prevent infant exposure.
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Overdose Information

Overdose Symptoms:

  • Chronic overdose or misuse can lead to systemic effects of hypercorticism (Cushing's syndrome), including: moon face, central obesity, striae, hypertension, hyperglycemia, osteoporosis, muscle weakness, and HPA axis suppression.

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

Monitoring

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Baseline Monitoring

Skin condition (e.g., erythema, scaling, lichenification)

Rationale: To assess severity of dermatosis and establish baseline for treatment efficacy.

Timing: Prior to initiation of therapy

Extent of affected body surface area

Rationale: To estimate potential for systemic absorption and guide appropriate dosing/duration.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (e.g., reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

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

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

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

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

Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension) - *if extensive/prolonged use*

Frequency: Periodically, especially in pediatric patients or with extensive/occlusive use

Target: Normal cortisol levels (if tested)

Action Threshold: Symptoms or abnormal cortisol levels require immediate medical attention and potential tapering/discontinuation.

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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 systemic absorption (e.g., weight gain, moon face, fatigue, weakness, delayed wound healing, blurred vision)

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. High-potency topical corticosteroids should be used sparingly and for the shortest duration possible.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoid high-potency steroids if possible. Risk of teratogenicity is low with topical use.
Second Trimester: Use with caution; systemic absorption is minimal but possible. Monitor for fetal growth restriction if extensive use.
Third Trimester: Use with caution; systemic absorption is minimal but possible. Monitor for fetal growth restriction if extensive 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. Use with caution. If used, avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use, but monitor for potential systemic effects in the infant if mother uses extensively.
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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 due to 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 of age for prolonged periods or on large body areas.

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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, which could increase the risk of local adverse effects like atrophy or bruising. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Betamethasone Dipropionate Augmented 0.05% Ointment is a high-potency topical corticosteroid; use it judiciously to avoid local and systemic side effects.
  • Limit treatment duration to 2 weeks for most conditions, and total weekly dose to 50g to minimize risk of HPA axis suppression.
  • Educate patients on proper application technique: apply a very thin film, do not rub in excessively, and do not use occlusive dressings unless specifically instructed.
  • Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
  • Consider tapering frequency (e.g., every other day) once control is achieved to reduce cumulative exposure and prevent rebound flares.
  • Always consider the underlying diagnosis; if no improvement after 2 weeks, re-evaluate the diagnosis and treatment plan.
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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: $30 - $100+ per 50g tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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 happened.