Betamethasone Dip 0.05% Oint 45gm

Manufacturer ACTAVIS MID ATLANTIC 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
Sep 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone dipropionate ointment is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by skin conditions like eczema and psoriasis. It works by calming down the body's inflammatory response.
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How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, 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 skin. 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. Before and after applying the medication, wash your hands thoroughly. If the affected area is on your hand, do not wash your hand after applying the medication.

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 the 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 the medication at room temperature, away from light and freezing temperatures. Keep all medications in a safe and secure location, out of the reach of children and pets.

Missing a Dose

If you miss a dose, 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 resume 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

  • Wash hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area, gently rubbing it in until it disappears.
  • Do not use more than directed or for longer than prescribed.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying to the face, groin, or armpits unless directed by a doctor.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash without consulting a doctor.
  • 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.
eczema: Apply a thin film to the affected skin areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Use with caution; apply a thin film to the affected skin areas once daily. Avoid prolonged use or occlusive dressings due to increased systemic absorption risk.
Child: Use with caution; apply a thin film to the affected skin areas once daily. Avoid prolonged use or occlusive dressings due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Avoid prolonged use or occlusive dressings.
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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 is a potent 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: Minimal systemic absorption (typically <5%), increased with inflamed skin, occlusion, or prolonged use.
Tmax: Not applicable for topical systemic effects; local effect onset is rapid.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use; systemically absorbed drug distributes widely.
ProteinBinding: High (to plasma proteins) if systemically absorbed.
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not precisely quantified for topical systemic absorption; systemic corticosteroids have variable half-lives (e.g., 300-500 minutes for betamethasone).
Clearance: Not precisely quantified for topical systemic absorption.
ExcretionRoute: Renal (primarily as metabolites) if systemically absorbed.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours (local anti-inflammatory effect)
PeakEffect: Days to weeks for full therapeutic effect.
DurationOfAction: Varies with application frequency, typically 12-24 hours for local effect.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Right Away

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 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:

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, consult 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 (signs of infection)
  • Severe burning, itching, or irritation that worsens after application
  • Skin thinning, easy bruising, or stretch marks in the treated area
  • Acne-like breakouts or increased hair growth in the treated area
  • Changes in skin color (lightening)
  • Any signs of systemic effects like unusual weight gain, swelling in ankles/feet, increased thirst/urination, or fatigue (rare, but possible with extensive or prolonged use)
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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 and its symptoms.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you are experiencing.

To ensure your safety, verify that it is acceptable to take this medication with all your other medications and health conditions. Never start, stop, or adjust 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. 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, plan 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 can lead to systemic effects of corticosteroids, including adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia, and glucosuria.

What to Do:

Discontinue use and consult a healthcare professional. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Contraindicated Interactions

  • None known for topical application
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Major Interactions

  • None known for topical application
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Moderate Interactions

  • None known for topical application
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Minor Interactions

  • None known for topical application

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of lesion)

Rationale: To establish baseline for efficacy and adverse effect monitoring.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, erythema)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.

Local adverse effects (skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection)

Frequency: Weekly or as clinically indicated

Target: Absence of new or worsening adverse effects

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

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings

Target: Normal adrenal function, blood glucose

Action Threshold: Symptoms or lab abnormalities indicative of systemic absorption require immediate medical attention and discontinuation.

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Symptom Monitoring

  • Burning or stinging sensation at application site
  • Itching or irritation
  • Redness or rash
  • Skin thinning or fragility
  • Stretch marks (striae)
  • Acne-like breakouts
  • Increased hair growth in treated areas
  • Changes in skin color (lightening)
  • Signs of infection (pus, fever, increased pain)
  • Unusual fatigue or weakness (potential systemic absorption)
  • Increased thirst or urination (potential systemic absorption)

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. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is minimal, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption is low.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Generally considered safer than first trimester, but still use with caution.
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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 due to minimal systemic absorption, but potential for adverse effects if ingested by infant.
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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 adults because of a larger skin surface area to body weight ratio. Avoid prolonged use, large surface areas, and occlusive dressings. Not recommended for infants under 1 year of age.

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Geriatric Use

No specific dosage adjustments are required. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy and purpura. Monitor closely.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% ointment is a high-potency topical corticosteroid; use sparingly and for limited durations to minimize local and systemic side effects.
  • Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically directed by a physician for resistant conditions.
  • Not for ophthalmic, oral, or intravaginal use.
  • Avoid use on the face, groin, or axillae unless specifically instructed by a dermatologist, as these areas are more prone to atrophy and other side effects.
  • 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 effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, 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
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.