Betamethasone Dip 0.05%oint 15gm

Manufacturer TEVA /ACTAVIS 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 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 certain skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response.
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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 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 make sure it is completely 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 this medication at room temperature, avoiding 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 to make up for a missed dose.
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Lifestyle & Tips

  • Apply a thin layer of ointment only to the affected skin areas as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • Do not cover the treated area with bandages or plastic wrap 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 prone to side effects.
  • Do not use for longer than prescribed, especially on children, as prolonged use can lead to serious side effects.
  • Avoid contact with eyes.

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 generally not recommended due to increased systemic absorption risk)
Infant: Not established (use generally not recommended due to increased systemic absorption risk)
Child: Apply a thin film to the affected skin areas once daily for short periods (e.g., up to 2 weeks). Avoid prolonged use or use on large body surface areas due to increased risk of systemic effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation).
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Limit duration of use and area of application.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for typical topical use.
Moderate: No adjustment needed for typical topical use.
Severe: No adjustment needed for typical topical use.
Dialysis: No specific considerations for typical topical use due to minimal systemic absorption.

Hepatic Impairment:

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

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: Not quantifiable (varies significantly)
Tmax: Not applicable (topical)
FoodEffect: Not applicable

Distribution:

Vd: Not clinically relevant for topical use (systemic: widely distributed)
ProteinBinding: Not clinically relevant for topical use (systemic: approximately 64% to plasma proteins)
CnssPenetration: Limited (not clinically relevant for topical use)

Elimination:

HalfLife: Approximately 5 hours (systemic, but biological half-life is longer)
Clearance: Not clinically relevant for topical use
ExcretionRoute: Renal (primarily via urine, some via bile)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Hours to days (for symptomatic relief)
PeakEffect: Days to weeks (for maximal therapeutic effect)
DurationOfAction: Varies, generally once or twice daily application is sufficient

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 immediately or seek medical attention:

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 minor ones, it's essential to contact your doctor if you notice any of the following:

Burning or stinging
Dry skin
* Itching

These are not all the possible side effects that may occur. If you have 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:

  • Skin irritation, burning, itching, or redness that worsens after application.
  • Development of new skin problems like acne, thinning skin, stretch marks, or changes in skin color.
  • Signs of skin infection (e.g., pus, fever, increased pain).
  • Unexplained weight gain, swelling in the face, or unusual fatigue (signs of systemic absorption).
  • Delayed growth or weight gain in children.
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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 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 you determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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. Additionally, avoid using this medication to treat diaper rash or redness, and refrain from applying it to the diaper area.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor. In children and teenagers, this medication may affect growth in some cases, necessitating regular growth checks. Consult your doctor to discuss the potential risks and benefits.

When administering this medication to 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, so consult your doctor before giving this medication 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 due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thinning skin, easy bruising), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

What to Do:

Discontinue the medication 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 (type, severity, extent of dermatosis)

Rationale: To establish baseline for treatment efficacy and identify contraindications.

Timing: Prior to initiation of therapy

Area of application and skin integrity

Rationale: To assess risk of systemic absorption (larger areas, broken skin increase absorption).

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly, at follow-up visits (e.g., weekly for acute conditions, monthly for chronic)

Target: Significant improvement or resolution of symptoms

Action Threshold: Lack of improvement, worsening symptoms, or development of adverse effects

Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: At each follow-up visit

Target: Absence of new or worsening adverse effects

Action Threshold: Presence of significant or progressive skin changes

Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome symptoms, hyperglycemia, growth retardation in children)

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

Target: Normal HPA axis function (e.g., normal cortisol levels if tested), absence of systemic symptoms

Action Threshold: Symptoms suggestive of systemic absorption; consider laboratory testing (e.g., ACTH stimulation test, plasma cortisol) if suspected.

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Symptom Monitoring

  • Worsening of skin condition
  • Development of new skin lesions (e.g., infection, acneiform eruptions)
  • Increased redness, swelling, or pain at application site
  • Thinning of skin, easy bruising, stretch marks (striae)
  • Increased hair growth at application site
  • Changes in skin color (hypopigmentation)
  • Symptoms of systemic absorption: unexplained weight gain, moon face, buffalo hump, easy bruising, muscle weakness, fatigue, increased thirst/urination (hyperglycemia), delayed growth in children.

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 amounts or prolonged use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids are limited and generally low risk with appropriate use.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction) with extensive or prolonged use.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., HPA axis suppression) with extensive or prolonged use.
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Lactation

Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Potential for adverse effects if significant systemic absorption occurs in mother and passes into breast milk, or if infant ingests directly from skin.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Use the least potent effective corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor closely for signs of systemic toxicity.

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Geriatric Use

No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local adverse effects.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% ointment is a high-potency topical corticosteroid. It should be used for short-term treatment of severe inflammatory dermatoses.
  • Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
  • Occlusive dressings significantly increase systemic absorption and local side effects; use only if prescribed and under close supervision.
  • Patients should be advised not to exceed the prescribed duration of treatment to minimize the risk of local and systemic adverse effects.
  • Tapering may be necessary after prolonged use to prevent rebound flares of the dermatosis.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy
  • Systemic corticosteroids (for severe, widespread conditions, short-term)
  • Phototherapy
  • Biologic agents (for severe psoriasis)
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Cost & Coverage

Average Cost: $15 - $40 per 15gm 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 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.