Betamethasone Dip 0.05% Oint 15gm

Manufacturer VIONA PHARMACEUTICALS 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 Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Jun 1974
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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 skin's immune 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 your doctor has instructed. Carefully read all the information provided with your medication and follow the instructions closely. 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 your skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause 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. Then, 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 place, out of the reach of children and pets.

Missing a Dose

If you forget to apply a dose of your medication, put it on 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 to the affected skin area as directed by your doctor, usually once or twice a day.
  • Do not use more than prescribed or for longer than recommended.
  • 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 to the face, groin, or armpits unless directed by your doctor, as these areas are more prone to side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash in infants.
  • 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 once or twice daily.
eczema: Apply once or twice daily.
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Pediatric Dosing

Neonatal: Not established (increased risk of systemic effects)
Infant: Not established (increased risk of systemic effects)
Child: Apply a thin film to the affected skin areas once daily. Use for shortest duration possible. Avoid occlusive dressings. Increased risk of systemic effects.
Adolescent: Apply a thin film to the affected skin areas once or twice daily.
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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 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: Minimal systemic absorption (typically <1-5%), varies with skin integrity, vehicle, occlusion, and site of application.
Tmax: Not well characterized for topical application due to minimal systemic absorption.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not well characterized for topical application.
ProteinBinding: Approximately 64% (if systemically absorbed).
CnssPenetration: Limited (if systemically absorbed).

Elimination:

HalfLife: Not well characterized for topical application; systemic half-life of corticosteroids varies.
Clearance: Not well characterized for topical application.
ExcretionRoute: Primarily renal excretion of metabolites (if systemically absorbed).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks for maximal therapeutic effect.
DurationOfAction: Varies, generally 12-24 hours per application.

Safety & Warnings

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Side Effects

Urgent 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 emergency 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 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 all 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:

  • Severe burning, itching, or irritation at the application site
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks in the treated area
  • Unusual hair growth in the treated area
  • Worsening of your skin condition
  • Any signs of systemic side effects like unusual weight gain, swelling in the face, or extreme tiredness (rare, but possible with extensive 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 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, health conditions, and concerns with your doctor. Please disclose all the following to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

To ensure your safety, always verify with your doctor that it is safe to take this medication with all your other medications and health conditions. Never 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 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, planning to become pregnant, or 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 side effects due to absorption, including Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia, and adrenal suppression (fatigue, weakness, low blood pressure).
  • Acute overdose is unlikely with topical application.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control) for advice if significant systemic symptoms are suspected.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (type and severity of lesion)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly for initial period, then as needed).

Target: Improvement in symptoms.

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

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, secondary infection)

Frequency: Regularly during treatment.

Target: Absence of or minimal adverse effects.

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

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

Frequency: Only if extensive, prolonged use, especially in children or with occlusive dressings.

Target: Normal adrenal function (e.g., normal plasma cortisol levels, normal ACTH stimulation test).

Action Threshold: Abnormal findings require immediate discontinuation and medical evaluation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Easy bruising
  • Increased hair growth in treated areas
  • Development of new skin infections
  • Unusual fatigue or weakness (potential sign of adrenal suppression)
  • Increased thirst or urination (potential sign of hyperglycemia)

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 data for topical corticosteroids are limited and generally reassuring for low-potency, limited use. High-potency corticosteroids used extensively may carry a theoretical risk.
Second Trimester: Similar considerations as first trimester. Risk of systemic absorption and potential fetal effects increases with extensive use.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., adrenal suppression) increases with extensive use. Neonatal adrenal insufficiency is a theoretical concern.
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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 expected to be low. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with proper use, but monitor infant for any unusual effects.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) than adult patients. Use the smallest amount for the shortest duration possible. Avoid occlusive dressings. Not recommended for use in infants under 1 year of age.

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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 purpura.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% ointment is a high-potency topical corticosteroid; use it judiciously to minimize local and systemic side effects.
  • Ointment formulations are generally more potent and occlusive than creams or gels, making them suitable for dry, scaly lesions but increasing the risk of absorption.
  • Limit treatment duration, especially on the face, intertriginous areas, and in children, to prevent skin atrophy, striae, and telangiectasias.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
  • Patients should be advised to apply a thin film and rub it in gently until it disappears. Excessive application does not improve efficacy but increases side effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate for higher potency, triamcinolone acetonide for medium potency, hydrocortisone for low potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids (e.g., tazarotene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions not responsive to topical treatment
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Cost & Coverage

Average Cost: $20 - $50 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 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 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.