Betamethasone Val 0.12% Foam 100gm

Manufacturer PERRIGO Active Ingredient Betamethasone Foam(bay ta METH a sone) Pronunciation bay ta METH a sone
It is used to treat scalp irritation. It is used to treat scalp psoriasis.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 2000
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone valerate foam is a medicine applied to the skin to reduce inflammation, redness, and itching caused by certain skin conditions like psoriasis or eczema. It belongs to a group of medicines called corticosteroids.
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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. Unless instructed by your doctor, do not cover the treated area with bandages or dressings.

Application Instructions

Do not take this medication by mouth. It is for use on your scalp and hair only.
Keep the medication away from your mouth, nose, ears, and eyes, as it may cause burning.
Wash your hands before and after applying the medication.
To apply, move and part your hair to expose the affected skin. Then, turn the can upside down and dispense the foam onto a cool surface, such as a saucer. Avoid placing the foam directly in your hands.
Pick up a small amount of foam with your fingers and gently rub it into the affected area. Repeat this process until you have treated the entire affected scalp area.

Important Safety Precautions

This medication is flammable, so do not use it near an open flame or while smoking.

Storage and Disposal

Store the medication at room temperature, away from light and heat sources.
Do not freeze the medication.
Protect the can from heat, open flames, or punctures, even if it appears to be empty.

Missed Dose Instructions

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 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

  • Shake the can well before each use.
  • Invert the can and dispense a small amount of foam into the cap or onto a cool surface (not directly onto hands, as it will melt).
  • Gently massage the foam into the affected skin area until it disappears.
  • Wash your hands thoroughly after applying the foam, unless your hands are the treated area.
  • Do not use more than prescribed or for longer than recommended.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • 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.
  • Do not use on the face, groin, or armpits unless directed by your doctor.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin areas twice daily.

Condition-Specific Dosing:

psoriasis: Apply to affected areas twice daily.
atopicDermatitis: Apply to affected areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 12 years of age for some indications (e.g., psoriasis). Use with caution and for limited duration if prescribed, due to increased risk of systemic absorption and HPA axis suppression.
Adolescent: For adolescents 12 years and older, apply to affected areas twice daily, similar to adult dosing, but with caution regarding systemic absorption.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Betamethasone valerate is a synthetic corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, collectively called 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. This action results in anti-inflammatory, antipruritic, and vasoconstrictive effects.
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Pharmacokinetics

Absorption:

Bioavailability: Low systemic bioavailability; varies with vehicle, skin integrity, site of application, and use of occlusive dressings. Increased absorption occurs with inflamed or damaged skin.
Tmax: Not precisely quantifiable for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely quantifiable for topical application; primarily local distribution.
ProteinBinding: Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily transcortin and albumin. However, systemic absorption from topical application is minimal.
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely quantifiable for topical application; systemic half-life of betamethasone is approximately 5-7 hours.
Clearance: Not precisely quantifiable for topical application.
ExcretionRoute: Primarily renal excretion for systemically absorbed drug, but systemic absorption from topical application is minimal.
Unchanged: Minimal unchanged drug excreted due to extensive metabolism.
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Days to weeks for maximal therapeutic effect.
DurationOfAction: Varies; typically requires twice-daily application for sustained effect.

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

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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:

  • Worsening of your skin condition or no improvement after a few weeks.
  • Severe burning, itching, irritation, or redness at the application site.
  • Signs of skin infection (e.g., pus, fever, spreading redness).
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area.
  • Unusual weight gain, swelling in the face or ankles, or increased thirst/urination (rare signs of systemic absorption).
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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 symptoms you experienced.
If you have thinning skin at the site where you will be applying this medication.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure your safety while taking this medication.

To guarantee your safety, always verify with your doctor before:
Starting any new medication
Stopping any medication
* Changing the dosage of any medication

Never modify your medication regimen 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 specified by your doctor, and avoid using it for an extended period.

When applying this medication to a large skin area, exercise caution and consult 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. Discuss this potential risk with your doctor. Furthermore, in some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential effect.

When administering this medication to a child, use it with caution, as the risk of certain side effects may be higher in children. Note that different brands of this medication may be suitable for different age groups of children, 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 using this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use of topical corticosteroids can lead to local side effects such as skin atrophy, striae, and telangiectasias.
  • Systemic absorption, though rare, can lead to Cushing's syndrome, hyperglycemia, and HPA axis suppression, especially with extensive use, prolonged duration, or in children.

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. For the US, call 1-800-222-1222. Treatment is generally supportive and may involve gradual withdrawal of the medication.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis (e.g., psoriasis, atopic dermatitis) and identify any pre-existing skin damage or infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, erythema)

Frequency: Weekly to bi-weekly during initial treatment, then as clinically indicated.

Target: Improvement in symptoms and skin appearance.

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, folliculitis, burning, itching)

Frequency: At each follow-up visit.

Target: Absence or minimal signs of adverse reactions.

Action Threshold: Presence of significant local adverse reactions may require dose reduction, discontinuation, or change in therapy.

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

Frequency: Periodically, especially with extensive use, prolonged therapy, or in pediatric patients.

Target: Absence of systemic effects.

Action Threshold: Any signs of systemic absorption warrant immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, burning, stinging, or itching at application site
  • Development of new skin lesions (e.g., acne, folliculitis)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Signs of infection (e.g., pus, fever)
  • Unusual fatigue or weakness (rare, indicative of systemic absorption)

Special Patient Groups

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Pregnancy

Betamethasone valerate is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with systemically administered corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate in animal studies with high systemic doses; human data are limited but generally do not show a strong association with topical use.
Second Trimester: Use with caution; minimal systemic absorption is expected with appropriate topical use.
Third Trimester: Use with caution; minimal systemic absorption is expected with appropriate topical use. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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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 in nursing mothers. If used, avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk with appropriate topical use due to minimal systemic absorption, but potential for adverse effects on the infant cannot be entirely excluded.
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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 because of a larger skin surface area to body weight ratio. Use with caution, for the shortest duration possible, and under close medical supervision. Not recommended for children under 12 years for some indications.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Betamethasone valerate foam is for external use only. Do not ingest.
  • The foam formulation may be preferred for hairy areas or large surface areas due to ease of application and spreadability.
  • Avoid prolonged use, especially on the face, groin, or axillae, as these areas are more susceptible to corticosteroid-induced skin atrophy.
  • If an infection develops at the treatment site, discontinue the foam and initiate appropriate antimicrobial therapy.
  • Patients should be advised to report any signs of local adverse reactions or lack of improvement to their healthcare provider.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, triamcinolone acetonide, fluocinonide)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe or widespread disease
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Cost & Coverage

Average Cost: Highly variable, typically $100 - $500+ per 100gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand) / Tier 1 (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 occurred.