Betamethasone Val 0.12% Foam 50gm

Manufacturer PERRIGO Active Ingredient Betamethasone Foam(bay ta METH a sone) Pronunciation bay-ta-METH-a-sone VAL-er-ate
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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Feb 2000
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Betamethasone valerate foam is a strong corticosteroid medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis or dermatitis. It works by calming down the immune 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. 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. 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 avoid using 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 schedule.
Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash your hands before and after applying the foam.
  • Shake the can well before 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.
  • Do not apply to the face, groin, or armpits unless specifically directed by your doctor.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not bandage, cover, or wrap the treated skin area unless directed by your doctor, as this can increase absorption.
  • Do not use for longer than 2 weeks unless advised by your doctor.
  • Keep away from open flames or heat, as the foam is flammable.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected skin areas once or twice daily. Do not use for more than 2 consecutive weeks.

Condition-Specific Dosing:

psoriasis: Apply a thin layer to affected skin areas once or twice daily for up to 2 weeks. Re-evaluate if no improvement.
dermatitis: Apply a thin layer to affected skin areas once or twice daily for up to 2 weeks. Re-evaluate if no improvement.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution, increased risk of systemic effects)
Child: Not established (use with extreme caution, increased risk of systemic effects due to higher surface area to body weight ratio and immature skin barrier). If used, limit to smallest amount for shortest duration.
Adolescent: Similar to adult dosing, but with caution regarding duration and area of application due to potential for systemic absorption.
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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 valerate is a corticosteroid that 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, area, duration, and occlusion; generally minimal systemic absorption)
Tmax: Not applicable for topical use (systemic levels are typically very low)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not precisely quantified for topical use; systemically absorbed corticosteroids are widely distributed.
ProteinBinding: High (systemically absorbed betamethasone is highly protein bound)
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Approximately 5 hours (for systemically absorbed betamethasone)
Clearance: Not precisely quantified for topical use
ExcretionRoute: Renal (metabolites), some biliary
Unchanged: Negligible (for topical application)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduced itching, redness)
PeakEffect: Days to weeks for full therapeutic effect (e.g., clearing of lesions)
DurationOfAction: Varies with application frequency; effects persist for several hours after application.

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 minor 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:

  • Worsening of your skin condition or no improvement after 2 weeks.
  • Severe burning, itching, irritation, or redness at the application site.
  • Signs of skin thinning (atrophy), such as easy bruising, shiny skin, or stretch marks.
  • Development of new skin problems like acne, folliculitis (hair follicle inflammation), or skin infections.
  • Signs of systemic side effects (rare with proper use) such as unusual weight gain, swelling in the face, or extreme tiredness.
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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 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, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 directed by your doctor, and avoid using it for an extended period.

When applying this medication to a large skin area, exercise caution and consult with 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; therefore, 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 with 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, so consult with your doctor before giving it to a child.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you, considering both your health and the baby's well-being.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects of corticosteroids, including Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia, and adrenal suppression.
  • Local skin atrophy, striae, telangiectasias.

What to Do:

Discontinue use 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 assessment

Rationale: To establish baseline severity, extent, and type of dermatosis.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, scaling)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms and lesion appearance

Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.

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

Frequency: At each follow-up visit

Target: Absence or minimal severity of adverse effects

Action Threshold: If severe or persistent, discontinue use and consider alternative therapy.

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

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

Target: Normal hypothalamic-pituitary-adrenal (HPA) axis function

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol) and gradually withdraw therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, itching, burning, or irritation at application site
  • Development of new skin lesions (e.g., folliculitis, acneiform eruptions)
  • Signs of skin atrophy (thinning, bruising, striae)
  • Signs of infection (pus, fever, spreading redness)
  • Unusual fatigue, weight gain, moon face (rare, indicative of systemic absorption)

Special Patient Groups

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Pregnancy

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 with topical use, but caution is advised, especially with large surface areas or prolonged use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk with topical minimal.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of adrenal suppression in the newborn if used extensively by the mother near term.
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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 proper use (minimal systemic absorption), but potential for adverse effects if significant amounts are ingested by the infant or if applied to large areas of the mother's skin.
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Pediatric Use

Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio and immature skin barrier. Adrenal suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use the least potent corticosteroid for the shortest duration possible. Not recommended for infants or young children unless specifically directed by a specialist.

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Geriatric Use

No specific dosage adjustments are generally needed. However, geriatric 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 0.12% foam is a high-potency topical corticosteroid. Use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • The foam formulation is often preferred for hairy areas or large surface areas due to its ease of application and rapid absorption.
  • Patients should be instructed on the proper technique for dispensing and applying the foam, as it melts quickly on contact with warm skin.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flare-ups of the skin condition.
  • Educate patients about the signs of skin atrophy (thinning, bruising, striae) and systemic absorption, and to report these to their healthcare provider.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas like the face.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Emollients and moisturizers for barrier repair and symptom relief.
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Cost & Coverage

Average Cost: $100 - $300 per 50gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (varies by insurance plan)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount, and the time it occurred.