Betamethasone Val 0.1% Crm 15gm

Manufacturer TARO 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 valerate cream is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response in the skin.
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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 directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, 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 directed by your doctor, 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, away from light and freezing temperatures. Keep all medications in a safe place, out of the reach of children and pets.

What to Do If You Miss 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 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

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream only to the affected skin areas, as directed by your doctor.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid applying the cream to your 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 skin thinning or other side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • 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 one to three times daily, or as directed by a physician.
Dose Range: 1 - 3 mg

Condition-Specific Dosing:

dermatoses: Apply a thin film to the affected skin areas one to three times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk)
Infant: Apply a thin film to the affected skin areas once daily, or as directed by a physician. Use with extreme caution due to increased systemic absorption risk and HPA axis suppression.
Child: Apply a thin film to the affected skin areas once daily, or as directed by a physician. Use with caution due to increased systemic absorption risk and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas one to three times daily, or as directed by a physician.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Betamethasone valerate is a potent synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are mediated through the induction of phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
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Pharmacokinetics

Absorption:

Bioavailability: Varies (systemic absorption is generally low but can increase with prolonged use, large surface area application, occlusion, or impaired skin barrier)
Tmax: Not precisely defined for topical absorption, systemic effects are delayed.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely defined for topical absorption, but if absorbed systemically, distributes widely.
ProteinBinding: High (if absorbed systemically, primarily to albumin)
CnssPenetration: Limited (if absorbed systemically)

Elimination:

HalfLife: Approximately 5-6 hours (systemic, if absorbed)
Clearance: Not precisely defined for topical absorption.
ExcretionRoute: Renal (primarily as metabolites), some biliary.
Unchanged: Minimal (if absorbed systemically)
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies depending on formulation and frequency of application, generally 12-24 hours per application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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 unusual symptoms, contact your doctor or seek medical help:

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 irritation, burning, or stinging where the cream is applied.
  • Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks.
  • Development of acne-like bumps or hair bumps (folliculitis).
  • Signs of a new skin infection (e.g., pus, spreading redness, fever).
  • If your skin condition worsens or does not improve after the prescribed treatment period.
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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 determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change 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 the recommended treatment period.

When applying this medication to a large skin area, exercise caution and consult your doctor. Additionally, this medication is not intended for treating diaper rash or redness, and it is crucial to avoid applying it to the diaper area.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, it is vital to discuss this potential risk with your doctor. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Your doctor will help determine the best course of action.

When administering this medication to children, it is crucial to exercise caution, as the risk of certain side effects may be higher in this population. Different brands of this medication may be suitable for various age groups, so it is essential to consult your doctor before giving it to a child.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to you and your baby. While breast-feeding, avoid applying this medication directly to the nipple or the surrounding area to minimize potential risks.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic absorption and symptoms of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, high blood pressure, muscle weakness, fatigue).
  • In children, systemic absorption can lead to growth retardation and HPA axis suppression.

What to Do:

Discontinue the medication 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 and extent of dermatosis

Rationale: To assess severity and guide treatment plan.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

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 require re-evaluation of diagnosis or treatment.

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

Frequency: At each follow-up visit.

Target: Absence of or minimal adverse effects.

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

Signs of infection (e.g., redness, warmth, pus)

Frequency: At each follow-up visit.

Target: Absence of infection.

Action Threshold: Presence of infection requires appropriate antimicrobial treatment and re-evaluation of corticosteroid use.

Signs of HPA axis suppression (rare with appropriate topical use, more common in children or with extensive/occlusive use)

Frequency: Consider if large areas, prolonged use, or in pediatric patients (e.g., plasma cortisol levels, ACTH stimulation test).

Target: Normal HPA axis function.

Action Threshold: Evidence of suppression requires gradual withdrawal of the drug or reduction in frequency/potency.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that worsens
  • Thinning of the skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions or folliculitis
  • Signs of skin infection (pus, fever, spreading redness)
  • Unusual fatigue or weakness (rare, indicative of 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. 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 low risk.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of HPA axis suppression in the fetus, especially with high potency or extensive use near term.
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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 appropriate use, but monitor for potential adverse effects if significant systemic absorption occurs in the mother.
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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 due to a larger skin surface area to body weight ratio. Use the least potent effective corticosteroid for the shortest duration possible. Monitor for growth retardation and HPA axis suppression.

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Geriatric Use

No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor for these effects.

Clinical Information

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Clinical Pearls

  • Betamethasone valerate 0.1% cream is a medium-to-high potency topical corticosteroid. Choose the lowest potency and shortest duration necessary to achieve therapeutic effect.
  • Avoid prolonged use (typically >2-4 weeks) to minimize the risk of local skin atrophy, striae, and telangiectasias.
  • Do not use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to corticosteroid-induced side effects.
  • Occlusive dressings significantly increase systemic absorption and local side effects; use only if specifically prescribed.
  • Patients should be instructed on proper application technique: apply a thin film, rub in gently, and wash hands after application.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, clobetasol, fluocinonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies for severe or widespread conditions (e.g., biologics, oral immunosuppressants)
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Cost & Coverage

Average Cost: $15 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 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 medication taken, the amount, and the time it occurred.