Betamethasone Val 0.1% Crm 45gm

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
Jan 1970
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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 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 use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you 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. Do not take it by mouth. 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 and after applying the medication, wash your hands thoroughly. However, if the affected area is on your hand, do not wash your hand after applying the medication.

Before applying the medication, clean the affected area and dry it well. Then, apply a thin layer of the medication to the affected skin and gently rub it in. Unless instructed by your doctor, avoid applying the medication to your face, underarms, or groin area.

Storing and Disposing of Your Medication

Store the 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.

Missing 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 dose, skip the missed dose and continue with 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

  • 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 use more than prescribed.
  • Gently rub the cream into the skin until it disappears.
  • 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.
  • 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 get the cream in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
  • Inform your doctor if your condition does not improve after 2-4 weeks of treatment or if it worsens.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas two to three times daily

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas two to three times daily
eczema: Apply a thin film to the affected skin areas two to three times daily
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Pediatric Dosing

Neonatal: Not established
Infant: Use with caution; apply a thin film to the affected skin areas once or twice daily, for short periods only. Avoid occlusive dressings.
Child: Use with caution; apply a thin film to the affected skin areas once or twice daily, for short periods only. Avoid occlusive dressings.
Adolescent: Apply a thin film to the affected skin areas two to three times daily
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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 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: Minimal systemic absorption; varies with skin integrity, vehicle, and occlusion. Can be up to 5-6% in healthy skin, higher in damaged skin.
Tmax: Not well-defined for topical application; systemic effects can occur with prolonged or extensive use.
FoodEffect: Not applicable

Distribution:

Vd: Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding: Approximately 64% (if systemically absorbed)
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Approximately 5-6 hours (if systemically absorbed)
Clearance: Not well-defined for topical application.
ExcretionRoute: Renal (primarily), some biliary (if systemically absorbed)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduced itching, redness)
PeakEffect: Days to weeks for full therapeutic effect
DurationOfAction: Varies; typically requires multiple daily applications 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 immediate 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, 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:

  • Severe burning, itching, or irritation at the application site
  • Signs of skin infection (e.g., pus, fever, spreading redness, warmth)
  • Skin thinning, easy bruising, or stretch marks appearing in the treated area
  • Acne-like breakouts or increased hair growth in the treated area
  • Changes in skin color (lightening or darkening)
  • Any signs of systemic side effects, such as unusual weight gain (especially in the face or trunk), increased thirst or urination, or unusual fatigue.
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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 issues.

Remember, do not start, stop, or adjust 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 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; 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 pediatric patients. 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 breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using 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:

  • While acute overdose with topical application is unlikely, prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic effects of corticosteroid excess, including Cushing's syndrome, hyperglycemia, and adrenal suppression.

What to Do:

Discontinue use and consult a healthcare professional. Symptomatic and supportive treatment may be necessary. For accidental ingestion or significant systemic symptoms, call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of dermatosis)

Rationale: To establish baseline for efficacy and adverse effect monitoring.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment, typically weekly to bi-weekly initially

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of condition after 2-4 weeks may indicate need for re-evaluation or alternative therapy.

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

Frequency: Regularly during treatment, especially with prolonged use or on sensitive areas

Target: Absence of adverse effects

Action Threshold: Presence of adverse effects warrants reduction in frequency, discontinuation, or change to a less potent steroid.

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

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

Target: Absence of systemic effects

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

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that worsens or does not improve
  • Skin thinning or easy bruising
  • Appearance of stretch marks (striae)
  • Acne-like breakouts (folliculitis)
  • Increased hair growth in treated areas (hypertrichosis)
  • Changes in skin color (hypopigmentation)
  • Signs of infection (pus, fever, spreading redness)
  • Unusual fatigue or weakness
  • Weight gain, especially around the face and trunk
  • Increased thirst or urination (signs 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 amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids are limited and generally reassuring for short-term, limited use.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with extensive or prolonged use.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with extensive or prolonged use. Neonates born to mothers who received substantial corticosteroids during pregnancy should be observed for signs of hypoadrenalism.
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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 systemic effects in infant if significant absorption occurs in mother and transfers via milk, or if applied to breast and ingested by infant.
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Pediatric Use

Pediatric patients 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, growth retardation) than adult patients. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin and be more susceptible to local adverse effects (e.g., skin atrophy, purpura). Monitor closely for skin integrity and adverse reactions.

Clinical Information

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Clinical Pearls

  • Betamethasone valerate 0.1% cream is a medium-to-high potency topical corticosteroid. It should be used judiciously, especially on sensitive areas like the face, groin, or axillae, and in pediatric patients.
  • Patients should be instructed on the 'thin film' application technique to avoid overuse and minimize systemic absorption.
  • Prolonged use (typically beyond 2-4 weeks) should be avoided without re-evaluation by a healthcare professional due to the risk of local skin atrophy and potential systemic effects.
  • Occlusive dressings significantly increase systemic absorption and should only be used if specifically directed by a physician.
  • If a skin infection is present, it should be treated appropriately (e.g., with an antifungal or antibacterial agent) in conjunction with the corticosteroid, or the corticosteroid may need to be temporarily withheld.
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Alternative Therapies

  • Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, clobetasol, fluocinonide, mometasone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread dermatoses
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube of 0.1% cream (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 safe and effective 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 consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.