Betamethasone Val 0.1% Lotn 60ml

Manufacturer FOUGERA Active Ingredient Betamethasone Lotion(bay ta METH a sone) Pronunciation bay ta METH a sone VAL er ate
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
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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 lotion is a 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 skin's immune response.
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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.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. If the treated area is on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.

Special Instructions

Some formulations of this medication require shaking before use. Be sure to check if this applies to your product before using it.

Storage and Disposal

Store the medication at room temperature, away from freezing temperatures.
Protect the medication from light.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose

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 hands before and after applying the lotion.
  • Apply a thin layer to the affected skin area and rub in gently. Do not use more than directed.
  • Avoid applying to the face, groin, or armpits unless specifically directed by your doctor.
  • Do not cover the treated area with bandages or other dressings unless instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or other side effects.
  • 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, or as directed by a physician.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas once or twice daily.
eczema: Apply a thin film to the affected skin areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Use with caution; apply a thin film to affected areas once daily. Avoid prolonged use or large surface areas.
Child: Use with caution; apply a thin film to affected areas once daily. Avoid prolonged use or large surface areas.
Adolescent: Apply a thin film to the affected skin areas once or twice 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 due to minimal systemic absorption.

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 synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inducing 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <5%) through intact skin; absorption increases with inflammation, skin barrier disruption, occlusion, and application to large surface areas.
Tmax: Not precisely quantified for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely quantified for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding: Systemically absorbed corticosteroids are extensively bound to plasma proteins (e.g., transcortin, albumin).
CnssPenetration: Limited for topical application; systemic absorption can lead to CNS effects, but rare.

Elimination:

HalfLife: Systemic half-life of betamethasone is approximately 300-360 minutes (for systemically absorbed drug).
Clearance: Not precisely quantified for topical application.
ExcretionRoute: Primarily renal excretion for systemically absorbed drug.
Unchanged: Minimal unchanged drug excreted for systemically absorbed drug.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Varies with frequency of application, typically 12-24 hours per 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 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Burning or stinging
Dry skin
* Itching

These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact 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 itching at the application site
  • Development of new skin infections (e.g., pus, redness, warmth)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth in treated areas
  • Signs of systemic absorption (rare): unusual weight gain, swelling in ankles/feet, increased thirst/urination, vision problems, 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 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 that it is safe to take this medication in conjunction with your other treatments. Never 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, 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, this medication is not intended for treating diaper rash or redness, and it is crucial to avoid applying it to the diaper area.

Be aware that using 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 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. It is also important to note that different brands of this medication may be suitable for different age groups of children. Before giving this medication to a child, consult with your doctor to ensure the correct brand and dosage are used.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you. When 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, especially over large surface areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek emergency medical attention if severe systemic symptoms occur.

Drug Interactions

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Contraindicated Interactions

  • Not applicable for topical betamethasone valerate due to minimal systemic absorption.
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Major Interactions

  • Not applicable for topical betamethasone valerate due to minimal systemic absorption.
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Moderate Interactions

  • Not applicable for topical betamethasone valerate due to minimal systemic absorption.
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Minor Interactions

  • Not applicable for topical betamethasone valerate due to minimal systemic absorption.

Monitoring

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Baseline Monitoring

Skin condition assessment (e.g., erythema, scaling, pruritus)

Rationale: To establish baseline severity of dermatosis and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated.

Target: Improvement in symptoms.

Action Threshold: Lack of improvement or worsening of symptoms may require re-evaluation of diagnosis or treatment.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit, especially with prolonged use.

Target: Absence of adverse effects.

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

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

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

Target: Absence of systemic effects.

Action Threshold: Presence of systemic effects requires immediate medical evaluation and discontinuation of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness or irritation at application site
  • Development of new skin lesions (e.g., acne, folliculitis)
  • Skin thinning or bruising
  • Unusual hair growth
  • Weight gain, moon face, or other signs of Cushing's syndrome (rare)
  • Blurred vision (rare)

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 or prolonged use.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Second Trimester: Limited data, but systemic absorption is minimal. Use with caution.
Third Trimester: Limited data, but systemic absorption is minimal. Use with caution. Potential for low birth weight or HPA axis suppression in neonates with extensive maternal use.
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Lactation

Use with caution. It is not known whether topical betamethasone is excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use due to minimal systemic absorption, but monitor infant for potential adverse effects if mother uses extensively.
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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, including HPA axis suppression and Cushing's syndrome. Use the least potent effective corticosteroid for the shortest duration possible. Avoid occlusion and large surface areas. Not recommended for infants under 1 year of age unless specifically directed by a physician.

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Geriatric Use

No specific dosage adjustments are required. However, geriatric patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor closely for skin integrity.

Clinical Information

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Clinical Pearls

  • Topical corticosteroids should be used for the shortest duration necessary to achieve control of symptoms.
  • Potency of topical steroids varies; betamethasone valerate 0.1% is a medium-potency corticosteroid.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound flares.
  • Educate patients on proper application technique: thin film, gentle rubbing, avoiding eyes/mucous membranes.
  • Occlusion (e.g., bandages, diapers) significantly increases absorption and risk of side effects, especially in children.
  • Not for use on infected skin without concomitant antimicrobial therapy.
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Alternative Therapies

  • 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
  • Antihistamines for pruritus
  • Phototherapy for severe psoriasis/eczema
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Cost & Coverage

Average Cost: $20 - $80 per 60ml lotion
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'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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.