Betamethasone Val 0.1% Oint 45gm

Manufacturer FOUGERA /SANDOZ Active Ingredient Betamethasone Cream, Gel, and Ointment(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 ointment is a strong corticosteroid medicine used on the skin to reduce redness, itching, and swelling caused by various skin conditions like eczema and psoriasis. It works by calming down the body's inflammatory 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 you are treating a skin condition on your hand, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, avoid applying the medication to your face, underarms, or groin area.

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 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

  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying to the face, groin, or armpits unless directed by your doctor.
  • 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.

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:

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

Neonatal: Not established. Use with extreme caution and under strict medical supervision due to increased systemic absorption and risk of HPA axis suppression.
Infant: Not established. Use with extreme caution and under strict medical supervision due to increased systemic absorption and risk of HPA axis suppression.
Child: Apply a thin film to the affected skin areas once or twice daily. Limit duration of treatment to the shortest possible period and the least amount effective. Avoid use on large surface areas or under occlusive dressings.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Limit duration of treatment to the shortest possible period and the least amount effective.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Betamethasone valerate is a potent synthetic corticosteroid. It 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: Low (variable, increased by inflammation, occlusion, thin skin, and large surface areas)
Tmax: Not typically quantified for topical application
FoodEffect: Not applicable

Distribution:

Vd: Not typically quantified for topical application
ProteinBinding: Not typically quantified for topical application (systemically, corticosteroids are highly protein bound)
CnssPenetration: Limited

Elimination:

HalfLife: Not typically quantified for topical application (systemically, variable)
Clearance: Not typically quantified for topical application
ExcretionRoute: Primarily renal (urine), with some biliary (feces) excretion of metabolites.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours of application
PeakEffect: Within 1-2 days of regular application
DurationOfAction: Varies with condition and frequency of application

Safety & Warnings

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Side Effects

Serious 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 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 redness, itching, or irritation at the application site
  • Signs of skin infection (pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth in the treated area
  • Unusual weight gain, swelling in the face or ankles, or increased fatigue (signs of systemic absorption, especially in children or with extensive use)
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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 and its symptoms.
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 in conjunction with your other treatments and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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 to discuss potential risks and benefits. Additionally, do not use this medication to treat diaper rash or redness, and avoid applying it to the diaper area to minimize potential irritation.

Be aware that this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk and any necessary precautions. Furthermore, in some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to determine the best course of action.

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

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent potential exposure to the baby.
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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, striae, hypertension, hyperglycemia)
  • Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control) 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 of treatment

Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially)

Target: Reduction in inflammation, pruritus, and lesion size

Action Threshold: Lack of improvement or worsening of symptoms may indicate need for re-evaluation or alternative therapy.

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

Frequency: At each follow-up visit

Target: Absence of adverse reactions

Action Threshold: Presence of significant local adverse reactions may require discontinuation or reduction in potency/frequency.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or in pediatric patients. Consider morning cortisol levels if suspicion is high.

Target: Normal HPA axis function

Action Threshold: Symptoms like weight gain, moon face, fatigue, or abnormal cortisol levels warrant investigation and potential discontinuation.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of systemic absorption (e.g., unusual fatigue, weight gain, swelling, mood changes)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts or prolonged use.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm not definitively established, but systemic absorption should be minimized.
Second Trimester: Potential for fetal harm not definitively established, but systemic absorption should be minimized.
Third Trimester: Potential for fetal harm not definitively established, but systemic absorption should be minimized.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use; higher risk with extensive application or prolonged use due to potential for systemic absorption and excretion into breast milk.
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Pediatric Use

Children are more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome) due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

Generally safe. 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 0.1% ointment is a high-potency topical corticosteroid. Use it judiciously.
  • Educate patients on the 'thin film' application technique to avoid overuse and minimize side effects.
  • Warn patients against using it on the face, groin, or axillae unless specifically instructed by a dermatologist, due to increased risk of skin atrophy and other side effects in these sensitive areas.
  • For chronic conditions, consider pulse therapy or step-down approaches to minimize long-term side effects.
  • Always consider the underlying cause of the dermatosis; corticosteroids treat symptoms, not the root cause.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate for higher potency, triamcinolone acetonide for medium potency, hydrocortisone for low potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effects
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole)
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., biologics, immunosuppressants) for severe, widespread conditions
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Cost & Coverage

Average Cost: Varies widely (e.g., $20 - $100+) per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 overdose, including the medication taken, the amount, and the time it occurred.