Betamethasone Val 0.1% Oint 15gm

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
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 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 immune 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 your doctor has instructed. Carefully read all the information provided with your medication 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. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning. Unless your doctor advises you to do so, 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. 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 and secure location, out of the reach of children and pets.

Missing a Dose

If you forget to apply a dose of your medication, 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 thoroughly before and after applying the ointment.
  • Apply a thin layer of ointment only to the affected skin areas, as directed by your doctor.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the ointment to your eyes, mouth, or other mucous membranes.
  • Do not use this ointment on your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than prescribed, especially in children, to minimize the risk of side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected skin areas one to three times daily.

Condition-Specific Dosing:

eczema_psoriasis: Apply a thin film to affected skin areas one to three times daily, or as directed by physician. Once daily application may be sufficient for maintenance.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Use with caution; not recommended for children under 12 years for prolonged use or on large areas due to increased systemic absorption risk. If used, apply once daily for short periods (e.g., 2 weeks maximum).
Adolescent: Apply a thin film to affected skin areas one to three times daily, or as directed by physician. Use lowest effective dose for shortest duration.
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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 synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces 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: Not available (highly variable with topical application)
Tmax: Not available
FoodEffect: Not applicable

Distribution:

Vd: Not available
ProteinBinding: Not available (systemic corticosteroids bind extensively to plasma proteins)
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not available
Clearance: Not available
ExcretionRoute: Renal (as inactive metabolites, if systemically absorbed)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours (for anti-inflammatory effects)
PeakEffect: Days to weeks (for full therapeutic effect)
DurationOfAction: Varies, typically allows for once to twice daily application

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 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 have mild 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, 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 a few days/weeks of use.
  • Signs of a new skin infection, such as increased redness, warmth, swelling, pus, or fever.
  • Severe burning, stinging, itching, or irritation at the application site.
  • Changes in your skin, such as thinning, easy bruising, stretch marks (striae), or changes in skin color.
  • Increased hair growth in the treated area.
  • Acne-like breakouts.
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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 in combination with your other medications and health issues.

Remember, do not start, stop, or modify 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. 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. 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 using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. Note that different brands of this medication may be suitable for different age groups of children, so consult with your doctor before administering it to a child.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the well-being of 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:

  • Symptoms of Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

If you suspect excessive systemic absorption or overdose, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management is supportive and may involve gradual withdrawal of the medication.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment

Target: Improvement in symptoms

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

Adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, signs of infection)

Frequency: Regularly during treatment

Target: Absence of adverse effects

Action Threshold: Development of adverse effects requires dose reduction, discontinuation, or alternative therapy.

Signs of HPA axis suppression (for extensive/prolonged use, especially in children)

Frequency: Periodically, if risk factors present

Target: Normal plasma cortisol levels

Action Threshold: Suppressed cortisol levels may require gradual withdrawal or alternative therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (increased redness, warmth, swelling, pus, fever)
  • Severe burning, stinging, or irritation at application site
  • Skin thinning, easy bruising, stretch marks (striae)
  • Increased hair growth (hypertrichosis)
  • Acne-like eruptions
  • Changes in skin pigmentation

Special Patient Groups

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Pregnancy

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 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. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully 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 direct infant ingestion.

Infant Risk: Low risk with appropriate use (small areas, short duration). Monitor infant for potential adverse effects if used on large areas or for prolonged periods.
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Pediatric Use

Children are more susceptible to systemic absorption and adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years for prolonged use. Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local side effects.

Clinical Information

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Clinical Pearls

  • Betamethasone valerate 0.1% ointment is a medium-to-high potency topical corticosteroid. Ointments are generally more potent than creams or lotions due to increased penetration.
  • Always apply a thin layer; using more does not increase efficacy but increases the risk of side effects.
  • Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to the risk of skin atrophy, telangiectasias (spider veins), and hypothalamic-pituitary-adrenal (HPA) axis suppression.
  • Do not use this medication for fungal or bacterial skin infections unless a concomitant antimicrobial therapy is also prescribed.
  • Patients should be advised to discontinue use once the condition is controlled and not to use for longer than the prescribed duration.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., hydrocortisone, triamcinolone, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids for psoriasis
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions
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Cost & Coverage

Average Cost: $20 - $50 per 15gm tube
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 your 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 happened.