Betamethasone Dip 0.05% Lotn 60ml

Manufacturer PERRIGO PHARMACEUTICALS Active Ingredient Betamethasone Lotion(bay ta METH a sone) Pronunciation bay-ta-METH-a-sone dye-PRO-pee-oh-nate
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
Anti-inflammatory Agent; Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist; Topical Corticosteroid
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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 dipropionate lotion is a strong steroid medicine applied to the skin. It helps reduce redness, swelling, and itching caused by various skin conditions like eczema or psoriasis.
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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 to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if your hand is the treated area, do not wash it 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 to do so by your doctor, avoid applying the medication to your face, underarms, or groin area.

Important Preparation 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 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 schedule.
Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Apply a thin layer of the lotion to the affected skin area and rub it in gently until it disappears. Do not use more than prescribed.
  • Wash your hands thoroughly before and after applying the lotion, unless your hands are the treated area.
  • Avoid applying the lotion to your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
  • Do not bandage, cover, or wrap the treated skin area with an occlusive dressing (e.g., plastic wrap) unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use this medication for longer than prescribed, typically no more than 2 weeks for adults, or on large areas of the body, as it can lead to serious side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily.

Condition-Specific Dosing:

psoriasis: Apply once or twice daily, typically for up to 2 weeks. Re-evaluate if no improvement.
eczema: Apply once or twice daily, typically for up to 2 weeks. Re-evaluate if no improvement.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (increased risk of systemic absorption)
Child: Use with extreme caution; apply the smallest amount for the shortest duration possible. Not recommended for children under 12 years for some formulations due to increased risk of systemic effects (e.g., HPA axis suppression, Cushing's syndrome) due to larger skin surface area to body weight ratio.
Adolescent: Similar to adult dosing, but caution regarding duration and area of application.
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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, as systemic absorption is minimal.

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 dipropionate is a high-potency synthetic corticosteroid. It induces phospholipase A2 inhibitory proteins, collectively called 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. Betamethasone also exhibits vasoconstrictive, antipruritic, and anti-inflammatory actions.
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Pharmacokinetics

Absorption:

Bioavailability: Not quantifiable as a single percentage; varies significantly based on skin integrity, vehicle, presence of inflammation, and use of occlusive dressings. Systemic absorption is generally low but can be significant.
Tmax: Not applicable for topical local effect; systemic absorption Tmax is variable and not well-defined for topical application.
FoodEffect: Not applicable

Distribution:

Vd: Not well-defined for topical application; if systemically absorbed, distributes widely.
ProteinBinding: Not well-defined for topical application; if systemically absorbed, binds to plasma proteins.
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not well-defined for topical application; if systemically absorbed, similar to other corticosteroids (variable, typically hours).
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal (metabolites), some biliary.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for local anti-inflammatory and antipruritic effects.
PeakEffect: Variable, typically within days of consistent application.
DurationOfAction: Variable, depends on frequency of application and individual response.

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 unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

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, 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:

  • Worsening of your skin condition or no improvement after 2 weeks of use.
  • Signs of a skin infection (e.g., pus, spreading redness, fever).
  • Severe burning, itching, or irritation at the application site.
  • Signs of skin thinning or damage (e.g., easy bruising, stretch marks, changes in skin color).
  • Signs of systemic absorption, which are rare but serious, including: unusual weight gain, swelling in your ankles or feet, increased thirst or urination, muscle weakness, or changes in your mood.
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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 as a result of the allergy.
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 whether it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not initiate, discontinue, 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 and do not exceed it without consulting your doctor.

When applying this medication to a large skin area, exercise caution and discuss it 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. Consult your doctor to discuss this potential risk. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will determine if growth monitoring is required.

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

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of using this medication during these situations. If you are 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 can lead to systemic absorption, potentially causing symptoms of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia), adrenal insufficiency upon abrupt withdrawal, and growth retardation in children.

What to Do:

If you suspect an overdose or systemic side effects, contact your doctor or poison control center immediately (Call 1-800-222-1222). Management is supportive and may involve gradual withdrawal of the medication under medical supervision.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for treatment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: If no improvement or worsening after 2 weeks, re-evaluate diagnosis and treatment.

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

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

Action Threshold: If significant adverse effects occur, reduce frequency, switch to lower potency, or discontinue.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusion

Target: Normal HPA axis function, normal blood glucose

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, fasting blood glucose) and consider discontinuation or dose reduction.

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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
  • Unusual weight gain
  • Swelling in ankles/feet
  • Increased thirst/urination (signs of hyperglycemia)
  • Fatigue
  • Weakness

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use 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 with high doses of systemic corticosteroids; topical absorption is generally low but caution advised.
Second Trimester: Similar considerations as first trimester; monitor for fetal growth.
Third Trimester: Similar considerations; potential for HPA axis suppression in the neonate if used extensively near term.
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Lactation

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

Infant Risk: Low risk with limited, short-term use on small areas, but potential for adverse effects if significant systemic absorption occurs in mother or if applied to breast and ingested by infant.
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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 because of a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Not recommended for children under 12 years for some formulations.

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Geriatric Use

No specific dose adjustments are generally needed. However, geriatric patients may have thinner skin, which could increase susceptibility to local adverse effects such as skin atrophy, purpura, and striae. Use with caution and monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% lotion is a high-potency topical corticosteroid. It should be used judiciously and typically for short durations (e.g., 2 weeks) to minimize the risk of local and systemic side effects.
  • Patients should be instructed on the correct application technique: a thin film, gently rubbed in, avoiding excessive amounts or prolonged use.
  • Avoid using this high-potency steroid on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to adverse effects like skin atrophy, telangiectasias, and perioral dermatitis.
  • Abrupt discontinuation after prolonged use on large body surface areas can lead to a rebound flare of the underlying dermatosis. Tapering may be necessary in such cases.
  • Educate patients on signs of local adverse effects (e.g., skin thinning, stretch marks) and systemic absorption (e.g., unusual weight gain, swelling).
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
  • Topical PDE4 inhibitors (e.g., crisaborole) for eczema.
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
  • Emollients and moisturizers for barrier repair and symptom management.
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Cost & Coverage

Average Cost: $20 - $60 per 60ml lotion
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.