Betamethasone Dip 0.05% Crm 45gm

Manufacturer TARO Active Ingredient Betamethasone Cream, Gel, and Ointment(bay ta METH a sone) Pronunciation bay ta METH a sone dye PROH 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
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 dipropionate cream is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the body's immune 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

Do not take this medication by mouth. It is for use on your skin only.
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.
Wash your hands before and after applying the medication. If your hand is the treated area, do not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.

Storing and Disposing of Your Medication

Store the medication at room temperature and do not freeze it.
Protect the medication from light.
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.
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 extra doses.
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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 cream than prescribed or apply it more often than directed.
  • Do not cover the treated area with bandages or other 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.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for longer than prescribed, typically no more than 2 weeks for adults, especially on the face or in skin folds.
  • 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.

Condition-Specific Dosing:

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

Neonatal: Not established (generally not recommended due to increased systemic absorption risk).
Infant: Not established (generally not recommended due to increased systemic absorption risk).
Child: Apply a thin film to the affected skin areas once daily. Use with caution and for the shortest duration possible. Avoid use on large body surface areas or under occlusive dressings. Not recommended for children under 12 years of age for certain indications.
Adolescent: Apply a thin film to the affected skin areas once or twice daily. Use with caution and for the shortest duration possible.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).
Dialysis: No specific considerations (minimal systemic absorption).

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).

Pharmacology

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Mechanism of Action

Betamethasone dipropionate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids diffuse across cell membranes and bind to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of mRNA and subsequent protein synthesis of various enzymes that are responsible for the anti-inflammatory effects. This includes the induction of lipocortins, which inhibit phospholipase A2, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (minimal systemic absorption; depends on vehicle, skin integrity, application site, duration, and occlusion).
Tmax: Not clinically relevant for topical application.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not clinically relevant for topical application.
ProteinBinding: Variable (if absorbed systemically, binds to plasma proteins).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not clinically relevant for topical application (systemic half-life of betamethasone is approximately 5-6 hours).
Clearance: Not clinically relevant for topical application.
ExcretionRoute: Renal (if absorbed systemically).
Unchanged: Not significant for topical use.
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Pharmacodynamics

OnsetOfAction: Within hours to days (local effect).
PeakEffect: Within days to weeks of consistent application.
DurationOfAction: Varies with individual and condition, generally maintains effect with once or twice daily application.

Safety & Warnings

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Side Effects

Urgent 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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual 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 skin condition or new skin problems (e.g., severe burning, itching, redness, pus, signs of infection)
  • Skin thinning, easy bruising, or stretch marks developing in the treated area
  • Unusual weight gain, swelling in the face, or increased fatigue (signs of too much medicine absorbed into the body)
  • Blurred vision or other vision problems (rare, but possible with long-term 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 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 conjunction with your other treatments and health issues. 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 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, 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, consult your doctor to discuss this potential risk. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to determine the best course of action.

When administering this medication to a child, use it with caution, as the risk of certain side effects may be higher in children. Note that 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, 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.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use of topical corticosteroids can lead to systemic effects, including adrenal suppression (Cushing's syndrome), hyperglycemia, and glucosuria.
  • Symptoms may include: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, and elevated blood sugar.

What to Do:

If you suspect an overdose or systemic side effects, contact your doctor or poison control center immediately (1-800-222-1222). Treatment involves gradual withdrawal of the corticosteroid under medical supervision and symptomatic management.

Drug Interactions

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Contraindicated Interactions

  • None (for topical application due to minimal systemic absorption)
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Major Interactions

  • None (for topical application due to minimal systemic absorption)
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Moderate Interactions

  • None (for topical application due to minimal systemic absorption)
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Minor Interactions

  • None (for topical application due to minimal systemic absorption)

Monitoring

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Baseline Monitoring

Skin condition (e.g., inflammation, erythema, pruritus, lesions)

Rationale: To assess the severity of the dermatosis and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Local skin reactions (e.g., burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria)

Frequency: Regularly during treatment, especially during initial weeks and with prolonged use.

Target: Absence or reduction of adverse effects.

Action Threshold: If severe or persistent, discontinue use and re-evaluate.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings, particularly in children.

Target: Normal endocrine function.

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol levels, urinary free cortisol) and discontinue drug gradually.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Thinning of the skin (atrophy)
  • Stretch marks (striae)
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts
  • Increased hair growth at application site
  • Signs of infection (pus, fever, worsening pain)
  • Unusual fatigue or weakness (potential systemic absorption)
  • Weight gain, moon face, buffalo hump (potential systemic absorption)

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 areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid effects; potential for low birth weight with prolonged, high-dose systemic use.
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Lactation

Caution is advised. 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 proper use (minimal systemic absorption), but monitor infant for potential adverse effects if used on large areas or for prolonged periods.
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Pediatric Use

Children 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) than adult patients. Use the least potent corticosteroid for the shortest duration possible. Not recommended for children under 12 years of age for certain indications.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local side effects like skin atrophy or purpura. Monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Betamethasone dipropionate 0.05% cream is a high-potency topical corticosteroid; use it judiciously to avoid local and systemic side effects.
  • Limit treatment duration, especially on the face, intertriginous areas, and in children, typically to no more than 2 weeks.
  • Educate patients on proper application technique: thin film, gentle rubbing, and avoiding occlusive dressings unless specifically instructed.
  • Warn patients about potential skin atrophy, striae, and telangiectasias with prolonged use, especially in sensitive areas.
  • Consider step-down therapy to a lower potency corticosteroid or non-steroidal options once acute inflammation is controlled.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • 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
  • Topical retinoids (e.g., tazarotene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube (generic)
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 is 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.