Betamethasone Dip Aug 0.05% Gel15gm

Manufacturer TARO Active Ingredient Betamethasone Cream, Gel, and Ointment(bay ta METH a sone) Pronunciation bay ta METH a sone
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.
đŸˇī¸
Drug Class
Topical Corticosteroid
đŸ§Ŧ
Pharmacologic Class
Corticosteroid, Synthetic; Glucocorticoid
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Betamethasone Dipropionate Augmented 0.05% Gel is a strong corticosteroid medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It works by calming down the immune response in the skin.
📋

How to Use This Medicine

Using Your Medication Correctly

To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, 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 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 applying the medication. Clean the affected area before applying the medication and make sure it is completely dry. Then, 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 place, out of the reach of children and pets.

What to Do If You Miss a Dose

If you forget to apply a dose of your medication, put it on 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.
💡

Lifestyle & Tips

  • Apply a thin layer to the affected skin area(s) as directed by your doctor, usually once or twice a day.
  • Rub in gently until the gel disappears.
  • Wash your hands before and after applying the gel, unless your hands are the treated area.
  • Do not use more than the prescribed amount or for longer than recommended (typically 2 weeks), as this can increase side effects.
  • Do not cover the treated area with bandages or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor.
  • Do not use for diaper rash.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily. Treatment should be limited to 2 weeks, and the total dosage should not exceed 50 g per week.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Re-evaluate if no improvement.
eczema: Apply a thin film to the affected skin areas once or twice daily for up to 2 weeks. Re-evaluate if no improvement.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use generally not recommended due to increased risk of systemic absorption and HPA axis suppression)
Infant: Not established (use generally not recommended due to increased risk of systemic absorption and HPA axis suppression)
Child: Use with caution and for the shortest duration possible. Limit to small areas. Not recommended for children under 12 years of age. Increased risk of systemic absorption and HPA axis suppression.
Adolescent: Use with caution and for the shortest duration possible. Limit to small areas. Increased risk of systemic absorption and HPA axis suppression.
âš•ī¸

Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

Mechanism of Action

Betamethasone dipropionate is a synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1-5%), but can increase significantly with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier.
Tmax: Not well-defined for topical application; local concentration peaks rapidly.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not well-defined for topical application; primarily local distribution.
ProteinBinding: Approximately 64% (for systemically absorbed betamethasone)
CnssPenetration: Limited (for systemically absorbed betamethasone); not relevant for topical use.

Elimination:

HalfLife: Approximately 5 hours (for systemically absorbed betamethasone)
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal, with some biliary excretion (if systemically absorbed).
Unchanged: Minimal (if systemically absorbed).
âąī¸

Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days to 1-2 weeks of consistent application.
DurationOfAction: Effects persist as long as applied; local effects can last for hours after application.

Safety & Warnings

âš ī¸

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. 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 attention 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Increased redness, burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area.
  • Development of new skin infections (e.g., pus-filled bumps, worsening redness).
  • Acne-like breakouts or increased hair growth in the treated area.
  • Unusual fatigue, weight gain, or swelling in the face (rare, but can indicate systemic absorption).
📋

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 (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 medications and health issues.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor.
âš ī¸

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, this medication is not intended for treating diaper rash or redness, and it is crucial to avoid applying it to the diaper area to prevent any adverse effects.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Therefore, it is vital to discuss this potential risk with your doctor. Furthermore, in some cases, this medication may affect growth in children and teenagers, making regular growth checks necessary. Your doctor will help determine the best course of action.

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

If you are pregnant, planning 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. If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent any potential harm to your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic side effects due to absorption, including Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia (high blood sugar), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to adrenal insufficiency upon withdrawal).
  • Local symptoms include severe skin atrophy, striae, and telangiectasias.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. If acute HPA axis suppression is suspected, appropriate tests (e.g., ACTH stimulation test) should be performed. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • None known for topical application due to minimal systemic absorption.
🔴

Major Interactions

  • None known for topical application due to minimal systemic absorption.
🟡

Moderate Interactions

  • None known for topical application due to minimal systemic absorption.
đŸŸĸ

Minor Interactions

  • None known for topical application due to minimal systemic absorption.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition assessment

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

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching)

Frequency: At each follow-up visit (e.g., 1-2 weeks after initiation)

Target: Absence or minimal reactions

Action Threshold: If severe or persistent reactions occur, discontinue use or reduce frequency.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.

Target: Normal adrenal function, normal glucose levels

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol, blood glucose).

đŸ‘ī¸

Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site
  • Development of new skin lesions (e.g., folliculitis, acneiform eruptions)
  • Skin thinning, bruising, or striae
  • Unusual fatigue, weight gain, or changes in mood (rare, indicative of systemic absorption)

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but high doses or prolonged use on large surface areas could lead to systemic effects.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure, but unlikely with appropriate topical use.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of HPA axis suppression in the neonate if used extensively by the mother near term.
🤱

Lactation

L3 (Moderately Safe). Use with caution. It is not known whether topically administered corticosteroids are 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 of adverse effects to the infant with appropriate use due to minimal systemic absorption. Monitor for signs of systemic effects in the infant if mother uses extensively.
đŸ‘ļ

Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the least potent corticosteroid for the shortest duration possible. Not recommended for children under 12 years of age. Monitor for HPA axis suppression, Cushing's syndrome, and growth retardation.

👴

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 and purpura. Monitor for skin integrity.

Clinical Information

💎

Clinical Pearls

  • Betamethasone Dipropionate Augmented 0.05% Gel is a super-potent topical corticosteroid. Use it sparingly and for short durations (typically no more than 2 weeks) to minimize the risk of local and systemic side effects.
  • The 'augmented' formulation significantly increases the potency compared to standard betamethasone dipropionate.
  • Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to corticosteroid-induced side effects.
  • Occlusive dressings (e.g., bandages, plastic wrap) should generally be avoided unless specifically instructed by a physician, as they can significantly increase systemic absorption.
  • Patients should be educated on the signs of skin atrophy (thinning, bruising, striae) and HPA axis suppression, especially with prolonged or extensive use.
🔄

Alternative Therapies

  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for eczema
  • Vitamin D analogs (e.g., Calcipotriene) for psoriasis
  • Topical retinoids for certain dermatoses
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions
💰

Cost & Coverage

Average Cost: $20 - $60 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
📚

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 information about the medication taken, the amount, and the time it happened.