Desoximetasone 0.05% Gel 15gm

Manufacturer TARO Active Ingredient Desoximetasone Cream, Gel, and Ointment(des oks i MET a sone) Pronunciation des-oks-i-MET-a-sone
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Synthetic Adrenocorticosteroid; Anti-inflammatory Agent
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Pregnancy Category
Category C
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FDA Approved
Mar 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone gel is a strong steroid medication 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 inflammatory response in the skin.
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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.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, 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 instructed by your doctor, do not cover the treated area with bandages or dressings.

Storage and Disposal

Store the medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your doctor or pharmacist. If you have questions about disposing of medications, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missed 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 use extra doses.
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Lifestyle & Tips

  • Apply a thin layer of the gel to the affected skin area as directed by your doctor, usually twice a day.
  • Gently rub it in completely.
  • Wash your hands thoroughly before and after applying the gel, unless your hands are the treated area.
  • 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 gel to your eyes, mouth, or inside your nose. If it gets into these areas, rinse thoroughly with water.
  • Do not use this medication for longer than prescribed, especially on the face, groin, or armpits, or in children, as it can cause skin thinning or other side effects.
  • Inform your doctor if your condition does not improve or worsens after a few weeks of treatment.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected areas two times daily.

Condition-Specific Dosing:

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

Neonatal: Not established. Increased risk of systemic absorption and HPA axis suppression.
Infant: Not established. Increased risk of systemic absorption and HPA axis suppression.
Child: Not recommended for children under 10 years for prolonged use or on large body surface areas due to increased risk of systemic absorption and HPA axis suppression. If used, apply sparingly for shortest duration possible.
Adolescent: Apply a thin film to the affected areas two times daily, with caution regarding duration and area of application due to potential for systemic effects.
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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

Desoximetasone is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It is thought to act by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins are believed to 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: Varies (systemic absorption depends on vehicle, integrity of epidermal barrier, use of occlusive dressings, and other factors)
Tmax: Not applicable for topical application (systemic levels are generally low)
FoodEffect: Not applicable

Distribution:

Vd: Not available (primarily local action)
ProteinBinding: Varies (systemic absorption is minimal, but once absorbed, corticosteroids are bound to plasma proteins)
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Not precisely determined for topical application (systemic half-life of absorbed drug is variable)
Clearance: Not precisely determined for topical application
ExcretionRoute: Primarily renal excretion (for systemically absorbed drug)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory and antipruritic effects)
PeakEffect: Days to weeks (with consistent application)
DurationOfAction: Varies (effects persist as long as applied, but prolonged use can lead to tachyphylaxis)

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe stomach upset 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 wound healing
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Thinning of the skin
Changes in vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people experience no side effects or only mild 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, contact your doctor for guidance:

Burning, itching, dryness, or irritation at the application site

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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:

  • Severe burning, itching, or irritation at the application site
  • Worsening of your skin condition
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Unusual hair growth
  • Acne-like breakouts
  • Changes in skin color
  • Any signs of systemic steroid absorption, such as unusual weight gain, swelling in the face (moon face), fatigue, or muscle weakness (rare with proper topical 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.

To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems

Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.

When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

Do not apply this medication to cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and consult with your doctor as needed.

Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.

Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary, so consult with your doctor to monitor growth and development.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

If you are breastfeeding, avoid applying this medication to your chest, and consult with your doctor for guidance on safe use.
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Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use of topical corticosteroids can lead to systemic effects due to significant absorption, including:
  • Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia)
  • Adrenal suppression (HPA axis suppression)
  • Growth retardation in children
  • Intracranial hypertension in children

What to Do:

If overdose is suspected, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management involves gradual withdrawal of the corticosteroid and supportive care for symptoms.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (e.g., erythema, scaling, pruritus)

Rationale: To assess severity of dermatosis and establish baseline for efficacy monitoring.

Timing: Prior to initiation of therapy

Area of involvement

Rationale: To determine appropriate amount of medication needed and assess risk of systemic absorption.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in symptoms)

Frequency: Weekly or as clinically indicated

Target: Improvement in skin condition

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

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

Frequency: At each follow-up visit

Target: Absence of adverse reactions

Action Threshold: Presence of significant adverse reactions may require discontinuation or change in therapy.

Signs of secondary infection

Frequency: At each follow-up visit

Target: Absence of infection

Action Threshold: Presence of infection requires appropriate antimicrobial treatment.

HPA axis suppression (e.g., plasma cortisol levels, ACTH stimulation test)

Frequency: Consider for prolonged use, large surface areas, or occlusive dressings

Target: Normal HPA axis function

Action Threshold: Evidence of suppression requires gradual withdrawal or reduction in potency/frequency.

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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., weight gain, moon face, fatigue, hyperglycemia, blurred vision)

Special Patient Groups

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Pregnancy

Category C. Desoximetasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though systemic absorption from topical use is generally low.
Second Trimester: Use with caution; monitor for potential systemic effects.
Third Trimester: Use with caution; monitor for potential systemic effects.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. If used, avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use, but potential for systemic effects in infant if significant absorption occurs or if applied to breast.
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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 adults because of a larger skin surface area to body weight ratio. Prolonged use or use on large surface areas should be avoided. Not recommended for children under 10 years for prolonged use.

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Geriatric Use

No specific dosage adjustments are necessary. However, geriatric patients may have thinner skin, which could increase susceptibility to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.05% gel is a high-potency topical corticosteroid. Use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • Avoid using on the face, groin, or axillae, or under occlusion, unless specifically directed by a physician, due to increased risk of adverse effects.
  • Patients should be instructed to apply a thin film to the affected areas and rub it in gently and completely.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
  • Be aware of the potential for HPA axis suppression, especially with prolonged use, large surface areas, or occlusive dressings. This risk is higher in children.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe cases
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Cost & Coverage

Average Cost: $50 - $200+ per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (generic often Tier 1 or 2)
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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 occurred.