Desoximetasone 0.05% Gel 60gm

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
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1990
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone gel is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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 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 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 pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

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 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

  • 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 dressings unless specifically told to do so by your doctor, as this can increase absorption and side effects.
  • Avoid applying the gel to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
  • Do not use this medication for longer than prescribed, especially on children, as prolonged use can lead to serious side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected areas twice daily.
eczema: Apply a thin film to the affected areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Dosing not well established; use with caution due to increased systemic absorption risk. Limit duration and amount.
Child: Apply a thin film to the affected areas twice daily, but use with caution and for the shortest duration possible due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected areas twice daily.
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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

Desoximetasone is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism involves binding to glucocorticoid receptors in the cytoplasm, leading to the formation of a steroid-receptor complex. This complex translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines).
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Pharmacokinetics

Absorption:

Bioavailability: Varies (systemic absorption is generally low but can increase with inflamed skin, occlusive dressings, or prolonged use)
Tmax: Not precisely defined for topical systemic absorption, local effect is rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical systemic absorption.
ProteinBinding: High (for systemically absorbed portion, similar to other corticosteroids)
CnssPenetration: Limited (minimal systemic absorption from topical application)

Elimination:

HalfLife: Not precisely defined for topical systemic absorption.
Clearance: Not precisely quantified for topical systemic absorption.
ExcretionRoute: Renal (primarily, for systemically absorbed portion)
Unchanged: Not precisely quantified for topical systemic absorption.
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Pharmacodynamics

OnsetOfAction: Within hours (local anti-inflammatory effect)
PeakEffect: Days to weeks (for full therapeutic effect)
DurationOfAction: Varies (depends on application frequency and skin condition)

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
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, itching, dryness, or other irritation where the medication was applied

Reporting Side Effects

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:

  • Increased irritation, burning, itching, or redness at the application site
  • Development of new skin problems like acne, folliculitis (hair follicle inflammation), or skin thinning
  • Signs of infection (e.g., pus, fever, worsening pain)
  • Unusual weight gain, swelling in the face or ankles, increased thirst or urination (signs of systemic absorption, especially in children or with extensive 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 symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 discuss any concerns with your doctor.

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 some cases, this medication may affect growth in children and teenagers. 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. Instead, consult with your doctor for guidance on safe use.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects of corticosteroids, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising)
  • Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

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 treatment efficacy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response of dermatosis

Frequency: Regularly, as determined by physician (e.g., weekly to bi-weekly initially, then as needed)

Target: Improvement in signs and symptoms (e.g., reduced inflammation, itching)

Action Threshold: Lack of improvement or worsening of condition may require re-evaluation of diagnosis or treatment.

Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit

Target: Absence of or minimal local side effects

Action Threshold: Presence of significant local adverse effects may require reduction in frequency, change in potency, or discontinuation.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings

Target: Absence of systemic effects

Action Threshold: Presence of systemic effects requires immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • New or increased redness, burning, itching, or stinging at application site
  • Development of skin thinning, stretch marks, or spider veins
  • Signs of infection (e.g., pus, fever)
  • Unusual fatigue, weight gain, swelling (signs of systemic absorption)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of potent corticosteroids, though systemic absorption from topical use is generally low.
Second Trimester: Risk generally considered low with appropriate topical use.
Third Trimester: Risk generally considered low with appropriate topical use.
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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. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use; however, potential for growth suppression or other adverse effects if significant systemic absorption occurs in the infant via breast milk or direct skin contact.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult patients due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.05% gel is a high-potency topical corticosteroid. Use it judiciously and for the shortest duration necessary to control symptoms.
  • The gel formulation may be preferred for hairy areas or weeping lesions due to its non-greasy nature.
  • Educate patients on the proper application technique: a thin film, gently rubbed in, and avoiding excessive amounts.
  • Warn patients about potential local side effects like skin atrophy, striae, and telangiectasias, especially with prolonged use or on sensitive areas.
  • Always consider the risk of HPA axis suppression, particularly in pediatric patients or when applying to large body surface areas or under occlusion.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids (e.g., tazarotene) for psoriasis
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe cases
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Cost & Coverage

Average Cost: $50 - $200 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for brand), Tier 1 (for 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, including the amount and time of ingestion.