Desoximetasone 0.25% Spray 100ml

Manufacturer TARO Active Ingredient Desoximetasone Topical Spray(des oks i MET a sone) Pronunciation des oks i MET a sone
It is used to treat plaque psoriasis.
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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
May 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone is a strong corticosteroid medicine applied to the skin to 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.
Do not apply the medication to the vaginal area.
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.

Important Safety Precautions

This medication is flammable, so avoid using it near an open flame or while smoking.
Do not apply the medication to your face, underarms, or groin area.
Avoid applying the medication to skin that is thinning.

Storage and Disposal

Store the medication at room temperature, protected from heat and open flames.
Discard any unused portion of the medication after 30 days.

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

  • Apply a thin layer to the affected skin areas only, as directed by your doctor.
  • Wash your hands before and after applying the spray.
  • Do not use more than the prescribed amount or for longer than directed.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor.
  • Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor, as this can increase absorption and 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 skin areas twice daily.

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established (increased risk of systemic absorption and HPA axis suppression)
Child: Not established (increased risk of systemic absorption and HPA axis suppression); use with caution and for limited duration if prescribed.
Adolescent: Apply a thin film to the affected skin areas twice daily, with caution and for limited duration.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Desoximetasone is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its anti-inflammatory effects are thought to involve the induction of phospholipase A2 inhibitory proteins, 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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, area, duration of exposure, and use of occlusive dressings); generally low systemic absorption.
Tmax: Not precisely defined for topical application due to variable absorption.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely defined for topical application.
ProteinBinding: Extensively bound to plasma proteins (e.g., albumin, corticosteroid-binding globulin) once absorbed systemically.
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not precisely defined for topical application; systemic half-life of absorbed drug is variable.
Clearance: Not precisely defined for topical application.
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days to weeks of consistent application.
DurationOfAction: Varies with individual and condition; effects persist as long as applied regularly.

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 immediately or seek emergency medical attention:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of adrenal insufficiency (weak adrenal gland): severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Skin changes: acne, stretch marks, slow healing, or 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 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 persist, contact your doctor for guidance:

Local irritation at the application site: burning, itching, dryness, or other discomfort.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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:

  • Severe burning, itching, or irritation at the application site.
  • Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks).
  • New skin infections or worsening of existing ones.
  • Unusual fatigue, weakness, dizziness, or nausea (signs of systemic absorption).
  • Blurred vision or other eye problems (if used near eyes).
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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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any existing health problems or conditions

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this 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 drug 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.

This medication is not approved for use in children, but your doctor may determine that the benefits outweigh the risks in certain cases. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks. If you have questions or concerns about giving this medication to your child, consult with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby. If you are breastfeeding, avoid applying this medication to your chest, and consult with your doctor for guidance.
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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, central obesity, buffalo hump, high blood pressure, diabetes), adrenal suppression, growth retardation in children, and cataracts/glaucoma.

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately (Call 1-800-222-1222). Treatment is symptomatic and supportive; gradual withdrawal of the corticosteroid may be necessary.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: Regularly during therapy, especially with prolonged use or on sensitive areas.

Target: Absence of severe reactions.

Action Threshold: Discontinue use or reduce frequency if severe reactions occur.

Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension)

Frequency: Periodically, especially with extensive use, prolonged therapy, or in pediatric patients.

Target: Normal cortisol levels (if tested).

Action Threshold: Consider ACTH stimulation test if suppression is suspected; taper drug or switch to less potent steroid.

Signs of infection (e.g., redness, pus, fever)

Frequency: Regularly during therapy.

Target: Absence of infection.

Action Threshold: Treat infection appropriately; discontinue steroid if infection worsens.

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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 Cushing's syndrome (e.g., moon face, central obesity, easy bruising)
  • Hyperglycemia
  • Glucosuria

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. High-potency topical corticosteroids should be used sparingly and for limited durations.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption is low.
Second Trimester: Potential for fetal growth restriction or other systemic effects with extensive use.
Third Trimester: Potential for fetal growth restriction or other systemic effects with extensive use.
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Lactation

Use with caution. 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 limited, short-term use; higher risk with extensive or prolonged use due to potential for systemic absorption.
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Pediatric Use

Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use the least potent effective corticosteroid for the shortest duration possible.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could increase the risk of local side effects like skin atrophy.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.25% spray is a high-potency topical corticosteroid; use should be limited to short-term treatment of severe dermatoses.
  • The spray formulation can be useful for hairy areas or large surface areas where creams/ointments are difficult to apply.
  • Patients should be advised on the proper application technique to ensure even coverage and avoid overuse.
  • Educate patients on signs of local skin reactions (e.g., thinning, stretch marks) and systemic absorption (e.g., fatigue, weight gain) and to report them to their healthcare provider.
  • Avoid abrupt discontinuation after prolonged, extensive use to prevent rebound flares or adrenal insufficiency.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for atopic dermatitis
  • Vitamin D analogs (e.g., Calcipotriene) for psoriasis
  • Systemic therapies for severe cases (e.g., biologics, methotrexate, cyclosporine)
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Cost & Coverage

Average Cost: Varies widely, typically $100-$500+ per 100ml spray
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (Brand), Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 happened.