Desoximetasone 0.05% Ointment 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
Corticosteroid, Topical
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Pharmacologic Class
Adrenocorticoid
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Pregnancy Category
Category C
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FDA Approved
Sep 1977
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone ointment is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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 precisely. Continue using the medication as directed, 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. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.

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 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 to do so by your doctor, do not cover the treated area with bandages or dressings.

Storing and Disposing of Your Medication

Store the medication at room temperature, away from direct sunlight and heat sources. Keep all medications in a safe and secure location, 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 way to dispose of medications, and consider participating in local drug take-back programs.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled 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 one.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Do not use more than prescribed or for longer than recommended.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
  • Do not cover the treated area with bandages or other occlusive dressings unless directed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • 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 two times daily.

Condition-Specific Dosing:

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

Neonatal: Not established (use with extreme caution due to higher risk of systemic absorption and HPA axis suppression)
Infant: Not established (use with extreme caution due to higher risk of systemic absorption and HPA axis suppression)
Child: Apply a thin film to the affected skin areas two times daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid use on large surface areas or under occlusive dressings. Monitor for signs of systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome).
Adolescent: Apply a thin film to the affected skin areas two times daily.
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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. Its primary mechanism of action involves binding to glucocorticoid receptors in the cytoplasm of target cells. This complex then translocates to the nucleus, where it modulates gene expression by activating or repressing the transcription of specific genes. This leads to the inhibition of phospholipase A2, thereby preventing the release of arachidonic acid and the subsequent formation of inflammatory mediators such as prostaglandins and leukotrienes. It also suppresses the migration of neutrophils and macrophages to the site of inflammation, reverses capillary permeability, and inhibits the release of lysosomal enzymes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, vehicle, site, duration, and use of occlusive dressings; generally low systemic absorption)
Tmax: Not precisely quantifiable for topical systemic absorption; local effect is rapid.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Extensive (for systemically absorbed portion, similar to other corticosteroids)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not precisely quantifiable for topical systemic absorption; for systemically absorbed corticosteroids, half-lives vary.
Clearance: Not precisely quantifiable for topical systemic absorption.
ExcretionRoute: Primarily renal (for systemically absorbed portion), some biliary.
Unchanged: Minimal (for systemically absorbed portion)
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Pharmacodynamics

OnsetOfAction: Within hours (local anti-inflammatory effect)
PeakEffect: Within days to a week (maximal therapeutic effect)
DurationOfAction: Varies with application frequency; local effects persist for several hours after application.

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
+ 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

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

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

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
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or folliculitis (inflammation of hair follicles)
  • Changes in skin color (lightening or darkening)
  • Signs of skin infection (pus, fever, spreading redness)
  • Unusual hair growth
  • Any signs of systemic side effects like unexplained weight gain, swelling in the face, or unusual fatigue (especially in children)
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. 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 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 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 benefits and risks of using this medication 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 absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, buffalo hump, skin thinning, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar, and growth retardation in children.
  • Acute overdose is unlikely due to topical administration.

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., skin infections).

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response of dermatosis

Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially, then as needed)

Target: Improvement in erythema, pruritus, scaling, and induration.

Action Threshold: Lack of improvement, worsening of condition, or development of adverse effects warrants re-evaluation of therapy.

Signs of local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypopigmentation)

Frequency: At each follow-up visit and patient self-monitoring

Target: Absence of adverse reactions.

Action Threshold: Presence of significant local adverse reactions requires discontinuation or reduction in frequency/potency.

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

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

Target: Normal HPA axis function (e.g., normal morning cortisol levels, normal ACTH stimulation test).

Action Threshold: Suspicion of systemic absorption warrants laboratory testing (e.g., ACTH stimulation test, plasma cortisol) and potential discontinuation or reduction of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, itching, burning, or stinging at application site
  • Development of new skin lesions (e.g., acne, folliculitis)
  • Thinning of skin, easy bruising, stretch marks (striae)
  • Changes in skin color (hypopigmentation)
  • Unusual hair growth
  • Signs of infection (pus, fever)
  • Symptoms of systemic corticosteroid excess (e.g., weight gain, moon face, fatigue, muscle weakness, mood changes, increased thirst/urination)

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. 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: Potential for fetal growth restriction or other adverse effects with high systemic exposure.
Third Trimester: Potential for fetal growth restriction or other adverse effects with high systemic exposure. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be observed for signs of hypoadrenalism.
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Lactation

Caution should be exercised when desoximetasone is administered to a nursing woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. L3 (Moderately Safe).

Infant Risk: Low risk with limited topical use. Avoid applying to the breast area to prevent direct infant exposure.
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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. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor for growth retardation and other systemic effects.

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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 potentially increase systemic absorption or local adverse effects. Use with caution and monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.05% ointment is a high-potency topical corticosteroid. It should be used for short durations (typically 2-4 weeks) to avoid local and systemic side effects.
  • The ointment formulation is generally more potent and occlusive than creams or gels, making it suitable for dry, scaly, or lichenified lesions.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas, as this can lead to rebound flares. Tapering the frequency of application may be necessary.
  • Educate patients on proper application technique: apply a very thin layer, rub in gently, and wash hands thoroughly.
  • Be vigilant for signs of skin atrophy (thinning, bruising, telangiectasias) especially on the face, intertriginous areas, and in children.
  • Consider alternative therapies or lower potency corticosteroids for maintenance therapy or for use on sensitive skin areas.
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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 steroid-sparing therapy, especially on face/intertriginous areas.
  • Vitamin D analogs (e.g., Calcipotriene) for psoriasis.
  • Emollients and moisturizers for barrier repair and symptom relief.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions.
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Cost & Coverage

Average Cost: Varies widely, typically $100 - $500+ per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for generic), Tier 3 or 4 (for brand)
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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 safe use, 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.