Desoximetasone 0.25% Ointment 15gm

Manufacturer PERRIGO PHARMACEUTICALS 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
Adrenocorticoids
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Pregnancy Category
Category C
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FDA Approved
Aug 1978
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone 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

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 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.

Important Application Instructions

Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.

Storing and Disposing of Your Medication

Store the medication at room temperature, away from children and pets. Properly dispose of unused or expired medication. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of your medication, and consider participating in a drug take-back program in your area.

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 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 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 tight dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use on open wounds, broken skin, or infections unless directed by a doctor.
  • Keep out of reach of children.

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

Neonatal: Not established. Use with caution due to increased systemic absorption and risk of HPA axis suppression.
Infant: Not established. Use with caution due to increased systemic absorption and risk of HPA axis suppression.
Child: Apply a thin film to the affected skin areas once or twice daily, for short periods and limited areas. Not recommended for children under 10 years of age for long-term use or extensive areas due to increased risk of systemic effects.
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 for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use, as systemic absorption is minimal.

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 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 synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines, histamine), thereby reducing inflammation, edema, and pruritus.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, vehicle, duration of exposure, and use of occlusive dressings). Systemic absorption can occur, especially with prolonged use, large surface areas, or compromised skin barrier.
Tmax: Not typically defined for topical application; systemic levels are generally low.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not specifically quantified for topical application; systemically absorbed drug distributes widely.
ProteinBinding: Approximately 90% (for systemically absorbed corticosteroids).
CnssPenetration: Limited for topical application; systemic absorption can lead to some CNS penetration.

Elimination:

HalfLife: Not precisely defined for topical application; systemic half-life of corticosteroids varies.
Clearance: Not precisely defined for topical application.
ExcretionRoute: Primarily renal excretion (for systemically absorbed drug).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Variable, often within days to weeks of consistent application.
DurationOfAction: Effects persist as long as applied; local effects can last for hours after application.

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, 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 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, contact your doctor for advice:

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

This is not an exhaustive list of potential side effects. If you have questions or concerns, 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:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that was not present before
  • Thinning of the skin, easy bruising, or stretch marks
  • Acne-like rash
  • Increased hair growth in treated areas
  • Changes in skin color
  • Blurred vision or other eye problems
  • Unusual weight gain, especially in the face or trunk
  • Muscle weakness or fatigue
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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. This information will help your doctor and pharmacist assess potential interactions.
* Any existing health problems, as this medication may interact with them.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dose 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 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 effects such as Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

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 assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or atrophy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy of treatment (reduction in inflammation, pruritus)

Frequency: Regularly during treatment, typically at follow-up visits (e.g., weekly to monthly depending on severity).

Target: Improvement in symptoms and skin appearance.

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, folliculitis, perioral dermatitis)

Frequency: At each follow-up visit, especially with prolonged use.

Target: Absence of or minimal adverse effects.

Action Threshold: Presence of significant adverse effects warrants reduction in frequency, discontinuation, or change to a less potent corticosteroid.

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

Frequency: Periodically, especially with extensive use, prolonged therapy, or in pediatric patients. Consider morning cortisol levels if HPA axis suppression is suspected.

Target: Normal physiological function.

Action Threshold: Abnormal findings require immediate medical attention and discontinuation/tapering of the drug.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, increased pain)
  • Thinning of skin
  • Easy bruising
  • Stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Changes in vision (e.g., blurred vision, glaucoma, cataracts)
  • Unusual fatigue or weakness
  • Weight gain (especially in trunk)
  • Moon face
  • Swelling in ankles/feet

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. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low but caution is advised.
Second Trimester: Risk of fetal growth restriction or HPA axis suppression with extensive or prolonged use.
Third Trimester: Risk of fetal growth restriction or HPA axis suppression with extensive or prolonged use.
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Lactation

Use with caution. It is not known whether topical desoximetasone is excreted in human milk. Systemic corticosteroids are excreted in breast milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for desoximetasone and any potential adverse effects on the breastfed infant from desoximetasone or from the underlying maternal condition. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: L3 - Moderate concern. Potential for systemic effects in the infant if significant maternal absorption occurs or if applied to areas where infant can ingest.
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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 patients because of a larger skin surface area to body weight ratio. Use the least potent effective corticosteroid for the shortest duration possible. Not recommended for children under 10 years of age for long-term use or extensive areas.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption and susceptibility to local adverse effects (e.g., skin atrophy, purpura). Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.25% ointment is a high-potency topical corticosteroid. It should be used for short-term treatment of severe dermatoses.
  • The ointment formulation is generally preferred for dry, scaly, or lichenified lesions due to its emollient properties.
  • Avoid abrupt discontinuation after prolonged use on extensive areas, as this can lead to rebound flares of the underlying skin condition.
  • Educate patients on the 'less is more' principle: a thin film is sufficient; excessive application does not improve efficacy but increases risk of side effects.
  • Warn patients about potential for skin atrophy, striae, and telangiectasias with prolonged use, especially in intertriginous areas or on the face.
  • Consider step-down therapy to a lower potency corticosteroid or intermittent use once control is achieved to minimize side effects.
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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
  • Vitamin D analogs (e.g., Calcipotriene) for psoriasis
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread disease
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Cost & Coverage

Average Cost: $50 - $150 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic), Tier 3 (Brand)
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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 for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.