Desoximetasone 0.25% Ointment 60gm

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
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid
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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 ointment is a strong medicine applied to the skin to reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema or psoriasis. It belongs to a class 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.

Important Usage Guidelines

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

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 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

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

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Use with caution; generally not recommended for children under 10 years of age for prolonged periods or on large body surface areas due to increased risk of systemic absorption and HPA axis suppression. If used, apply once daily for short durations.
Adolescent: Apply a thin film to the affected skin areas twice daily, with caution regarding duration and area of application.
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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. Corticosteroids diffuse across cell membranes and bind to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be responsible for the anti-inflammatory effects. These effects include the induction of phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Desoximetasone also exhibits vasoconstrictive, antipruritic, and immunosuppressive actions.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption through intact skin; increased by inflammation, occlusive dressings, large surface areas, prolonged use, and in pediatric patients.
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not well-defined for topical application.
ProteinBinding: Not well-defined for topical application; systemically absorbed corticosteroids are extensively bound to plasma proteins.
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not well-defined for topical application.
Clearance: Not well-defined for topical application.
ExcretionRoute: Systemically absorbed corticosteroids are excreted primarily by the kidneys, and also in the bile.
Unchanged: Not well-defined for topical application.
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Pharmacodynamics

OnsetOfAction: Anti-inflammatory and antipruritic effects typically observed within hours to days of initiation.
PeakEffect: Peak therapeutic effect usually within several days to a week of consistent application.
DurationOfAction: Effects persist as long as the medication is applied; duration of effect after discontinuation varies.

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

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 for advice:

Burning, itching, dryness, or other irritation at the site 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 redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that was not present before
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Acne-like breakouts or increased hair growth where the ointment is applied
  • Any signs of systemic side effects like unusual weight gain, swelling in the face, increased thirst or urination, or unusual 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 as a result of the allergy.
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 between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change 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 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.

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 side effects due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
  • Symptoms of HPA axis suppression may include fatigue, weakness, nausea, vomiting, low blood pressure, and dizziness.

What to Do:

If systemic symptoms of overdose occur, contact your doctor or emergency services immediately. Management is supportive and may involve gradual withdrawal of the corticosteroid under medical supervision. For accidental ingestion, contact a poison control center (1-800-222-1222) or seek emergency medical attention.

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 damage or infection.

Timing: Prior to initiation of therapy.

Patient history (allergies, systemic conditions)

Rationale: To identify contraindications or risk factors for adverse effects (e.g., diabetes, Cushing's syndrome).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

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

Target: Improvement in symptoms and appearance of affected skin.

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

Local skin reactions (atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

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

Target: Absence of adverse skin reactions.

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

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

Frequency: Periodically, especially with prolonged use, large surface areas, occlusive dressings, or in pediatric patients. Consider morning cortisol levels or ACTH stimulation test if suspicion is high.

Target: Normal HPA axis function, normal blood glucose.

Action Threshold: Abnormal findings require immediate medical attention and discontinuation of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Development of new skin lesions (e.g., acne, folliculitis)
  • Skin thinning, bruising, or striae
  • Increased hair growth at application site
  • Signs of infection (redness, pus, fever)
  • Increased thirst or urination (potential hyperglycemia)
  • Unusual fatigue or weakness (potential HPA axis suppression)
  • Moon face, buffalo hump, central obesity (signs of Cushing's syndrome)

Special Patient Groups

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Pregnancy

Desoximetasone is Pregnancy Category C. Animal studies have shown corticosteroids to be teratogenic. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity based on animal studies; human data limited.
Second Trimester: Potential for fetal growth restriction or other systemic effects with prolonged or high-dose use; human data limited.
Third Trimester: Potential for fetal growth restriction or other systemic effects with prolonged or high-dose use; human data limited.
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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. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when desoximetasone is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate 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 patients due to a larger skin surface area to body weight ratio. Use in children under 10 years of age is generally not recommended for prolonged periods or on large body surface areas. If used, limit duration and frequency of application. Monitor for signs of systemic toxicity and growth retardation.

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Geriatric Use

Clinical studies of desoximetasone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin, increasing susceptibility to local adverse effects like atrophy.

Clinical Information

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Clinical Pearls

  • Desoximetasone 0.25% ointment is a high-potency topical corticosteroid. Use it judiciously and for the shortest duration possible to achieve therapeutic effect.
  • Avoid prolonged use on the face, groin, axillae, or under occlusive dressings due to increased risk of local and systemic side effects.
  • Educate patients on proper application technique: apply a thin film, do not rub excessively, and wash hands after application.
  • Monitor for signs of skin atrophy (thinning, bruising, telangiectasias) and HPA axis suppression, especially in children or with extensive use.
  • Consider step-down therapy to a lower potency corticosteroid or non-steroidal agent once the acute inflammation is controlled.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., clobetasol propionate, halobetasol propionate, fluocinonide)
  • Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, mometasone furoate)
  • Low-potency topical corticosteroids (e.g., hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
  • Emollients and moisturizers for barrier repair
  • Systemic therapies for severe dermatoses (e.g., methotrexate, biologics, oral corticosteroids)
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 for generic, Tier 3 or 4 for brand, depending on insurance plan.
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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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.