Desonide 0.05% Gel 60gm

Manufacturer CINTEX Active Ingredient Desonide Cream, Gel, and Ointment(DES oh nide) Pronunciation DES-oh-nide
It is used to treat skin rashes and other skin irritation.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Corticosteroid
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Pregnancy Category
Category C
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FDA Approved
Mar 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desonide gel is a mild corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or dermatitis. It helps calm down the skin's immune response.
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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.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Unless directed by your doctor, do not apply the medication to your face, underarms, or groin area.

Storage and Disposal

Store the medication at room temperature and do not freeze it.
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 way to dispose of medications, and consider participating in drug take-back programs in your area.

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 gel to the affected skin area(s) as directed by your doctor, usually once or 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, dressings, or plastic wrap unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the gel to the eyes, mouth, or inside the nose.
  • Do not use this medication for longer than prescribed or on large areas of the body without consulting your doctor.
  • Do not use on broken or infected skin unless directed by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Apply a thin film to the affected skin areas once or twice daily. Use with caution; increased risk of systemic absorption and HPA axis suppression.
Child: Apply a thin film to the affected skin areas once or twice daily. Use with caution; increased risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas once or twice daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Desonide is a low-potency corticosteroid. It acts by inducing 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. Corticosteroids also possess vasoconstrictive and antipruritic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1%) through intact skin; varies with vehicle, skin integrity, site of application, and occlusion.
Tmax: Not applicable for topical application (systemic levels are generally undetectable or very low).
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not available (minimal systemic absorption).
ProteinBinding: Not available (minimal systemic absorption).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not precisely determined for topical application due to minimal systemic absorption; systemic corticosteroids have half-lives ranging from 18-36 hours.
Clearance: Not precisely determined for topical application.
ExcretionRoute: Renal (primarily) and biliary (once systemically absorbed).
Unchanged: Not significant for topical use.
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Pharmacodynamics

OnsetOfAction: Hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies; effects persist as long as applied, and for some time after discontinuation.

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 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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin irritation
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Change in skin color
Changes in eyesight, eye pain, or severe eye irritation

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Burning or stinging
Dry skin
* Signs of a common cold

This is not an exhaustive list of all 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:

  • Worsening of your skin condition or no improvement after a few days/weeks of use.
  • Signs of a skin infection (e.g., increased redness, swelling, pain, pus, fever).
  • Severe burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, stretch marks, or changes in skin color where the gel is applied.
  • Unusual fatigue, weakness, nausea, vomiting, or dizziness (rare, but can indicate systemic absorption and adrenal suppression, especially with prolonged or 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 allergic reaction you experienced, including any symptoms that occurred.
The presence of an infection at the site where this medication will be applied.
* Any areas of thinning skin where you plan to apply this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other medications and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.

When applying this medication, avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this can increase the amount of medication absorbed into the body. Do not apply this medication to cuts, scrapes, or damaged skin. If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor.

Use this medication only for the duration prescribed by your doctor. Prolonged use can increase the risk of developing cataracts or glaucoma, so it is crucial to monitor your condition and discuss any concerns with your doctor.

When using this medication in children, it is essential to exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication can affect growth in children and teenagers, and regular growth checks may be necessary. Your doctor will need to monitor your child's growth and development.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you. If you are breastfeeding and apply this medication to your breast or nipple, be sure to wash the area thoroughly before nursing your child.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use of topical corticosteroids can lead to systemic effects due to increased absorption, including:
  • Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Adrenal suppression (HPA axis suppression), which can lead to adrenal crisis upon withdrawal (e.g., severe fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately (e.g., call 1-800-222-1222 in the US). Treatment is supportive and may involve gradual withdrawal of the corticosteroid if HPA axis suppression is confirmed.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly to bi-weekly initially, then as needed).

Target: Improvement in dermatological symptoms.

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

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

Frequency: At each follow-up visit.

Target: Absence or minimal local reactions.

Action Threshold: Presence of significant or worsening local reactions may require discontinuation or change in therapy.

Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension) - especially with extensive use, occlusion, or in children

Frequency: Periodically, if risk factors are present (e.g., large surface area treated, prolonged use, occlusion).

Target: Normal HPA axis function.

Action Threshold: Symptoms or signs of HPA axis suppression warrant immediate evaluation (e.g., ACTH stimulation test) and potential discontinuation or tapering of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pus (signs of infection)
  • Severe burning, itching, or irritation at application site
  • Thinning of skin, easy bruising, or stretch marks (striae)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Fatigue, weakness, nausea, vomiting (potential signs of systemic absorption/HPA axis suppression)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption of topical corticosteroids is minimal, but caution is advised, especially with prolonged use or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk with topical use is considered low due to minimal systemic absorption.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid effects; avoid large areas or prolonged use near term.
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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. If used, avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk due to minimal systemic absorption, but monitor infant for any unusual effects.
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Pediatric Use

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

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Geriatric Use

No specific dosage adjustments are typically needed. However, geriatric patients may have thinner skin, which could potentially increase systemic absorption. Monitor for local and systemic side effects.

Clinical Information

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Clinical Pearls

  • Desonide is a low-potency topical corticosteroid, making it suitable for use on sensitive areas like the face, groin, and axillae, or for mild-to-moderate dermatoses.
  • Gel formulations are often preferred for hairy areas or weeping lesions as they are less occlusive and can be cooling.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and avoid excessive use or prolonged application to large areas to minimize systemic absorption.
  • Warn patients against using occlusive dressings unless specifically instructed by a physician, as this significantly increases systemic absorption.
  • Monitor for signs of skin atrophy (thinning, telangiectasias) with long-term use, especially in areas with naturally thinner skin.
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Alternative Therapies

  • Other low-potency topical corticosteroids (e.g., hydrocortisone)
  • Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinolone acetonide) for more severe cases or different body areas.
  • Non-steroidal topical agents for inflammatory skin conditions (e.g., topical calcineurin inhibitors like tacrolimus or pimecrolimus, topical PDE4 inhibitors like crisaborole).
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Cost & Coverage

Average Cost: $30 - $100 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for 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 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.