Tridesilon 0.05% Ointment 60gm

Manufacturer BAYER 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; Anti-inflammatory
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Pregnancy 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?

Desonide ointment is a mild corticosteroid medicine applied to the skin to reduce redness, itching, and swelling 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 local drug take-back programs.

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

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer of the ointment to the affected skin area, gently rubbing it in until it disappears.
  • Do not use more than directed or for longer than prescribed.
  • Avoid applying the ointment to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid getting the ointment in your eyes, nose, or mouth. If it gets into your eyes, 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 two to three times daily.

Condition-Specific Dosing:

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

Neonatal: Not established (generally not recommended for infants under 3 months due to increased systemic absorption risk).
Infant: Not established (generally not recommended for infants under 3 months due to increased systemic absorption risk). For older infants, use with caution, limit duration and area of application.
Child: Apply a thin film to the affected skin areas two to three times daily. Use with caution, limit duration and area of application due to higher surface area to body weight ratio and potential for increased systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas two to three times daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment typically needed for topical use due to minimal systemic absorption.
Moderate: No adjustment typically needed for topical use due to minimal systemic absorption.
Severe: No adjustment typically needed for topical use due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Desonide is a low-potency synthetic corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, collectively called 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. Desonide also possesses anti-inflammatory, antipruritic, and vasoconstrictive properties.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption through intact skin; varies depending on the integrity of the epidermal barrier, vehicle, and use of occlusive dressings. Absorption is increased by inflammation, skin damage, and prolonged use.
Tmax: Not applicable for topical application with minimal systemic absorption.
FoodEffect: Not applicable for topical application.

Distribution:

Vd: Not precisely quantified for topical use due to minimal systemic absorption. Systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding: Not precisely quantified for topical use. Systemically absorbed corticosteroids are bound to plasma proteins.
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Not precisely quantified for topical use due to minimal systemic absorption. Systemically absorbed corticosteroids are primarily eliminated renally.
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Primarily renal for systemically absorbed drug; minimal systemic absorption.
Unchanged: Not precisely quantified for topical use.
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Pharmacodynamics

OnsetOfAction: Within hours for initial anti-inflammatory and antipruritic effects.
PeakEffect: Days for maximal therapeutic effect, depending on the condition and severity.
DurationOfAction: Varies with application frequency and individual response; effects typically last until next 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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

Burning or stinging
Dry skin
* Signs of a common cold

Reporting Side Effects

This is not a complete 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 the skin condition or no improvement after a few days/weeks of use.
  • Signs of a new skin infection (e.g., pus, spreading redness, fever).
  • Severe burning, itching, or irritation at the application site.
  • Thinning of the skin, easy bruising, stretch marks (striae), or changes in skin color where the ointment is applied.
  • Unusual hair growth.
  • Acne-like breakouts.
  • If used extensively or for prolonged periods, watch for signs of systemic absorption, especially in children: unexplained weight gain, 'moon face', fatigue, muscle weakness, or delayed growth.
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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 conjunction with your other treatments 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. Do not exceed the recommended treatment period. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

When using this medication in children, 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. Consult with your doctor to discuss the potential risks and benefits.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of using this medication for both you and your baby. 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:

  • Acute overdose with topical desonide is unlikely due to minimal systemic absorption.
  • Chronic overdose or prolonged, extensive use can lead to systemic effects of hypercorticism (Cushing's syndrome) and suppression of the hypothalamic-pituitary-adrenal (HPA) axis, characterized by symptoms such as: weight gain (especially in the face and trunk), 'moon face', buffalo hump, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, and hyperglycemia.

What to Do:

If systemic effects are suspected due to prolonged or extensive use, consult a healthcare professional immediately. Management involves gradual withdrawal of the drug, reduction in frequency of application, or substitution with a less potent corticosteroid. Symptomatic and supportive care may be necessary. For accidental ingestion, call a poison control center (e.g., 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, identify areas of involvement, and rule out contraindications (e.g., fungal/bacterial infections).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy of treatment (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 of symptoms may indicate need for re-evaluation, change in therapy, or diagnosis.

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

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

Target: Absence of new or worsening local adverse effects.

Action Threshold: Development of significant local adverse effects warrants reduction in frequency, discontinuation, or change to a different therapy.

Signs of secondary infection

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

Target: Absence of signs of bacterial, fungal, or viral infection.

Action Threshold: Presence of infection requires appropriate antimicrobial treatment or discontinuation of desonide.

Hypothalamic-Pituitary-Adrenal (HPA) axis suppression (e.g., plasma cortisol levels, ACTH stimulation test)

Frequency: Consider for patients on prolonged, extensive, or occlusive therapy, especially in children.

Target: Normal HPA axis function.

Action Threshold: Evidence of HPA axis suppression requires gradual withdrawal of the drug, reduction in frequency, or change to a less potent steroid.

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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
  • Systemic effects (rare with proper use): weight gain, moon face, fatigue, weakness, mood changes (signs of Cushing's syndrome or HPA axis suppression)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Desonide should be used 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 can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though risk with topical use is low due to minimal systemic absorption. Use only if clearly needed.
Second Trimester: Generally considered safer than first trimester, but still use with caution and limit duration/area.
Third Trimester: No specific risks identified beyond general corticosteroid concerns. Avoid large areas or prolonged use near term.
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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. Systemically administered corticosteroids are excreted into breast milk. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.

Infant Risk: Low risk with limited, short-term use. Avoid applying to the breast area to prevent direct infant ingestion or 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 patients due to a larger skin surface area to body weight ratio. Use with caution, limit duration of therapy, and avoid occlusive dressings. Not recommended for infants under 3 months of age.

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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, though this is generally not clinically significant with low-potency topical steroids like desonide. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Desonide is a low-potency topical corticosteroid, making it suitable for use on sensitive areas such as the face, groin, and axillae, and for pediatric patients.
  • The ointment formulation is generally more potent and occlusive than the cream or gel, providing better hydration and penetration for dry, scaly lesions.
  • Educate patients on the 'thin film' application technique to avoid overuse and minimize potential side effects.
  • Avoid prolonged continuous use (e.g., more than 2-4 weeks) to prevent local skin side effects like atrophy, striae, and telangiectasias.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis or consider a different treatment approach.
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Alternative Therapies

  • Other low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate) for more severe cases or different body areas.
  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair and symptom relief.
  • Antihistamines (oral) for associated pruritus.
  • Phototherapy (UVB) for certain chronic dermatoses.
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Cost & Coverage

Average Cost: $20 - $100+ per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic)
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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 taken, the amount, and the time it happened.