Elocon Cream 15gm

Manufacturer MERCK SHARP & DOHME Active Ingredient Mometasone (Topical)(moe MET a sone) Pronunciation moe MET a sone
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
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Aug 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Elocon Cream is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema and psoriasis. It works by calming down the body's inflammatory response in the skin.
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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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Wash your hands before and after applying the medication. If the treated area is on your hand, do not wash your 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.
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 doctor or pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program 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 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 cream to the affected skin area once daily, as directed by your doctor. Do not use more often or for longer than prescribed.
  • Wash your hands before and after applying the cream, unless your hands are the treated area.
  • Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Do not get the cream in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Keep out of reach of children. Children are more sensitive to the effects of this medicine.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once daily.

Condition-Specific Dosing:

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

Neonatal: Not established (use with extreme caution due to increased systemic absorption and HPA axis suppression risk)
Infant: Not established (use with extreme caution due to increased systemic absorption and HPA axis suppression risk)
Child: Apply a thin film to the affected skin areas once daily for up to 3 weeks (for patients 2 years of age and older). Use with caution due to increased systemic absorption and HPA axis suppression risk.
Adolescent: Apply a thin film to the affected skin areas once 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

Mometasone furoate is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It induces 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (approximately 0.4% after 8 hours of contact with normal skin without occlusion)
Tmax: Not clinically relevant for topical application due to minimal systemic absorption
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not clinically relevant for topical application
ProteinBinding: Not available (for topical application)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant for topical application
Clearance: Not clinically relevant for topical application
ExcretionRoute: Primarily urine and feces (after systemic absorption)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief
PeakEffect: Within days to weeks of consistent application
DurationOfAction: Varies, generally once daily application is sufficient due to sustained effect

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 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
Irritation at the site of application
Thinning of the skin
Changes in eyesight

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 or stinging
Tingling
* Itching

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 new skin irritation (e.g., burning, itching, stinging)
  • Signs of skin infection (e.g., increased redness, swelling, pus, warmth)
  • Skin thinning, stretch marks, or changes in skin color where the cream is applied
  • Unusual fatigue, weakness, nausea, vomiting, or dizziness (especially with prolonged or extensive use, or in children) – these could be signs of systemic absorption and adrenal suppression.
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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.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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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.

Do not use this medication to treat diaper rash. If you are applying it to an area that will be covered by a diaper, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body. Additionally, some products may not be suitable for use in the diaper area, so it is crucial to consult with your doctor beforehand.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.

Do not use this medication for an extended period beyond what your doctor has prescribed. Prolonged use may increase the risk of developing cataracts or glaucoma, so it is essential to discuss this with your doctor.

When using this medication in children, it is vital to consider the different formulations available, as they may be suitable for different age groups. Consult with your doctor before administering this medication to a child, as they may be more susceptible to certain side effects. 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 this and discuss any concerns with you.

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

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic corticosteroid effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria. Symptoms may include: moon face, buffalo hump, central obesity, skin thinning, easy bruising, muscle weakness, fatigue, high blood pressure, and mood changes.

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, extent of dermatosis)

Rationale: To establish baseline for efficacy monitoring and identify areas of concern.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, erythema)

Frequency: Regularly, typically weekly to bi-weekly during initial treatment phase

Target: Improvement or resolution of symptoms

Action Threshold: Lack of improvement after 2-3 weeks, or worsening of condition, warrants re-evaluation.

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, acneiform eruptions, perioral dermatitis, hypopigmentation)

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant or worsening local adverse effects warrants discontinuation or change in therapy.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia)

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

Target: Absence of symptoms

Action Threshold: Any signs or symptoms warrant immediate medical evaluation and potential HPA axis testing (e.g., ACTH stimulation test).

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Symptom Monitoring

  • Worsening of skin condition
  • New skin irritation, burning, itching, or stinging
  • Skin thinning, easy bruising, stretch marks
  • Changes in skin color (lightening)
  • Development of acne-like lesions or folliculitis
  • Signs of infection (redness, warmth, pus)
  • Unusual fatigue, weakness, dizziness, nausea (potential systemic absorption)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Mometasone furoate is classified as Pregnancy 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 minimal. Avoid large areas or prolonged use.
Second Trimester: Minimal systemic absorption, but still use with caution. Avoid large areas or prolonged use.
Third Trimester: Minimal systemic absorption, but still use with caution. Avoid large areas or prolonged use. Potential for neonatal adrenal insufficiency if significant systemic absorption occurs.
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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 with proper use due to minimal systemic absorption. Monitor infant for any signs of systemic corticosteroid effects (e.g., growth suppression) if mother uses extensively.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier function. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use the least potent corticosteroid for the shortest duration possible. Not recommended for children under 2 years of age.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor closely for skin integrity and adverse reactions.

Clinical Information

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Clinical Pearls

  • Mometasone furoate cream is a high-potency topical corticosteroid. Use it sparingly and only on affected areas.
  • Educate patients on the 'less is more' principle for topical corticosteroids to minimize side effects.
  • Avoid prolonged use, especially on the face, intertriginous areas, or in children, due to increased risk of skin atrophy, telangiectasias, and HPA axis suppression.
  • If no improvement is seen after 2-3 weeks, re-evaluate the diagnosis and treatment plan.
  • Tapering may be necessary after prolonged use to prevent rebound flares, though less common with topical agents than systemic ones.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids (e.g., tazarotene) for psoriasis
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread disease
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Cost & Coverage

Average Cost: $20 - $100 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand) for most insurance plans
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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.