Elocon Ointment 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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Jul 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Elocon Ointment is a 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 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.
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 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 advises 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. You can also check with your pharmacist for guidance on the best way to dispose of medications. Additionally, you may want to explore 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 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 ointment to the affected skin area once daily, as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid applying the ointment to the face, groin, or armpits unless directed by your doctor.
  • Do not use this medicine for longer than prescribed, especially in children.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken or infected skin unless advised by your doctor.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas once daily.
atopicDermatitis: 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 risk)
Infant: Not established (use with extreme caution due to increased systemic absorption risk)
Child: Apply a thin film to the affected skin areas once daily for up to 3 weeks. Use with caution, limit to smallest amount necessary, and avoid prolonged use or use under occlusion due to increased risk of systemic effects.
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, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inducing 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: <1% (systemic absorption is minimal, varies with skin integrity, area, duration, and occlusion)
Tmax: Not well-quantified for topical application (local action)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not well-quantified (minimal systemic distribution)
ProteinBinding: Not well-quantified (minimal systemic absorption)
CnssPenetration: Limited (due to minimal systemic absorption)

Elimination:

HalfLife: Not well-defined for topical application (systemic half-life of absorbed drug is approximately 5.8 hours)
Clearance: Not well-quantified for topical application
ExcretionRoute: Renal and biliary (for systemically absorbed drug)
Unchanged: Not available (minimal unchanged drug excreted systemically)
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Pharmacodynamics

OnsetOfAction: Within hours to days (local anti-inflammatory effect)
PeakEffect: Within days to weeks of consistent use
DurationOfAction: Up to 24 hours (with once-daily application)

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 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning or stinging
Tingling
* Itching

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 (signs of infection)
  • Severe burning, itching, or irritation at the application site
  • Thinning of the skin, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of systemic absorption, especially in children: weight gain, rounding of the face (moon face), slow growth, fatigue, weakness.
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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, any of 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 existing health problems, 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 of your current medications and health conditions. Do not initiate, discontinue, or modify the dosage 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.

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. Some products may not be suitable for use in the diaper area, so consult your doctor before application.

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

Note that different formulations of this medication may be suitable for different age groups of children. Before administering this medication to a child, consult your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use of topical corticosteroids can lead to systemic effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
  • Symptoms may include: fatigue, weakness, nausea, vomiting, low blood pressure, weight gain, moon face, central obesity, striae, muscle weakness.

What to Do:

If you suspect an overdose or experience systemic symptoms, contact your doctor or poison control center immediately. Call 1-800-222-1222 for poison control assistance.

Drug Interactions

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Contraindicated Interactions

  • None known (due to minimal systemic absorption)
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Major Interactions

  • None known (due to minimal systemic absorption)
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Moderate Interactions

  • None known (due to minimal systemic absorption)
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Minor Interactions

  • None known (due to minimal systemic absorption)

Monitoring

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Baseline Monitoring

Skin condition and extent of dermatosis

Rationale: To establish baseline severity and guide treatment duration.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, erythema)

Frequency: Regularly during treatment (e.g., weekly or bi-weekly)

Target: Improvement in symptoms

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, burning, itching)

Frequency: Regularly during treatment

Target: Absence of or minimal adverse effects

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

Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension) - especially with prolonged use, large surface areas, or occlusion

Frequency: Periodically, especially in high-risk patients (e.g., pediatric, extensive use)

Target: Normal HPA axis function

Action Threshold: Symptoms suggestive of HPA axis suppression warrant immediate evaluation (e.g., ACTH stimulation test).

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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
  • Signs of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension)
  • Hyperglycemia
  • Glucosuria

Special Patient Groups

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Pregnancy

Mometasone furoate is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects observed in animal studies; use with caution.
Second Trimester: Use with caution; systemic absorption is minimal but possible.
Third Trimester: Use with caution; systemic absorption is minimal but possible. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for hypoadrenalism.
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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 infant ingestion.

Infant Risk: Low risk with appropriate use due to minimal systemic absorption, but monitor infant for potential adverse effects.
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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 the smallest amount necessary for the shortest duration. Not recommended for use in children under 2 years 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 the risk of local adverse effects like skin atrophy.

Clinical Information

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Clinical Pearls

  • Elocon Ointment is a high-potency topical corticosteroid; use sparingly and for short durations, especially on sensitive areas like the face, groin, or axillae.
  • Educate patients on the 'thin layer' rule: only enough to cover the affected area, not to rub in excessively.
  • Avoid prolonged continuous use to minimize the risk of skin atrophy, striae, and HPA axis suppression.
  • Consider step-down therapy or intermittent use once control is achieved to reduce cumulative exposure.
  • Not for ophthalmic use. Avoid contact with eyes.
  • Patients should be advised to report any signs of local irritation, infection, or systemic side effects.
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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 phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe cases
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Cost & Coverage

Average Cost: $20 - $100 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred brand or non-preferred brand)
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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 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 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.