Elocon Ointment 45gm

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 Receptor Agonist
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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 Ointment contains a strong medicine called a corticosteroid, which helps reduce redness, swelling, and itching caused by certain skin conditions like eczema and psoriasis. It works by calming down the immune response in your 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 to do so 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 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 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. 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 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

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area only, as directed by your doctor. Do not use more than prescribed.
  • 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 your face, groin, or armpits unless specifically directed by your doctor.
  • Do not get the ointment in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or other side effects.
  • 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 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
Infant: Not recommended for infants under 2 years of age. For children 2 years and older, apply a thin film to the affected skin areas once daily. Use for the shortest duration possible.
Child: Apply a thin film to the affected skin areas once daily. Use for the shortest duration possible.
Adolescent: Apply a thin film to the affected skin areas once daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties. Its mechanism of action is thought to involve the induction of 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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (approximately 0.7% of the applied dose over 8 hours without occlusion in healthy volunteers). Absorption increases with skin barrier compromise, inflammation, occlusion, and application to large surface areas.
Tmax: Not applicable for topical systemic effects due to minimal absorption; local effect is immediate.
FoodEffect: Not applicable (topical administration).

Distribution:

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

Elimination:

HalfLife: Not precisely determined for topical application due to minimal systemic absorption; systemically absorbed corticosteroids are generally eliminated via renal and biliary routes.
Clearance: Not precisely determined for topical application.
ExcretionRoute: Renal and biliary (for systemically absorbed drug)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours (local anti-inflammatory effect)
PeakEffect: Days to weeks (for full therapeutic effect)
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

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe stomach upset 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 wound healing
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ Excessive hair growth
Irritation at the application site
Thinning of the skin
Changes in vision

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 sensations
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:

  • Increased redness, itching, or irritation at the application site.
  • Development of new skin problems like acne, thinning skin, stretch marks, or changes in skin color.
  • Signs of infection (pus, fever, worsening pain).
  • Any signs of systemic side effects, such as unusual weight gain, swelling in the face or ankles, increased thirst or urination, or blurred vision. Contact your doctor immediately if these occur.
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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.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust 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 skin products, including soaps, consult your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss this with your doctor.

Do not use this medication for a longer duration than prescribed by your doctor. Prolonged use may increase the risk of developing cataracts or glaucoma, so consult your doctor about this potential risk.

Note that different formulations of this medication may be suitable for different age groups of children. Before giving this medication to a child, consult your doctor to ensure you are using the correct formulation and dosage. 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, so regular growth checks may be necessary. Discuss this potential risk with your doctor.

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

Overdose Symptoms:

  • Acute overdose is unlikely with topical application.
  • Chronic overuse or misuse (e.g., applying to large areas, prolonged use, or under occlusion) can lead to systemic effects of corticosteroids, including adrenal suppression, Cushing's syndrome, hyperglycemia, and growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. Adrenal function may need to be monitored. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., skin infections).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

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

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 adverse reactions (e.g., atrophy, striae, folliculitis, burning, itching)

Frequency: Regularly during treatment

Target: Absence or minimal local side effects.

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

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusion.

Target: Absence of systemic effects.

Action Threshold: Any signs of systemic absorption (e.g., weight gain, moon face, fatigue, hyperglycemia) require immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Burning
  • Itching
  • Stinging
  • Folliculitis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Secondary infection
  • Skin atrophy (thinning, easy bruising)
  • Striae (stretch marks)
  • Miliaria (heat rash)
  • Signs of systemic corticosteroid effects (e.g., weight gain, facial puffiness, fatigue, muscle weakness, increased thirst/urination, blurred vision)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though systemic absorption is minimal.
Second Trimester: Potential for fetal growth restriction with high doses or prolonged use of potent corticosteroids.
Third Trimester: Potential for fetal growth restriction and adrenal suppression in the neonate with high doses 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 infant ingestion.

Infant Risk: Low risk with proper use due to minimal systemic absorption, but monitor for potential effects if large areas or prolonged use.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation) than adult patients. 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 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 absorption or susceptibility to local side effects like atrophy.

Clinical Information

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Clinical Pearls

  • Elocon Ointment is a high-potency topical corticosteroid. Use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • Avoid abrupt discontinuation after prolonged use, especially on the face, as this can lead to rebound dermatitis.
  • Educate patients on proper application technique: a thin film, gently rubbed in, once daily.
  • Warn patients about the risk of skin atrophy, striae, and telangiectasias with prolonged use, particularly in intertriginous areas or on the face.
  • Consider alternative, less potent corticosteroids or non-steroidal options for maintenance therapy or less severe conditions.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids (e.g., tazarotene) for psoriasis
  • Emollients and moisturizers for barrier repair
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Cost & Coverage

Average Cost: $30 - $100 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 2-3 (for brand), Tier 1 (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 details. 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 information about the medication taken, the amount, and the time it occurred.