Mometasone 0.1% Cream 15gm

Manufacturer PERRIGO 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
Dec 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mometasone cream is a type of medicine called a corticosteroid, or 'steroid' for short. It works by reducing inflammation, redness, and itching caused by certain skin conditions like eczema or psoriasis. You apply a very thin layer directly to the affected 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 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 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 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

  • Wash your hands before and after applying the cream.
  • Apply a very thin layer of cream to the affected skin area, usually once daily, as directed by your doctor.
  • Gently rub it in until it disappears.
  • Do not use more cream than prescribed or apply it more often than directed.
  • Do not apply to the face, groin, or armpits unless specifically instructed by your doctor.
  • Avoid getting the cream in your eyes, nose, or mouth. If it gets into these areas, rinse thoroughly with water.
  • Do not cover the treated area with bandages, plastic wrap, or tight clothing unless your doctor tells you to, as this can increase absorption and side effects.
  • Do not use for longer than prescribed, especially on 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.
atopic_dermatitis: 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 due to increased risk of systemic absorption and HPA axis suppression.
Child: Apply a thin film to the affected skin areas once daily for children 2 years of age and older. Limit treatment duration to 3 weeks or less. Use smallest effective amount.
Adolescent: Apply a thin film to the affected skin areas once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Mometasone furoate is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its anti-inflammatory effects are 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% with intact skin without occlusion). Absorption increases with inflammation, skin barrier disruption, occlusion, and prolonged use.
Tmax: Not applicable for topical systemic absorption, peak local effect is within hours.
FoodEffect: Not applicable

Distribution:

Vd: Not widely distributed systemically due to minimal absorption.
ProteinBinding: Not available for topical, but systemic corticosteroids are highly protein bound.
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely determined for topical, but systemically absorbed corticosteroids have variable half-lives.
Clearance: Not precisely determined for topical.
ExcretionRoute: Metabolites are primarily excreted in the urine and feces.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory effects.
PeakEffect: Within days to a week of consistent application.
DurationOfAction: Effects persist for about 24 hours after a single 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: 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, or swelling of the mouth, face, lips, tongue, or throat.
Signs of a weak adrenal gland: severe stomach upset or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Skin changes: acne, stretch marks, slow healing, or 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 that bother you or persist, contact your doctor:

Burning or stinging sensations.
Tingling.
* Itching.

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult 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 irritation, burning, stinging, or redness where the cream is applied.
  • Development of new skin problems like acne, folliculitis (inflamed hair follicles), or skin infections.
  • Signs of skin thinning, such as easy bruising, stretch marks (striae), or spider veins (telangiectasias).
  • Any signs of systemic absorption, especially in children, such as unusual weight gain, swelling, or changes in mood/behavior (though rare with proper topical 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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 identify 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 dose 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 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 skin area, exercise caution and discuss this with your doctor.

Do not exceed the prescribed treatment duration. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma, so consult your doctor about potential risks.

Note that different formulations of this medication may be intended for use in children of various ages. Before administering this medication to a child, consult your doctor to ensure the correct formulation and dosage are used. 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. Discuss this 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 this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, striae, muscle weakness, hyperglycemia, hypertension, and adrenal suppression.

What to Do:

If you suspect an overdose or have used too much for too long, contact your doctor or poison control center immediately (call 1-800-222-1222). Management is supportive and may involve gradual withdrawal of the steroid under medical supervision.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for application.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially)

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, at follow-up visits

Target: Absence or minimal reactions

Action Threshold: Presence of significant local adverse reactions may require discontinuation or reduction in frequency/potency.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)

Frequency: Periodically, especially with extensive use, prolonged therapy, or in pediatric patients.

Target: Absence of systemic effects

Action Threshold: Presence of systemic effects requires immediate discontinuation and medical evaluation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, burning, stinging, or itching at application site
  • Development of new skin lesions (e.g., folliculitis, acneiform eruptions)
  • Thinning of skin, easy bruising, stretch marks (striae)
  • Increased hair growth (hypertrichosis)
  • Changes in vision (e.g., cataracts, glaucoma)
  • Unusual fatigue, weight gain, swelling (signs of systemic absorption)

Special Patient Groups

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Pregnancy

Mometasone furoate is classified as 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 with high doses of corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though systemic absorption from topical use is minimal.
Second Trimester: Minimal systemic absorption, but use with caution.
Third Trimester: Minimal systemic absorption, but use with caution. Avoid large areas or prolonged use.
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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. Caution should be exercised when mometasone furoate cream is administered to a nursing woman. 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 potential for adverse effects if ingested by infant or if significant systemic absorption occurs in mother.
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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 adults because of a larger skin surface area to body weight ratio. Use in children under 2 years of age is not recommended. Limit treatment duration and amount used in older children.

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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 increase susceptibility to local adverse effects like skin atrophy.

Clinical Information

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Clinical Pearls

  • Mometasone furoate 0.1% cream is a potent topical corticosteroid. Use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • Educate patients on the 'fingertip unit' for appropriate dosing to avoid overuse.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the skin condition.
  • Be vigilant for signs of skin atrophy (thinning, bruising, striae) with long-term use, especially on sensitive areas like the face or skin folds.
  • Consider lower potency corticosteroids or intermittent therapy for maintenance once the acute flare is controlled.
  • Not for use on infected skin unless an appropriate antimicrobial agent is also being used.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, clobetasol, 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
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: $20 - $100 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 information about the medication taken, the amount, and the time it happened.