Mometasone 0.1% Cream 45gm

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
Mar 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mometasone cream is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by skin conditions like eczema or psoriasis. It works by calming down the immune 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 instructed to do so by your doctor.

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. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missed Dose Instructions

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 hands before and after applying the cream.
  • Apply a very thin layer only to the affected skin areas.
  • Do not use more often or for longer than prescribed by your doctor.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on the face, groin, or armpits unless directed by your doctor.
  • 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:

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
Infant: Not established (use with caution, generally not recommended for infants <2 years)
Child: For children 2 years of age or older: Apply a thin film to the affected skin areas once daily. Limit treatment to 3 weeks. Safety and effectiveness in pediatric patients <2 years of age have not been established.
Adolescent: Apply a thin film to the affected skin areas once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (systemic absorption is minimal)
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: No adjustment needed (systemic absorption is minimal)
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Mometasone furoate, a synthetic corticosteroid, exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating gene expression. This leads to the inhibition of phospholipase A2, thereby decreasing the synthesis and release of inflammatory mediators such as prostaglandins and leukotrienes. It also suppresses the migration of neutrophils and macrophages, reduces capillary permeability, and stabilizes lysosomal membranes.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (approximately 0.4% with intact skin, higher with compromised skin, occlusive dressings, or large surface areas)
Tmax: Not applicable for topical, systemic levels are generally below quantification limits.
FoodEffect: Not applicable

Distribution:

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

Elimination:

HalfLife: Not precisely determined for topical application due to minimal systemic absorption; systemically absorbed mometasone is rapidly cleared.
Clearance: Not precisely determined for topical application.
ExcretionRoute: Primarily via bile and, to a lesser extent, urine (for systemically absorbed drug).
Unchanged: Not available (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Within days to weeks of consistent application.
DurationOfAction: Approximately 24 hours (due to once-daily dosing regimen).
Confidence: Medium

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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 skin condition or new skin problems (e.g., severe burning, itching, irritation, thinning of skin, stretch marks, acne, increased hair growth)
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Signs of systemic absorption (rare but serious): unusual tiredness, weakness, nausea, vomiting, dizziness, swelling in ankles/feet, vision changes, or changes in mood/behavior.
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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 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 your current medications and health conditions. Never start, stop, or change 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 may come into contact with 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 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. Children may be more susceptible to certain side effects, and this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor 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 effects of corticosteroids, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to adrenal insufficiency upon withdrawal).

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. 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 pre-existing skin atrophy or infection.

Timing: Prior to initiation of therapy

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)

Frequency: At each follow-up visit, or as symptoms arise

Target: Absence of new or worsening reactions

Action Threshold: Discontinue or reduce frequency if severe reactions occur; consider alternative therapy.

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

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

Target: Absence of symptoms

Action Threshold: Perform HPA axis assessment (e.g., ACTH stimulation test) if symptoms present; gradually withdraw therapy.

Signs of infection (e.g., worsening redness, pus, fever)

Frequency: At each follow-up visit, or as symptoms arise

Target: Absence of infection

Action Threshold: Treat infection appropriately; discontinue mometasone if infection worsens.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, burning, itching, or irritation at application site
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Visible small blood vessels (telangiectasias)
  • Acne-like eruptions
  • Folliculitis
  • Signs of systemic absorption: unusual fatigue, weakness, nausea, vomiting, dizziness, weight loss, swelling in ankles/feet, vision changes.

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animals. Systemic absorption is minimal with topical use, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk with topical minimal.
Second Trimester: Minimal systemic absorption, generally considered low risk.
Third Trimester: Minimal systemic absorption, generally considered low risk. 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. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: L3 - Moderate risk. Minimal systemic absorption, but potential for infant exposure if applied to breast or if significant absorption occurs.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use with caution, for the shortest duration possible, and limit to the smallest effective amount. Not recommended for children under 2 years of age. Monitor for growth retardation.

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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 the risk of local adverse effects.

Clinical Information

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Clinical Pearls

  • Mometasone 0.1% cream is a high-potency topical corticosteroid; use sparingly and for limited durations to minimize local and systemic side effects.
  • Once-daily application is usually sufficient due to its potent and sustained action.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy and other side effects in these sensitive areas.
  • Educate patients on proper application technique: thin film, gentle rubbing, and avoiding occlusive dressings.
  • Monitor pediatric patients closely for signs of HPA axis suppression and growth retardation.
  • If no improvement is seen after 2-3 weeks, re-evaluate diagnosis and treatment plan.
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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 vitamin D analogues (e.g., calcipotriene) 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 1 or 2 (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.