Mometasone 0.1% Top Soln/lot 30ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mometasone 0.1% Topical Solution is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response in the skin.
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 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 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 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.
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 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 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 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.
Lifestyle & Tips
- Wash hands before and after applying the solution.
- Apply a thin film of the solution to the affected skin area once daily, as directed by your doctor.
- Do not use more than the prescribed amount or for longer than directed, as this can increase the risk of side effects.
- Do not cover the treated area with bandages or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the solution to the face, groin, or armpits unless specifically directed by your doctor.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on broken, infected, or irritated skin without consulting your doctor.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of Mometasone Furoate 0.1% Topical Solution to the affected skin areas once daily.
Condition-Specific Dosing:
psoriasis:
Apply once daily to affected areas.
atopicDermatitis:
Apply once daily to affected areas.
Pediatric Dosing
Neonatal:
Not established
Infant:
Use with caution; increased risk of systemic absorption and HPA axis suppression. Not recommended for infants under 2 years.
Child:
For children 2 years of age or older, apply a thin film to affected skin areas once daily. Limit treatment duration to the least amount of time necessary to achieve therapeutic effect. Avoid use on face, groin, or axillae, or under occlusive dressings.
Adolescent:
Apply a thin film to affected skin areas once daily.
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
Mechanism of Action
Mometasone furoate is a synthetic corticosteroid that possesses 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (approximately 0.7% of the applied dose) through intact skin. Absorption can increase with inflammation, skin barrier disruption, occlusive dressings, and prolonged use.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation due to minimal systemic absorption.
ProteinBinding:
Not available for topical formulation; systemic corticosteroids are highly protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption; systemic corticosteroids have variable half-lives.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Metabolites are primarily excreted in the urine and feces.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Effects persist as long as treatment is continued; varies based on condition and individual response.
Safety & Warnings
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: 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, 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 belly, 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. Although 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.
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: 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, 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 belly, 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. Although 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.
Seek Immediate Medical Attention If You Experience:
- Worsening of your skin condition or new skin problems (e.g., severe irritation, burning, itching, redness, pus, signs of infection).
- Skin thinning, easy bruising, or stretch marks at the application site.
- Acne-like breakouts or increased hair growth where applied.
- Signs of systemic absorption, especially in children or with prolonged/extensive use: unusual tiredness, weight loss, dizziness, nausea, swelling in ankles/feet, increased thirst or urination (signs of high blood sugar).
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 you are taking.
* Any health problems you have, 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. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting 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 you are taking.
* Any health problems you have, 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. Do not initiate, discontinue, or adjust the dosage of any medication without first consulting your doctor.
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 an extended period beyond what your doctor has prescribed. Long-term 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 intended for use in children of various ages. 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 with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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 an extended period beyond what your doctor has prescribed. Long-term 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 intended for use in children of various ages. 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 with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects due to absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Symptoms of HPA axis suppression may include fatigue, weakness, nausea, vomiting, dizziness, and low blood pressure.
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. Treatment is supportive and symptomatic. Gradual withdrawal of the corticosteroid may be necessary if HPA axis suppression is confirmed.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Regularly during treatment (e.g., weekly to bi-weekly initially, then as needed).
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation.
Local adverse reactions (e.g., skin atrophy, striae, folliculitis, burning, itching)
Frequency: At each follow-up visit.
Target: Absence of or minimal local side effects.
Action Threshold: Presence of significant local adverse effects may require discontinuation or change in therapy.
Signs of HPA axis suppression (e.g., fatigue, weight loss, dizziness, nausea)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms warrants investigation (e.g., ACTH stimulation test) and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching
- Skin thinning or atrophy
- Stretch marks (striae)
- Acne-like eruptions
- Folliculitis
- Signs of infection (pus, fever)
- Unusual fatigue or weakness
- Weight loss
- Dizziness
- Nausea or vomiting
Special Patient Groups
Pregnancy
Mometasone furoate is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is minimal. Use only if clearly needed.
Second Trimester:
Potential for teratogenicity, though systemic absorption from topical use is minimal. Use only if clearly needed.
Third Trimester:
Potential for teratogenicity, though systemic absorption from topical use is minimal. Use only if clearly needed. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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 topical solution is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper application (minimal systemic absorption), but potential for adverse effects if ingested by infant or if large amounts are applied to the mother's skin.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients 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 avoid occlusive dressings. Monitor for growth retardation and delayed weight gain.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy, so monitor carefully.
Clinical Information
Clinical Pearls
- Mometasone 0.1% Topical Solution is a high-potency topical corticosteroid. Use it sparingly and only on affected areas.
- Instruct patients to apply a thin film once daily. More frequent application does not increase efficacy but increases the risk of side effects.
- Warn patients about potential local side effects such as skin atrophy, striae, and telangiectasias, especially with prolonged use or on sensitive skin areas.
- Emphasize that this solution is for external use only and should not be used in the eyes, mouth, or internally.
- For scalp conditions, the solution formulation is often preferred over creams or ointments due to ease of application and less residue.
- Consider tapering treatment or using a lower potency steroid for maintenance once the acute flare is controlled to minimize side effects.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
- Emollients and moisturizers for barrier repair
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread disease
Cost & Coverage
Average Cost:
$30 - $100 per 30ml bottle of 0.1% solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.