Mometasone 0.1% Ointment 15gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Mar 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mometasone 0.1% ointment is a strong corticosteroid medicine applied to the skin. It helps reduce redness, itching, and swelling caused by skin conditions like eczema or psoriasis.
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 local drug take-back programs.
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 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 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 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 application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a very thin layer of ointment only to the affected skin areas as directed by your doctor, usually once daily.
- Wash your hands thoroughly before and after applying the ointment.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with your eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use this ointment on your face, groin, or armpits unless specifically advised by your doctor, as these areas are more susceptible to side effects.
- Do not use for longer than prescribed, even if your skin condition improves, to minimize the risk of side effects.
- Do not use on broken, infected, or irritated skin unless directed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas once daily.
Condition-Specific Dosing:
eczema:
Apply a thin film to the affected skin areas once daily.
psoriasis:
Apply a thin film to the affected skin areas once daily.
Pediatric Dosing
Neonatal:
Not established. Use is generally not recommended due to increased risk of systemic absorption and adverse effects.
Infant:
Not established. Use is generally not recommended due to increased risk of systemic absorption and adverse effects.
Child:
Apply a thin film to the affected skin areas once daily. Use the smallest amount for the shortest duration possible. Not recommended for children under 2 years of age.
Adolescent:
Apply a thin film to the affected skin areas once daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Mometasone furoate is a synthetic corticosteroid that possesses 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.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 0.7% (for 0.1% ointment without occlusion) in healthy subjects. Absorption varies with skin integrity, area of application, duration of treatment, and use of occlusive dressings.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not widely distributed systemically due to minimal absorption.
ProteinBinding:
Not available (minimal systemic absorption).
CnssPenetration:
Limited (due to minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption.
Clearance:
Not well-defined for topical application due to minimal systemic absorption.
ExcretionRoute:
Renal and biliary (for systemically absorbed drug).
Unchanged:
Not available (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Local anti-inflammatory effects can be observed within hours to days.
PeakEffect:
Typically within days to one week for significant clinical improvement.
DurationOfAction:
Effects persist for approximately 24 hours with once-daily application.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burning or stinging
Tingling
* Itching
This is not a complete 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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 where the medication was applied
Thinning of the skin
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have minor ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Burning or stinging
Tingling
* Itching
This is not a complete 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.
Seek Immediate Medical Attention If You Experience:
- Worsening of your skin condition or no improvement after a few days/weeks of use.
- Signs of a new skin infection (e.g., pus, increased pain, redness, warmth, fever).
- Severe burning, itching, stinging, or irritation at the application site.
- Skin thinning, easy bruising, stretch marks (striae), or changes in skin color where the ointment is applied.
- Acne or increased hair growth in the treated area.
- Any signs of systemic side effects, especially if used on large areas or for a long time: unusual weight gain, swelling in your face or ankles, muscle weakness, fatigue, vision problems, or feeling generally unwell. Contact your doctor immediately if these occur.
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 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. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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 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. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Important Warnings and Precautions:
Do not use this medication to treat diaper rash.
When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body. However, 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 to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin.
When using this medication on a large area of skin, exercise caution and consult your doctor.
Do not use this medication for an extended period beyond what your doctor has prescribed.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so discuss this potential risk with your doctor.
This medication is available in different forms, which may be suitable for different age groups of children. Before giving this medication to a child, consult your doctor to determine the appropriate form 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, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to you and your baby.
Important Warnings and Precautions:
Do not use this medication to treat diaper rash.
When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body. However, 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 to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin.
When using this medication on a large area of skin, exercise caution and consult your doctor.
Do not use this medication for an extended period beyond what your doctor has prescribed.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so discuss this potential risk with your doctor.
This medication is available in different forms, which may be suitable for different age groups of children. Before giving this medication to a child, consult your doctor to determine the appropriate form 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, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose with topical application is unlikely due to minimal systemic absorption.
- Chronic overuse or use on large body surface areas, especially under occlusion or in children, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia) or suppression of the hypothalamic-pituitary-adrenal (HPA) axis (e.g., fatigue, weakness, nausea, vomiting, low blood pressure).
What to Do:
If you suspect chronic overuse or systemic effects, contact your doctor or poison control center immediately. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity, type, and extent of dermatosis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Therapeutic efficacy (reduction in inflammation, pruritus)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially, then as needed).
Target: Significant improvement in symptoms and appearance of affected skin.
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence or minimal local adverse effects.
Action Threshold: Presence of significant local adverse effects may require dose reduction, discontinuation, or change in therapy.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome)
Frequency: Periodically, especially with extensive use, prolonged use, occlusion, or in pediatric patients.
Target: Normal HPA axis function (e.g., normal cortisol levels).
Action Threshold: Symptoms of systemic absorption (e.g., unexplained weight gain, moon face, fatigue, weakness) or abnormal HPA axis tests (e.g., ACTH stimulation test) require immediate medical attention and discontinuation/tapering of therapy.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (e.g., pus, increased redness, warmth, fever)
- Severe burning, itching, or irritation at the application site
- Skin thinning, easy bruising, stretch marks (striae)
- Acne-like eruptions
- Increased hair growth (hypertrichosis)
- Unusual weight gain, swelling in ankles/feet, muscle weakness, fatigue, changes in vision (signs of systemic absorption/Cushing's syndrome)
- Delayed wound healing
Special Patient Groups
Pregnancy
Mometasone furoate is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Limited data. Animal studies show teratogenicity with high systemic doses. Use with caution.
Second Trimester:
Limited data. Use with caution, considering minimal systemic absorption.
Third Trimester:
Limited data. Use with caution, considering minimal systemic absorption. Potential for HPA axis suppression in the neonate with extensive maternal use.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk to infant due to minimal maternal systemic absorption, but monitor for potential adverse effects if used on large areas or for prolonged periods.
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 the smallest amount for the shortest duration possible. Not recommended for children under 2 years of age. Monitor closely for growth retardation and other systemic effects.
Geriatric Use
Generally safe. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like atrophy, purpura, or skin tears. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Mometasone 0.1% ointment is a high-potency topical corticosteroid, typically applied once daily.
- Educate patients on proper application technique: apply a thin film only to the affected area and rub in gently.
- Emphasize avoiding prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to increased risk of skin atrophy, striae, telangiectasias, and systemic absorption.
- Not for use on infected skin without appropriate concomitant antimicrobial therapy.
- Patients should be advised to contact their healthcare provider if their condition worsens, if signs of infection appear, or if they experience significant local or systemic side effects.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, fluocinonide, triamcinolone, hydrocortisone, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream) for eczema
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
- Emollients and moisturizers for dry skin conditions
- Phototherapy (UVB, PUVA) for extensive psoriasis or eczema
- Systemic agents (e.g., methotrexate, cyclosporine, biologics) for severe, refractory dermatoses
Cost & Coverage
Average Cost:
$20 - $50 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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.