Mometasone 0.1% Top Soln/lot 60ml
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
Jan 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mometasone 0.1% Topical Solution/Lotion is a strong corticosteroid medicine applied to the skin. It helps reduce redness, swelling, and itching caused by various 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 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 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 disposal, consult your pharmacist. You may also want to check if there are 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 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 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 disposal, consult your pharmacist. You may also want to check if there are 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.
Lifestyle & Tips
- Apply a thin layer of the solution/lotion only to the affected skin areas as directed by your doctor. Do not use more than prescribed or for longer than recommended.
- Wash your hands thoroughly before and after applying the medication, unless your hands are the treated area.
- Avoid contact with your eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages, dressings, or tight clothing unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Do not use on the face, groin, or armpits unless specifically advised by your doctor, as these areas are more susceptible to side effects.
- Do not use for diaper rash in infants.
- Inform your doctor if your condition worsens or does not improve after 2 weeks of treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas once daily.
Condition-Specific Dosing:
dermatoses:
Apply a thin film to the affected skin areas once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not recommended for children under 2 years of age due to increased risk of systemic absorption and HPA axis suppression.
Child:
For children 2 years of age or older: Apply a thin film to the affected skin areas once daily. Use the smallest amount necessary for the shortest duration to achieve therapeutic goals.
Adolescent:
Apply a thin film to the affected skin areas once daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific 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, collectively called 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. Corticosteroids also inhibit the migration of macrophages and leukocytes to the area of inflammation, reverse vasodilation and vascular permeability, and reduce edema.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic absorption through intact skin, varies with skin integrity, vehicle, occlusion, and application site)
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption. Systemically absorbed corticosteroids are extensively bound to plasma proteins.
ProteinBinding:
>98% (for systemically absorbed drug)
CnssPenetration:
Limited (for systemically absorbed drug)
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily urine and bile (for systemically absorbed drug)
Unchanged:
Negligible (for systemically absorbed drug)
Pharmacodynamics
OnsetOfAction:
Anti-inflammatory effects can be observed within hours to days.
PeakEffect:
Maximal therapeutic effect often seen within 1-2 weeks of consistent daily application.
DurationOfAction:
Effects persist as long as applied; local effects can last for hours after application.
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 do not experience any side effects or only have mild ones, it is 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 do not go away, contact your doctor:
Burning or stinging sensations.
Tingling.
* Itching.
This is not an exhaustive list of possible 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 do not experience any side effects or only have mild ones, it is 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 do not go away, contact your doctor:
Burning or stinging sensations.
Tingling.
* Itching.
This is not an exhaustive list of possible 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:
- Severe burning, stinging, or irritation at the application site.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Worsening of your skin condition or new skin problems (e.g., severe acne, unusual hair growth, skin thinning, stretch marks, easy bruising, changes in skin color).
- Signs of systemic absorption, especially with prolonged or extensive use (e.g., unusual weight gain, swelling in the face, fatigue, muscle weakness, delayed healing).
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.
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.
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 with your doctor.
Do not exceed the prescribed treatment duration. Prolonged use 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 may affect growth in children and teenagers, and 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 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 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 with your doctor.
Do not exceed the prescribed treatment duration. Prolonged use 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 may affect growth in children and teenagers, and 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 to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including:
- Weight gain (especially in the trunk and face, 'moon face')
- Fatigue and muscle weakness
- High blood pressure
- High blood sugar (hyperglycemia)
- Glucosuria (sugar in urine)
- Osteoporosis
- Growth retardation in children
- Adrenal insufficiency upon abrupt withdrawal
What to Do:
If overdose is suspected, contact a poison control center (Call 1-800-222-1222) or seek immediate medical attention. Management is supportive and symptomatic. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis (e.g., inflammation, erythema, pruritus, scaling) and identify any pre-existing skin infections or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Therapeutic efficacy
Frequency: Periodically, typically within 1-2 weeks of initiation, then as clinically indicated.
Target: Reduction in signs and symptoms of dermatosis (e.g., decreased erythema, pruritus, scaling).
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment plan. If significant improvement, consider tapering or discontinuing.
Local adverse effects
Frequency: At each follow-up visit, or if patient reports new symptoms.
Target: Absence of or minimal skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, acneiform eruptions, hypopigmentation.
Action Threshold: If significant local adverse effects develop, reduce frequency, switch to lower potency, or discontinue.
Signs of infection
Frequency: At each follow-up visit, or if patient reports new symptoms.
Target: Absence of signs of bacterial, fungal, or viral infection (e.g., pus, fever, worsening pain, spreading lesions).
Action Threshold: If infection suspected, discontinue mometasone and initiate appropriate antimicrobial therapy.
HPA axis suppression (for extensive/prolonged use)
Frequency: Consider if used on large body surface areas, under occlusion, or for prolonged periods, especially in children. May involve morning cortisol levels or ACTH stimulation test.
Target: Normal morning cortisol levels.
Action Threshold: If HPA axis suppression is suspected or confirmed, gradually withdraw mometasone, or switch to a lower potency corticosteroid. Consult endocrinology if severe.
Symptom Monitoring
- Local irritation (burning, stinging, itching)
- Dryness
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy (thinning, easy bruising, shiny skin)
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Secondary infection (redness, swelling, pus, fever)
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, delayed wound healing, growth retardation in children)
Special Patient Groups
Pregnancy
Mometasone furoate is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. 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:
Potential for teratogenicity observed in animal studies with high systemic doses. Human data are limited.
Second Trimester:
Risk of fetal growth restriction or other systemic effects with high systemic exposure.
Third Trimester:
Risk of fetal growth restriction or other systemic effects with high systemic exposure. 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. Use with caution in nursing mothers. Avoid applying to the breast area to prevent accidental ingestion by the infant.
Infant Risk:
Low risk with appropriate use due to minimal systemic absorption. Monitor infant for any signs of adverse effects (e.g., growth suppression) if mother uses extensively.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids, including hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension, due to their larger skin surface area to body weight ratio. Not recommended for children under 2 years of age. Use the smallest amount necessary for the shortest duration in children 2 years and older. Monitor for growth retardation.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, increasing their susceptibility to local adverse effects such as skin atrophy and purpura. Use with caution and monitor for skin integrity.
Clinical Information
Clinical Pearls
- Mometasone furoate 0.1% topical solution/lotion is a high-potency corticosteroid. It should be used judiciously and for limited durations, especially on sensitive areas like the face, groin, or axillae.
- Patients should be educated on the correct application technique: a thin film, once daily, only to affected areas. Emphasize not to use more than prescribed or for longer than recommended.
- Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the underlying skin condition or, rarely, adrenal insufficiency.
- Topical corticosteroids can mask or worsen skin infections. If signs of infection develop, discontinue mometasone and treat the infection appropriately.
- Not indicated for rosacea or perioral dermatitis, as it can exacerbate these conditions.
Alternative Therapies
- Medium-potency topical corticosteroids (e.g., triamcinolone acetonide 0.1%)
- Low-potency topical corticosteroids (e.g., hydrocortisone 1%)
- Topical calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses
Cost & Coverage
Average Cost:
$20 - $60 per 60ml bottle (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations) on most commercial and Medicare Part D plans.
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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.