Mometasone 0.1% Ointment 45gm

Manufacturer G & W 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
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mometasone ointment is a medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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 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 have access to 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.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer of the ointment to the affected skin area, usually once a day, as directed by your doctor.
  • Rub it in gently until it disappears.
  • Do not use more than prescribed or for longer than recommended.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid applying to the face, groin, or armpits unless 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.

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.
atopicDermatitis: Apply a thin film to the affected skin areas once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Use with caution; limited to smallest amount for shortest duration due to increased systemic absorption risk.
Child: Apply a thin film to the affected skin areas once daily. Limit treatment to 3 weeks in children 2 years of age or older. Not recommended for children under 2 years of age.
Adolescent: Apply a thin film to the affected skin areas once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.

Pharmacology

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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. 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, higher with damaged skin or occlusion).
Tmax: Not applicable for topical systemic absorption; local effect is immediate.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not widely distributed systemically due to minimal absorption.
ProteinBinding: Not available (minimal systemic absorption).
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely determined for topical systemic absorption; local effect is prolonged.
Clearance: Not precisely determined for topical systemic absorption.
ExcretionRoute: Primarily via urine and feces for systemically absorbed drug, but absorption is minimal.
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist for 24 hours after once-daily application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 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 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 or seek medical help:

Burning or stinging
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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of your skin condition or no improvement after a few days/weeks.
  • Signs of a skin infection (e.g., pus, increased pain, fever, spreading redness).
  • Severe burning, itching, irritation, or dryness at the application site.
  • Development of new skin problems like acne, thinning skin, stretch marks, or changes in skin color.
  • Unusual fatigue, weakness, dizziness, or weight loss (rare signs of systemic absorption).
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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, 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication 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 area of skin, exercise caution and discuss this with your doctor.

Do not exceed the prescribed duration of treatment. 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 specific age groups of children. 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 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.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (e.g., fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, erythema)

Frequency: Regularly during treatment, typically weekly or bi-weekly.

Target: Improvement in symptoms.

Action Threshold: Lack of improvement or worsening symptoms warrants re-evaluation.

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit, especially with prolonged use.

Target: Absence of adverse reactions.

Action Threshold: Presence of adverse reactions may require discontinuation or change in therapy.

Signs of HPA axis suppression (e.g., fatigue, weight loss, dizziness) - *rare*

Frequency: Considered for extensive or prolonged use, especially in children or with occlusion.

Target: Normal HPA axis function.

Action Threshold: Symptoms or abnormal laboratory tests (e.g., morning cortisol, ACTH stimulation test) require immediate medical attention and discontinuation.

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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., acne, folliculitis)
  • Signs of skin infection (pus, fever, spreading redness)
  • Skin thinning, easy bruising, stretch marks (striae)
  • Unusual fatigue, weakness, weight loss (signs of systemic absorption/HPA suppression)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects; use with caution and only if clearly needed.
Second Trimester: Use with caution; minimal systemic absorption reduces risk, but still consider benefit vs. risk.
Third Trimester: Use with caution; minimal systemic absorption reduces risk, but still consider benefit vs. risk.
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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. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use due to minimal systemic absorption, but monitor infant for potential adverse effects.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 2 years of age. Limit treatment duration to 3 weeks in children 2 years of age or older. Use the least potent effective corticosteroid for the shortest duration.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Mometasone ointment is a potent topical corticosteroid; use it sparingly and for the shortest duration necessary to achieve control of symptoms.
  • The ointment formulation is generally preferred for dry, scaly, or lichenified lesions, while creams or lotions may be better for weeping or intertriginous areas.
  • Educate patients on the 'fingertip unit' for appropriate dosing to avoid overuse.
  • Warn patients about the risk of skin atrophy, striae, and telangiectasias with prolonged use, especially on sensitive areas like the face or skin folds.
  • If no improvement is seen after 2-3 weeks, re-evaluate the diagnosis and treatment plan.
  • Abrupt discontinuation after prolonged, extensive use can lead to rebound flares of the dermatosis or signs of adrenal insufficiency.
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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
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medication taken, the amount, and the time it occurred.