Lotrisone Cream 15gm

Manufacturer MERCK SHARP & DOHME Active Ingredient Betamethasone and Clotrimazole Cream(bay ta METH a sone & kloe TRIM a zole) Pronunciation bay ta METH a sone & kloe TRIM a zole
It is used to treat certain skin problems when a fungal skin infection is present.
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Drug Class
Topical Corticosteroid and Antifungal Combination
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Pharmacologic Class
Glucocorticoid (topical) and Imidazole Antifungal
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Pregnancy Category
Category C
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FDA Approved
Jun 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lotrisone Cream is a medicine that combines two ingredients: a steroid (betamethasone) to reduce redness, swelling, and itching, and an antifungal (clotrimazole) to kill the fungus causing the infection. It's used to treat certain fungal skin infections like athlete's foot, jock itch, and ringworm.
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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. Use this medication only as directed and continue to use it even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, avoiding the mouth, nose, vagina, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it 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.
When applying to the groin area, use a small amount and avoid wearing tight clothing.
Do not use this medication to treat diaper rash or redness, and avoid applying it to the diaper area.

Storage and Disposal

Store this medication at room temperature, out of the reach of children and pets.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program 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 application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash and dry the affected area thoroughly before applying the cream.
  • Apply a thin layer of cream to the affected skin and surrounding area, rubbing it in gently.
  • Wash your hands immediately after applying the cream, unless your hands are the treated area.
  • Do not cover the treated area with bandages or other dressings unless directed by your doctor.
  • Wear loose-fitting clothing, especially for jock itch.
  • Keep the affected area clean and dry.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin areas twice a day (morning and evening).

Condition-Specific Dosing:

tinea_cruris_corporis: Apply twice daily for up to 2 weeks.
tinea_pedis: Apply twice daily for up to 4 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with caution, increased risk of systemic absorption)
Child: Apply a thin layer to the affected skin areas twice a day for up to 2 weeks. Not recommended for prolonged use or on large body surface areas due to increased risk of systemic corticosteroid effects.
Adolescent: Apply a thin layer to the affected skin areas twice a day for up to 2 weeks (tinea cruris/corporis) or 4 weeks (tinea pedis).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Betamethasone dipropionate is a synthetic corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are thought to be mediated through the induction of phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Clotrimazole is an imidazole antifungal agent that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This inhibition leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (variable, depends on skin integrity, site, duration, and use of occlusive dressings).
Tmax: Not applicable for topical systemic effects; local concentration achieved rapidly.
FoodEffect: Not applicable (topical).

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Betamethasone: Approximately 64% (systemically absorbed portion); Clotrimazole: Not well quantified for topical use.
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Betamethasone: Approximately 5 hours (systemically absorbed portion); Clotrimazole: Not well quantified for topical use.
Clearance: Not well quantified for topical use.
ExcretionRoute: Betamethasone: Primarily renal; Clotrimazole: Primarily biliary/fecal.
Unchanged: Minimal (for both components systemically)
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Pharmacodynamics

OnsetOfAction: Within days for symptomatic relief (itching, redness); full antifungal effect takes longer.
PeakEffect: Within 1-2 weeks for significant improvement.
DurationOfAction: Effects persist as long as applied; resolution of infection requires full course.

Safety & Warnings

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Side Effects

Serious 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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Change in skin color
Thinning of the skin
Irritation at the site of application
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 contact your doctor or seek medical help if you notice any of the following:

Burning
* Skin tingling

These are not all the possible side effects that may occur. 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of the rash or symptoms
  • Severe burning, itching, or irritation at the application site
  • Signs of a new skin infection (e.g., pus, spreading redness)
  • Skin thinning, easy bruising, or stretch marks in the treated area (with prolonged use)
  • Unusual fatigue, weight gain, or swelling (rare, signs of systemic steroid 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 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 or exacerbate underlying health issues.

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 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. When applying this drug to a large area of skin or near open wounds, exercise caution and consult with your doctor.

Before using any other medications or products on your skin, including soaps, discuss them with your doctor to ensure safe use. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

Avoid applying this drug to cuts, scrapes, or damaged skin. Additionally, do not use this medication on the face or underarms, as it may cause adverse effects.

There is a potential risk of developing cataracts or glaucoma associated with this medication. Consult with your doctor to discuss this risk. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

In children and teenagers, this drug may affect growth in some cases. Regular growth checks may be necessary, so it is crucial to discuss this with your doctor. This medication is not recommended for children under 17 years of age.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the benefits and risks of using this medication to ensure the best outcome for you and your baby. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
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Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use, especially under occlusion or on large surface areas, can lead to systemic corticosteroid effects such as Cushing's syndrome, hyperglycemia, and glucosuria.
  • Acute overdose with topical application is unlikely due to minimal systemic absorption.

What to Do:

Discontinue the medication. Symptomatic and supportive treatment should be initiated. Systemic corticosteroid effects are usually reversible upon discontinuation. Call 1-800-222-1222 (Poison Control Center) for advice if significant exposure or symptoms occur.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition (redness, scaling, itching, lesion size)

Rationale: To assess initial severity and guide treatment duration.

Timing: Prior to initiation of therapy.

Diagnosis confirmation (e.g., KOH prep for fungal infection)

Rationale: To ensure appropriate use for fungal infections susceptible to clotrimazole.

Timing: Prior to initiation of therapy (if not already confirmed).

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Routine Monitoring

Resolution of symptoms (itching, redness)

Frequency: Daily/Weekly

Target: Decrease in severity

Action Threshold: If no improvement after 1 week (tinea cruris/corporis) or 2 weeks (tinea pedis), re-evaluate diagnosis.

Signs of local adverse reactions (burning, stinging, irritation, dryness, folliculitis, skin atrophy, striae)

Frequency: Regularly during treatment

Target: Absence or mild, transient reactions

Action Threshold: If severe or persistent reactions occur, discontinue use and re-evaluate.

Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, glucosuria) - especially with prolonged/extensive use or in children

Frequency: Periodically, if risk factors present

Target: Normal

Action Threshold: If suspected, discontinue use and manage symptoms.

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Symptom Monitoring

  • Worsening redness
  • Increased itching or burning
  • New rash or irritation
  • Pus or signs of bacterial infection
  • Skin thinning or discoloration
  • Stretch marks (striae)
  • Unusual fatigue or weakness (rare, systemic effects)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone is a Category C drug, and systemic absorption can occur. Clotrimazole is Category B, but systemic absorption is minimal.

Trimester-Specific Risks:

First Trimester: Avoid if possible, or use with caution due to potential for systemic absorption of betamethasone.
Second Trimester: Use with caution, weigh benefits vs. risks.
Third Trimester: Use with caution, weigh benefits vs. risks. Prolonged or extensive use of potent corticosteroids near term may affect fetal adrenal development.
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Lactation

It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption of betamethasone can occur. Exercise caution when administering to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use on small areas. Higher risk with extensive or prolonged use due to potential for systemic absorption and excretion into breast milk.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression, Cushing's syndrome, and intracranial hypertension than adult patients because of a larger skin surface area to body weight ratio. Avoid prolonged use, especially on large surface areas or under occlusion. Not recommended for children under 12 years for tinea pedis.

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Geriatric Use

No specific dosage adjustments are required. Elderly patients may have thinner skin, which could potentially increase systemic absorption, but this is generally not clinically significant with appropriate use. Monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • This cream is for external use only. Do not use in the eyes, mouth, or vagina.
  • Do not use this cream for longer than prescribed, especially in children, due to the corticosteroid component.
  • If there is no improvement after the recommended treatment duration (2 weeks for tinea cruris/corporis, 4 weeks for tinea pedis), the diagnosis should be re-evaluated.
  • Avoid using occlusive dressings (e.g., plastic wrap, tight bandages) over the treated area, as this can increase systemic absorption of the corticosteroid.
  • This combination cream is specifically for fungal infections where inflammation is also present. For fungal infections without significant inflammation, a plain antifungal cream may be preferred.
  • Patients should be advised on proper hygiene to prevent reinfection (e.g., keeping feet dry, changing socks frequently, not sharing towels).
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Alternative Therapies

  • Topical antifungals (e.g., clotrimazole, miconazole, terbinafine, econazole, ketoconazole)
  • Topical corticosteroids (e.g., betamethasone, triamcinolone, hydrocortisone) used alone for inflammatory dermatoses without fungal infection.
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Cost & Coverage

Average Cost: $20 - $60 per 15gm 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's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.