Lotrisone Lotion 30ml

Manufacturer SCHERING Active Ingredient Betamethasone and Clotrimazole Lotion(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 Antifungal and Corticosteroid Combination
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Pharmacologic Class
Corticosteroid (topical); Imidazole Antifungal (topical)
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Pregnancy Category
Category C
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FDA Approved
Aug 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lotrisone Lotion is a medicine that combines two active ingredients: a steroid (betamethasone) and an antifungal (clotrimazole). It's used to treat fungal skin infections like athlete's foot, jock itch, and ringworm, while also reducing the redness, itching, and swelling that often come with these infections.
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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 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.

Special Handling

Shake the medication well before use.

Storage and Disposal

Store the medication at room temperature, upright, and with the cap on.
Keep all medications in a safe place, out of the reach of children and pets.

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 continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash and dry the affected skin area thoroughly before applying the lotion.
  • Apply a thin layer of lotion to the affected area and gently rub it in.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor.
  • Wear loose-fitting clothing, especially for jock itch or athlete's foot, to allow air circulation.
  • Keep the affected area clean and dry to prevent recurrence of fungal infections.
  • Wash hands thoroughly after applying the lotion to prevent spreading the infection or medication to other areas.
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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, in the morning and evening. Gently massage into the skin. Treatment duration should not exceed 2 weeks for tinea cruris and tinea corporis, and 4 weeks for tinea pedis.

Condition-Specific Dosing:

tineaCruris_Corporis: Apply twice daily for no more than 2 weeks.
tineaPedis: Apply twice daily for no more than 4 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not recommended for children under 17 years of age for tinea cruris, tinea corporis, or tinea pedis due to increased risk of systemic absorption and HPA axis suppression.
Adolescent: For adolescents 17 years and older, apply a thin layer to the affected skin areas twice a day, in the morning and evening. Treatment duration should not exceed 2 weeks for tinea cruris and tinea corporis, and 4 weeks for tinea pedis. Use with caution and monitor for systemic effects.
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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, a potent corticosteroid, exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Clotrimazole, an imidazole antifungal, inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and cell death.
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Pharmacokinetics

Absorption:

Bioavailability: Not quantifiable for topical use; minimal systemic absorption, but can increase with occlusive dressings, inflamed skin, or large surface areas.
Tmax: Not applicable for topical use.
FoodEffect: Not applicable for topical use.

Distribution:

Vd: Not quantifiable for topical use; primarily local.
ProteinBinding: Not quantifiable for topical use; for systemically absorbed betamethasone, high protein binding.
CnssPenetration: Not applicable for topical use; limited for systemically absorbed components.

Elimination:

HalfLife: Not quantifiable for topical use; for systemically absorbed betamethasone, approximately 5 hours.
Clearance: Not quantifiable for topical use.
ExcretionRoute: Not quantifiable for topical use; systemically absorbed betamethasone and its metabolites are primarily excreted in the urine and bile.
Unchanged: Not quantifiable for topical use.
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Pharmacodynamics

OnsetOfAction: Symptomatic relief (itching, redness) typically within a few days; mycological cure may take 2-4 weeks.
PeakEffect: Peak symptomatic relief within 1-2 weeks; full antifungal effect within 2-4 weeks.
DurationOfAction: Duration of effect after discontinuation depends on the complete resolution of the infection and inflammation.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Burning
* Skin tingling

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 skin condition or no improvement after the recommended treatment period.
  • Severe burning, itching, or irritation at the application site.
  • Signs of skin thinning, such as easy bruising, shiny skin, or visible blood vessels.
  • Development of stretch marks (striae) in the treated area.
  • Unusual weight gain, swelling in the face (moon face), or other signs of systemic steroid absorption (rare, but possible with prolonged or extensive use).
  • Signs of a new infection (e.g., pus, increased pain, fever).
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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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, 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 other medications and health conditions. Never start, stop, or change 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. Additionally, before using any other medications or products on your skin, including soaps, discuss this 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 it to cuts, scrapes, or damaged skin. Furthermore, this drug should not be used on the face or underarms.

Be aware that this medication may increase the risk of developing cataracts or glaucoma; therefore, it is crucial to discuss this with your doctor. 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 potentially affect growth in some cases, necessitating regular growth checks. Consult with your doctor to discuss this further. This medication is not intended for use in children under the age of 17.

If you are pregnant, planning to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of using this medication with your doctor. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause acute systemic symptoms.
  • Prolonged or excessive use, especially over large surface areas or under occlusive dressings, can lead to systemic effects of corticosteroids, including Cushing's syndrome, hyperglycemia, and glucosuria.
  • Symptoms of Cushing's syndrome may include moon face, central obesity, thinning skin, easy bruising, and muscle weakness.

What to Do:

Discontinue the medication. If systemic effects are suspected, consult a healthcare professional immediately. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Clinical assessment of skin condition

Rationale: To determine the extent and severity of fungal infection and inflammation.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Resolution of symptoms (itching, redness, scaling)

Frequency: Daily/Weekly

Target: Progressive improvement

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

Local adverse reactions (burning, stinging, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria)

Frequency: Daily/Weekly

Target: Absence or minimal

Action Threshold: Discontinue if irritation, sensitization, or significant adverse effects occur.

Signs of HPA axis suppression (rare with appropriate use)

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings

Target: Normal adrenal function

Action Threshold: If suspected, perform ACTH stimulation test; discontinue or reduce frequency.

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Symptom Monitoring

  • Worsening of rash or symptoms
  • Severe burning, stinging, or itching at application site
  • Signs of skin thinning (e.g., easy bruising, shiny skin, visible blood vessels)
  • Development of stretch marks (striae)
  • Unusual weight gain, moon face, or other signs of Cushing's syndrome (rare, indicates systemic absorption)
  • Signs of secondary bacterial infection (e.g., pus, increased pain, fever)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid extensive use, large amounts, or prolonged periods.

Trimester-Specific Risks:

First Trimester: Potential risk, use only if clearly needed.
Second Trimester: Potential risk, use only if clearly needed.
Third Trimester: Potential risk, use only if clearly needed.
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Lactation

Use with caution. It is not known whether topically administered corticosteroids or clotrimazole 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 with appropriate use, but monitor for potential adverse effects in the infant.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity, including HPA axis suppression and Cushing's syndrome. Not recommended for children under 17 years of age for tinea cruris, tinea corporis, or tinea pedis. Use in older adolescents should be with caution and for the shortest duration possible.

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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 overall risk is low with appropriate use. Monitor for skin fragility.

Clinical Information

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Clinical Pearls

  • Lotrisone Lotion is for external use only. Do not use in the eyes, mouth, or vagina.
  • Do not use for longer than the recommended duration (2 weeks for tinea cruris/corporis, 4 weeks for tinea pedis) to minimize the risk of corticosteroid-related side effects and to prevent the development of corticosteroid-induced dermatoses.
  • If irritation or sensitization develops, discontinue treatment and institute appropriate therapy.
  • If there is no improvement after the recommended treatment period, the diagnosis should be re-evaluated.
  • The corticosteroid component can mask the clinical signs of a fungal infection or worsen it if used inappropriately or for too long.
  • Ensure patients understand that this is a combination product and should not be used for conditions that only require a corticosteroid or only an antifungal.
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Alternative Therapies

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

Average Cost: Varies, typically $50-$150 per 30ml tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (brand), Tier 1 (generic)
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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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.