Lotrisone Cream 45gm
It is used to treat certain skin problems when a fungal skin infection is present.
Drug Class
Topical corticosteroid and antifungal combination
Pharmacologic Class
Glucocorticoid; Imidazole antifungal
Pregnancy Category
Category C
FDA Approved
Jun 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lotrisone Cream is a medicine that combines a steroid (betamethasone) to reduce redness, swelling, and itching, with an antifungal (clotrimazole) to kill the fungus causing skin infections like athlete's foot, jock itch, and ringworm. It helps clear up the infection and relieve uncomfortable symptoms.
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, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, vagina, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, 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 instructs you to do so.
When applying the medication 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.
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 pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, 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.
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, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, vagina, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, 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 instructs you to do so.
When applying the medication 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.
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 pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, 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.
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.
- Do not use more cream than prescribed or apply it more often than directed.
- Do not cover the treated area with bandages or tight dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Wash hands thoroughly after applying the cream.
- Do not use for longer than the prescribed duration (usually 2 weeks), even if symptoms improve, to prevent recurrence and minimize steroid side effects.
- Wear loose-fitting clothing and keep the affected area dry and clean to help prevent recurrence of fungal infections.
- Do not share this medication with others.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice a day, in the morning and evening.
Condition-Specific Dosing:
tineaPedis:
Apply twice daily for 2 weeks
tineaCruris:
Apply twice daily for 2 weeks
tineaCorporis:
Apply twice daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, increased systemic absorption risk)
Child:
Apply a thin layer to the affected skin areas twice a day for up to 2 weeks. Use with caution, especially in children due to higher surface area to body mass ratio and potential for systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin layer to the affected skin areas twice a day for up to 2 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Betamethasone dipropionate is a potent synthetic corticosteroid that 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 by inhibiting the release of their common precursor, arachidonic acid. 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 fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1% for betamethasone, less than 0.5% for clotrimazole) through intact skin; increased with inflammation, occlusive dressings, or prolonged use.
Tmax:
Not applicable for topical systemic effects; local concentration achieved rapidly.
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Betamethasone: Approximately 64% (systemically absorbed); Clotrimazole: Not well quantified for topical absorption.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Betamethasone: Approximately 5 hours (systemically absorbed); Clotrimazole: Not well quantified for topical absorption.
Clearance:
Not applicable (minimal systemic clearance)
ExcretionRoute:
Betamethasone: Renal; Clotrimazole: Biliary/fecal
Unchanged:
Not significant for topical use
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (anti-inflammatory, antipruritic); full antifungal effect within 1-2 weeks.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; recurrence possible if underlying fungal infection not fully eradicated.
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 medical attention immediately:
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 where the medication was applied
Change 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 mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor or seek medical attention:
Burning
* Skin tingling
This is not an exhaustive 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.
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 medical attention immediately:
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 where the medication was applied
Change 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 mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor or seek medical attention:
Burning
* Skin tingling
This is not an exhaustive 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 skin condition or no improvement after 1-2 weeks of use.
- Severe burning, stinging, itching, or irritation at the application site.
- Development of new skin problems like thinning skin, stretch marks, acne, or changes in skin color.
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing).
- Signs of systemic steroid absorption (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, vision changes) - rare but possible with extensive or prolonged use.
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 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 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 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. 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.
Using this medication may increase the risk of developing cataracts or glaucoma. Therefore, it is crucial to discuss this potential risk 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 affect growth in some cases. Regular growth checks may be necessary, so it is essential to consult 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 and your doctor will need to discuss the potential 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 to prevent potential harm to your baby.
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.
Using this medication may increase the risk of developing cataracts or glaucoma. Therefore, it is crucial to discuss this potential risk 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 affect growth in some cases. Regular growth checks may be necessary, so it is essential to consult 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 and your doctor will need to discuss the potential 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 to prevent potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption of betamethasone, potentially causing Cushing's syndrome, hyperglycemia, and adrenal insufficiency.
- Symptoms may include: moon face, central obesity, thinning skin, easy bruising, striae, muscle weakness, fatigue, high blood pressure, increased blood sugar, and growth retardation in children.
What to Do:
If overdose is suspected due to extensive or prolonged use, contact a poison control center (call 1-800-222-1222) or seek immediate medical attention. Treatment is supportive and may involve gradual withdrawal of the corticosteroid.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical diagnosis of fungal infection (e.g., tinea pedis, cruris, corporis)
Rationale: To ensure appropriate use for indicated conditions.
Timing: Prior to initiation of therapy
Assessment of skin condition (e.g., inflammation, erythema, scaling, pruritus)
Rationale: To establish baseline severity and monitor treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly
Target: Improvement or resolution
Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms, requires re-evaluation of diagnosis and treatment.
Signs of local adverse reactions (e.g., burning, stinging, irritation, skin atrophy, striae, folliculitis)
Frequency: Daily/Weekly
Target: Absence or minimal
Action Threshold: Persistent or severe reactions warrant discontinuation and medical evaluation.
Signs of HPA axis suppression (especially with prolonged use, large surface areas, or occlusive dressings)
Frequency: Periodically, if risk factors present
Target: Normal cortisol levels
Action Threshold: Symptoms of Cushing's syndrome, hyperglycemia, or adrenal insufficiency require immediate medical attention and gradual withdrawal.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Erythema
- Folliculitis
- Skin atrophy
- Striae
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Secondary infection
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, muscle weakness, blurred vision - rare with appropriate topical use)
Special Patient Groups
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, though minimal, can occur. High doses or prolonged use of topical corticosteroids during pregnancy have been associated with adverse effects in animal studies.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, or use with extreme caution, due to potential for teratogenicity with systemic corticosteroids.
Second Trimester:
Use with caution, minimal systemic absorption is expected with appropriate topical use.
Third Trimester:
Use with caution, minimal systemic absorption is expected with appropriate topical use. Avoid large areas or prolonged use.
Lactation
It is not known whether topically administered corticosteroids are excreted in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Lotrisone Cream is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate topical use, but potential for systemic effects if significant absorption occurs in mother.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Not recommended for children under 12 years of age for tinea infections. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase the risk of local adverse effects like skin atrophy or purpura. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Lotrisone is a combination product and should only be used when both a corticosteroid and an antifungal are indicated, typically for inflammatory fungal infections.
- Limit treatment duration to 2 weeks for tinea infections to minimize corticosteroid side effects and prevent resistance.
- If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis. Prolonged use can lead to skin atrophy, striae, and HPA axis suppression.
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, due to increased risk of local side effects (e.g., skin thinning, striae).
- This cream is for external use only. Do not use in the eyes, mouth, or vagina.
- Patients should be advised that this medication is not for ophthalmic, oral, or intravaginal use.
Alternative Therapies
- Topical antifungals alone (e.g., clotrimazole cream, miconazole cream, terbinafine cream) for non-inflammatory fungal infections.
- Topical corticosteroids alone (e.g., betamethasone dipropionate cream, triamcinolone cream) for inflammatory dermatoses without fungal infection.
- Oral antifungals (e.g., terbinafine, fluconazole) for extensive or recalcitrant fungal infections.
Cost & Coverage
Average Cost:
$50 - $150 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most insurance plans, generic preferred)
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 for more information. 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.