Clotrimazole-Betamethasone Lot 30ml
It is used to treat certain skin problems when a fungal skin infection is present.
Drug Class
Topical Corticosteroid/Antifungal Combination
Pharmacologic Class
Corticosteroid; Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Jun 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a lotion that contains two active ingredients: a steroid (betamethasone) and an antifungal (clotrimazole). The steroid helps reduce redness, swelling, and itching caused by skin inflammation, while the antifungal kills the fungus causing the infection. It's used to treat certain fungal skin infections that also have inflammation.
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 and dry the affected area before applying a thin layer of the medication and gently rubbing 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 each 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 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. 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 and dry the affected area before applying a thin layer of the medication and gently rubbing 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 each 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 resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands thoroughly before and after applying the lotion.
- Apply a thin layer of the lotion to the affected skin area only, and rub it in gently.
- Do not cover the treated area with bandages or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid getting the lotion in your eyes, mouth, or vagina. If it gets into these areas, rinse thoroughly with water.
- Use the medication for the full prescribed duration, even if symptoms improve, to ensure the infection is fully cleared.
- Do not use this medication for longer than 2 weeks for fungal infections in the groin or armpit areas, or for longer than 4 weeks for other body areas, unless directed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice daily (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 (increased risk of systemic absorption and HPA axis suppression)
Child:
Not recommended for children under 12 years for prolonged use or large areas due to risk of HPA axis suppression. For children âĨ12 years with tinea pedis, tinea cruris, or tinea corporis, apply twice daily for 2 weeks.
Adolescent:
Apply a thin layer to the affected skin areas twice daily (morning and evening) for 2 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use.
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use.
Pharmacology
Mechanism of Action
Betamethasone, 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 by inhibiting the release of their common precursor, arachidonic acid. 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 fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (topical, variable systemic absorption)
Tmax:
Not available (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not available (topical)
ProteinBinding:
Betamethasone: High (approx. 64%); Clotrimazole: Not available (topical)
CnssPenetration:
Limited (topical)
Elimination:
HalfLife:
Betamethasone: 300-360 minutes (systemic); Clotrimazole: Not available (topical)
Clearance:
Not available (topical)
ExcretionRoute:
Betamethasone: Renal; Clotrimazole: Biliary and Renal
Unchanged:
Not available (topical)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief (itching, inflammation) within days; Antifungal effect within 1-2 weeks.
PeakEffect:
Clinical improvement typically seen within 1-2 weeks.
DurationOfAction:
Effects persist as long as applied; resolution of infection requires full course.
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 high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Changes in skin color
Thinning of the skin
Irritation at the application site
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning sensation
* Skin tingling
This is not an exhaustive list of possible side effects. If you have 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 high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Changes in skin color
Thinning of the skin
Irritation at the application site
Changes in vision
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning sensation
* Skin tingling
This is not an exhaustive list of possible side effects. If you have 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:
- Worsening of the skin condition or no improvement after 1-2 weeks of use.
- Severe burning, stinging, redness, or irritation at the application site.
- Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks.
- Development of new skin infections or pus-filled bumps.
- Unusual fatigue, weakness, or dizziness (rare, but could indicate systemic absorption).
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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
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 consult with your doctor to monitor growth and development. 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. It is crucial to discuss the benefits and risks of using this medication during these situations. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area to prevent potential harm to the 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.
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 consult with your doctor to monitor growth and development. 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. It is crucial to discuss the benefits and risks of using this medication during these situations. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area to prevent potential harm to the baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical use.
- Prolonged or excessive use, especially over large areas or under occlusion, could lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., weight gain, moon face, thinning skin, high blood pressure) or adrenal suppression.
What to Do:
If systemic effects are suspected, contact your doctor immediately. For accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of skin condition
Rationale: To determine the extent and type of fungal infection and assess baseline inflammation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical improvement of skin lesions
Frequency: Weekly or as clinically indicated
Target: Reduction in erythema, scaling, pruritus; resolution of fungal infection.
Action Threshold: If no improvement after 1-2 weeks, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., skin atrophy, striae, folliculitis, irritation)
Frequency: At each follow-up visit
Target: Absence of new or worsening skin changes.
Action Threshold: Discontinue if severe irritation or signs of skin atrophy develop.
Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, extensive body surface area application, or in children.
Target: Normal adrenal function and glucose levels.
Action Threshold: If suspected, perform appropriate diagnostic tests (e.g., ACTH stimulation test, plasma cortisol) and consider discontinuation or dose reduction.
Symptom Monitoring
- Worsening rash
- Increased redness or swelling
- Severe burning or stinging
- Pus or signs of secondary bacterial infection
- Signs of skin thinning (e.g., easy bruising, shiny skin)
- Unusual fatigue or weakness (possible sign of HPA axis suppression, rare)
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. Avoid extensive use, large areas, or prolonged treatment.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic absorption of betamethasone could theoretically pose risks. Use with caution.
Second Trimester:
Use with caution, avoid large areas or prolonged use.
Third Trimester:
Use with caution, avoid large areas or prolonged use. Neonatal adrenal suppression is a theoretical risk with extensive maternal use of potent corticosteroids near term.
Lactation
Use with caution. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is generally low. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use, but monitor infant for any unusual effects.
Pediatric Use
Children are more susceptible to systemic absorption of topical corticosteroids and thus to HPA axis suppression and Cushing's syndrome than adults, due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years for prolonged use. Use with extreme caution and for the shortest duration possible if necessary in older children.
Geriatric Use
No specific dosage adjustments are generally required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption of the corticosteroid component. Monitor for skin atrophy and other local adverse effects.
Clinical Information
Clinical Pearls
- This combination product is intended for inflammatory fungal infections. If inflammation is not present, a single antifungal agent may be more appropriate.
- Limit treatment duration to 2 weeks for tinea cruris and tinea corporis, and 4 weeks for tinea pedis, to minimize the risk of corticosteroid-related side effects.
- If no clinical improvement is seen after the recommended treatment duration, the diagnosis should be re-evaluated.
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, due to increased risk of skin atrophy and other local side effects in these sensitive areas.
- Not for ophthalmic, oral, or intravaginal use.
Alternative Therapies
- Topical antifungals (e.g., Clotrimazole cream, Miconazole cream, Terbinafine cream)
- Topical corticosteroids (e.g., Betamethasone valerate cream, Triamcinolone acetonide cream)
- Oral antifungals (for severe or widespread infections, e.g., Terbinafine, Fluconazole)
Cost & Coverage
Average Cost:
Varies, typically $20-$100 per 30ml lotion
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 medical attention. When seeking help, be prepared to provide information about what was taken, the amount, and the time it occurred.