Clotrimazole-Betamethasone Crm 15gm
It is used to treat certain skin problems when a fungal skin infection is present.
Drug Class
Topical Corticosteroid and Antifungal Combination
Pharmacologic Class
Synthetic Corticosteroid; Imidazole Antifungal
Pregnancy Category
Category C
FDA Approved
Mar 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
This cream contains two medicines: 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 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 your hand 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.
Storage and Disposal
Store this medication at room temperature, keeping it out of the reach of children and pets.
Dispose of unused or expired medication by throwing it away, but 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 information on 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 continue with 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 your hand 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.
Storage and Disposal
Store this medication at room temperature, keeping it out of the reach of children and pets.
Dispose of unused or expired medication by throwing it away, but 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 information on 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 continue with your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash hands before and after applying the cream.
- Clean and dry the affected area thoroughly before application.
- Apply a thin layer of cream to cover the affected skin area completely.
- Do not use more cream than prescribed or apply more often than directed.
- Do not cover the treated area with bandages or dressings unless instructed by your doctor, as this can increase absorption.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence of the infection.
- Wear loose-fitting clothing and breathable footwear (for foot infections) to keep the area dry and promote healing.
- Avoid sharing towels or personal items to prevent spreading the infection.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas twice daily, 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 extreme caution due to increased systemic absorption risk)
Child:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Use with caution and for the shortest duration possible due to potential for systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks.
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 adjustment needed for topical use.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Betamethasone dipropionate 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. 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption for both components when applied topically to intact skin. Absorption can increase with inflammation, skin barrier disruption, prolonged use, or occlusive dressings.
Tmax:
Not applicable for topical application for systemic effects; local concentration achieved rapidly.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable for topical application for systemic effects; primarily localized to skin.
ProteinBinding:
Betamethasone: Approximately 64% (systemic absorption). Clotrimazole: Not well quantified for topical, but low systemic absorption.
CnssPenetration:
No (not systemically significant).
Elimination:
HalfLife:
Betamethasone: Approximately 3-5 hours (systemic). Clotrimazole: Not well quantified for topical, but rapid systemic clearance if absorbed.
Clearance:
Not well quantified for topical.
ExcretionRoute:
Betamethasone: Primarily renal. Clotrimazole: Primarily biliary/fecal.
Unchanged:
Minimal unchanged drug excreted systemically.
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (anti-inflammatory) and antifungal effect.
PeakEffect:
Within 1-2 weeks for full therapeutic effect.
DurationOfAction:
Effects persist as long as applied; local duration of action is hours.
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 signs or symptoms, contact your doctor or seek immediate medical attention:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Changes in skin color
Thinning of the skin
Irritation at the site of application
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 or seek medical help if they bother you or do not go away:
Burning sensation
* Skin tingling
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek immediate medical attention:
Allergic reaction symptoms, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty 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
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
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 stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow healing
+ Excessive hair growth
Changes in skin color
Thinning of the skin
Irritation at the site of application
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 or seek medical help if they bother you or do not go away:
Burning sensation
* Skin tingling
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.
Seek Immediate Medical Attention If You Experience:
- Worsening of the skin condition or no improvement after 1-2 weeks of use.
- Severe burning, itching, irritation, or redness at the application site.
- Development of new skin problems like thinning skin, stretch marks, or acne-like bumps.
- Signs of a more serious infection (e.g., pus, fever, spreading redness).
- Unusual fatigue, weakness, or weight gain (signs of systemic steroid 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 interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may affect the safety or efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may affect the safety or efficacy of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 this with your doctor to ensure safe use. Do not use this medication for a longer period than 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. It is necessary to discuss the benefits and risks of using this medication to ensure the health and well-being of both you and your baby. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
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 a longer period than 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. It is necessary to discuss the benefits and risks of using this medication to ensure the health and well-being of both you and your baby. When breastfeeding, avoid applying this drug directly to the nipple or the surrounding area.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large surface areas or under occlusive dressings, can lead to systemic absorption of betamethasone.
- Symptoms of systemic corticosteroid excess (Cushing's syndrome): weight gain, moon face, buffalo hump, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar.
- HPA axis suppression (adrenal insufficiency) upon abrupt discontinuation after prolonged high-dose use: fatigue, weakness, nausea, vomiting, low blood pressure.
What to Do:
Discontinue use and consult a healthcare professional. Management is symptomatic and supportive. For suspected HPA axis suppression, gradual withdrawal of the corticosteroid may be necessary. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (type of lesion, extent, signs of infection)
Rationale: To assess initial severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus, fungal signs)
Frequency: Daily by patient, weekly by clinician if needed.
Target: Improvement in symptoms and lesion appearance.
Action Threshold: Lack of improvement or worsening after 1-2 weeks may indicate need for re-evaluation or alternative therapy.
Adverse skin reactions (atrophy, striae, telangiectasias, irritation, folliculitis)
Frequency: Regularly during treatment.
Target: Absence of significant adverse effects.
Action Threshold: Development of significant skin changes warrants discontinuation or reduction in frequency/potency.
Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Normal physiological parameters.
Action Threshold: Any signs or symptoms warrant immediate medical evaluation and discontinuation.
Symptom Monitoring
- Worsening of skin rash or infection
- Increased redness, itching, or burning at application site
- Development of new skin lesions (e.g., thinning skin, stretch marks, acne-like eruptions)
- Unusual fatigue or weakness
- Increased thirst or urination (signs of hyperglycemia)
- Weight gain, moon face, buffalo hump (signs of Cushing's syndrome)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Betamethasone is Pregnancy Category C. Clotrimazole is Pregnancy Category B. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Avoid if possible, especially high-potency steroids, due to theoretical risk of teratogenicity, though data for topical steroids is limited.
Second Trimester:
Use with caution, for shortest duration, and on smallest area possible.
Third Trimester:
Use with caution, for shortest duration, and on smallest area possible. Risk of HPA axis suppression in the neonate with prolonged high-dose maternal use.
Lactation
It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is minimal, so risk to infant is generally considered low. Use with caution. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk, but monitor infant for adverse effects if significant maternal absorption is suspected.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the smallest amount for the shortest duration possible. Not recommended for use in children under 12 years of age for tinea infections, and generally not recommended for infants. Monitor growth and development if prolonged use is necessary.
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 atrophy and other local adverse effects.
Clinical Information
Clinical Pearls
- This combination cream is specifically for fungal infections that also have significant inflammation. If inflammation is absent or resolves, a single antifungal agent may be more appropriate.
- Do not use for longer than the prescribed duration (typically 2 weeks) to minimize the risk of corticosteroid-related side effects like skin atrophy, striae, and HPA axis suppression.
- Not for ophthalmic, oral, or intravaginal use.
- Avoid use on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to corticosteroid side effects.
- If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
- Patients should be advised to complete the full course of antifungal treatment, even if symptoms improve, to prevent relapse.
Alternative Therapies
- Topical antifungal agents alone (e.g., clotrimazole, miconazole, terbinafine, econazole)
- Topical corticosteroids alone (e.g., betamethasone, triamcinolone, hydrocortisone) if inflammation is the primary issue without fungal infection.
- Oral antifungal agents for severe or widespread infections (e.g., terbinafine, fluconazole).
Cost & Coverage
Average Cost:
$15 - $50 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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.