Clotrimazole-Betamethasone Crm 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
Corticosteroid; Imidazole antifungal
Pregnancy Category
Category C
FDA Approved
Jun 1984
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 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.
Storage and Disposal
Store this medication at room temperature, keeping it in a safe place out of the reach of children and pets.
Dispose of unused or expired medication by throwing it away. 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
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, 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.
Storage and Disposal
Store this medication at room temperature, keeping it in a safe place out of the reach of children and pets.
Dispose of unused or expired medication by throwing it away. 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
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 area and gently rub it in completely.
- 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.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not use this cream for longer than prescribed, typically 2 weeks, as prolonged use can lead to side effects.
- Do not use this cream for any condition other than for which it was prescribed.
- Keep out of reach of children.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin area twice daily, in the morning and evening.
Condition-Specific Dosing:
tineaPedis:
Apply for 2 weeks
tineaCruris:
Apply for 2 weeks
tineaCorporis:
Apply for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Apply a thin layer to the affected skin area twice daily for up to 2 weeks. Use with caution and for the shortest duration possible due to increased risk of systemic absorption.
Adolescent:
Apply a thin layer to the affected skin area 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 potent 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 that 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 ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 5% for betamethasone, less than 0.5% for clotrimazole) through intact skin; absorption increases with inflammation, occlusive dressings, or large surface areas.
Tmax:
Not applicable for topical systemic effects; local peak concentration achieved shortly after application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not available for topical application; betamethasone is highly protein-bound systemically.
ProteinBinding:
Betamethasone: Approximately 64% (systemic); Clotrimazole: Not available for topical.
CnssPenetration:
Limited/No (systemic absorption is minimal).
Elimination:
HalfLife:
Betamethasone: Approximately 5 hours (systemic); Clotrimazole: Not available for topical.
Clearance:
Not available for topical.
ExcretionRoute:
Betamethasone: Primarily renal; Clotrimazole: Primarily biliary/fecal.
Unchanged:
Not available for topical.
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief (itching, inflammation); full antifungal effect may take 1-2 weeks.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; recurrence if treatment stopped prematurely.
Confidence:
Medium
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 at the site of application
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only 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, 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 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 at the site of application
Changes in eyesight
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only 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, 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
- Severe irritation, redness, or burning at the application site
- Signs of a new skin infection (e.g., pus, spreading redness)
- Unusual skin changes like thinning, stretch marks, or discoloration
- Signs of systemic steroid absorption (rare): unusual weight gain, swelling in ankles/feet, increased thirst/urination, vision problems, mood changes, fatigue.
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 use, 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 use, 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 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 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 weigh 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 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 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 weigh 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:
- Prolonged or excessive use may lead to systemic corticosteroid effects, including adrenal suppression, Cushing's syndrome, hyperglycemia, and glucosuria. Symptoms may include moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, and high blood pressure.
What to Do:
Discontinue the medication. Symptomatic and supportive treatment. In case of suspected systemic overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To determine the extent and type of fungal infection and inflammation.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in inflammation, itching, fungal lesions)
Frequency: Daily/Weekly
Target: Improvement in symptoms and lesion appearance
Action Threshold: Lack of improvement after 1 week or worsening symptoms warrants re-evaluation.
Adverse skin reactions (e.g., atrophy, striae, folliculitis, irritation)
Frequency: Weekly
Target: Absence of significant skin changes
Action Threshold: Development of significant skin changes requires discontinuation or re-evaluation.
Signs of systemic corticosteroid absorption (rare with proper use)
Frequency: Periodically, especially with prolonged use, large areas, or occlusive dressings
Target: Absence of Cushing's syndrome symptoms, adrenal suppression
Action Threshold: Any signs of systemic effects require immediate discontinuation and medical evaluation.
Symptom Monitoring
- Redness
- Itching
- Burning
- Stinging
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin maceration
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
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 with topical use, can occur. High doses or prolonged use should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic absorption is low.
Second Trimester:
Potential for fetal harm, though systemic absorption is low.
Third Trimester:
Potential for fetal harm, though systemic absorption is low. Risk of low birth weight or adrenal suppression in neonate with prolonged high-dose use.
Lactation
Caution should be exercised when administered to a nursing woman. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic absorption is minimal, but avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk, but monitor for potential effects if significant maternal absorption occurs.
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 smallest amount for the shortest duration possible. Not recommended for children under 12 years for tinea infections.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects like skin atrophy. Monitor for skin integrity.
Clinical Information
Clinical Pearls
- This combination cream is effective for fungal infections that also present with significant inflammation (e.g., severe itching, redness).
- It is generally not recommended for long-term use (beyond 2-4 weeks) due to the corticosteroid component, which can lead to skin atrophy, striae, and potential systemic effects.
- If the fungal infection persists or worsens after the recommended treatment duration, re-evaluate the diagnosis and consider alternative antifungal therapies without a corticosteroid.
- Avoid using this cream on the face, groin, or axillae unless specifically directed by a physician, as these areas are more susceptible to corticosteroid side effects.
- Patients should be advised not to use occlusive dressings unless specifically instructed by a healthcare provider, as this significantly increases systemic absorption of the corticosteroid.
Alternative Therapies
- Topical antifungals alone (e.g., clotrimazole cream, miconazole cream, terbinafine cream)
- Topical corticosteroids alone (e.g., betamethasone cream, triamcinolone cream) for inflammatory dermatoses without fungal infection.
- Oral antifungals (e.g., terbinafine, fluconazole) for severe or widespread fungal infections.
Cost & Coverage
Average Cost:
$30 - $100 per 45gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.