Usage
This combination cream is prescribed for the topical treatment of inflammatory skin conditions complicated by bacterial and fungal infections, such as:
- Infected eczema or dermatitis
- Infected psoriasis
- Intertrigo
- Secondarily infected fungal infections (e.g., athlete’s foot, ringworm)
- Minor infected wounds or burns
Pharmacological Classification: This is a combination product containing drugs from multiple classes:
- Clioquinol: Hydroxyquinoline antifungal and antibacterial agent
- Clobetasol: Corticosteroid (anti-inflammatory)
- Ketoconazole & Tolnaftate: Antifungals
- Neomycin: Aminoglycoside antibiotic
Mechanism of Action: The cream combines the effects of its components. Clioquinol disrupts bacterial DNA synthesis and cell membranes, with some antifungal properties. Clobetasol reduces inflammation by suppressing the immune response. Ketoconazole and Tolnaftate inhibit ergosterol and squalene epoxidase synthesis respectively, both crucial for fungal cell membrane synthesis, thus disrupting fungal growth. Neomycin inhibits bacterial protein synthesis, leading to bacterial death.
Alternate Names
This combination is known by various brand names, including Xeploderm-K5, Dermidevak 5, Dermikem KT 5, and Clododerm-K5 among others. There are no widely recognized international non-proprietary names (INNs). Regional variations may exist.
How It Works
Pharmacodynamics: The combined actions of the corticosteroid, antifungals, and antibiotic work synergistically to manage skin inflammation and secondary infection. Clobetasol reduces inflammation and itching. Ketoconazole and Tolnaftate target the fungal pathogens by disrupting cell membrane synthesis, while Neomycin and Clioquinol eliminate bacterial infections.
Pharmacokinetics: Topical application minimizes systemic absorption. However, absorption can increase with damaged skin, prolonged use, application to large areas, or use of occlusive dressings. Clobetasol is metabolized in the liver and Neomycin is primarily excreted by the kidneys. The pharmacokinetics of topical Ketoconazole, Tolnaftate, and Clioquinol are less well-defined, but a small amount may be absorbed systemically.
Mode of Action: At the cellular level:
- Clioquinol: Disrupts bacterial DNA and cell wall synthesis, and shows some antifungal activity.
- Clobetasol: Binds to glucocorticoid receptors, suppressing pro-inflammatory cytokine production and immune cell activity.
- Ketoconazole: Inhibits fungal ergosterol synthesis, a key component of fungal cell membranes.
- Tolnaftate: Inhibits fungal squalene epoxidase, an enzyme vital for fungal cell membrane synthesis.
- Neomycin: Binds to the 30S ribosomal subunit of bacteria, inhibiting protein synthesis.
Elimination:
- Clobetasol: Hepatic metabolism.
- Neomycin: Renal excretion.
- Ketoconazole, Tolnaftate, and Clioquinol: Primarily local elimination, some systemic absorption and subsequent metabolism/excretion via hepatic and renal pathways.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected area two to three times daily. The total dosage should not exceed 50g per week. Treatment duration should be as short as possible, typically not exceeding 7 days for clioquinol-containing formulations. Do not use on large areas of the body. Avoid use with occlusive dressings unless directed by a physician.
Children: Use in children younger than 12 years is generally not recommended, particularly with high-potency corticosteroids like clobetasol. If deemed necessary by a physician, the dosage and duration should be minimized.
Special Cases:
- Elderly Patients: Use with caution due to increased risk of skin thinning and systemic absorption. Shortest duration and lowest effective dose should be used.
- Patients with Renal Impairment: Use neomycin with caution. Monitor renal function, especially with prolonged use.
- Patients with Hepatic Dysfunction: Caution is advised due to the potential for altered metabolism of clobetasol.
Clinical Use Cases
This combination cream is not typically indicated for intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its primary use is for dermatological conditions in outpatient settings.
Dosage Adjustments
Dose adjustments may be necessary based on the severity of the condition and individual patient factors, such as renal or hepatic impairment.
Side Effects
Common Side Effects:
- Itching
- Burning
- Irritation
- Redness at the application site
- Dry skin
Rare but Serious Side Effects:
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- Skin atrophy (thinning)
- Hypopigmentation
- Systemic absorption of clobetasol (Cushingoid features, hyperglycemia)
Long-Term Effects:
Prolonged use, especially of high-potency corticosteroids like clobetasol, can lead to skin atrophy, telangiectasia, striae, and hypopigmentation. Long-term use of clioquinol may rarely cause peripheral neuropathy.
Contraindications
- Hypersensitivity to any of the components
- Viral skin infections (herpes simplex, varicella, vaccinia)
- Tuberculous or syphilitic skin lesions
- Rosacea
- Acne
- Perioral dermatitis
Drug Interactions
- Oral corticosteroids (increased risk of systemic side effects)
- Immunosuppressants (additive effects)
- Neuromuscular blocking agents (neomycin interaction)
- NSAIDs (potential interaction)
- Systemic antifungals (potential interaction)
Pregnancy and Breastfeeding
Topical clobetasol is Pregnancy Category C. Safety has not been established for the other components. Avoid using this combination during pregnancy and breastfeeding unless the potential benefits outweigh the risks.
Drug Profile Summary
- Mechanism of Action: Combination of corticosteroid, antifungal, and antibiotic actions.
- Side Effects: Local irritation, burning, itching, redness; rarely allergic reactions, skin atrophy, systemic absorption.
- Contraindications: Hypersensitivity, viral skin infections, tuberculosis, rosacea, acne.
- Drug Interactions: Oral corticosteroids, immunosuppressants, neuromuscular blockers.
- Pregnancy & Breastfeeding: Use with caution; safety not fully established.
- Dosage: Apply a thin layer 2-3 times daily, not exceeding 7 days for clioquinol-containing products.
- Monitoring Parameters: Observe for local and systemic side effects, skin atrophy.
Popular Combinations
Not applicable for a fixed-dose combination product.
Precautions
- Avoid contact with eyes, nose, and mouth.
- Do not use for longer than prescribed.
- Monitor for local and systemic side effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clioquinol + Clobetasol + Ketoconazole + Neomycin + Tolnaftate?
A: Apply a thin layer to the affected area 2-3 times daily, not exceeding 7 days for clioquinol-containing formulations. The total weekly dose should not exceed 50g.
Q2: What are the common side effects?
A: Common side effects include local irritation, burning, itching, redness, and dryness.
Q3: Can this cream be used on the face?
A: Use on the face should be under strict medical supervision and for a limited time due to the risk of skin atrophy and other side effects.
Q4: What are the contraindications for this medication?
A: Contraindications include hypersensitivity to any component, viral, tuberculous, or syphilitic skin lesions, rosacea, acne, and perioral dermatitis.
Q5: Can this medication interact with any other medications?
A: It can interact with oral corticosteroids, immunosuppressants, neuromuscular blockers, and potentially with NSAIDs and systemic antifungals.
Q6: Can it be used during pregnancy or breastfeeding?
A: Use with caution. Safety has not been fully established. Consult a physician before using it during pregnancy or breastfeeding.
Q7: What should patients be advised about using this cream?
A: Advise patients to use it as directed, avoid contact with eyes and mucous membranes, report any unusual side effects, and complete the full course of treatment.
Q8: What should I do if a patient develops a severe allergic reaction?
A: Discontinue use immediately and provide appropriate medical care, including antihistamines, corticosteroids, and epinephrine if necessary.
Q9: What is the role of each component in this combination?
A: Clioquinol and neomycin provide antibacterial action; ketoconazole and tolnaftate offer antifungal effects; clobetasol reduces inflammation.
Q10: Is this cream suitable for long-term use?
A: No. Prolonged use, especially of high-potency corticosteroids like clobetasol, can cause side effects like skin atrophy. Clioquinol can potentially cause peripheral neuropathy with prolonged use. Treatment duration should generally not exceed 7 days.
