Usage
This combination medication is prescribed for the treatment of various inflammatory skin infections with bacterial and fungal components. Conditions commonly treated include:
- Infected eczema or dermatitis
- Secondarily infected psoriasis
- Intertrigo (inflammation of skin folds)
- Infected contact dermatitis
- Ringworm infections with secondary bacterial infection
Pharmacological Classification: This is a combination product with components belonging to the following classes:
- Clioquinol: Antibacterial, Antifungal
- Clobetasol: Corticosteroid (topical)
- Clotrimazole: Antifungal (Imidazole)
- Gentamicin: Aminoglycoside Antibiotic
- Tolnaftate: Antifungal (Thiocarbamate)
Mechanism of Action: This combination targets multiple aspects of skin infections:
- Clioquinol: Disrupts bacterial and fungal cell processes, inhibiting their growth.
- Clobetasol: Suppresses the immune response, reducing inflammation, redness, and itching.
- Clotrimazole: Damages fungal cell walls, leading to cell death.
- Gentamicin: Inhibits bacterial protein synthesis, hindering their growth and leading to their eradication.
- Tolnaftate: Disrupts fungal cell membrane permeability and inhibits squalene epoxidase, a crucial enzyme for fungal survival.
Alternate Names
While this combination doesn’t have a single, universally recognized international nonproprietary name (INN), it’s often identified by its components. Regional variations may exist.
Brand Names: Various brand names exist depending on the manufacturer and region, including Dermi 5, Ketolam K5, GETOCRAZ-5, Dermicraft 5C, and others. It’s important to check the composition of the specific brand for accurate information.
How It Works
Pharmacodynamics: The combined effect of this medication results in a reduction of infection (bacterial and fungal), inflammation, and related symptoms like itching, redness, and swelling.
Pharmacokinetics: The medication is applied topically. Absorption is minimal under normal circumstances. Some systemic absorption might occur if applied to large areas, broken skin, or for extended periods. Individual component pharmacokinetics:
- Clobetasol: Metabolized in the liver and excreted through the kidneys.
- Gentamicin: Minimally absorbed through intact skin. When absorbed systemically, it’s excreted renally.
- Clioquinol, Clotrimazole, Tolnaftate: Limited data on topical absorption and metabolism. Primarily metabolized hepatically.
Mode of Action (Cellular/Molecular): Already described under “Mechanism of Action” above.
Receptor Binding/Enzyme Inhibition/Neurotransmitter Modulation:
- Clobetasol: Binds to glucocorticoid receptors.
- Gentamicin: Inhibits bacterial ribosomes.
- Tolnaftate: Inhibits squalene epoxidase.
- Clioquinol & Clotrimazole: Interact with fungal cell membranes.
Elimination Pathways: Primarily hepatic metabolism followed by renal excretion for most components. Limited data available for topical application.
Dosage
Standard Dosage
Due to the potent nature of clobetasol and potential for toxicity with clioquinol, this combination is generally prescribed for short-term use and under strict medical supervision. Dosage guidelines vary depending on the severity and location of the infection.
Adults:
A thin layer is typically applied to the affected area once or twice daily. The duration of treatment is usually limited to a few weeks. Always follow the physician’s prescribed dosage and duration.
Children:
Use in children should be minimized due to higher risk of systemic absorption and potential adverse effects from clobetasol. Only use under strict medical supervision. Safety and efficacy in children have not been fully established.
Special Cases:
- Elderly Patients: Use cautiously for limited durations due to increased risk of skin atrophy. Monitor closely for side effects.
- Patients with Renal Impairment: Dosage adjustment may be necessary. Monitor renal function.
- Patients with Hepatic Dysfunction: Use with caution and monitor liver function.
- Patients with Comorbid Conditions: Consider underlying medical conditions and potential drug interactions.
Clinical Use Cases
This combination is intended for topical skin infections and isn’t appropriate for systemic infections, surgical procedures, or life-threatening conditions. It’s not typically used in scenarios like intubation, mechanical ventilation, or the ICU. For emergency situations, systemic therapy is preferred.
Dosage Adjustments
Adjustments are made cautiously based on individual patient factors, including age, renal/hepatic function, and other medical conditions.
Side Effects
Common Side Effects:
- Burning
- Itching
- Irritation
- Redness
- Dryness at the application site
- Skin peeling
Rare but Serious Side Effects:
- Skin atrophy (thinning)
- Telangiectasia (spider veins)
- Hypopigmentation (skin lightening)
- Hypertrichosis (excess hair growth)
- Allergic contact dermatitis
- Cushing’s syndrome (with prolonged or excessive use)
With Clioquinol specifically:
- Peripheral neuropathy (rare but serious)
Long-Term Effects:
Prolonged or excessive use, especially of clobetasol, can lead to skin thinning, striae (stretch marks), and systemic absorption with associated adverse effects.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), though rare, require immediate medical attention.
Contraindications
- Hypersensitivity to any of the components
- Viral skin infections (e.g., herpes simplex, varicella)
- Rosacea
- Perioral dermatitis
- Extensive open wounds or burns (increased systemic absorption risk)
Drug Interactions
- Oral anticoagulants: May increase bleeding risk.
- Other topical corticosteroids: May potentiate adverse effects.
- NSAIDs: May increase risk of gastrointestinal side effects.
- Systemic antifungals: Potential for altered efficacy.
Pregnancy and Breastfeeding
The safety during pregnancy and breastfeeding hasn’t been fully established. The use of this combination should be minimized and only when potential benefits outweigh risks to the fetus or nursing infant. Clioquinol is generally avoided during pregnancy. Clobetasol is classified as Pregnancy Category C. Consult a physician before use.
Drug Profile Summary
- Mechanism of Action: See “Mechanism of Action” section.
- Side Effects: Local reactions (burning, itching, irritation), skin thinning, allergic reactions. Clioquinol carries a risk of neurotoxicity.
- Contraindications: Hypersensitivity, viral skin infections, rosacea, perioral dermatitis.
- Drug Interactions: See “Drug Interactions” section.
- Pregnancy & Breastfeeding: Consult a physician; safety not established. Generally avoid Clioquinol. Clobetasol is Pregnancy Category C.
- Dosage: Topical application, thin layer once or twice daily to the affected area. Short-term use only. Specific dosage varies.
- Monitoring Parameters: Local skin reactions, signs of infection, systemic corticosteroid effects (with prolonged use).
Popular Combinations
This combination already includes multiple active ingredients. Additional topical medications are generally avoided.
Precautions
- General Precautions: Screen for allergies and pre-existing skin conditions. Avoid application near eyes, mucous membranes, or broken skin.
- Pregnant Women: Consult a physician. Risks haven’t been fully evaluated. Clioquinol is usually avoided. Clobetasol is Pregnancy Category C.
- Breastfeeding Mothers: Consult a physician before use. Safety hasn’t been established.
- Children & Elderly: Use with extreme caution and under strict medical supervision due to increased risk of adverse effects. Short-term use only.
- Lifestyle Considerations: Avoid excessive sun exposure. No specific restrictions on alcohol or smoking.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clioquinol + Clobetasol + Clotrimazole + Gentamicin + Tolnaftate?
A: The dosage is determined by a physician and is typically a thin layer applied to the affected area once or twice daily. The duration of treatment is usually limited to a few weeks.
Q2: Can this combination be used on the face?
A: Use on the face should be limited and under close medical supervision due to the increased risk of skin atrophy and other adverse effects from clobetasol.
Q3: What are the serious side effects of Clioquinol?
A: Although rare, clioquinol carries a risk of peripheral neuropathy (SMON). Discontinue use and consult a physician if any neurological symptoms develop.
Q4: Can this combination be used during pregnancy or breastfeeding?
A: Consult a physician. The safety hasn’t been fully established. Clioquinol is typically avoided during pregnancy. Clobetasol is Pregnancy Category C.
Q5: Is this medication suitable for children?
A: Use in children should be minimized and only under strict medical supervision. Children have a greater risk of systemic absorption.
Q6: How long does it take to see improvement?
A: It may take several days to weeks for symptoms to improve. Complete the prescribed course even if symptoms resolve earlier to prevent recurrence.
Q7: What should I do if the infection worsens or doesn’t improve?
A: Consult your physician. They may adjust the treatment or prescribe an alternative therapy.
Q8: Can I use this combination with other topical medications?
A: Generally avoid using other topical medications concomitantly, especially other corticosteroids, without consulting your physician.
Q9: Can this cream be used for diaper rash?
A: This combination is not generally recommended for diaper rash. Simpler preparations are usually preferred. Consult a pediatrician.
Q10: Are there any long-term side effects of using this cream?
A: Prolonged use, particularly of the corticosteroid component (clobetasol), can lead to skin thinning, striae, and potentially systemic side effects. Follow the prescribed duration strictly.
