Usage
This combination cream is prescribed for the topical treatment of superficial skin infections caused by a combination of fungi and bacteria, along with an inflammatory component. It’s commonly used for conditions like:
- Athlete’s foot (tinea pedis) with secondary bacterial infection
- Jock itch (tinea cruris) with secondary bacterial infection
- Ringworm (tinea corporis) with secondary bacterial infection
- Other dermatomycoses complicated by bacterial superinfections and inflammation.
Pharmacological Classification:
- Clobetasol: Corticosteroid (Topical)
- Clotrimazole: Antifungal (Imidazole derivative)
- Ofloxacin: Antibiotic (Fluoroquinolone)
- Ornidazole: Antibiotic (Nitroimidazole)
Mechanism of Action: This combination targets different aspects of the infection and inflammation:
- Clobetasol: Reduces inflammation by suppressing the immune response and decreasing the production of inflammatory mediators.
- Clotrimazole: Inhibits ergosterol synthesis, a crucial component of fungal cell membranes, leading to fungal cell death.
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, resulting in bacterial death.
- Ornidazole: Damages bacterial/protozoal DNA by forming reactive nitrogen species, leading to their death.
Alternate Names
This combination does not have a universally recognized International Nonproprietary Name (INN). It’s typically referred to by various brand names depending on the manufacturer. Some examples of brand names include O2 Derm Cream and Panderm V Gel.
How It Works
Pharmacodynamics: The combined action of the four components addresses both infection and inflammation. Clobetasol provides rapid relief from inflammatory symptoms like itching and redness. Clotrimazole targets fungal pathogens, while Ofloxacin and Ornidazole offer broad-spectrum coverage against bacterial infections.
Pharmacokinetics: Primarily topical; systemic absorption is minimal with proper application. However, some absorption can occur with prolonged use or application to large areas, especially with clobetasol.
- Clobetasol: Metabolized in the liver and excreted via the kidneys.
- Ofloxacin: Primarily excreted unchanged in the urine, with some hepatic metabolism.
- Ornidazole: Metabolized in the liver and excreted in urine and feces.
- Clotrimazole: Metabolized in the liver and excreted in bile and feces.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected skin area twice daily, typically for 2-4 weeks. The duration depends on the severity and location of the infection.
Children: Use in children below 12 years of age is generally not recommended due to the potential for increased systemic absorption of clobetasol and its associated risks. Some sources advise against use in children under 17.
Special Cases:
-
Elderly Patients: Use with caution and for limited periods due to potential for skin thinning. Monitor for systemic side effects.
-
Patients with Renal/Hepatic Impairment: Use with caution, especially with prolonged use or large areas of application, as it can increase systemic exposure.
Clinical Use Cases
This combination cream is not indicated for systemic use and thus is not appropriate for the following:
- Intubation
- Surgical Procedures
- Mechanical Ventilation
- Intensive Care Unit (ICU) Use
- Emergency Situations
Its use is restricted to topical application for specific skin infections as outlined above.
Side Effects
Common Side Effects:
- Burning or stinging sensation at the application site
- Itching
- Dryness
- Redness
Rare but Serious Side Effects:
- Skin atrophy (thinning) with prolonged use
- Telangiectasia (spider veins)
- Hypopigmentation
- Allergic contact dermatitis
Long-Term Effects:
- Skin atrophy
- Striae (stretch marks)
- Cushing’s syndrome (with extensive use or application to large areas)
Contraindications
- Hypersensitivity to any component of the cream
- Rosacea
- Perioral dermatitis
- Acne vulgaris
- Viral skin infections (e.g., herpes simplex, chickenpox)
- Tuberculosis of the skin
- Ulcerated lesions
Drug Interactions
- Interactions with other topical medications applied to the same area should be considered.
- Avoid concomitant use with other topical corticosteroids.
Pregnancy and Breastfeeding
- Use only if clearly needed and under strict medical supervision.
- Potential for fetal harm with systemic absorption, particularly with extensive use.
- Limited data on breast milk excretion; exercise caution if breastfeeding.
Drug Profile Summary
- Mechanism of Action: See above.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: See above.
- Dosage: See above.
- Monitoring Parameters: Monitor for local skin reactions and systemic side effects with prolonged use.
Popular Combinations
This specific combination itself is a popular formulation. Single-ingredient antifungal or antibiotic creams may be used separately depending on the infection.
Precautions
- General Precautions: Perform a patch test prior to widespread application to assess for potential allergic reactions.
- Pregnant Women: Avoid use unless absolutely necessary and under close medical supervision.
- Breastfeeding Mothers: Exercise caution.
- Children & Elderly: Not recommended for children under 12. Use with caution in the elderly.
- Lifestyle Considerations: Avoid excessive sun exposure of treated areas.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Clotrimazole + Ofloxacin + Ornidazole?
A: Apply a thin layer to the affected skin area twice daily for 2-4 weeks.
Q2: Can this cream be used on the face?
A: Use with extreme caution on the face due to the risk of skin atrophy and telangiectasia.
Q3: What should I do if I miss a dose?
A: Apply the missed dose as soon as you remember. Do not double the dose.
Q4: Can I use this cream if I am pregnant or breastfeeding?
A: Consult a doctor before use during pregnancy or breastfeeding.
Q5: What are the common side effects?
A: Common side effects include burning, itching, dryness, and redness at the application site.
Q6: How long does it take to see improvement?
A: Improvement can be seen within a few days, but complete resolution may take several weeks.
Q7: Can this cream be used for all types of skin infections?
A: No, this cream is specifically for superficial fungal and bacterial skin infections with an inflammatory component. It should not be used for viral infections or other skin conditions.
Q8: What should I do if my symptoms worsen or do not improve after several weeks?
A: Consult a doctor for further evaluation.
Q9: Can I use this cream with other topical medications?
A: Be cautious when combining with other topical medications. Consult a doctor before using this cream with other topical treatments on the same area.
