Usage
This combination medication is prescribed for the topical treatment of superficial skin infections caused by a mix of bacteria and fungi, especially when accompanied by inflammation. It is effective against dermatophyte infections (e.g., tinea corporis, tinea cruris, tinea pedis), bacterial infections (e.g., impetigo), and inflammatory skin conditions such as infected eczema and dermatitis. It is also used in the treatment of mixed and complicated fungal, protozoal, and bacterial infections; mild to moderate vaginitis; candidiasis and trichomoniasis; pruritus vulvae; and genito-urinary infections. It is available as a cream, gel, or ointment for topical application. This combination is classified as a corticosteroid, antibacterial, and antifungal agent.
The mechanism of action involves the combined effects of its components: Clobetasol, a potent corticosteroid, reduces inflammation; Ofloxacin, a fluoroquinolone antibiotic, inhibits bacterial DNA replication; Ornidazole, a nitroimidazole antibiotic, disrupts bacterial DNA and protein synthesis (effective against anaerobic bacteria and some protozoa); and Terbinafine, an antifungal, inhibits fungal cell membrane synthesis by targeting squalene epoxidase.
Alternate Names
This combination is often referred to as Clobetasol/Ofloxacin/Ornidazole/Terbinafine combination cream/ointment/gel. Brand names include Dermomix, Combicid, Olciderm, Oftiderm, Terbinaforce-Plus, Offtex-OT, Alnabate Forte, and Antilox TC, among others. Availability of specific brands depends on the manufacturer and region. Please note that the combination is banned in India due to potential for severe side effects.
How It Works
Pharmacodynamics: Clobetasol exerts anti-inflammatory, antipruritic, and vasoconstrictive effects by binding to glucocorticoid receptors. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Ornidazole forms reactive metabolites that damage bacterial DNA. Terbinafine inhibits squalene epoxidase, a key enzyme in fungal ergosterol biosynthesis.
Pharmacokinetics: The combination is applied topically. Clobetasol is absorbed percutaneously, metabolized in the liver, and excreted mainly in urine and bile. Ofloxacin exhibits minimal systemic absorption after topical application but can have systemic effects if used on large areas or broken skin, it is metabolized in the liver. Ornidazole also has low systemic absorption following topical application, it is metabolized in the liver and excreted in urine. Terbinafine is absorbed through the skin, reaching peak plasma concentrations within a few hours, it is metabolized by CYP enzymes in the liver and eliminated primarily in urine.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected skin area twice daily. Treatment duration typically ranges from 1-2 weeks depending on the infection.
Children: Use in children under 12 years is generally not recommended due to limited safety data. Some sources recommend against use in children under 18. If necessary, use under strict medical supervision with careful monitoring.
Special Cases:
- Elderly Patients: Use with caution due to potential for increased systemic absorption, monitor for side effects.
- Patients with Renal Impairment: Dosage adjustments may be needed if significant systemic absorption occurs.
- Patients with Hepatic Dysfunction: Dosage adjustments may be needed if significant systemic absorption occurs, closely monitor for side effects.
- Patients with Comorbid Conditions: Exercise caution in patients with diabetes, as topical corticosteroids can affect blood glucose levels.
Clinical Use Cases
This topical medication is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. It is meant for treating superficial skin infections.
Dosage Adjustments
Adjustments are usually not necessary for topical application unless substantial systemic absorption is suspected due to factors like open wounds or application over a large area. Monitor patients with renal or hepatic impairment if such situations arise.
Side Effects
Common Side Effects
Burning, itching, irritation, dry skin, skin peeling, skin thinning (with long-term use), redness at application site.
Rare but Serious Side Effects
Allergic reactions (rash, itching, swelling, shortness of breath), skin atrophy, hypopigmentation, telangiectasia, striae, folliculitis.
Long-Term Effects
Skin atrophy, telangiectasia, striae, hypopigmentation.
Adverse Drug Reactions (ADR)
Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome, toxic epidermal necrolysis.
Contraindications
Hypersensitivity to any of the components, viral skin infections (e.g., herpes simplex, varicella), cutaneous tuberculosis, fungal infections caused by non-susceptible species, rosacea, perioral dermatitis, acne, ulcerative conditions. Use with caution in patients with a history of gastrointestinal disease, liver impairment, or autoimmune disorders.
Drug Interactions
May interact with oral or topical corticosteroids (e.g., prednisolone), other systemic antibiotics or antifungals (e.g., itraconazole), NSAIDs (e.g., diclofenac), antacids (e.g., aluminum hydroxide), multivitamins containing zinc or iron, blood thinners (e.g., warfarin, heparin), and some seizure medications (e.g., phenytoin). Tizanidine should not be used concurrently due to severe interactions.
Pregnancy and Breastfeeding
Safety during pregnancy and breastfeeding has not been established. Use only if clearly needed and under strict medical supervision.
Drug Profile Summary
- Mechanism of Action: Combined anti-inflammatory, antibacterial, and antifungal actions.
- Side Effects: Burning, itching, irritation, skin peeling, thinning, redness, allergic reactions.
- Contraindications: Hypersensitivity, viral skin infections, cutaneous tuberculosis.
- Drug Interactions: Corticosteroids, antibiotics, antifungals, NSAIDs, antacids, blood thinners, seizure medications.
- Pregnancy & Breastfeeding: Safety not established.
- Dosage: Thin layer applied twice daily for 1-2 weeks.
- Monitoring Parameters: Observe for local skin reactions, signs of infection resolution, and systemic effects.
Popular Combinations
This combination itself is a popular formulation, but not approved in India. Individual components may be combined with other drugs for specific conditions. For instance, Clobetasol may be used with other antifungals if Terbinafine isn’t suitable.
Precautions
- General Precautions: Screen for allergies, avoid contact with eyes and mucous membranes. Avoid prolonged or excessive use.
- Pregnant Women: Use only if essential.
- Breastfeeding Mothers: Avoid applying on or near the nipples.
- Children & Elderly: Use cautiously, especially in children under 12, and monitor for adverse effects.
- Menstruating Individuals: No specific precautions identified.
- Lifestyle Considerations: Alcohol or smoking shouldn’t significantly interact with topical application. No specific driving restrictions.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Ofloxacin + Ornidazole + Terbinafine?
A: Apply a thin layer to the affected skin twice daily for 1-2 weeks in adults. Use in children under 12 is generally not recommended.
Q2: Can this combination be used on the face?
A: Use with caution on the face due to the potential for skin thinning and other adverse effects. Avoid application near the eyes.
Q3: What are the common side effects?
A: Common side effects include burning, itching, irritation, dryness, peeling, and redness at the application site.
Q4: Are there any serious drug interactions?
A: Yes, it can interact with other medications, including certain antibiotics, antifungals, blood thinners, and seizure medications. Concurrent use of tizanidine is contraindicated. Consult a healthcare professional to review all medications being taken.
Q5: Is it safe during pregnancy or breastfeeding?
A: Safety during pregnancy and breastfeeding is not established. Consult a doctor before using it.
Q6: Can it be used for longer than prescribed?
A: No, prolonged use, especially of clobetasol, can lead to skin thinning, striae, and other side effects. Follow the prescribed duration.
Q7: What should I do if I miss an application?
A: Apply the missed dose as soon as you remember. If it’s almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Q8: What if the infection doesn’t improve?
A: If symptoms don’t improve within the expected timeframe, consult a doctor. The infection might require a different treatment approach.
Q9: What is the mechanism of action for the Ornidazole component?
A: Ornidazole disrupts bacterial DNA and protein synthesis, particularly effective against anaerobic bacteria and some protozoa.
Q10: What are the considerations for elderly patients?
A: Elderly patients should be monitored for potential increased systemic absorption and adverse effects. Use with caution.
