Usage
- This combination medication is prescribed for the topical treatment of superficial mixed skin infections caused by susceptible bacteria and fungi. It is effective against dermatophyte infections (e.g., tinea corporis, tinea cruris, tinea pedis), bacterial infections (e.g., impetigo), and inflammatory skin conditions like eczema and dermatitis complicated by secondary infection.
- Pharmacological Classification: Combination product containing a corticosteroid (Clobetasol), a fluoroquinolone antibiotic (Ofloxacin), and an antifungal (Terbinafine).
- Mechanism of Action: Clobetasol reduces inflammation and itching, Ofloxacin inhibits bacterial DNA replication and repair, and Terbinafine interferes with fungal cell membrane synthesis.
Alternate Names
- Clobetasol/Ofloxacin/Terbinafine combination cream/ointment
- Brand names: Oftiderm, Combicid, Alnabate Forte Cream, Lefla Plus Cream, Axxo Cream, Combicid Cream, Combo 4 Cream, Dermacom Cream, Dermomix Cream, Dermoquad Cream, Mycofree-OC Cream, Tetramix Cream, others. Brand names vary by region and manufacturer.
How It Works
- Pharmacodynamics: Clobetasol exerts anti-inflammatory, antipruritic, and vasoconstrictive effects by activating phospholipase A2 inhibitory proteins. Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication and repair. Terbinafine inhibits squalene epoxidase, disrupting fungal cell membrane synthesis. Ornidazole interferes with microbial DNA, leading to cell death.
- Pharmacokinetics: Primarily topical action. Minimal systemic absorption occurs, although it can increase with prolonged use or application over large areas. Each component has its own pharmacokinetic profile, but specific data on the combination product’s absorption, distribution, metabolism, and excretion is limited.
- Elimination pathways: Each component has its unique elimination pathway. Clobetasol is primarily metabolized in the liver and excreted via the kidneys. Ofloxacin is mainly excreted unchanged in urine and feces. Terbinafine undergoes hepatic metabolism and is eliminated primarily in the urine.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected skin area twice daily.
Children: Use in children under 12 years is generally not recommended due to limited safety and efficacy data. Some sources advise against use in those under 18. When prescribed, the dosage and duration should be determined by a physician based on the child’s age, weight, and the specific condition.
Special Cases:
- Elderly Patients: Same as adult dosing, but monitor closely for adverse effects due to potentially thinner skin and increased absorption.
- Patients with Renal Impairment: Caution advised; monitor for systemic side effects.
- Patients with Hepatic Dysfunction: Caution advised; monitor for systemic side effects due to potential changes in drug metabolism.
- Patients with Comorbid Conditions: Assess patient-specific conditions for potential drug interactions or contraindications.
Clinical Use Cases
The combination is intended for topical use only and is not indicated for:
- Intubation
- Surgical Procedures
- Mechanical Ventilation
- Intensive Care Unit (ICU) Use
- Emergency Situations
Dosage Adjustments
Adjustments based on renal/hepatic dysfunction should be made cautiously with close monitoring for side effects. Consider reducing the application frequency or using a lower potency corticosteroid in such cases.
Side Effects
Common Side Effects
- Burning sensation
- Itching or stinging sensation
- Dryness or peeling of skin
- Redness or irritation
- Skin atrophy (with prolonged use)
Rare but Serious Side Effects
- Allergic reactions
- Skin hypopigmentation or hyperpigmentation (reversible)
- Systemic absorption of the corticosteroid, potentially leading to Cushing’s syndrome or adrenal suppression (rare, usually with prolonged use or over large areas)
Long-Term Effects
- Skin thinning
- Telangiectasia
- Striae
Adverse Drug Reactions (ADR)
- Angioedema
- Urticaria
- Contact dermatitis
Contraindications
- Hypersensitivity to any of the components.
- Viral skin infections (e.g., herpes simplex, varicella zoster).
- Untreated parasitic infections.
- Rosacea.
- Acne.
- Children under 12 years of age (some sources state under 18 years of age)
Drug Interactions
- Limited data are available regarding drug interactions.
- Avoid concomitant use of other topical medications on the same area unless directed by a physician.
- Systemic interactions are unlikely due to low absorption. However, potential interactions with systemic medications may occur if significant absorption happens, particularly with prolonged use or over large areas. Consult a drug interaction database for a comprehensive list.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been established. Use only if the potential benefit outweighs the potential risk to the fetus or infant. Some sources indicate that topical clobetasol can be used in pregnancy and breastfeeding with caution. Consult a physician before use.
Drug Profile Summary
- Mechanism of Action: Combined anti-inflammatory, antibacterial, and antifungal actions.
- Side Effects: Burning, itching, irritation, dryness, skin atrophy, allergic reactions.
- Contraindications: Hypersensitivity, viral skin infections, rosacea, acne, children under 12 years of age (some sources indicate children under 18 years old).
- Drug Interactions: Limited data; consult a drug interaction database.
- Pregnancy & Breastfeeding: Safety not established; use with caution and only if clearly needed. Consult a physician.
- Dosage: Topical application twice daily.
- Monitoring Parameters: Monitor for local and systemic side effects.
Popular Combinations
This formulation itself is a popular combination.
Precautions
- Avoid application near the eyes, nose, and mouth.
- Do not use on open wounds or broken skin.
- Avoid prolonged use or application to large areas without medical supervision.
- Monitor for local and systemic side effects, especially with prolonged use.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Ofloxacin + Terbinafine?
A: Apply a thin layer to the affected area twice daily for adults. Use in children is not generally recommended.
Q2: Can this combination be used during pregnancy?
A: Safety during pregnancy has not been established. Use only if potential benefit outweighs risk and consult a physician.
Q3: What are the common side effects?
A: Burning, itching, irritation, dryness, and skin atrophy (with prolonged use).
Q4: Is it safe to use this cream on my face?
A: Use on the face should be limited and under the supervision of a physician due to the potential for skin thinning and other side effects.
Q5: Can this combination be used for diaper rash?
A: Not recommended. Consult a pediatrician for diaper rash treatment.
Q6: What should I do if I accidentally swallow this cream?
A: Seek immediate medical attention. Contact a poison control center.
Q7: How long does it take to see improvement?
A: Improvement can vary, but you should consult your physician if you don’t see any improvement within a few weeks.
Q8: Can I use this cream with other topical medications?
A: Avoid using other topical medications on the same area unless directed by your physician.
Q9: Are there any long-term side effects of using this medication?
A: Yes, prolonged use can cause skin thinning, telangiectasia, and striae.
