Usage
This combination cream is prescribed for the topical treatment of mixed skin infections caused by bacteria and fungi, especially when inflammation is also present. It is effective against dermatophyte infections (e.g., tinea corporis, tinea cruris, tinea pedis), infected eczema, infected psoriasis, and inflamed cutaneous mycoses. It combines the anti-inflammatory, antibacterial, antifungal, and moisturizing properties of its constituent drugs.
Pharmacological Classification:
- Corticosteroid (Clobetasol)
- Emollient/Moisturizer (Dexpanthenol)
- Antibiotic (Fluoroquinolone - Ofloxacin, Nitroimidazole - Tinidazole)
- Antifungal (Allylamine - Terbinafine)
Mechanism of Action:
This combination targets multiple aspects of skin infection and inflammation:
- Clobetasol: Reduces inflammation by binding to glucocorticoid receptors, inhibiting the release of inflammatory mediators.
- Dexpanthenol: Provitamin of pantothenic acid (vitamin B5), improves skin hydration and promotes wound healing.
- Ofloxacin: Inhibits bacterial DNA gyrase, essential for bacterial DNA replication and repair.
- Terbinafine: Inhibits fungal squalene epoxidase, disrupting fungal cell membrane formation, thus preventing fungal growth.
- Tinidazole: Damages microbial DNA, affecting bacterial and some protozoal cell function.
Alternate Names
There are no officially recognized alternate names for this five-drug combination. It’s marketed under various brand names, including Actoskin Cream, Dermonix Plus Cream, Terbiex Plus Cream, Terbinik Plus Cream, and others. Individual components have alternate names: Clobetasol Propionate, Dexpanthenol (Panthenol), Ofloxacin, Terbinafine Hydrochloride, and Tinidazole.
How It Works
Pharmacodynamics:
- Clobetasol: Exerts potent anti-inflammatory, antipruritic, and vasoconstrictive effects.
- Dexpanthenol: Converted to pantothenic acid in the skin, supporting cell growth and differentiation, contributing to wound healing.
- Ofloxacin: Bactericidal effect on a broad spectrum of bacteria.
- Terbinafine: Fungicidal against dermatophytes and some other fungi.
- Tinidazole: Active against anaerobic bacteria and certain protozoa.
Pharmacokinetics: Topical application limits systemic absorption. However, some absorption can occur, particularly with prolonged use, application to large areas, or damaged skin. Each component has its own metabolic and elimination pathways. Clobetasol is metabolized primarily in the liver and excreted through urine and bile. Ofloxacin is also metabolized in the liver and excreted mainly by the kidneys. Tinidazole undergoes hepatic metabolism and is excreted through urine. Terbinafine is metabolized extensively in the liver and excreted primarily in the urine. Dexpanthenol, after conversion to pantothenic acid, is widely distributed in body tissues and excreted largely unchanged in urine.
Mode of Action:
- Clobetasol: Binds to intracellular glucocorticoid receptors, modulating gene expression and reducing inflammatory responses.
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription.
- Terbinafine: Inhibits fungal squalene epoxidase, blocking ergosterol synthesis, a key component of the fungal cell membrane.
- Tinidazole: Forms toxic metabolites that damage bacterial DNA.
Elimination Pathways: Vary depending on individual components.
Dosage
Standard Dosage
Adults: Apply a thin layer to the affected skin area twice daily. The duration of treatment should typically not exceed 2-4 weeks.
Children: Use in children under 12 years of age is generally not recommended, as safety and efficacy have not been established. For adolescents (12-17 years), application should be under strict medical supervision and for limited periods.
Special Cases:
- Elderly Patients: Use with caution; monitor for adverse effects.
- Patients with Renal Impairment: Caution advised; dose adjustments may be necessary.
- Patients with Hepatic Dysfunction: Use with caution; monitor for adverse effects.
- Patients with Comorbid Conditions: Monitor closely, especially patients with diabetes, Cushing’s syndrome, or glaucoma.
Clinical Use Cases
Dosages in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not specifically defined for this topical combination.
Dosage Adjustments
Dose adjustments are usually made based on patient response, the affected skin area, and potential side effects.
Side Effects
Common Side Effects:
- Burning, irritation, itching, and redness at the application site
- Dryness or peeling of skin
- Changes in skin color
- Skin thinning (with prolonged use)
Rare but Serious Side Effects:
- Allergic contact dermatitis
- Skin atrophy
- Striae (stretch marks)
- Telangiectasia (spider veins)
- Hyperglycemia (with systemic absorption of clobetasol)
Long-Term Effects:
- Skin thinning
- Striae
- Telangiectasia
- Cushing’s syndrome (with excessive systemic absorption of clobetasol)
Adverse Drug Reactions (ADR):
- Severe allergic reactions (anaphylaxis)
- Worsening of existing skin infections
Contraindications
- Hypersensitivity to any of the components
- Viral skin infections (e.g., herpes simplex, varicella zoster)
- Untreated parasitic infections
- Rosacea
- Acne vulgaris
- Perioral dermatitis
Drug Interactions
Concomitant use with other topical corticosteroids may increase the risk of local side effects. Systemic drug interactions are possible, particularly with significant systemic absorption of clobetasol. Consult drug interaction databases for specific information.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and breastfeeding has not been established. Use with caution only if the potential benefit outweighs the risk. Consider alternative therapies.
Drug Profile Summary
Please refer to the respective sections for “Mechanism of Action,” “Side Effects,” “Contraindications,” and “Drug Interactions.”
- Pregnancy & Breastfeeding: Not established, use with caution.
- Dosage: See “Dosage” section.
- Monitoring Parameters: Monitor for local skin reactions and signs of systemic absorption (especially with prolonged use).
Popular Combinations
This specific five-drug combination is not a widely used standard combination. Usually, combinations of a corticosteroid, an antifungal, and an antibiotic are used.
Precautions
- Avoid application to open wounds or mucous membranes.
- Wash hands before and after application.
- Avoid prolonged or excessive use.
- Monitor for local and systemic side effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Dexpanthenol + Ofloxacin + Terbinafine + Tinidazole?
A: Apply a thin layer to the affected skin twice daily, usually for no longer than 2-4 weeks. Consult a doctor for individual guidance.
Q2: Can this combination be used during pregnancy?
A: The safety during pregnancy has not been established. Use with caution and only if the potential benefit outweighs the risk.
Q3: What are the common side effects?
A: Common side effects include burning, itching, irritation, redness, dryness, and peeling at the application site.
Q4: Are there any serious side effects?
A: Rare but serious side effects include allergic contact dermatitis, skin atrophy, striae, telangiectasia, and hyperglycemia.
Q5: Can this combination be used on the face?
A: Use with caution on the face and avoid prolonged application due to the risk of skin thinning and other adverse effects.
Q6: What if I miss a dose?
A: Apply the missed dose as soon as you remember, unless it’s almost time for the next dose. Do not apply extra to make up for a missed dose.
Q7: How long should I use this cream?
A: Use for the prescribed duration, typically 2-4 weeks. Consult your doctor if the condition persists or worsens.
Q8: Can I use this cream on open wounds?
A: Avoid applying to open wounds, broken skin, or mucous membranes.
Q9: Can this cream interact with other medications?
A: It may interact with other topical or systemic medications. Consult your doctor about all medications you are taking.
Q10: Should I cover the treated area with a bandage?
A: Avoid covering the treated area unless directed by your doctor.
