Usage
Clobetasol + Terbinafine is a topical combination medication prescribed for inflammatory skin conditions, particularly those complicated by fungal infections. It is classified as a corticosteroid (clobetasol) combined with an antifungal (terbinafine). Clobetasol works by reducing inflammation, itching, and redness, while terbinafine prevents the growth of dermatophytes (fungi) by inhibiting squalene epoxidase, an enzyme crucial for fungal cell wall synthesis.
Alternate Names
There are no internationally recognized non-proprietary names besides “Clobetasol + Terbinafine.” Brand names may vary depending on the region and manufacturer. Some examples include “Axxo Cream,” “Combicid Cream,” “Combo 4 Cream,” “Dermacom Cream,” “Dermomix Cream,” “Dermoquad Cream,” “Mycofree-OC Cream,” and “Tetramix Cream.”
How It Works
Pharmacodynamics: Clobetasol, a potent corticosteroid, binds to glucocorticoid receptors in the skin cells, modulating gene expression and suppressing inflammatory mediators. Terbinafine inhibits fungal squalene epoxidase, disrupting ergosterol synthesis, a critical component of fungal cell membranes, leading to fungal cell death.
Pharmacokinetics: Topical application leads to minimal systemic absorption of both drugs when used as directed. Clobetasol is metabolized primarily in the liver and excreted via the kidneys. Terbinafine is also extensively metabolized in the liver by CYP450 enzymes and eliminated through biliary and renal routes.
Dosage
Standard Dosage
Adults:
Apply a thin layer to the affected skin area twice daily, usually for a maximum of two weeks. For localized lesions of moderate to severe plaque psoriasis, treatment may be extended up to 2 additional weeks if there is insufficient improvement after the initial 2 weeks. The total dosage should not exceed 50 g (or 50 mL) per week.
Children:
Use is not recommended for children under 12 years of age. Limited data exists for adolescents aged 12 to 17 years, and use should be under strict medical supervision.
Special Cases:
- Elderly Patients: Elderly patients may be more susceptible to side effects and require closer monitoring.
- Patients with Renal Impairment: Dose adjustments may be needed for patients with severe renal impairment.
- Patients with Hepatic Dysfunction: Close monitoring is advised in patients with hepatic impairment.
- Patients with Comorbid Conditions: Patients with diabetes, glaucoma, or Cushing’s syndrome should be monitored carefully.
Clinical Use Cases
The combination is not typically used in clinical settings such as intubation, surgical procedures, mechanical ventilation, or emergency situations. It is specifically intended for topical dermatological use.
Dosage Adjustments
Dosage adjustments are primarily based on the severity of the skin condition, the size of the affected area, and the patient’s response to treatment. Adjustments may also be required for patients with renal or hepatic dysfunction.
Side Effects
Common Side Effects
Burning, stinging, itching, dryness, irritation, redness, and skin thinning at the application site.
Rare but Serious Side Effects
Allergic reactions (rash, swelling, difficulty breathing), skin discoloration, telangiectasia (spider veins), striae (stretch marks), acneiform eruptions, folliculitis, hypertrichosis (excessive hair growth), hypopigmentation (skin lightening), perioral dermatitis (rash around the mouth). Systemic effects are rare with topical use but can include hyperglycemia, hypertension, and Cushing’s syndrome with prolonged use of high doses.
Long-Term Effects
Prolonged use can lead to skin atrophy, telangiectasia, and striae. Long-term high-dose use may also result in systemic corticosteroid side effects, such as adrenal suppression.
Adverse Drug Reactions (ADR)
Severe allergic reactions, skin infections, adrenal suppression, worsening of existing skin conditions.
Contraindications
Hypersensitivity to clobetasol or terbinafine, rosacea, perioral dermatitis, acne vulgaris, viral skin infections (e.g., herpes simplex, chickenpox), untreated parasitic infections, fungal infections not susceptible to terbinafine (e.g., candidiasis), ulcerated skin lesions.
Drug Interactions
Interactions are limited with topical application, but concurrent use of other topical corticosteroids, antibiotics, or antifungals may increase the risk of local side effects or alter drug efficacy. Terbinafine is metabolized by multiple CYP450 enzymes and can theoretically interact with drugs that inhibit or induce these enzymes, but clinically significant interactions are rare with topical application.
Pregnancy and Breastfeeding
The safety of Clobetasol + Terbinafine during pregnancy has not been established. Topical corticosteroids and terbinafine are absorbed systemically to some extent, and animal studies suggest potential fetal harm. Therefore, use during pregnancy should be restricted to cases where the benefits clearly outweigh the risks.
Clobetasol and terbinafine can be excreted in breast milk. While the amount is likely small with topical application, it is advisable to exercise caution and avoid applying the medication to the nipple area.
Drug Profile Summary
- Mechanism of Action: Clobetasol: Binds to glucocorticoid receptors, suppressing inflammation. Terbinafine: Inhibits fungal squalene epoxidase, disrupting ergosterol synthesis.
- Side Effects: Local: Burning, itching, dryness, irritation, skin thinning. Systemic (rare): Hyperglycemia, hypertension, Cushing’s syndrome.
- Contraindications: Hypersensitivity, viral skin infections, rosacea, acne, ulcerated lesions.
- Drug Interactions: Limited with topical use.
- Pregnancy & Breastfeeding: Use with caution during pregnancy and breastfeeding. Avoid nipple area.
- Dosage: Apply a thin layer twice daily for up to 2 weeks, not exceeding 50g/week.
- Monitoring Parameters: Monitor for local side effects, skin atrophy, and signs of systemic corticosteroid effects with prolonged or high-dose use.
Popular Combinations
This combination itself is a popular combination. No specific additional drug combinations are generally recommended.
Precautions
Avoid application to the face, groin, or axillae. Avoid prolonged use and occlusive dressings. Monitor for signs of skin atrophy and systemic corticosteroid effects.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clobetasol + Terbinafine?
A: Apply a thin layer to the affected skin twice daily, usually for a maximum of two weeks. Total weekly dose should not exceed 50g.
Q2: Can this combination be used during pregnancy or breastfeeding?
A: Use with caution and only if the benefits outweigh the potential risks. Consult a physician. Avoid applying to the nipple area during breastfeeding.
Q3: What are the common side effects?
A: Burning, itching, dryness, irritation, redness, and skin thinning at the application site.
Q4: What should I do if side effects occur?
A: Discontinue use and consult a physician.
Q5: How does Clobetasol + Terbinafine work?
A: Clobetasol reduces inflammation, while terbinafine kills fungi.
Q6: Can I use this combination on my face?
A: It is generally advised to avoid applying to the face, groin, axillae, or other sensitive areas due to increased risk of side effects.
Q7: What conditions is this combination used to treat?
A: Primarily inflammatory skin conditions complicated by fungal infections.
Q8: Can I use this cream for longer than two weeks?
A: Treatment duration should generally not exceed two weeks unless specifically directed by a physician, particularly due to the risk of skin thinning and other side effects associated with prolonged use of potent topical corticosteroids.
Q9: Are there any drug interactions I should be aware of?
A: Drug interactions are minimal with topical application. However, inform your physician about all other medications you are using, including other topical preparations.
