Drug Guide
Betamethasone Dipropionate and Clotrimazole
Classification
Therapeutic: Topical antifungal and corticosteroid combination
Pharmacological: Betamethasone Dipropionate: corticosteroid; Clotrimazole: antifungal (azoles)
FDA Approved Indications
- Treatment of superifical fungal infections of the skin (e.g., tinea, candidiasis) with associated inflammation and itching
Mechanism of Action
Betamethasone Dipropionate reduces inflammation, swelling, and itching by suppressing multiple inflammatory cytokines. Clotrimazole inhibits fungal cytochrome P450 enzyme 14α-demethylase, impairing ergosterol synthesis vital for fungal cell membrane integrity, leading to cell death.
Dosage and Administration
Adult: Apply a thin layer to affected area twice daily. Use for no more than 2 weeks unless directed by a healthcare provider.
Pediatric: Use with caution; safety and efficacy in children under 17 years have not been established.
Geriatric: No specific adjustments; monitor closely for skin thinning or adverse effects.
Renal Impairment: No specific adjustments, as the drug is topical.
Hepatic Impairment: No specific adjustments.
Pharmacokinetics
Absorption: Minimal systemic absorption when used topically, but absorption increases with large surface areas or compromised skin.
Distribution: Widespread distribution possible if absorbed systemically.
Metabolism: Betamethasone is metabolized in the liver; Clotrimazole is extensively metabolized in the liver.
Excretion: Metabolites excreted primarily via urine and bile.
Half Life: Betamethasone: approximately 36-54 hours; Clotrimazole: variable, as it is extensively metabolized.
Contraindications
- Hypersensitivity to betamethasone, clotrimazole, or any component of the formulation.
- Viral skin infections (e.g., herpes simplex, vaccinia).
Precautions
- Use with caution in areas with broken or ulcerated skin, or on sensitive skin areas such as face, groin, or underarms. Avoid prolonged use to prevent skin atrophy.
Adverse Reactions - Common
- Burning or itching at application site (Common)
- Skin irritation or allergic contact dermatitis (Common)
Adverse Reactions - Serious
- Skin atrophy, striae, telangiectasia with prolonged use (Uncommon)
- Secondary infection due to immunosuppression (Uncommon)
Drug-Drug Interactions
- None significant with topical use
Drug-Food Interactions
- None
Drug-Herb Interactions
- Caution with products that may irritate skin or alter absorption
Nursing Implications
Assessment: Inspect skin before and during therapy for signs of irritation or infection.
Diagnoses:
- Risk of skin atrophy, secondary infection, adverse reaction.
Implementation: Apply thin layer, do not occlude unless instructed, avoid covering with tight bandages.
Evaluation: Monitor skin response and patient safety.
Patient/Family Teaching
- Use only as directed; do not cover treated areas unless instructed.
- Avoid contact with eyes, mouth, or mucous membranes.
- Report any signs of irritation, worsening infection, or other adverse effects.
Special Considerations
Black Box Warnings:
- Chronic use of topical corticosteroids can lead to skin atrophy, hypothalamic-pituitary-adrenal (HPA) axis suppression
Genetic Factors: No specific genetic considerations.
Lab Test Interference: None reported.
Overdose Management
Signs/Symptoms: Overuse can cause systemic corticosteroid effects such as HPA axis suppression, dermatologic thinning.
Treatment: Discontinue use, supportive care, monitor for adrenal suppression.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F). Keep out of reach of children.
Stability: Stable for the duration of labeling when stored properly.