clobetasone butyrate + nystatin + oxytetracycline calcium: clinical use

Prescribing considerations

• Confirm that the skin condition is steroid-responsive and bacterial or candidal involvement is present, suspected or likely.
• Reassess promptly if infection spreads or the condition worsens; corticosteroid activity can mask progression.
• Systemic absorption rises with extensive, inflamed, broken, thin or occluded skin. Nappies may act as occlusive dressings.
• Children absorb proportionally more topical corticosteroid and are more susceptible to systemic effects.
• Avoid dilution of this antimicrobial-containing product.
• Repeated use can promote contact sensitisation; oxytetracycline does not cover every clinically important organism.

Contraindications and cautions

• Hypersensitivity to an active substance or formulation component
• Primary viral skin infections
• Primary bacterial, fungal or yeast skin lesions
• Infections caused by MRSA, Acinetobacter, Pseudomonas, Proteus, Serratia or group B streptococci
• Rosacea
• Acne vulgaris
• Perioral dermatitis
• Itching without inflammation

Monitoring

• Clinical response and any extension of infection
• Local hypersensitivity, photosensitivity, skin thinning and pigment change
• Features of HPA-axis suppression when systemic absorption risk is increased
• Growth and weight gain in children when exposure is extended or substantial
• Visual symptoms, especially after eyelid or facial application
• Rebound or withdrawal-type inflammation after stopping

Clinical pharmacology

Clobetasone butyrate is a moderately potent anti-inflammatory corticosteroid. Nystatin binds fungal membrane sterols, and oxytetracycline inhibits susceptible bacterial protein synthesis at the 30S ribosomal subunit. Nystatin and oxytetracycline are expected to have minimal systemic absorption through skin, while corticosteroid absorption varies with the skin barrier, site, inflammation and occlusion.

Formulation and product differences

• The product is a yellow, water-miscible cream suited to moist or weeping surfaces.
• It contains cetostearyl alcohol, which may cause local dermatitis, and chlorocresol, which may cause allergic reactions.
• It may slightly stain skin, hair or fabric; staining can be removed by washing.
• Cream residue on clothing, bedding or dressings creates a serious fire hazard.