A fixed-dose combination topical medication containing a potent corticosteroid (Betamethasone) and a broad-spectrum fluoroquinolone antibiotic (Ofloxacin). It is primarily used for the treatment of inflammatory dermatoses with secondary or suspected bacterial infections. The combination provides anti-inflammatory, immunosuppressive, anti-pruritic, and antibacterial actions.
Adult: Apply a thin film to the affected area 1 to 2 times daily. Frequency depends on severity; often initiated as twice daily and reduced to once daily as condition improves.
Note: 1. Wash and dry hands and affected area gently. 2. Apply a thin layer and rub in gently until it disappears. 3. Do not cover with airtight occlusive dressings unless specifically directed by a physician. 4. Avoid contact with eyes, nostrils, mouth, and mucous membranes. 5. Wash hands after application unless hands are the treated area.
Betamethasone exerts potent anti-inflammatory, immunosuppressive, vasoconstrictive, and anti-proliferative effects by binding to cytoplasmic glucocorticoid receptors, modulating gene transcription. Ofloxacin is a bactericidal antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, enzymes essential for DNA replication, transcription, repair, and recombination.
Pregnancy: Category C (US FDA). Topical corticosteroids, especially potent ones, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use should be limited in amount and duration. Avoid large areas or occlusive dressings. Ofloxacin is Category C; quinolones are generally avoided in pregnancy due to arthropathy risk in animal studies.
Driving: No known effects on driving ability from topical application.
| Other Topical Corticosteroids | Additive risk of local and systemic side effects (atrophy, HPA suppression). | Major |
| Systemic Corticosteroids (e.g., Prednisolone) | Increased risk of systemic corticosteroid adverse effects. | Moderate |
| Non-steroidal Anti-inflammatory Drugs (NSAIDs) topical/systemic | May increase risk of CNS stimulation and seizures (quinolone effect). | Moderate |
| Oral Anticoagulants (e.g., Warfarin) | Ofloxacin may potentiate anticoagulant effect; monitor INR if significant systemic absorption occurs. | Moderate |
| Theophylline | Ofloxacin may inhibit metabolism, increasing theophylline levels and toxicity risk. | Moderate |
| CYP3A4 Inhibitors (e.g., Ketoconazole, Itraconazole) | May increase systemic levels of Betamethasone if absorbed. | Minor |
Same composition (Betamethasone (0.1% w/v) + Ofloxacin (0.3% w/v)), different brands: