Starting Fespixion
Indications and Dosage
- Indication：
Diabetic foot ulcer
- Dosage and Administration：
The Cream shall be applied to the lesion twice daily by fully covering the ulcer.
Drug Safety
The Cream is contraindicated in the patients who are hypersensitive to the ingredients of the Cream, including Plectranthus amboinicus, Centella asiatica or excipients.
The Cream is for external use only and should not be taken orally or used in or around eyes or in mucosa.
The Cream hasn’t been studied in drug-drug interaction with other medications. It is not known if the Cream interacts with other medications.
The Cream is for topical administration with very limited systemic exposure which raises no concerns in systemic effect. Clinical trials were conducted on adult patients with diabetic foot ulcers. There are currently no studies specifically carried out on the populations with liver and renal impairment, children, the elderly, pregnant women or breastfeeding women.
Oral teratogenicity test in rats shows that the Cream is not teratogenic. However, there has been no clinical trials specifically conducted with the Cream on pregnant or breastfeeding women so it is also not known whether the Cream would cause fetal harm when it is administered to a pregnant woman or can affect reproductive capacity. The Cream should be given to pregnant women only if clearly needed.
It is not known whether PA-F4 and S1 are excreted in human milk. Because many drugs are secreted in human milk, extra caution should be exercised when the Cream is administered to breastfeeding women.