Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET
**RECOMMENDED DOSAGE** Dosage depends on the severity of the disease and the response of the patient. The lowest possible dose should be used to control the condition being treated, and a reduction in dosage should be made (gradually) when possible. **Adrenocorticoid Insufficiency (chronic).** In Addison’s disease, the combination of **FLORINEF** with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity. The usual dose for adults, adolescents, and elderly patients is one tablet (0.1 mg) of **FLORINEF** daily – range: one tablet (0.1 mg) three times a week to two tablets (0.2 mg) daily. If treatment-associated hypertension develops, the dose should be reduced to 0.05 mg daily. **FLORINEF** is preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses). **Salt-losing Adrenogenital Syndrome** The recommended dosage for treating salt-losing adrenogenital syndrome is one tablet (0.1 mg) to two tablets (0.2 mg) of **FLORINEF** daily. Pediatric and Adolescent: One half tablet (0.05 mg) to one tablet (0.1 mg) daily.
ORAL
Medical Information
**INDICATIONS AND USAGE** **FLORINEF** is indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease and for the treatment of salt-losing adrenogenital syndrome.
**CONTRAINDICATIONS** Corticosteroids are contraindicated in patients with systemic fungal infections and in those with suspected or known hypersensitivity to fludrocortisone or any of the inactive ingredients.
H02AA02
fludrocortisone
Manufacturer Information
DCH AURIGA SINGAPORE
Haupt Pharma Amareg GmbH
Active Ingredients
Documents
Package Inserts
Florinef Tablet PI.pdf
Approved: July 29, 2019