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Fludrocortisone Acetate 0.1 Mg Tabs 500 By Global Pharma

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Fludrocortisone Acetate 0.1 Mg Tabs 500 By Global Pharma

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Fludrocortisone Acetate 0.1 Mg Tabs 500 By Global Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3934379/RXB10056588/RXa033027
Size : 500
Selling UoM : EA
NDC: 00115-7033-02
UPC Barcode :301157033027
Supplier: 0050001664 GLOBAL PHARMACEUTICAL CORP
Supplier Material : 703302
Generic Code : 006812 FLUDROCORTISONE ACETATE ORAL TABLET 0.1
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
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Product Description.:

7033
tablet , white , scored , round round
ConvexWhite to off-white

Florinef Acetate (Fludrocortisone Acetate Tablets USP) contains fludrocortisone acetate, a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity it is used only for its mineralocorticoid effects.

Florinef Acetate is available for oral administration as scored tablets providing 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: calcium phosphate, corn starch, lactose, magnesium stearate, sodium benzoate, and talc.

INDICATIONS

Florinef Acetate 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.
DOSAGE AND ADMINISTRATION

Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma) (see WARNINGS and PRECAUTIONS, General).
Addison's Disease

In Addison's disease, the combination of Florinef Acetate (Fludrocortisone Acetate Tablets USP) with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects.

The usual dose is 0.1 mg of Florinef Acetate daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Florinef Acetate 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 the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of Florinef Acetate daily.

SIDE EFFECTS

Most adverse reactions are caused by the drug's mineralocorticoid activity (retention of sodium and water) and include hypertension, edema, cardiac enlargement, congestive heart failure, potassium loss, and hypokalemic alkalosis.

When fludrocortisone is used in the small dosages recommended, the glucocorticoid side effects often seen with cortisone and its derivatives are not usually a problem however the following untoward effects should be kept in mind, particularly when fludrocortisone is used over a prolonged period of time or in conjunction with cortisone or a similar glucocorticoid.

Musculoskeletal-muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, pathologic fracture of long bones, and spontaneous fractures.

Gastrointestinal-peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic-impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions, and hives reactions to skin tests may be suppressed.

Neurological-convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances.

Endocrine-menstrual irregularities development of the cushingoid state suppression of growth in children secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness) decreased carbohydrate tolerance manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic-posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic-hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism.

Allergic Reactions-allergic skin rash, maculopapular rash, and urticaria.

Other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions.