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Florinef

   Also found in: Wikipedia 0.01 sec.
Flor·i·nef (flôr-nf)
A trademark for the drug fludrocortisone acetate.

fludrocortisone acetate

Florinef (UK), Florinef Acetate

Pharmacologic class: Adrenocorticoid

Therapeutic class: Synthetic mineralocorticoid and glucocorticoid

Pregnancy risk category C

Action

Acts on renal distal tubule, increasing sodium reabsorption and potassium excretion

Availability

Tablets: 0.1 mg

Indications and dosages

Addison's disease (adrenocortical insufficiency)

Adults: 0.1 mg P.O. daily

Salt-losing adrenogenital syndrome

Adults: 0.1 to 0.2 mg P.O. daily

Off-label uses

• Hyponatremia
• Severe orthostatic hypotension

Contraindications

• Hypersensitivity to drug, tartrazine (some products), or sulfites (some products)
• Systemic fungal infection

Precautions

Use cautiously in:
• cardiovascular disease, cirrhosis, diverticulitis, ulcerative colitis, peptic ulcer, renal insufficiency, hypertension, myasthenia gravis, adrenal insufficiency
• pregnant or breastfeeding patients.

Administration

• Know that typical dosage may range from 0.1 mg three times weekly to 0.2 mg daily.
• Give with food to reduce GI upset.
Reduce dosage, as ordered, if transient hypertension develops.
Avoid abrupt discontinuation. Taper dosage gradually when withdrawing.

RouteOnsetPeakDuration
P.O.Variable2 hr1-2 days

Adverse reactions

CNS: headache, vertigo, seizures

CV: hypertension, cardiac hypertrophy, increased blood volume, heart failure

GU: glycosuria

Metabolic: hypernatremia, hypokalemia, hyperglycemia

Musculoskeletal: joint pain, tendon contractures, arm and leg weakness

Skin: urticaria, allergic rash, bruising, diaphoresis

Other: edema, infection, impaired wound healing, hypersensitivity reactions including anaphylaxis

Interactions

Drug-drug. Amphotericin B, potassium-depleting diuretics: enhanced hypokalemia

Anabolic steroids: increased risk of edema

Aspirin: increased ulcerogenic effect; decreased pharmacologic effect of aspirin; rarely, salicylate toxicity (in patients who discontinue fludrocortisone after concurrent high-dose aspirin therapy)

Barbiturates, phenytoin, rifampin: decreased fludrocortisone effects

Cardiac glycosides: increased risk of arrhythmias or digitalis toxicity associated with hypokalemia

Estrogen: increased risk of toxicity

Insulin, oral hypoglycemics: decreased hypoglycemic effect

Oral anticoagulants: decreased prothrombin time

Drug-diagnostic tests. Cholesterol, urine glucose: increased levels

Nitroblue tetrazolium test (for bacterial infection): false-negative result

Potassium, thyroxine, thyroid hormones: decreased levels

Drug-food. Sodium-containing foods: increased blood pressure

Drug-herbs . Echinacea: antagonism of fludrocortisone's immunosuppressive effect

Patient monitoring

Monitor blood pressure. Report hypertension immediately.
• Assess for serious adverse reactions, particularly hypersensitivity and cardiovascular problems.
• Monitor sodium, potassium, and glucose levels carefully.
• Assess for signs and symptoms of infection.
• Weigh patient daily; report sudden gain.

Patient teaching

• Tell patient to take with meals or snack to minimize GI upset.
Caution patient on long-term therapy not to stop taking drug abruptly.
• Advise patient on long-term therapy to wear or carry identification stating that he is receiving this drug.
Teach patient to recognize and immediately report signs and symptoms of adrenal insufficiency (fatigue, appetite loss, nausea, vomiting, diarrhea, weight loss, weakness, dizziness, and low blood glucose level).
• Advise patient to consume a diet low in sodium and high in potassium and protein.
• Tell female patient to inform prescriber if she is pregnant or breastfeeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.



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The Company believes this is the first approval by the FDA of a generic version of Florinef.
 
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