fludrocortisone

REMS

Sodium loss and hypotension associated with adrenocortical insufficiency (in combination with hydrocortisone or cortisone).
Sodium loss due to congenital adrenogenital syndrome (congenital adrenal hyperplasia).

Unlabeled Use:

Idiopathic orthostatic hypotension (with increased sodium intake).
Type IV renal tubular acidosis.

Action ⬆ ⬇

Causes sodium reabsorption, hydrogen and potassium excretion, and water retention by its effects on the distal renal tubule.

Therapeutic effects:

Maintenance of sodium balance and BP in patients with adrenocortical insufficiency.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-Life: 3.5 hr.

Time/Action Profile ⬆ ⬇

(mineralocorticoid activity)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	1–2 days

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

HF;
Addison’s disease (patients may have exaggerated response);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, edema, HF, hypertension

Endo: adrenal suppression

F and E: hypokalemia, hypokalemic alkalosis

GI: anorexia, nausea

Metab: weight gain

MS: arthralgia, muscular weakness, tendon contractures

Neuro: ascending paralysis, dizziness, headache

Misc: hypersensitivity reactions

Interactions ⬆ ⬇

Drug-drug:

Use with thiazide diuretics, loop diuretics, piperacillin, or amphotericin B may ↑ risk of hypokalemia.
Hypokalemia may ↑ risk of digoxin toxicity.
May produce prolonged neuromuscular blockade following the use of nondepolarizing neuromuscular blocking agents.
Phenobarbital or rifampin may ↑ metabolism and ↓ effectiveness.

Large amounts of salt or sodium-containing foods may cause excessive sodium retention and potassium loss.

Route/Dosage ⬆ ⬇

PO (Adults ): Adrenocortical insufficiency: 0.1 mg/day (range 0.1 mg 3 times weekly—0.2 mg daily). Doses as small as 0.05 mg daily may be required by some patients. Use with 10–37.5 mg cortisone daily or 10–30 mg hydrocortisone daily. Adrenogenital syndrome: 0.1–0.2 mg/day. Idiopathic hypotension: 0.05–0.2 mg/day (unlabeled).
PO (Children ): 0.05–0.1 mg/day.

Availability ⬆ ⬇

(Generic available)

Tablets: 0.1 mg

Assessment ⬆ ⬇

Monitor BP periodically during therapy. Report significant changes. Hypotension may indicate insufficient dose.
Monitor for fluid retention (weigh daily, assess for edema, and auscultate lungs for rales/crackles).
Monitor patients with Addison’s disease closely and stop treatment if a significant increase in weight or BP, edema, or cardiac enlargement occurs. Patients with Addison’s disease are more sensitive to the action of fludrocortisone and may have an exaggerated response.

Lab Test Considerations:

Monitor serum electrolytes periodically during therapy. Fludrocortisone causes ↓ serum potassium levels.

Implementation ⬆ ⬇

PO: Administer without regard to food; take with food if GI upset occurs. Tablets are scored and may be broken if dose adjustment is necessary. May require higher doses when subject to stress.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take medication as directed. Take missed doses as soon as remembered but not just before next dose is due. Explain that lifelong therapy may be necessary and that abrupt discontinuation may lead to Addisonian crisis. Patient should keep an adequate supply available at all times. Discontinue gradually if needed.
Advise patient to follow dietary modification prescribed by health care professional. Instruct patient to follow a diet high in potassium (see Food Sources for Specific Nutrients). Amount of sodium allowed in diet varies with pathophysiology.
Instruct patient to inform health care professional if weight gain or edema, muscle weakness, cramps, nausea, anorexia, or dizziness occurs.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Monitor newborns of patients taking fludrocortisone during pregnancy for hypoadrenalism.
Advise patient to carry identification at all times describing disease process and medication regimen.

Evaluation/Desired Outcomes ⬆ ⬇

Normalization of fluid and electrolyte balance without the development of hypokalemia or hypertension.

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

0115- Amneal Pharmaceuticals of New York LLC
- 0115-7033- Fludrocortisone Acetate
  - 0115-7033-01- 100 TABLET in 1 BOTTLE (0115-7033-01)

0115- Amneal Pharmaceuticals of New York LLC
- 0115-7033- Fludrocortisone Acetate
  - 0115-7033-02- 500 TABLET in 1 BOTTLE (0115-7033-02)

0115- Amneal Pharmaceuticals of New York LLC
- 0115-7033- Fludrocortisone Acetate
  - 0115-7033-03- 1000 TABLET in 1 BOTTLE (0115-7033-03)

0555- Teva Pharmaceuticals USA, Inc.
- 0555-0997- Fludrocortisone Acetate
  - 0555-0997-02- 100 TABLET in 1 BOTTLE (0555-0997-02)

42291- AvKARE, Inc.
- 42291-529- FLUDROCORTISONE ACETATE
  - 42291-529-01- 100 TABLET in 1 BOTTLE (42291-529-01)

50268- AvPAK
- 50268-330- FLUDROCORTISONE ACETATE
  - 50268-330-15- 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-330-15) > 1 TABLET in 1 BLISTER PACK (50268-330-11)

55154- Cardinal Health
- 55154-6645- Fludrocortisone Acetate
  - 55154-6645-0- 10 BLISTER PACK in 1 BAG (55154-6645-0) > 1 TABLET in 1 BLISTER PACK

63629- Bryant Ranch Prepack
- 63629-7780- Fludrocortisone Acetate
  - 63629-7780-1- 30 TABLET in 1 BOTTLE (63629-7780-1)

63629- Bryant Ranch Prepack
- 63629-7780- Fludrocortisone Acetate
  - 63629-7780-2- 60 TABLET in 1 BOTTLE (63629-7780-2)

68084- American Health Packaging
- 68084-288- Fludrocortisone Acetate
  - 68084-288-01- 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-288-01) > 1 TABLET in 1 BLISTER PACK (68084-288-11)

71335- Bryant Ranch Prepack
- 71335-0976- Fludrocortisone Acetate
  - 71335-0976-1- 30 TABLET in 1 BOTTLE (71335-0976-1)

71335- Bryant Ranch Prepack
- 71335-0976- Fludrocortisone Acetate
  - 71335-0976-2- 60 TABLET in 1 BOTTLE (71335-0976-2)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇