Dosage guidance:
Clinical considerations: Due to risk of hypokalemia, periodically monitor serum potassium during therapy; ensure adequate dietary potassium intake as appropriate (Ref).
Adrenal insufficiency, chronic:
Note: For use in patients with mineralocorticoid deficiency due to primary adrenal insufficiency. Patients with central adrenal insufficiency rarely require fludrocortisone; however, may be needed in patients with longstanding central disease with documented mineralocorticoid deficiency (Ref).
Oral: Initial: 0.05 to 0.1 mg once daily in the morning (in combination with glucocorticoid therapy). May adjust dose in 0.05 mg increments if needed based on symptoms of under- or over-replacement; usual maintenance dose: 0.05 to 0.2 mg once daily. If hypertension develops, dose reduction is suggested; antihypertensive therapy may be necessary if hypertension remains uncontrolled (Ref).
Adrenal insufficiency due to classic congenital adrenal hyperplasia
Note: For use in patients with confirmed mineralocorticoid deficiency (Ref).
Oral: 0.05 to 0.2 mg/day in 1 or 2 divided doses (in combination with glucocorticoid therapy) (Ref). May adjust dose in 0.05 to 0.1 mg increments within this range if needed based on symptoms of under- or over-replacement. If hypertension develops, dose reduction is suggested; antihypertensive therapy may be necessary if hypertension remains uncontrolled (Ref).
Orthostatic hypotension (off-label use):
Note: For use in conjunction with nonpharmacologic measures (eg, high-salt diet, adequate fluid intake, head-up tilt sleeping). Use with caution or avoid in patients with heart failure or low serum albumin (Ref).
Oral: Initial: 0.05 to 0.1 mg once daily (Ref). May adjust dose (eg, in 0.05 to 0.1 mg/day increments) at weekly intervals if needed based on response; usual dose range: 0.05 to 0.2 mg/day administered in 1 or 2 divided daily doses (Ref). Doses >0.2 mg/day have been associated with an increased risk of adverse effects without added benefit (Ref).
Postural orthostatic tachycardia syndrome (off-label use):
Oral: Initial: 0.05 to 0.1 mg once daily. May increase slowly based on response and tolerability up to 0.1 to 0.2 mg/day (Ref).
Septic shock (adjunctive agent) (off-label use): Note: If used, administer in combination with hydrocortisone in patients with ongoing vasopressor requirements (Ref).
Oral: 0.05 mg once daily for up to 7 days or until glucocorticoid is discontinued, whichever comes first. Discontinue fludrocortisone without a taper (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment likely to be necessary (eliminated mostly as inactive metabolites) (Ref).
Hemodialysis, intermittent (thrice weekly): Dialyzability unknown: No supplemental dose or dosage adjustment likely to be necessary (eliminated mostly as inactive metabolites) (Ref).
Peritoneal dialysis: Dialyzability unknown: No dosage adjustment likely to be necessary (eliminated mostly as inactive metabolites) (Ref).
CRRT: No dosage adjustment likely to be necessary (eliminated mostly as inactive metabolites) (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment likely to be necessary (eliminated mostly as inactive metabolites) (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Refer to adult dosing.
(For additional information see "Fludrocortisone: Pediatric drug information")
Dosage guidance:
Dosing: Dosing should be individualized to lowest effective dose.
Adrenal insufficiency, autoimmune (primary adrenal insufficiency, aldosterone deficiency component Addison disease); replacement therapy: Limited data available: Infants, Children, and Adolescents: Oral: 0.05 to 0.2 mg daily (Ref).
Congenital adrenal hyperplasia (salt losers) (eg, 21-hydroxylase deficiency): Limited data available: Note: Use in combination with glucocorticoid therapy (eg, hydrocortisone); concurrent sodium replacement therapy may be required, particularly in young infants.
Maintenance therapy:
Infants, Children, and Adolescents (actively growing): Oral: Usual range: 0.05 to 0.2 mg daily in 1 or 2 divided doses; doses as high as 0.3 mg/day may be necessary (Ref).
Adolescents (fully grown): Oral: 0.05 to 0.2 mg once daily (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling.
Glucocorticoids may inhibit bone growth (linear growth) in pediatric patients (Ref).
Mechanism: Dose-related; glucocorticoids decrease bone formation and increase bone resorption by a combination of factors, including decreasing calcium absorption and increasing calcium secretion; suppressing the somatotropic axis, resulting in suppressed growth hormone secretion; and increasing catabolism of the bone protein matrix and decreasing sex hormone production (Ref).
Risk factors:
• Drug exposure (Ref)
Fludrocortisone is associated with hypertension (most commonly supine systolic) and heart failure with reduced ejection fraction (HFrEF) (Ref). When using fludrocortisone to treat orthostatic hypotension (OH), it is important to consider comorbid conditions, as fludrocortisone patients have an increased risk of heart failure and all cause hospitalization (Ref). Supine hypertension was more common with autonomic failure (Ref). In a study of older adults with OH, the incidence of hypertension and acute HFrEF was estimated at 6% and 11%, respectively (Ref). Development of HFrEF after initiation of fludrocortisone for treatment of adrenal insufficiency, although rare, is documented in 3 cases across all age groups (Ref). Children receiving fludrocortisone for congenital adrenal hyperplasia (CAH) have a higher incidence of hypertension (55%) compared to children not receiving fludrocortisone (31%) (Ref).
Mechanism: Transient increase in plasma volume due to potent mineralocorticoid activity promoting sodium retention, thereby expanding plasma volume and increasing cardiac afterload (Ref). Sustained changes in blood pressure are from heightened sensitivity of alpha-adrenoreceptors and enhanced release of norepinephrine and angiotensin II (Ref). Long-term use may promote cardiac fibrosis, oxidative stress, and endothelial dysfunction that could affect cardiac remolding (Ref).
Onset: Varies; heart failure has been reported within 2 to 3 weeks after therapy initiation (Ref) and following long-term use (Ref). In a study of older adults with OH, the mean time to development of hypertension and heart failure was 5 months and 7 months, respectively (Ref).
Risk factors:
• Long-term treatment (independent of dose) in older adults with OH (Ref)
• History of HFrEF (Ref)
• History of Addison disease (Ref)
• Dose in children <8 years of age with CAH (Ref)
Fludrocortisone is associated with hypokalemia and hypomagnesemia (Ref). In 2 studies of adults with orthostatic hypotension, the incidence of hypokalemia and hypomagnesemia was estimated at 24% to 50% and ~5%, respectively (Ref). These electrolyte disturbances have the potential to further exacerbate underlying conditions (eg, arrhythmias), especially in those with heart failure with reduced ejection fraction (Ref). Hypomagnesemia was not reported in children receiving fludrocortisone for the treatment of primary adrenal insufficiency for an average of 6.5 years (Ref).
Mechanism: Effect on the distal tubule in the kidney elicit sodium ion and water transport into the plasma, thereby increasing potassium and hydrogen ions into the urine (Ref).
Onset: Varies; duration of therapy prior to development of hypokalemia ranges from within 1 week to several months (Ref). In a study with older adults with orthostatic hypotension, the mean onset was 8 months (range: 2 to 21 months) (Ref).
Risk factors:
• Concurrent amphotericin B, diuretics, or digoxin
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Cardiomegaly, edema, heart failure (Grijalva 2017), hypertension (Bonfig 2015; Grijalva 2017)
Dermatologic: Allergic skin rash, atrophic striae, diaphoresis, ecchymoses, facial erythema, hyperpigmentation (skin and nails), maculopapular rash, skin atrophy, subcutaneous atrophy, urticaria
Endocrine & metabolic: Cushing syndrome, growth retardation, hirsutism, HPA-axis suppression, hyperglycemia, hypokalemia (Grijalva 2017), hypokalemic alkalosis, menstrual disease, negative nitrogen balance, prediabetes
Gastrointestinal: Abdominal distention, esophageal ulcer, pancreatitis, peptic ulcer
Genitourinary: Glycosuria
Hematologic & oncologic: Bruise, petechia, purpuric disease
Local: Local acneiform eruptions
Nervous system: Amyotrophy, headache, intracranial hypertension (idiopathic), mental status changes (severe), myasthenia, seizure, vertigo
Neuromuscular & skeletal: Aseptic necrosis of femoral head, aseptic necrosis of humeral head, bone fracture (including pathological fracture and vertebral compression fracture), osteoporosis, steroid myopathy
Ophthalmic: Exophthalmos, glaucoma, subcapsular posterior cataract
Miscellaneous: Wound healing impairment
Postmarketing:
Endocrine & metabolic: Hypomagnesemia (Grijalva 2017)
Hematologic & oncologic: Kaposi sarcoma (Goedert 2002)
Hypersensitivity: Anaphylaxis (Burgdorff 2002, Pryse-Phillips 1984, Sieck 1990)
Respiratory: Pulmonary edema (Misra 2018)
Hypersensitivity to fludrocortisone or any component of the formulation; systemic fungal infections
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.
• Kidney impairment: Use with caution in patients with kidney impairment; fluid retention may occur.
• Myasthenia gravis: Use may cause transient worsening of myasthenia gravis (MG) (eg, within first 2 weeks of treatment); monitor for worsening MG (AAN [Narayanaswami 2021]).
• Systemic sclerosis: Use with caution in patients with systemic sclerosis; an increase in scleroderma renal crisis incidence has been observed with corticosteroid use. Monitor BP and kidney function in patients with systemic sclerosis treated with corticosteroids (EULAR [Kowal-Bielecka 2017]).
• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in patients with hyperthyroidism and decreases in patients with hypothyroidism.
Special populations:
• Older adults: Because of the risk of adverse effects, use with caution in older adults; use with the smallest possible effective dose for the shortest duration.
Other warnings/precautions:
• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.
• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe illness).
Transient hypertrophic cardiomyopathy following treatment with dexamethasone and hydrocortisone has been reported in premature neonates (Alpert 1984; Jiang 2019; Röhr 2014; Vimala 2011).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as acetate:
Generic: 0.1 mg
Yes
Tablets (Fludrocortisone Acetate Oral)
0.1 mg (per each): $0.75 - $1.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as acetate:
Florinef: 0.1 mg
Oral: Administer without regard to food; if GI upset, may take with food. For septic shock (off-label use), administer via nasogastric tube (Ref).
Oral: May administer without regard to food; if GI upset, may take with food. Tablets may be crushed and mixed with about 1 teaspoon of water or soft food such as applesauce, chocolate syrup, jelly, or yogurt.
Adrenal insufficiency, chronic: Partial replacement therapy for primary and central adrenocortical insufficiency.
Congenital adrenal hyperplasia, classic (salt-losing adrenogenital syndrome): Treatment of classic congenital adrenal hyperplasia (salt-losing adrenogenital syndrome).
Orthostatic hypotension; Postural orthostatic tachycardia syndrome; Septic shock
Florinef may be confused with Fioricet, Fiorinal, Floranex, Florastor
Substrate of CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Abrocitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Abrocitinib. Management: The use of abrocitinib in combination with other immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may increase adverse/toxic effects of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor
Aldesleukin: Corticosteroids (Systemic) may decrease therapeutic effects of Aldesleukin. Risk X: Avoid
Amphotericin B: Corticosteroids (Systemic) may increase hypokalemic effects of Amphotericin B. Risk C: Monitor
Androgens: Corticosteroids (Systemic) may increase fluid-retaining effects of Androgens. Risk C: Monitor
Antacids: May decrease bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider Therapy Modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Antithymocyte Globulin (Equine): Corticosteroids (Systemic) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of systemic corticosteroid is reduced. Corticosteroids (Systemic) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Baricitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Baricitinib. Management: The use of baricitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
BCG Products: Corticosteroids (Systemic) may decrease therapeutic effects of BCG Products. Corticosteroids (Systemic) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Bile Acid Sequestrants: May decrease absorption of Corticosteroids (Oral). Risk C: Monitor
Brincidofovir: Corticosteroids (Systemic) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Corticosteroids (Systemic). Risk X: Avoid
Calcitriol (Systemic): Corticosteroids (Systemic) may decrease therapeutic effects of Calcitriol (Systemic). Risk C: Monitor
CAR-T Cell Immunotherapy: Corticosteroids (Systemic) may decrease therapeutic effects of CAR-T Cell Immunotherapy. Corticosteroids (Systemic) may increase adverse/toxic effects of CAR-T Cell Immunotherapy. Specifically, the severity and duration of neurologic toxicities may be increased. Management: Avoid use of corticosteroids as premedication before treatment with CAR-T cell immunotherapy agents. Corticosteroids are indicated and may be required for treatment of toxicities such as cytokine release syndrome or neurologic toxicity. Risk D: Consider Therapy Modification
Cardiac Glycosides: Corticosteroids (Systemic) may increase adverse/toxic effects of Cardiac Glycosides. Risk C: Monitor
Chikungunya Vaccine (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Cladribine: Corticosteroids (Systemic) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
Coccidioides immitis Skin Test: Coadministration of Corticosteroids (Systemic) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing systemic corticosteroids (dosed at 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks) several weeks prior to coccidioides immitis skin antigen testing. Risk D: Consider Therapy Modification
Corticorelin: Corticosteroids (Systemic) may decrease therapeutic effects of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor
Cosyntropin: Coadministration of Corticosteroids (Systemic) and Cosyntropin may alter diagnostic results. Risk C: Monitor
COVID-19 Vaccine (Inactivated Virus): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Corticosteroids (Systemic) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Fludrocortisone. Risk C: Monitor
Deferasirox: Corticosteroids (Systemic) may increase adverse/toxic effects of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor
Dengue Tetravalent Vaccine (Live): Corticosteroids (Systemic) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Corticosteroids (Systemic) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and systemic corticosteroids. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Desirudin: Corticosteroids (Systemic) may increase anticoagulant effects of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Risk D: Consider Therapy Modification
Desmopressin: Corticosteroids (Systemic) may increase hyponatremic effects of Desmopressin. Risk X: Avoid
Deucravacitinib: May increase immunosuppressive effects of Corticosteroids (Systemic). Management: The use of deucravacitinib in combination with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Dinutuximab Beta: Corticosteroids (Systemic) may increase immunosuppressive effects of Dinutuximab Beta. Management: Corticosteroids are not recommended for 2 weeks prior to dinutuximab beta, during therapy and for 1 week after treatment. Doses equivalent to over 2 mg/kg or 20 mg/day of prednisone (persons over 10 kg) for 2 or more weeks are considered immunosuppressive Risk D: Consider Therapy Modification
Estrogen Derivatives: May increase serum concentration of Corticosteroids (Systemic). Risk C: Monitor
Etrasimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Etrasimod. Risk C: Monitor
Filgotinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Filgotinib. Management: Coadministration of filgotinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification
Gallium Ga 68 Dotatate: Coadministration of Corticosteroids (Systemic) and Gallium Ga 68 Dotatate may alter diagnostic results. Risk C: Monitor
Growth Hormone Analogs: Corticosteroids (Systemic) may decrease therapeutic effects of Growth Hormone Analogs. Growth Hormone Analogs may decrease active metabolite exposure of Corticosteroids (Systemic). Risk C: Monitor
Hyaluronidase: Corticosteroids (Systemic) may decrease therapeutic effects of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider Therapy Modification
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Corticosteroids (Systemic) may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Management: Carefully consider the need for corticosteroids, at doses of a prednisone-equivalent of 10 mg or more per day, during the initiation of immune checkpoint inhibitor therapy. Use of corticosteroids to treat immune related adverse events is still recommended Risk D: Consider Therapy Modification
Indium 111 Capromab Pendetide: Coadministration of Corticosteroids (Systemic) and Indium 111 Capromab Pendetide may alter diagnostic results. Risk X: Avoid
Inebilizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider Therapy Modification
Isoniazid: Corticosteroids (Systemic) may decrease serum concentration of Isoniazid. Risk C: Monitor
Leflunomide: Corticosteroids (Systemic) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as systemic corticosteroids. Risk D: Consider Therapy Modification
Licorice: May increase serum concentration of Corticosteroids (Systemic). Risk C: Monitor
Loop Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Loop Diuretics. Risk C: Monitor
Lutetium Lu 177 Dotatate: Corticosteroids (Systemic) may decrease therapeutic effects of Lutetium Lu 177 Dotatate. Management: Avoid repeated use of high-doses of corticosteroids during treatment with lutetium Lu 177 dotatate. Use of corticosteroids is still permitted for the treatment of neuroendocrine hormonal crisis. The effects of lower corticosteroid doses is unknown. Risk D: Consider Therapy Modification
Macimorelin: Coadministration of Corticosteroids (Systemic) and Macimorelin may alter diagnostic results. Risk X: Avoid
MetyraPONE: Coadministration of Corticosteroids (Systemic) and MetyraPONE may alter diagnostic results. Management: Consider alternatives to the use of the metyrapone test in patients taking systemic corticosteroids. Risk D: Consider Therapy Modification
Mifamurtide: Corticosteroids (Systemic) may decrease therapeutic effects of Mifamurtide. Risk X: Avoid
MiFEPRIStone: May decrease therapeutic effects of Corticosteroids (Systemic). MiFEPRIStone may increase serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (eg, for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Risk X: Avoid
Mineralocorticoid (Aldosterone) Receptor Antagonists: Fludrocortisone may decrease therapeutic effects of Mineralocorticoid (Aldosterone) Receptor Antagonists. Mineralocorticoid (Aldosterone) Receptor Antagonists may decrease therapeutic effects of Fludrocortisone. Risk C: Monitor
Mumps- Rubella- or Varicella-Containing Live Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Corticosteroids (Systemic) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Corticosteroids (Systemic) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Neuromuscular-Blocking Agents (Nondepolarizing): May increase adverse neuromuscular effects of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Management: If concomitant therapy is required, use the lowest dose for the shortest duration to limit the risk of myopathy or neuropathy. Monitor for new onset or worsening muscle weakness, reduction or loss of deep tendon reflexes, and peripheral sensory decriments Risk D: Consider Therapy Modification
Nicorandil: Corticosteroids (Systemic) may increase adverse/toxic effects of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (Nonselective): Corticosteroids (Systemic) may increase adverse/toxic effects of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents (Topical): May increase adverse/toxic effects of Corticosteroids (Systemic). Specifically, the risk of gastrointestinal bleeding, ulceration, and perforation may be increased. Risk C: Monitor
Ocrelizumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Ozanimod: Corticosteroids (Systemic) may increase immunosuppressive effects of Ozanimod. Risk C: Monitor
Phenobarbital-Primidone: May decrease serum concentration of Fludrocortisone. Risk C: Monitor
Pidotimod: Corticosteroids (Systemic) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk X: Avoid
Pneumococcal Vaccines: Corticosteroids (Systemic) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Corticosteroids (Systemic) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Corticosteroids (Systemic) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Corticosteroids (Systemic) may increase adverse/toxic effects of Polymethylmethacrylate. Specifically, the risk for hypersensitivity or implant clearance may be increased. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Quinolones: Corticosteroids (Systemic) may increase adverse/toxic effects of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor
Rabies Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ritodrine: Corticosteroids (Systemic) may increase adverse/toxic effects of Ritodrine. Risk C: Monitor
Ruxolitinib (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Salicylates: May increase adverse/toxic effects of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor
Sargramostim: Corticosteroids (Systemic) may increase therapeutic effects of Sargramostim. Specifically, corticosteroids may enhance the myeloproliferative effects of sargramostim. Risk C: Monitor
Sipuleucel-T: Corticosteroids (Systemic) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing immunosuppressants, such as systemic corticosteroids, prior to initiating sipuleucel-T therapy. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone given for 2 or more weeks are immunosuppressive. Risk D: Consider Therapy Modification
Sitafloxacin: Corticosteroids (Systemic) may increase adverse/toxic effects of Sitafloxacin. Specifically, the risk of tendonitis and tendon rupture may be increased. Management: Consider alternatives to coadministration of corticosteroids and sitafloxacin unless the benefits of coadministration outweigh the risk of tendon disorders. Risk D: Consider Therapy Modification
Sodium Benzoate: Corticosteroids (Systemic) may decrease therapeutic effects of Sodium Benzoate. Risk C: Monitor
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Corticosteroids (Systemic). Risk C: Monitor
Succinylcholine: Corticosteroids (Systemic) may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor
Tacrolimus (Systemic): Corticosteroids (Systemic) may decrease serum concentration of Tacrolimus (Systemic). Conversely, when discontinuing corticosteroid therapy, tacrolimus concentrations may increase. Risk C: Monitor
Tacrolimus (Topical): Corticosteroids (Systemic) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Corticosteroids (Systemic) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Corticosteroids (Systemic) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may increase hypokalemic effects of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Tofacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Tofacitinib. Management: Coadministration of tofacitinib with potent immunosuppressants is not recommended. Doses equivalent to more than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks are considered immunosuppressive. Risk D: Consider Therapy Modification
Typhoid Vaccine: Corticosteroids (Systemic) may decrease therapeutic effects of Typhoid Vaccine. Corticosteroids (Systemic) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Corticosteroids (Systemic) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Corticosteroids (Systemic) may increase immunosuppressive effects of Upadacitinib. Management: Coadministration of upadacitinib with systemic corticosteroids at doses equivalent to greater than 2 mg/kg or 20 mg/day of prednisone (for persons over 10 kg) administered for 2 or more weeks is not recommended. Risk D: Consider Therapy Modification
Urea Cycle Disorder Agents: Corticosteroids (Systemic) may decrease therapeutic effects of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Risk C: Monitor
Vaccines (Live): Corticosteroids (Systemic) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone > 2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines 4 weeks prior to therapy if possible. Risk D: Consider Therapy Modification
Vaccines (Non-Live/Inactivated/Non-Replicating): Corticosteroids (Systemic) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Administer vaccines at least 2 weeks prior to immunosuppressive corticosteroids if possible. If patients are vaccinated less than 14 days prior to or during such therapy, repeat vaccination at least 3 months after therapy if immunocompetence restored. Risk D: Consider Therapy Modification
Vitamin K Antagonists: Corticosteroids (Systemic) may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor
Yellow Fever Vaccine: Corticosteroids (Systemic) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Yellow Fever Vaccine. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Corticosteroids (Systemic) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Corticosteroids (Systemic) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Animal reproduction studies have not been conducted with fludrocortisone; adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie 2000; Pradat 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor.
When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010). Fludrocortisone may be used to treat women during pregnancy who require therapy for congenital adrenal hyperplasia or primary adrenal insufficiency (Endocrine Society [Bornstein 2016; Speiser 2018]).
It is not known if fludrocortisone is excreted in breast milk; corticosteroids are excreted in breast milk. The manufacturer recommends that caution be exercised when administering fludrocortisone to nursing women.
Systemic use of mineralocorticoids/corticosteroids may require a diet with increased potassium, vitamins A, B6, C, D, folate, calcium, zinc, and phosphorus, and decreased sodium. With fludrocortisone, a decrease in dietary sodium is often not required as the increased retention of sodium is usually the desired therapeutic effect.
BP, volume status; blood glucose, electrolytes, potassium (eg, 1 week after changing dose and every 3 to 4 months during therapy [Miller 2018]); weight; growth and development in children; HPA axis suppression.
Very potent mineralocorticoid with high glucocorticoid activity; used primarily for its mineralocorticoid effects. Promotes increased reabsorption of sodium and loss of potassium from renal distal tubules.
Metabolism: Hepatic.
Half-life elimination: Plasma: ≥3.5 hours; Biological: 18 to 36 hours.
Excretion: Eliminated by the kidneys mostly as inactive metabolites (New Zealand datasheet).