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Florinef

Florinef is a corticosteroid based on fludrocortisone, registered in 20 countries and used in the management of adrenal insufficiency. The active ingredient is classified as both a glucocorticoid and a mineralocorticoid, which is the pharmacological basis for its role in long-term hormone replacement rather than the short-course anti-inflammatory uses associated with many other corticosteroids.

Fludrocortisone is prescribed for Addison's disease and for adrenogenital syndrome — conditions in which the adrenal cortex does not produce adequate mineralocorticoid activity, leading to disturbances in salt and water balance that require ongoing replacement therapy. The structured indication list further down this page details the registered uses recognised across the markets where Florinef is sold.

The 20-country footprint spans several regions rather than clustering in one — markets where Florinef is registered include Japan, Canada, Norway, Australia, and Chile, alongside smaller markets such as Iceland, Malta, and Lebanon. Travellers and expatriates who depend on fludrocortisone for daily adrenal replacement will often find the same molecule available abroad, although the brand on the box may differ and prescription pathways vary considerably from one country to another. A local pharmacist can usually confirm whether a fludrocortisone-containing product is available under a different name in the destination market.

Other corticosteroids exist worldwide, but the specific glucocorticoid-plus-mineralocorticoid profile of fludrocortisone is not generally substitutable on a like-for-like basis with more common corticosteroids. Anyone managing adrenal insufficiency while travelling should treat substitution as a clinical decision led by a healthcare provider familiar with the patient's history.

Countries
Australia Canada Chile Denmark Finland Hong Kong Iceland Ireland Japan Lebanon Malta New Zealand Norway Russia Slovenia South Africa Sweden Switzerland Taiwan United Kingdom
Diseases
Addison's disease Adrenogenital syndrome
Ingredients
Fludrocortisone
Drug Actions
Glucocorticoid Mineralocorticoid

Drugs with the same active ingredients

Lonikan Astonin-h Paroticin Florinefe Cortineff Florinef acetate Astonin Florinef acetaat Fludrocortisone кортинефф флоринеф флудрокортизон Cortineff ophtalm. 0.1% Dicortineff

Overdose

Development of hypertension, edema, hypokalemia, excessive increase in weight, and increase in heart size are signs of overdosage of fludrocortisone acetate. When these are noted, administration of the drug should be discontinued, after which the symptoms will usually subside within several days; subsequent treatment with fludrocortisone acetate should be with a reduced dose. Muscular weakness may develop due to excessive potassium loss and can be treated by administering a potassium supplement. Regular monitoring of blood pressure and serum electrolytes can help to prevent overdosage (see WARNINGS).

Contraindications

Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

Undesirable 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.

Therapeutic indications

Florinef (fludrocortisone) 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.

Qualitative and quantitative composition

Florinef Acetate Tablets (Fludrocortisone Acetate Tablets USP), 0.1 mg/tablet: white, round, biconvex, scored tablets in bottles of 100 (NDC 61570-190-01); identification no. 429.

Storage

Store at room temperature; avoid excessive heat.

Prescribing Information as of July 2003. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly wned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08540 USA. FDA Rev date: 6/9/2004

Special warnings and precautions for use

WARNINGS

BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION, THE USE OF FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER THAN THOSE INDICATED HEREIN IS NOT ADVISED.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. However, since fludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, edema, or weight gain.

Periodic checking of serum electrolyte levels is advisable during prolonged therapy; dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response.

The use of Florinef Acetate (Fludrocortisone Acetate Tablets USP) in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy these patients should receive chemoprophylaxis.

Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chicken pox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. In such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered.

PRECAUTIONS General

Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards.

There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible.

Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids.

Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinemia. Corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.

Laboratory Tests

Patients should be monitored regularly for blood pressure determinations and serum electrolyte determinations (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate studies have not been performed in animals to determine whether fludrocortisone acetate has carcinogenic or mutagenic activity or whether it affects fertility in males or females.

Pregnancy: Category C

Adequate animal reproduction studies have not been conducted with fludrocortisone acetate. However, many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Teratogenicity of these agents in man has not been demonstrated. It is not known whether fludrocortisone acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fludrocortisone acetate should be given to a pregnant woman only if clearly needed.

Pregnancy: Nonteratogenic Effects

Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism.

Maternal treatment with corticosteroids should be carefully documented in the infant's medical records to assist in follow up.

Nursing Mothers

Corticosteroids are found in the breast milk of lactating women receiving systemic therapy with these agents. Caution should be exercised when fludrocortisone acetate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Geriatric Use

Elderly subjects may commonly have conditions that may be exacerbated by fludrocortisone therapy including, but not limited to, hypertension, edema, hypokalemia, congestive heart failure, cataracts, glaucoma, increased intraocular pressure, renal insufficiency, and osteoporisis (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS). Elderly subjects may also commonly be taking concomitant drug therapy such as digitalis glycosides, oral anticoagulants, antidiabetic drugs (oral agents and insulin), and aspirin which may interact with fludrocortisone (see PRECAUTIONS-DRUG INTERACTIONS). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Dosage (Posology) and method of 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 (fludrocortisone) 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 (fludrocortisone) 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 (fludrocortisone) Acetate daily.

Interaction with other medicinal products and other forms of interaction

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.

DRUG INTERACTIONS

When administered concurrently, the following drugs may interact with adrenal corticosteroids.

Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)-enhanced hypokalemia. Check serum potassium levels at frequent intervals; use potassium supplements if necessary (see WARNINGS).

Digitalis glycosides-enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Monitor serum potassium levels; use potassium supplements if necessary.

Oral anticoagulants-decreased prothrombin time response. Monitor prothrombin levels and adjust anticoagulant dosage accordingly.

Antidiabetic drugs (oral agents and insulin)-diminished antidiabetic effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary.

Aspirin-increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Rarely salicylate toxicity may occur in patients who discontinue steroids after concurrent high-dose aspirin therapy. Monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see PRECAUTIONS, General).

Barbiturates, phenytoin, or rifampin-increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. Observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly.

Anabolic steroids (particularly C-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds)-enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease.

Vaccines-neurological complications and lack of antibody response (see WARNINGS).

Estrogen-increased levels of corticosteroid-binding globulin, thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids. When estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated.

Drug/Laboratory Test Interactions

Corticosteroids may affect the nitrobluetetrazolium test for bacterial infection and produce false-negative results.

Frequently asked questions

What conditions does Florinef treat?

Florinef is prescribed for the management of Addison's disease and adrenogenital syndrome — conditions in which the adrenal glands do not produce sufficient mineralocorticoid hormone. The active ingredient supplements the body's own corticosteroid activity, which is the mechanism behind its inclusion in both the glucocorticoid and mineralocorticoid categories. The complete indication list as registered with national regulators is shown in the structured section below this introduction.

Which active substance is in Florinef?

Florinef contains fludrocortisone, a corticosteroid with both glucocorticoid and mineralocorticoid activity. Fludrocortisone is the same molecule whether sold under the Florinef brand or under another name — internationally, the same active ingredient circulates under several commercial names, and a pharmacist in any regulated market can identify the local fludrocortisone-containing product.

In how many countries is Florinef available?

Florinef is registered in 20 countries, spanning several regions rather than concentrated in one. Examples include Japan, Canada, Norway, Australia, Chile, Russia, and Lebanon. If your country is not represented on this list, a local pharmacist can usually confirm whether fludrocortisone is available in that market under a different brand name or as a generic preparation suited to long-term adrenal replacement therapy.

Are there other medications with the same active ingredient as Florinef?

Fludrocortisone is sold under several brand names worldwide, particularly because it is a long-established molecule used for adrenal replacement. Other corticosteroids with glucocorticoid or mineralocorticoid activity also exist, although they are not freely interchangeable — the balance of activities differs meaningfully between molecules in the class. To identify a local fludrocortisone-containing product, search the active ingredient on Pill2Trip or ask a pharmacist.

Should I consult a doctor before taking Florinef?

Yes. Florinef is a prescription medication, and corticosteroid replacement therapy in particular is calibrated closely to the individual patient and adjusted over time. This matters especially for travellers and people relocating between countries, since prescription requirements, branded packaging, and available generics can vary across regulatory regimes. Any decision to start, stop, switch, or substitute fludrocortisone should involve a healthcare provider familiar with the patient's history.

Florinef

Available in 20 countries