Florinef_pi_internet02

THAN THOSE INDICATED HEREIN IS NOT ADVISED.
FLORINEF® ACETATE
Corticosteroids may mask some signs of infection, and new infections may Fludrocortisone Acetate Tablets USP
appear during their use. There may be decreased resistance and inability tolocalize infection when corticosteroids are used. If an infection occurs during DESCRIPTION
fludrocortisone acetate therapy, it should be promptly controlled by suitable Florinef Acetate (Fludrocortisone Acetate Tablets USP) contains fludrocorti- sone acetate, a synthetic adrenocortical steroid possessing very potent Prolonged use of corticosteroids may produce posterior subcapsular mineralocorticoid properties and high glucocorticoid activity; it is used only cataracts, glaucoma with possible damage to the optic nerves, and may enhance for its mineralocorticoid effects. The chemical name for fludrocortisone the establishment of secondary ocular infections due to fungi or viruses.
acetate is 9-fluoro-11ß,17,21-trihydroxypregn-4-ene-3,20-dione 21- Average and large doses of hydrocortisone or cortisone can cause ele- vation of blood pressure, salt and water retention, and increased excretionof potassium. These effects are less likely to occur with the synthetic deriv- atives 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 hyper- tension, 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
Patients should not be vaccinated against smallpox while on corticosteroid therapy. Other immunization procedures should not be undertaken in patients Florinef Acetate is available for oral administration as scored tablets pro- who are on corticosteroids, especially on high dose, because of possible haz- viding 0.1 mg fludrocortisone acetate per tablet. Inactive ingredients: ards of neurological complications and a lack of antibody response.
calcium phosphate, corn starch, lactose, magnesium stearate, sodium ben- The use of Florinef Acetate (Fludrocortisone Acetate Tablets USP) in patients with active tuberculosis should be restricted to those cases of ful- CLINICAL PHARMACOLOGY
minating or disseminated tuberculosis in which the corticosteroid is used for Corticosteroids are thought to act, at least in part, by controlling the rate of the management of the disease in conjunction with an appropriate antituber- synthesis of proteins. Although there are a number of instances in which the culous regimen. If corticosteroids are indicated in patients with latent synthesis of specific proteins is known to be induced by corticosteroids, the tuberculosis or tuberculin reactivity, close observation is necessary since links between the initial actions of the hormones and the final metabolic reactivation of the disease may occur. During prolonged corticosteroid thera- effects have not been completely elucidated.
py these patients should receive chemoprophylaxis.
The physiologic action of fludrocortisone acetate is similar to that of Children who are on immunosuppressant drugs are more susceptible to hydrocortisone. However, the effects of fludrocortisone acetate, particularly infections than healthy children. Chicken pox and measles, for example, can on electrolyte balance, but also on carbohydrate metabolism, are consider- have a more serious or even fatal course in children on immunosuppressant ably heightened and prolonged. Mineralocorticoids act on the distal tubules corticosteroids. In such children, or in adults who have not had these dis- of the kidney to enhance the reabsorption of sodium ions from the tubular eases, particular care should be taken to avoid exposure. If exposed, therapy fluid into the plasma; they increase the urinary excretion of both potassium with varicella zoster immune globulin (VZIG) or pooled intravenous and hydrogen ions. The consequence of these three primary effects togeth- immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox er with similar actions on cation transport in other tissues appear to account develops, treatment with antiviral agents may be considered.
for the entire spectrum of physiological activities that are characteristic of PRECAUTIONS
mineralocorticoids. In small oral doses, fludrocortisone acetate produces marked sodium retention and increased urinary potassium excretion. It also Adverse reactions to corticosteroids may be produced by too rapid with- causes a rise in blood pressure, apparently because of these effects on elec- drawal or by continued use of large doses.
To avoid drug-induced adrenal insufficiency, supportive dosage may be In larger doses, fludrocortisone acetate inhibits endogenous adrenal corti- cal secretion, thymic activity, and pituitary corticotropin excretion; promotes required in times of stress (such as trauma, surgery, or severe illness) both the deposition of liver glycogen; and, unless protein intake is adequate, during treatment with fludrocortisone acetate and for a year afterwards.
There is an enhanced corticosteroid effect in patients with hypothyroidism The approximate plasma half-life of fludrocortisone (fluorohydrocortisone) is 3.5 hours or more and the biological half-life is 18 to 36 hours.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
INDICATIONS AND USAGE
The lowest possible dose of corticosteroid should be used to control the Florinef Acetate is indicated as partial replacement therapy for primary and condition being treated. A gradual reduction in dosage should be made secondary adrenocortical insufficiency in Addison's disease and for the treat-ment of salt-losing adrenogenital syndrome.
Psychic derangements may appear when corticosteroids are used. These CONTRAINDICATIONS
may range from euphoria, insomnia, mood swings, personality changes, and Corticosteroids are contraindicated in patients with systemic fungal infec- severe depression to frank psychotic manifestations. Existing emotional tions and in those with a history of possible or known hypersensitivity to instability or psychotic tendencies may also be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with corticosteroids in WARNINGS
BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION, THE USE OF
Corticosteroids should be used with caution in patients with nonspecific FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER
ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. Corticosteroids should also be used cautiously in may be required when estrogen is terminated.
patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic Drug/Laboratory Test Interactions
ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.
Corticosteroids may affect the nitrobluetetrazolium test for bacterial infec- Information for Patients
tion and produce false-negative results.
The physician should advise the patient to report any medical history of Carcinogenesis, Mutagenesis, Impairment of Fertility
heart disease, high blood pressure, or kidney or liver disease and to report Adequate studies have not been performed in animals to determine current use of any medicines to determine if these medicines might interact whether fludrocortisone acetate has carcinogenic or mutagenic activity or adversely with fludrocortisone acetate (see Drug Interactions).
whether it affects fertility in males or females.
Patients who are on immunosuppressant doses of corticosteroids should Pregnancy: Category C
be warned to avoid exposure to chicken pox or measles and, if exposed, to Adequate animal reproduction studies have not been conducted with flu- drocortisone acetate. However, many corticosteroids have been shown to be The patient's understanding of his steroid-dependent status and increased teratogenic in laboratory animals at low doses. Teratogenicity of these dosage requirement under widely variable conditions of stress is vital. Advise agents in man has not been demonstrated. It is not known whether fludro- the patient to carry medical identification indicating his dependence on cortisone acetate can cause fetal harm when administered to a pregnant steroid medication and, if necessary, instruct him to carry an adequate sup- woman or can affect reproduction capacity. Fludrocortisone acetate should ply of medication for use in emergencies.
be given to a pregnant woman only if clearly needed.
Stress to the patient the importance of regular follow-up visits to check his Pregnancy: Nonteratogenic Effects
progress and the need to promptly notify the physician of dizziness, severe or Infants born of mothers who have received substantial doses of fludro- continuing headaches, swelling of feet or lower legs, or unusual weight gain.
cortisone acetate during pregnancy should be carefully observed for signs Advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next dose, and not Maternal treatment with corticosteroids should be carefully documented in the infant's medical records to assist in follow up.
Inform the patient to keep this medication and all drugs out of the Nursing Mothers
Corticosteroids are found in the breast milk of lactating women receiving Laboratory Tests
systemic therapy with these agents. Caution should be exercised when fludro- Patients should be monitored regularly for blood pressure determinations cortisone acetate is administered to a nursing woman.
and serum electrolyte determinations (see WARNINGS).
Pediatric Use
Drug Interactions
Safety and effectiveness in children have not been established.
When administered concurrently, the following drugs may interact with Growth and development of infants and children on prolonged corticos- teroid therapy should be carefully observed.
Amphotericin B or potassium-depleting diuretics (benzothiadiazines and ADVERSE REACTIONS
related drugs, ethacrynic acid and furosemide)-enhanced hypokalemia.
Most adverse reactions are caused by the drug's mineralocorticoid Check serum potassium levels at frequent intervals; use potassium supple- activity (retention of sodium and water) and include hypertension, ments if necessary (see WARNINGS).
edema, cardiac enlargement, congestive heart failure, potassium loss, Digitalis glycosides-enhanced possibility of arrhythmias or digitalis toxi- city associated with hypokalemia. Monitor serum potassium levels; use When fludrocortisone is used in the small dosages recommended, the glu- cocorticoid side effects often seen with cortisone and its derivatives are not Oral anticoagulants-decreased prothrombin time response. Monitor pro- usually a problem; however the following untoward effects should be kept in thrombin levels and adjust anticoagulant dosage accordingly.
mind, particularly when fludrocortisone is used over a prolonged period of Antidiabetic drugs (oral agents and insulin)-diminished antidiabetic time or in conjunction with cortisone or a similar glucocorticoid.
effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabet- Musculoskeletal-muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of Aspirin-increased ulcerogenic effect; decreased pharmacologic effect of femoral and humeral heads, pathologic fracture of long bones, and sponta- aspirin. Rarely salicylate toxicity may occur in patients who discontinue steroids after concurrent high-dose aspirin therapy. Monitor salicylate levels Gastrointestinal-peptic ulcer with possible perforation and hemorrhage, or the therapeutic effect for which aspirin is given; adjust salicylate dosage pancreatitis, abdominal distention, and ulcerative esophagitis.
accordingly if effect is altered (see PRECAUTIONS, General).
Dermatologic-impaired wound healing, thin fragile skin, bruising, Barbiturates, phenytoin, or rifampin-increased metabolic clearance of petechiae and ecchymoses, facial erythema, increased sweating, subcu- fludrocortisone acetate because of the induction of hepatic enzymes.
taneous fat atrophy, purpura, striae, hyperpigmentation of the skin and Observe the patient for possible diminished effect of steroid and increase nails, hirsutism, acneiform eruptions, and hives; reactions to skin tests Anabolic steroids (particularly C-17 alkylated androgens such as Neurological-convulsions, increased intracranial pressure with papillede- oxymetholone, methandrostenolone, norethandrolone, and similar com- ma (pseudotumor cerebri) usually after treatment, vertigo, headache, and pounds)-enhanced tendency toward edema. Use caution when giving these drugs together, especially in patients with hepatic or cardiac disease.
Endocrine-menstrual irregularities; development of the cushingoid state; Vaccines-neurological complications and lack of antibody response (see suppression of growth in children; secondary adrenocortical and pituitary WARNINGS).
unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or ill- Estrogen-increased levels of corticosteroid-binding globulin, thereby ness); decreased carbohydrate tolerance; manifestations of latent diabetes increasing the bound (inactive) fraction; this effect is at least balanced by mellitus; and increased requirements for insulin or oral hypoglycemic agents decreased metabolism of corticosteroids. When estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts Ophthalmic-posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.
with minimal risks of unwanted effects.
Metabolic-hyperglycemia, glycosuria, and negative nitrogen balance due The usual dose is 0.1 mg of Florinef Acetate daily, although dosage rang- ing from 0.1 mg three times a week to 0.2 mg daily has been employed. In Allergic Reactions-allergic skin rash, maculopapular rash, and urticaria.
the event transient hypertension develops as a consequence of therapy, the Other adverse reactions that may occur following the administration of a dose should be reduced to 0.05 mg daily. Florinef Acetate is preferably corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or mask- administered in conjunction with cortisone (10 mg to 37.5 mg daily in divid- ing of infections, insomnia, syncopal episodes, and anaphylactoid reactions.
ed doses) or hydrocortisone (10 mg to 30 mg daily in divided doses).
OVERDOSAGE
Salt-Losing Adrenogenital Syndrome
Development of hypertension, edema, hypokalemia, excessive increase in The recommended dosage for treating the salt-losing adrenogenital syn- weight, and increase in heart size are signs of overdosage of fludrocortisone drome is 0.1 mg to 0.2 mg of Florinef Acetate daily.
acetate. When these are noted, administration of the drug should be discon-tinued, after which the symptoms will usually subside within several days; HOW SUPPLIED
subsequent treatment with fludrocortisone acetate should be with a reduced Florinef Acetate Tablets (Fludrocortisone Acetate Tablets USP), 0.1 dose. Muscular weakness may develop due to excessive potassium loss and mg/tablet: white, round, biconvex, scored tablets in bottles of 100 (NDC can be treated by administering a potassium supplement. Regular monitor- 61570-190-01); identification no. 429.
ing of blood pressure and serum electrolytes can help to prevent overdosage (see WARNINGS).
Store at room temperature; avoid excessive heat.
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 PRE-
CAUTIONS, General).
Addison's Disease
In Addison's disease, the combination of Florinef Acetate (Fludrocortisone Distributed by: Monnarch Pharmaceuticals, Inc., Bristol, TN 37620 Acetate Tablets USP) with a glucocorticoid such as hydrocortisone or corti- Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08540 USA sone provides substitution therapy approximating normal adrenal activity

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