Cortef Information
Cortef (Hydrocortisone) Description
Cortef (Hydrocortisone) Oral Suspension contains hydrocortisone cypionate which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone cypionate is the water-insoluble cypionate ester of hydrocortisone. It is both tasteless and odorless, and by the oral route and in equimolar doses, is equivalent to hydrocortisone free alcohol in biologic activity (rat liver-glycogen assay). Determinations of plasma and urinary 17-hydroxycorticoid levels in man following oral administration indicate that this ester is as efficiently absorbed and metabolized as the free alcohol.
The chemical name for hydrocortisone cypionate is pregn-4-ene-3,20-dione,21-(3-cyclopentyl-1-oxopropoxy)-11,17-dihydroxy-,(11β)- and the molecular weight is 486.65. The structural formula is represented below:
Cortef (Hydrocortisone) , a preparation for oral use, contains 13.4 mg hydrocortisone cypionate (equivalent to 10 mg hydrocortisone) in each 5 mL. Cortef (Hydrocortisone) also contains the following inactive ingredients: benzoic acid, citric acid, FD&C yellow #6 as a color additive, flavors, glycerin, methylparaben, propylparaben, sucrose, xanthan gum NF food grade, and purified water. Cortef (Hydrocortisone) is stable at room temperature. The pH is within a range of 2.8 to 3.2.
Cortef (Hydrocortisone) Actions
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.
Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.
Cortef (Hydrocortisone) Indications
Cortef (Hydrocortisone) Oral Suspension is indicated in the following conditions:
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Seasonal or perennial allergic rhinitisSerum sicknessBronchial asthmaAtopic dermatitisContact dermatitisDrug hypersensitivity reactions
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis
For palliative management of:
Leukemias and lymphomas in adultsAcute leukemia of childhood
To tide the patient over a critical period of the disease in:
Ulcerative colitisRegional enteritis
Cortef (Hydrocortisone) Contraindications
Systemic fungal infections and known hypersensitivity to components.
Cortef (Hydrocortisone) Warnings
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.
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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.
These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.
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.
Cortef (Hydrocortisone) Precautions
Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.
There is an enhanced effect of corticosteroids on 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 under treatment, and when reduction in dosage is possible, the reduction should be gradual.
Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.
Cortef (Hydrocortisone) Dosage And Administration
The initial dosage of Cortef (Hydrocortisone) Oral Suspension may vary from 2 to 24 teaspoonsful (10–120 mL) per day depending on the specific disease entity being treated. This provides a daily dosage of 26.8 mg to 321.6 mg of hydrocortisone cypionate, equivalent in activity to 20 to 240 mg of hydrocortisone. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Cortef (Hydrocortisone) should be discontinued and the patient transferred to other appropriate therapy. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Cortef (Hydrocortisone) for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Cortef (Hydrocortisone) How Supplied
Cortef (Hydrocortisone) Oral Suspension is available in four fluidounce bottles (NDC 0009-0142-01).
Each 5 mL contains 13.4 mg hydrocortisone cypionate (equivalent to 10 mg hydrocortisone).
Cortef (Hydrocortisone)
Cortef (Hydrocortisone)
