Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1687
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A-HYDROCORT (Injection, Powder, Lyophilized, For Solution)
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This preparation may be administered by intravenous
injection, by intravenous infusion, or by intramuscular injection,
the preferred method for initial emergency use being intravenous injection.
Following the initial emergency period, consideration should be given
to employing a longer acting injectable preparation or an oral preparation. Therapy is initiated by administering A-Hydrocort sterile
powder intravenously over a period of 30 seconds (eg, 100 mg) to 10
minutes (eg, 500 mg or more). In general, high-dose corticosteroid
therapy should be continued only until the patient's condition
has stabilized���usually not beyond 48 to 72 hours. Although
adverse effects associated with high-dose, short-term corticoid therapy
are uncommon, peptic ulceration may occur. Prophylactic antacid therapy
may be indicated. When high-dose hydrocortisone
therapy must be continued beyond 48-72 hours, hypernatremia may occur.
Under such circumstances it may be desirable to replace hydrocortisone
sodium succinate with a corticoid such as methylprednisolone sodium
succinate which causes little or no sodium retention. The initial dose of A-Hydrocort sterile powder is 100 mg to 500 mg,
depending on the severity of the condition. This dose may be repeated
at intervals of 2, 4 or 6 hours as indicated by the patient's
response and clinical condition. While the dose may be reduced for
infants and children, it is governed more by the severity of the condition
and response of the patient than by age or body weight but should
not be less than 25 mg daily. Patients subjected
to severe stress following corticosteroid therapy should be observed
closely for signs and symptoms of adrenocortical insufficiency. Corticoid therapy is an adjunct to, and not a replacement
for, conventional therapy. Preparation of Solutions 100 mg���For intravenous
or intramuscular injection, prepare solution by aseptically adding not more than 2 mL of Bacteriostatic Water
for Injection or Bacteriostatic Sodium Chloride Injection to the contents
of one vial. Further dilution is not necessary
for intravenous or intramuscular injection. For intravenous infusion, first prepare solution
by adding not more than 2 mL of
Bacteriostatic Water for Injection to the vial; this solution maythen be added to 100 to 1000 mL of the following: 5% dextrose in water
(or isotonic saline solution or 5% dextrose in isotonic saline solution
if patient is not on sodium restriction). In cases where administration
of a small volume of fluid is desirable, 100 mg of hydrocortisone
sodium succinate may be added to 50 mL of the above diluents. The
resulting solutions are stable for at least 4 hours and may be administered
either directly or by IV piggyback. When reconstituted
as directed, pH's of the solutions range from 7 to 8 and the
tonicities are: 100 mg vial, .36 osmolar. (Isotonic saline = .28 osmolar.)
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A-Hydrocort sterile powder contains hydrocortisone
sodium succinate as the active ingredient. Hydrocortisone sodium succinate,
is a white, or nearly white, odorless, hygroscopic, amorphous solid.
It is very soluble in water and in alcohol, very slightly soluble
in acetone and insoluble in chloroform.The chemical name is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-,
monosodium salt, (11��)- and its molecular weight is 484.52. The structural formula is represented below: Hydrocortisone sodium succinate
is an anti-inflammatory adrenocortical steroid. This highly water-soluble
sodium succinate ester of hydrocortisone permits the immediate intravenous
administration of high doses of hydrocortisone in a small volume of
diluent and is particularly useful where high blood levels of hydrocortisone
are required rapidly. A-Hydrocort sterile powder
is available for intravenous or intramuscular administration. 100 mg���Vials
containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone,
also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic
sodium phosphate anhydrous. When necessary,
the pH was adjusted with sodium hydroxide so that the pH of the reconstituted
solution is within the USP specified range of 7 to 8. For intravenous or intramuscular injection, vial should be reconstituted
with Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride. For intravenous infusion, vial should be reconstituted
with Bacteriostatic Water for Injection.
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Hydrocortisone sodium succinate has the same metabolic
and anti-inflammatory actions as hydrocortisone. When given parenterally
and in equimolar quantities, the two compounds are equivalent in biologic
activity. Following the intravenous injection of hydrocortisone sodium
succinate, demonstrable effects are evident within one hour and persist
for a variable period. Excretion of the administered dose is nearly
complete within 12 hours. Thus, if constantly high blood levels are
required, injections should be madeevery 4 to 6 hours. This preparation
is also rapidly absorbed when administered intramuscularly and is
excreted in a pattern similar to that observed after intravenous injection.
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The use of A-Hydrocort sterile powder is contraindicated
in premature infants because the 100 mg vial is reconstituted with
Bacteriostatic Water for Injection or Bacteriostatic Sodium Chloride
Injection containing benzyl alcohol. Benzyl alcohol has been reported
to be associated with a fatal���Gasping Syndrome���in
premature infants. A-Hydrocort sterile powder is also contraindicated
in systemic fungal infections and patients with known hypersensitivity
to the product and its constituents.
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A-Hydrocort sterile powder is available in the following
package: STORAGE CONDITIONS Store unreconstituted product at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] Store solution at 20 to 25��C (68 to 77��F).
[See USP Controlled Room Temperature.] Protect from light. Use solution only if it is clear. Unused solution should
be discarded after 3 days. Lyophilized in container. Revised: October, 2005
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General 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 in patients with hypothyroidism and in those with
cirrhosis. Corticosteroids should be used cautiously
in patients with ocular herpes simplex for fear of 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 must 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. Aspirin should be used cautiously in conjunction with
corticosteroids in hypoprothrombinemia. Steroids
should be used with caution in nonspecific ulcerative colitis, if
there is a probability of impending perforation, abscess or other
pyogenic infection, also in 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 followed. Although
controlled clinical trials have shown corticosteroids to be effective
in speeding the resolution of acute exacerbations of multiple sclerosis,
they do not show that corticosteroids affect the ultimate outcome
or natural history of the disease. The studies do show that relatively
high doses of corticosteroids are necessary to demonstrate a significant
effect. (See DOSAGE AND ADMINISTRATION). Since
complications of treatment with glucocorticoids are dependent on the
size of the dose and duration of treatment, a risk/benefit decision
must be made in each individual case as to dose and duration of treatment
and as to whether daily or intermittent therapy should be used.
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Hydrocortisone Sodium Succinate
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A-HYDROCORT (Injection, Powder, Lyophilized, For Solution)
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Fluid and Electrolyte Disturbances Sodium retention, Fluid retention, Congestive
heart failure in susceptible patients, Potassium loss, Hypokalemic
alkalosis, Hypertension 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 Gastrointestinal Peptic ulcer with
possible perforation and hemorrhage, Pancreatitis, Abdominal distention,
Ulcerative esophagitis Dermatologic Impaired wound healing,
Thin fragile skin, Petechiae and ecchymoses, Facial erythema, Increased
sweating, May suppress reactions to skin tests Neurological Convulsions, Increased intracranial pressure with papilledema (pseudotumor
cerebri) usually after treatment, Vertigo, Headache Endocrine Menstrual irregularities, Development of Cushingoid state, Suppression
of growth in children, Secondary adrenocortical and pituitary unresponsiveness,
particularly in times of stress, as in trauma, surgery, or illness,
Decreased carbohydrate tolerance, Manifestations of latent diabetes
mellitus, Increased requirements of insulin or oral hypoglycemic agents
in diabetics Ophthalmic Posterior subcapsular cataracts, Increased
intraocular pressure, Glaucoma, Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism The following additional reactions are related to parenteral corticosteroid
therapy: Allergic, anaphylactic or other hypersensitivity
reactions, Hyperpigmentation or hypopigmentation, Subcutaneous and
cutaneous atrophy, Sterile abscess
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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. 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. Usage in pregnancy. Since adequate human
reproduction studies have not been done with corticosteroids, the
use of these drugs in pregnancy, nursing mothers, or women of childbearing
potential requires that the possible benefits of the drug be weighed
against the potential hazards to the mother and embryo or fetus. Infants
born of mothers who have received substantial doses of corticosteroids
during pregnancy should be carefully observed for signs of hypoadrenalism. Average and large doses of hydrocortisone 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. Dietary salt restriction
and potassium supplementation may be necessary. All corticosteroids
increase calcium excretion. While on corticosteroid therapy patients should not
be vaccinated against smallpox. 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 A-Hydrocort sterile powder in 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 appropriate antituberculous regimen. If corticosteroids are indicated in patients with latent
tuberculosis or tuberculin reactivity, close observation is necessary
as reactivation of the disease may occur. During prolonged corticosteroid
therapy, these patients should receive chemoprophylaxis. Because rare instances of anaphylactoid reactions (eg,
bronchospasm) have occurred in patients receiving parenteral corticosteroid
therapy, appropriate precautionary measures should be taken prior
to administration, especially when the patient has a history of allergy
to any drug. Persons who are on drugs which
suppress the immune system are more susceptible to infections than
healthy individuals. Chicken pox and measles, for example, can have
a more serious or even fatal course in non-immune children or adults
on corticosteroids. In such children or adults who have not had these
diseases, particular care should be taken to avoid exposure. How the
dose, route and duration of corticosteroid administration affects
the risk of developing a disseminated infection is not known. The
contribution of the underlying disease and/or prior corticosteroid
treatment to the risk is alsonot known. If exposed to chicken pox,
prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin
(IG) may be indicated. (See the respective package inserts for complete
VZIG and IG prescribing information.) If chicken pox develops, treatment
with antiviral agents may be considered.
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When oral therapy is not feasible, and the strength,
dosage form and route of administration of the drug reasonably lend
the preparation to the treatment of the condition, A-Hydrocort sterile
powder is indicated for intravenous or intramuscular use in the following
conditions: Endocrine
Disorders Primary or secondary
adrenocortical insufficiency (hydrocortisone or cortisone is the drug
of choice; synthetic analogs may be used in conjunction with mineralocorticoids
where applicable; in infancy, mineralocorticoid supplementation is
of particular importance) Acute adrenocortical
insufficiency (hydrocortisone or cortisone is the drug of choice;
mineralocorticoid supplementation may be necessary, particularly when
synthetic analogs are used) Preoperatively
and in the event of serious trauma or illness, in patients with known
adrenal insufficiency or when adrenocortical reserve is doubtful Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is suspected Congenital
adrenal hyperplasia Hypercalcemia associated
with cancer Nonsuppurative thyroiditis Rheumatic Disorders As adjunctive therapy for short-term
administration (to tide the patient over an acute episode or exacerbation)
in: Post-traumatic osteoarthritis Synovitis of osteoarthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected
cases may require low-dose maintenance therapy) Acute and subacute bursitis Epicondylitis Acute nonspecific tenosynovitis Acute gouty arthritis Psoriatic arthritis Ankylosing spondylitis Collagen Diseases During an exacerbation or as maintenance therapy in selected cases
of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Severe erythema
multiforme (Stevens-Johnson syndrome) Exfoliative
dermatitis Bullous dermatitis herpetiformis Severe seborrheic dermatitis Severe psoriasis Mycosis fungoides Allergic States Control of severe or incapacitating allergic
conditions intractable to adequate trials of conventional treatment
in: Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Seasonal
or perennial allergic rhinitis Drug hypersensitivity
reactions Urticarial transfusion reactions Acute noninfectious laryngeal edema (epinephrine
is the drug of first choice) Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving
the eye, such as: Herpes zoster ophthalmicus Iritis, iridocyclitis Chorioretinitis Diffuse posterior uveitis
and choroiditis Optic neuritis Sympathetic ophthalmia Anterior segment inflammation Allergic
conjunctivitis Allergic corneal marginal
ulcers Keratitis Gastrointestinal Diseases To tide the patient over a critical period of the
disease in: Ulcerative colitis (systemic
therapy) Regional enteritis (systemic therapy) Respiratory Diseases Symptomatic sarcoidosis Berylliosis Fulminating or
disseminated pulmonary tuberculosis when used concurrently with appropriate
antituberculous chemotherapy Loeffler's
syndrome not manageable by other means Aspiration pneumonitis Hematologic Disorders Acquired
(autoimmune) hemolytic anemia Idiopathic
thrombocytopenic purpura in adults (IV only; IM administration is
contraindicated) Secondary thrombocytopenia
in adults Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood Edematous States To induce diuresis or remission of proteinuria in
the nephrotic syndrome, without uremia, of the idiopathic type or
that due to lupus erythematosus Nervous System Acute exacerbations of multiple sclerosis Miscellaneous Tuberculous meningitis with subarachnoid block or impending
block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
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A-HYDROCORT
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