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> Hormones and Synthetic Substitutes 68:00
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> Adrenals 68:04
Hydrocortisone, Hydrocortisone Acetate, Hydrocortisone
Cypionate, Hydrocortisone Sodium Phosphate,
Hydrocortisone Sodium Succinate
Sub-sections
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Introduction
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Uses
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Dosage and Administration
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Chemistry and Stability
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Additional Information
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Preparations
Drug Nomenclature
Generic Name: Hydrocortisone
CAS Number: 50-23-7
Synonyms: Compound F; Cortisol
Drug Nomenclature
Generic Name: Hydrocortisone Acetate
CAS Number: 50-03-3
Drug Nomenclature
Generic Name: Hydrocortisone Cypionate
CAS Number: 508-99-6
Drug Nomenclature
Generic Name: Hydrocortisone Sodium Phosphate
CAS Number: 6000-74-4
Drug Nomenclature
Generic Name: Hydrocortisone Sodium Succinate
CAS Number: 125-04-2
Synonyms: A-hydrocort inj 1000mg/8ml; A-hydrocort inj 100mg/2ml; Ahydrocort inj 250mg/2ml; A-hydrocort inj 500mg/4ml; Barriere hc; Cortate
crm 1%; Cortate ont 1%; Cortef tablets 10mg; Cortef tablets 20 mg;
Cortenema; Cortisporin (combination product); Cortisporin (combination
product); Cortoderm ont 1%; Emo cort cream 1%; Emo cort cream 2.5%;
Emo cort lotion 1%; Emo cort lotion 2.5%; Emo cort sol 2.5% usp; Hycort
retention enema 100mg/60ml; Hydrocortisone sod succinate inj 100mg/vial;
Hydrocortisone sod succinate inj 250mg/vial; Hydrocortisone sodium succin
inj 500mg/vial; Hydrocortisone sodium succinate inj 1gm/vial; NOVOhydrocort crm 1%; Pramox hc cream (combination product); Pramox hc
lotion (combination product); Prevex hc cream 1%; Proctol ointment
(combination product); Proctol suppositories (combination product);
Proctosedyl ointment (combination product); Proctosedyl suppositories
(combination product); RATIO-proctosone (combination product); Sandoz
cortimyxin (combination product); Sandoz cortimyxin (combination
product); Sandoz proctomyxin hc (combination product); Sandoz
proctomyxin hc suppositories (combination product); Sarna hc; Solu-cortef 1
gm act-o-vial; Solu-cortef 100 mg act-o-vial; Solu-cortef 250 mg act-o-vial;
Solu-cortef 500 mg act-o-vial; Spor-hc otic susp (combination product);
Sterex crm plus (combination product); Sterex lot plus (combination
product); Vioform hydrocortisone (combination product)
Introduction
Hydrocortisone (cortisol) is a glucocorticoid secreted by the adrenal cortex.
See also: Corticosteroids General Statement (Uses)
Uses
Hydrocortisone or cortisone is usually the corticosteroid of choice for
replacement therapy in patients with adrenocortical insufficiency, because
these drugs have both glucocorticoid and mineralocorticoid properties.
Concomitant administration of a more potent mineralocorticoid
(fludrocortisone) may be required in some patients. For anti-inflammatory or
immunosuppressive uses, synthetic glucocorticoids which have minimal
mineralocorticoid activity are preferred.
See also: Corticosteroids General Statement (Dosage and Administration)
Dosage and Administration
Administration
The route of administration and dosage of hydrocortisone and its derivatives
depend on the condition being treated and the response of the patient.
Hydrocortisone
Hydrocortisone is administered orally; the drug also was previously
administered by IM injection, but absorption of the drug from the injection
site is slow (4–8 hours) and a parenteral dosage form currently is not
commercially available in the US.
Hydrocortisone Sodium Phosphate
Hydrocortisone sodium phosphate may be administered by IM,
subcutaneous, or IV injection or by IV infusion. Usually the drug is given
parenterally at 12-hour intervals. When hydrocortisone sodium phosphate is
administered by IV infusion, the drug can be added to dextrose or sodium
chloride injections.
Hydrocortisone Sodium Succinate
Hydrocortisone sodium succinate may be administered by IM or IV injection
or by IV infusion. Hydrocortisone sodium succinate is reconstituted for IM or
IV injection with bacteriostatic water for injection or bacteriostatic 0.9%
sodium chloride injection according to the manufacturer’s instructions. When
the drug is administered by direct IV injection, it should be administered
over a period of at least 30 seconds. For IV infusion, the reconstituted
hydrocortisone sodium succinate should be further diluted with 5% dextrose,
0.9% sodium chloride, or 5% dextrose in 0.9% sodium chloride injection to
a concentration of 0.1–1 mg/mL.
Hydrocortisone Acetate
Hydrocortisone acetate may be administered by intra-articular, intrasynovial,
intrabursal, intralesional, or soft tissue injection. Systemic absorption of
hydrocortisone acetate from intra-articular injection sites is usually complete
within 24–48 hours. A local anesthetic, such as procaine hydrochloride, may
be infiltrated into the soft tissue surrounding the joint and/or injected into
the joint before the administration of hydrocortisone acetate. Alternatively,
the local anesthetic may be mixed in the syringe with hydrocortisone acetate
suspension immediately prior to administration.
Dosage
Dosage of hydrocortisone cypionate, sodium phosphate, and sodium
succinate is expressed in terms of hydrocortisone. IM or IV therapy is
generally reserved for patients who are unable to take the drug orally or for
use in emergency situations. The sodium phosphate and sodium succinate
esters of hydrocortisone are absorbed rapidly, and peak plasma
concentrations are attained within 1 hour following IM administration.
Parenteral injection of the soluble esters of hydrocortisone must be given at
4- to 6-hour intervals if constant high blood concentrations of hydrocortisone
are required. After the initial emergency period, a longer-acting injectable
corticosteroid preparation or oral administration of a corticosteroid should be
considered. Dosage for infants and children should be based on the severity
of the disease and the response of the patient rather than on strict
adherence to dosage indicated by age, body weight, or body surface area.
After a satisfactory response is obtained, dosage should be decreased in
small decrements to the lowest level that maintains an adequate clinical
response. 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). If hydrocortisone is used
orally for prolonged anti-inflammatory therapy, an alternate-day dosage
regimen should be considered. Following long-term therapy, hydrocortisone
should be withdrawn gradually. (See the Corticosteroids General Statement
68:04.)
Hydrocortisone
The initial adult oral dosage of hydrocortisone as the free alcohol may range
from 10–320 mg daily, depending on the disease being treated, and is
usually administered in 3 or 4 divided doses. Some clinicians state that
children may be given an oral dosage of 0.56–8 mg/kg daily or 16–240
mg/m2 daily, administered in 3 or 4 divided doses.
Hydrocortisone Sodium Phosphate
The usual initial adult dosage of hydrocortisone sodium phosphate ranges
from 15–240 mg daily depending on the disease being treated. In lifethreatening situations, extremely high parenteral dosage may be justified
and may be a multiple of the usual oral dosage. Some clinicians state that
children are usually given hydrocortisone sodium phosphate 0.16–1 mg/kg
or 6–30 mg/m2 IM 1 or 2 times daily.
Hydrocortisone Sodium Succinate
The IM or IV dosage of hydrocortisone as the sodium succinate may range
from 100 mg to 8 g daily. The usual dosage is 100–500 mg IM or IV initially
and every 2–10 hours as needed. Some clinicians state that the usual IM or
IV dosage for children is 0.16–1 mg/kg or 6–30 mg/m2 administered 1 or 2
times daily.
In life-threatening shock, massive IV doses of hydrocortisone as the sodium
succinate (such as 50 mg/kg initially and repeated in 4 hours and/or every
24 hours if needed, or 0.5–2 g IV initially and repeated at 2- to 6-hour
intervals as required) have been recommended by some clinicians. In such
cases, the drug is administered by direct IV injection over a period of one to
several minutes. High-dose therapy should be continued only until the
patient’s condition has stabilized and usually should not be continued beyond
48–72 hours. If massive corticosteroid therapy is needed beyond 72 hours, a
corticosteroid which causes less sodium retention (such as
methylprednisolone sodium succinate or dexamethasone sodium phosphate)
should be used to minimize the risk of hypernatremia.
Hydrocortisone Acetate
For intrasynovial, intrabursal, or intra-articular injection, the dosage of
hydrocortisone acetate varies with the degree of inflammation and the size
and location of the affected area. For large joints such as the knee, 25–50
mg of hydrocortisone acetate may be used. For smaller joints, 10–25 mg
may be adequate. The dose for bursae is 25–50 mg and for ganglia 10–25
mg. For soft tissue injection, dosage varies from 5–12.5 mg in tendon
sheath inflammation to as much as 25–75 mg for soft tissue infiltration.
Injections may be repeated from once every 3–5 days (for bursae) to once
every 1–4 weeks (for joints).
See also: Corticosteroids General Statement (Cautions)
See also: Corticosteroids General Statement (Drug Interactions)
See also: Corticosteroids General Statement (Laboratory Test
Interferences)
See also: Corticosteroids General Statement (Pharmacology)
See also: Corticosteroids General Statement (Pharmacokinetics)
See also: Corticosteroids General Statement (Chemistry and Stability)
Chemistry and Stability
Chemistry
Hydrocortisone (cortisol) is a corticosteroid secreted by the adrenal cortex.
The corticosteroid is commercially available as hydrocortisone and various
derivatives of hydrocortisone. Hydrocortisone and hydrocortisone acetate
occur as white to practically white, crystalline powders. Hydrocortisone and
hydrocortisone acetate are odorless, and hydrocortisone cypionate is
odorless or has a slight odor. Hydrocortisone is very slightly soluble and the
acetate and cypionate esters are insoluble in water. Hydrocortisone is
sparingly soluble, hydrocortisone acetate is slightly soluble, and
hydrocortisone cypionate is soluble in alcohol. Hydrocortisone sodium
phosphate occurs as a white to light yellow, odorless or practically odorless
powder and is freely soluble in water and slightly soluble in alcohol.
Hydrocortisone sodium succinate occurs as a white or nearly white, odorless,
amorphous solid and is very soluble in water and in alcohol. The sodium
phosphate and sodium succinate esters of hydrocortisone are hygroscopic.
Commercially available sterile suspensions of hydrocortisone acetate have a
pH of 5–7. Hydrocortisone sodium phosphate injection has a pH of 7.5–8.5.
Following reconstitution with bacteriostatic water for injection,
hydrocortisone sodium succinate injection has a pH of 7–8. Hydrocortisone
cypionate oral suspension has a pH of 2.8–3.2.
Stability
Commercially available preparations of hydrocortisone should be stored at a
temperature less than 40°C, preferably between 15–30°C; freezing of the
oral suspension and sterile suspensions should be avoided. Hydrocortisone
tablets should be stored in well-closed containers. Reconstituted solutions of
hydrocortisone sodium succinate should be stored at 25°C or below.
Reconstituted solutions of the drug should not be used unless they are clear,
and unused solutions should be discarded after 3 days. Solutions and
suspensions of hydrocortisone and its derivatives are heat labile and must
not be autoclaved.
Injections of hydrocortisone and its esters have been reported to be
incompatible with various drugs, but the compatibility depends on several
factors (e.g., concentration of the drugs, resulting pH, temperatures).
Specialized references should be consulted for more specific compatibility
information.
Additional Information
For further information on chemistry, pharmacology, pharmacokinetics,
uses, cautions, drug interactions, laboratory test interferences, and dosage
and administration of hydrocortisone, see the Corticosteroids General
Statement 68:04. For EENT and topical uses, see 52:08.08 and 84:06,
respectively.
Preparations
Excipients in commercially available drug preparations may have clinically
important effects in some individuals; consult specific product labeling for
details.
Hydrocortisone
Dosage
Routes Forms Strengths Brand Names Manufacturer
Bulk
Powder
Oral
Tablets
5 mg
Cortef®
(scored)
Pfizer
10 mg
Cortef®
(scored)
Pfizer
Hydrocortone® Merck
(scored)
20 mg*
Cortef®
(scored)
Pfizer
Generic
Name:
Hydrocortisone
Tablets
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Hydrocortisone Acetate
Routes
Dosage
Forms
Bulk
Powder
Strengths Brand Names Manufacturer
Parenteral Injectable 25
suspension mg/mL*
Generic
Name:
Hydrocortisone
Acetate
Injectable
Suspension
50
mg/mL*
Generic
Name:
Hydrocortisone
Acetate
Injectable
Suspension
Hydrocortone® Merck
Acetate
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Hydrocortisone Sodium Phosphate
Routes
Dosage
Forms Strengths
Brand
Names
Manufacturer
Parenteral Injection 50 mg (of
Hydrocortone® Merck
hydrocortisone) Phosphate
per mL
Hydrocortisone Sodium Succinate
Routes
Dosage
Forms Strengths
Brand Names Manufacturer
Parenteral For
100 mg (of
A-hydroCort®
injection hydrocortisone)*
Hospira
Routes
Dosage
Forms Strengths
Brand Names Manufacturer
Generic
Name:
Hydrocortisone
Sodium
Succinate for
Injection
Solu-Cortef®
250 mg (of
A-hydroCort®
hydrocortisone)*
Pfizer
Hospira
Generic
Name:
Hydrocortisone
Sodium
Succinate for
Injection
Solu-Cortef®
500 mg (of
A-hydroCort®
hydrocortisone)*
Pfizer
Hospira
Generic
Name:
Hydrocortisone
Sodium
Succinate for
Injection
Solu-Cortef®
1 g (of
A-hydroCort®
hydrocortisone)*
Pfizer
Hospira
Generic
Name:
Hydrocortisone
Sodium
Succinate for
Injection
Solu-Cortef®
Pfizer
* available from one or more manufacturer, distributor, and/or repackager
by generic (nonproprietary) name
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS
Pharmacy. This pricing information was updated 02/2013. For the most
current and up-to-date pricing information, please visit www.drugstore.com.
Actual costs to patients will vary depending on the use of specific retail or
mail-order locations and health insurance copays.
Cortef 10MG Tablets (PFIZER U.S.): 30/$29.99 or 90/$66.97
Cortef 20MG Tablets (PFIZER U.S.): 30/$48.37 or 90/$145.10
Cortef 5MG Tablets (PFIZER U.S.): 50/$29.99 or 100/$48.97
Hydrocortisone 10MG Tablets (QUALITEST): 100/$59.99 or 200/$109.98
Hydrocortisone 20MG Tablets (QUALITEST): 30/$39.99 or 90/$95.97
Hydrocortisone 5MG Tablets (GLADES PHARMACEUTICALS): 50/$23.99 or
100/$36.98
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions March
1, 2010. American Society of Health-System Pharmacists, Inc., 7272
Wisconsin Avenue, Bethesda, Maryland 20814.
AHFS Drug Information © American Society of Health-System Pharmacists 2013
MedicinesComplete © The Pharmaceutical Press 2013