Hydrocortisone

Generic Name: hydrocortisone sodium succinate Pronunciation: (HIGH-droe-CORE-tih-sone) 
Dosage Form: for Injection, USP:  For Intravenous or Intramuscular Administration

Hydrocortisone Sodium Succinate

Trade Names:
A-Hydrocort
- Injection 100 mg/vial
- Injection 500 mg/vial

Trade Names:
Solu-Cortef
- Injection 100 mg/vial
- Injection 250 mg/vial
- Injection 500 mg/vial
- Injection 1,000 mg/vial

Solu-Cortef Description

Solu-Cortef 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, (11β)- 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.

Solu-Cortef Sterile Powder is available in several packages for intravenous or intramuscular administration.

100 mg Plain—Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, also 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. Solu-Cortef 100 mg plain does not contain diluent

When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.

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 response to diverse stimuli.

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 made every 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.

Trade Names:
Ala-Cort
- Cream 1%
- Lotion 1%

Trade Names:
Ala-Scalp
- Lotion 2%

Trade Names:
Anusol-HC
- Cream 2.5%

Trade Names:
Anusol-HC-1
- Ointment 1%

Trade Names:
Aquanil-HC
- Lotion 1%

Trade Names:
Beta-HC
- Lotion 1%

Trade Names:
Cetacort
- Lotion 1%

Trade Names:
Colocort
- Enema 100 mg hydrocortisone in 60 mL

Trade Names:
Corta-Cap
- Spray 1%

Trade Names:
Cortaid Intensive Therapy
- Cream 1%

Trade Names:
Cortaid Maximum Strength
- Cream 1%
- Sticks 1%

Trade Names:
Cortef
- Tablets 5 mg
- Tablets 10 mg
- Tablets 20 mg

Trade Names:
Corticaine
- Cream 0.5%

Trade Names:
Corticool Maximum Strength
- Gel 1%

Trade Names:
Cortizone 5
- Ointment 0.5%

Trade Names:
Cortizone 10 Maximum Strength
- Cream 1%
- Ointment 1%

Trade Names:
Cortizone 10 Quick Shot
- Spray 1%

Trade Names:
Dermarest Dricort
- Cream 1%

Trade Names:
Dermarest Eczema
- Lotion 1%

Trade Names:
Dermtex-HC
- Cream 1%
- Spray 1%

Trade Names:
Earsol-HC
- Solution 1%

Trade Names:
Hemorrodil
- Ointment 1%

Trade Names:
Hydrocortisone
- Ointment 2.5%

Trade Names:
Hytone
- Cream 2.5%
- Lotion 1%

Trade Names:
Instacort-5
- Cream 0.5%

Trade Names:
Instacort-10
- Cream 1%

Trade Names:
Instacort-10 Maximum Strength
- Ointment 1%

Trade Names:
Keratol HC
- Cream 1%

Trade Names:
Microcort
- Lotion 0.5%

Trade Names:
Mycin Scalp
- Liquid 1%

Trade Names:
NuCort
- Lotion 2%

Trade Names:
Post Peel Balm
- Cream 1%

Trade Names:
Preparation H Hydrocortisone
- Cream 1%

Trade Names:
Proctocare-HC
- Cream 2.5%

Trade Names:
Proctocort
- Cream 1%

Trade Names:
Proctocream-HC
- Cream 2.5%

Trade Names:
Proctosol-HC
- Cream 2.5%

Trade Names:
Proctozone-HC
- Cream 2.5%

Trade Names:
Recort Plus
- Cream 1%

Trade Names:
Sarnol-HC Maximum Strength
- Lotion 1%

Trade Names:
Scalacort DK
- Lotion 2%

Trade Names:
Scalpcort
- Lotion 1%

Trade Names:
Texacort
- Solution 2.5%

Trade Names:
Therasoft Anti-Itch
- Ointment 1%

Trade Names:
Tucks
- Ointment 1%

Claritin Skin Itch Relief (Canada)
Cortoderm (Canada)
Emo-Cort (Canada)
Hydrosone (Canada)
Prevex HC (Canada)
Sarna HC (Canada)
Hydrocortisone Acetate

Trade Names:
Anu-Med-HC
- Suppositories 25 mg

Trade Names:
Anucort-HC
- Suppositories 25 mg

Trade Names:
Anusol-HC
- Suppositories 25 mg

Trade Names:
Caldecort
- Cream 1%

Trade Names:
Cortaid Maximum Strength
- Ointment 1%

Trade Names:
Cortifoam
- Foam 10%

Trade Names:
Hemorrhoidal-HC
- Cream 1%
- Suppositories 25 mg

Trade Names:
Hemril-30
- Suppositories 30 mg

Trade Names:
Hemril-HC Uniserts
- Suppositories 25 mg

Trade Names:
Keratol-HC
- Cream 1%

Trade Names:
Nuzon
- Gel 2%

Trade Names:
Proctocort
- Suppositories 30 mg

Trade Names:
Proctosert-HC
- Suppositories 30 mg

Trade Names:
Proctosol-HC
- Suppositories 25 mg

Trade Names:
Raskando
- Cream 0.5%

Trade Names:
Rectasol-HC
- Suppositories 25 mg

Trade Names:
U-Cort
- Cream 1%

Cortef Cream (Canada)
Hyderm (Canada)
Hydrocortisone Butyrate

Trade Names:
Locoid
- Cream 0.1%
- Ointment 0.1%
- Solution 0.1%

Trade Names:
Lociod Lipocream
- Cream 0.1%

Hydrocortisone Probutate

Trade Names:
Pandel
- Cream 0.1%

Hydrocortisone Sodium Succinate

Trade Names:
A-Hydrocort
- Injection 100 mg/vial
- Injection 500 mg/vial

Trade Names:
Solu-Cortef
- Injection 100 mg/vial
- Injection 250 mg/vial
- Injection 500 mg/vial
- Injection 1,000 mg/vial

Hydrocortisone Valerate
Trade Names:
Westcort
- Cream 0.2%
- Ointment 0.2%

INDICATIONS

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, Solu-Cortef Sterile Powder is indicated for intravenous or intramuscular use in the following conditions:

1.

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

2.

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

3.

Collagen Diseases
During an exacerbation or as maintenance therapy in selected cases of:
Systemic lupus erythematosus
Systemic dermatomyositis (polymyositis)
Acute rheumatic carditis

4.

Dermatologic Diseases
Pemphigus
Severe erythema multiforme (Stevens-Johnson syndrome)
Exfoliative dermatitis
Bullous dermatitis herpetiformis
Severe seborrheic dermatitis
Severe psoriasis
Mycosis fungoides

5.

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)

6.

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

7.

Gastrointestinal Diseases
To tide the patient over a critical period of the disease in:
Ulcerative colitis (systemic therapy)
Regional enteritis (systemic therapy)

8.

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

9.

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

10.

Neoplastic Diseases
For palliative management of:
Leukemias and lymphomas in adults
Acute leukemia of childhood

11.

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

12.

Nervous System
Acute exacerbations of multiple sclerosis

13.

Miscellaneous
Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
Trichinosis with neurologic or myocardial involvement

Solu-Cortef Dosage and Administration

NOTE: CONTAINS BENZYL ALCOHOL

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 Solu-Cortef 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 Solu-Cortef with a corticoid such as methylprednisolone sodium succinate which causes little or no sodium retention.

The initial dose of Solu-Cortef 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 Plain—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. For intravenous infusion, first prepare solution by adding not more than 2 mL of Bacteriostatic Water for Injection to the vial; this solution may then 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).

DIRECTIONS FOR USING THE ACT-O-VIAL SYSTEM

1. Press down on plastic activator to force diluent into the lower compartment.
2. Gently agitate to effect solution.
3. Remove plastic tab covering center of stopper.
4. Sterilize top of stopper with a suitable germicide.
5. Insert needle squarely through center of stopper until tip is just visible. Invert vial and withdraw dose.

Further dilution is not necessary for intravenous or intramuscular injection. For intravenous infusion, first prepare solution as just described. The 100 mg solution may then be added to 100 to 1000 mL of 5% dextrose in water (or isotonic saline solution or 5% dextrose in isotonic saline solution if patient is not on sodium restriction). The 250 mg solution may be added to 250 to 1000 mL, the 500 mg solution may be added to 500 to 1000 mL and the 1000 mg solution to 1000 mL of the same diluents. In cases where administration of a small volume of fluid is desirable, 100 mg to 3000 mg of SOLUCORTEF 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 ACT-O-VIAL, .36 osmolar; 250 mg ACT-O-VIAL, 500 mg ACT-O-VIAL, and the 1000 mg ACT-O-VIAL, .57 osmolar. (Isotonic saline=.28 osmolar.)

Contraindications

The use of Solu-Cortef Sterile Powder is contraindicated in premature infants because the 100 mg, 250 mg, 500 mg and 1000 mg ACT-O-VIAL System contain benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Solu-Cortef Sterile Powder is also contraindicated in systemic fungal infections and patients with known hypersensitivity to the product and its constituents.

Intra-articular or soft tissue administration

Treatment of synovitis of osteoarthritis and symptoms of rheumatoid arthritis, bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, and post-traumatic osteoarthritis.

Hydrocortisone
Adults and Children

PO 20 to 240 mg/day.

Hydrocortisone Sodium Succinate
Adults and Children

IV / IM 100 to 500 mg every 2 to 6 h.

Hydrocortisone Acetate (Intralesional, Intra-Articular or Soft Tissue Injection Only)
Large Joints (Knee) and Bursae Adults and Children

25 to 37.5 mg.

Small Joints (Interphalangeal, Temporomandibular) Adults and Children

10 to 25 mg.

Tendon Sheaths Adults and Children

5 to 12.5 mg.

Soft Tissue Infiltration Adults and Children

25 to 75 mg.

Drug Interactions

Oral administration of hydrocortisone:

Anticholinesterases

May antagonize anticholinesterase effects in myasthenia gravis.

Anticoagulants, oral

May alter anticoagulant dose requirements.

Barbiturates

May decrease effect of hydrocortisone.

Cholestyramine

May decrease hydrocortisone levels.

Contraceptives (oral) estrogens

May decrease Cl of hydrocortisone.

Hydantoins, rifampin

May increase Cl and decrease therapeutic efficacy of hydrocortisone.

Salicylates

May reduce serum levels and efficacy of salicylates.

Troleandomycin

May increase effects of hydrocortisone.

Laboratory Test Interactions

May cause increased urine glucose and serum cholesterol, decreased serum levels of potassium, T ₃ and T ₄ , decreased uptake of Thyroid I ¹³¹ , false-negative nitroblue-tetrazolium test for bacterial infection, suppression of skin test reactions.

Adverse Reactions

Cardiovascular

Thromboembolism or fat embolism; thrombophlebitis; necrotizing angiitis; cardiac arrhythmias or ECG changes; syncopal episodes; hypertension; myocardial rupture; CHF.

CNS

Convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri); vertigo; headache; neuritis; paresthesias; psychosis.

Dermatologic

Impaired wound healing; thin, fragile skin; petechiae and ecchymoses; erythema; lupus erythematosus-like lesions; subcutaneous fat atrophy; striae; hirsutism; acneiform eruptions; allergic dermatitis; urticaria; angioneurotic edema; perineal irritation; hyperpigmentation or hypopigmentation. Topical application may cause burning; irritation; erythema; dryness; folliculitis; hypertrichosis; pruritus; perioral dermatitis; allergic contact dermatitis; stinging, cracking and tightening of skin; secondary infections; skin atrophy; striae; miliaria; telangiectasia.

EENT

Posterior subcapsular cataracts; increased IOP; glaucoma; exophthalmos.

GI

Pancreatitis; abdominal distension; ulcerative esophagitis; nausea; vomiting; increased appetite and weight gain; peptic ulcer with perforation and hemorrhage; bowel perforation.

Genitourinary

Increased or decreased motility and number of spermatozoa.

Hematologic

Leukocytosis.

Metabolic

Sodium and fluid retention; hypokalemia; hypokalemic alkalosis; metabolic alkalosis; hypocalcemia.

Miscellaneous

Musculoskeletal effects (eg, weakness, myopathy, muscle mass loss, osteoporosis, spontaneous fractures); endocrine abnormalities (eg, menstrual irregularities, cushingoid state, growth suppression in children, sweating, decreased carbohydrate tolerance, hyperglycemia, glycosuria, increased insulin or sulfonylurea requirements in diabetics); anaphylactoid or hypersensitivity reactions; aggravation or masking of infections; malaise; fatigue; insomnia. Topical use may cause same adverse reactions seen with systemic use because of possibility of absorption.

Precautions

Pregnancy

Safety not established (systemic use); Category C (topical).

Lactation

Excreted in breast milk.

Children

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Observe growth and development of infants and children on prolonged therapy.

Elderly

May require lower doses.

Renal Function

Use cautiously; monitor renal function.

Adrenal suppression

Prolonged (daily systemic) therapy (more than 7 days) may lead to hypothalamic-pituitary-adrenal suppression.

Fluid and electrolyte balance

May cause elevation of BP, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be needed.

Hepatitis

May be harmful in chronic active hepatitis positive for hepatitis B surface antigen.

Infections

May mask signs of infection. May decrease host-defense mechanisms.

Ocular effects

Use caution in patients with ocular herpes simplex because of possible corneal perforation.

Peptic ulcer

May contribute to peptic ulceration, especially in large doses.

Repository injections

Do not inject subcutaneously; avoid injection into deltoid and repeated IM injection into the same site.

Stress

Increased dosage of rapidly acting corticosteroid may be needed before, during, and after stressful situations.

Withdrawal

Abrupt discontinuation may result in adrenal insufficiency. Discontinue gradually; increase supplementation during times of stress.

Overdosage

Symptoms

Acute toxicity and death are rare. Acute adrenal insufficiency (caused by withdrawal after long-term use): Fever, myalgia, arthralgia, malaise, anorexia, nausea, shedding of skin, orthostatic hypotension, dizziness, fainting, dyspnea, hypoglycemia Cushingoid symptoms (caused by chronic large doses): Moonface, central obesity, striae, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes, hyperlipidemia, peptic ulcer, increased susceptibility to infection, electrolyte and fluid imbalance.

This is a Generic drug and not a brand name medicine; because of it's generic form a compulsary licence(s) were issued in numerous countries allowing their fabrication, importation and distribution where they are legally permitted; and not in violation of any accords in regards to trademarks and patents. Be sure you are able to import these generic pharmaceuticals into your country prior to ordering; as some countries will not allow their importation.