Corticosteroids (systemic)

Budesonide (Entocort™ EC)	cortisone acetate (Cortone):
dexamethasone (Decadron):	fludrocortisone (Florinef):
hydrocortisone (Cortef, Solu-Cortef):	methylprednisolone (Solu-medrol):
prednisone

Budesonide (Entocort™ EC)

INDICATIONS: - Intranasal: Children >/= 6 years of age and Adults: Management of symptoms of seasonal or perennial rhinitis. Nebulization: Children 12 months to 8 years: Maintenance and prophylactic treatment of asthma. Oral capsule: Treatment of active Crohn's disease (mild to moderate) involving the ileum and/or ascending colon . Oral inhalation: Maintenance and prophylactic treatment of asthma; includes patients who require corticosteroids and those who may benefit from systemic dose reduction/elimination.

Mechanism of Action - Controls the rate of protein synthesis, depresses the migration of polymorphonuclear leukocytes, fibroblasts, reverses capillary permeability, and lysosomal stabilization at the cellular level to prevent or control inflammation

Dosing:
Nasal inhalation: (Rhinocort® Aqua®): Children >/= 6 years and Adults: 64 mcg/day as a single 32 mcg spray in each nostril. Some patients who do not achieve adequate control may benefit from increased dosage. A reduced dosage may be effective after initial control is achieved.
Maximum dose: Children <12 years: 128 mcg/day; Adults: 256 mcg/day

Nebulization: Children 12 months to 8 years: Pulmicort Respules®: Titrate to lowest effective dose once patient is stable; start at 0.25 mg/day or use as follows:
Previous therapy of bronchodilators alone: 0.5 mg/day administered as a single dose or divided twice daily (maximum daily dose: 0.5 mg) .
Previous therapy of inhaled corticosteroids: 0.5 mg/day administered as a single dose or divided twice daily (maximum daily dose: 1 mg).
Previous therapy of oral corticosteroids: 1 mg/day administered as a single dose or divided twice daily (maximum daily dose: 1 mg).

Oral inhalation:
Children >/= 6 years:
Previous therapy of bronchodilators alone: 200 mcg twice initially which may be increased up to 400 mcg twice daily.
Previous therapy of inhaled corticosteroids: 200 mcg twice initially which may be increased up to 400 mcg twice daily.
Previous therapy of oral corticosteroids: The highest recommended dose in children is 400 mcg twice daily.

Adults:
Previous therapy of bronchodilators alone: 200-400 mcg twice initially which may be increased up to 400 mcg twice daily.
Previous therapy of inhaled corticosteroids: 200-400 mcg twice initially which may be increased up to 800 mcg twice daily.
Previous therapy of oral corticosteroids: 400-800 mcg twice daily which may be increased up to 800 mcg twice daily.

NIH Guidelines (NIH, 1997) (give in divided doses twice daily):
Children:
"Low" dose: 100-200 mcg/day
"Medium" dose: 200-400 mcg/day (1-2 inhalations/day)
"High" dose: >400 mcg/day (>2 inhalation/day)

Adults:
"Low" dose: 200-400 mcg/day (1-2 inhalations/day)
"Medium" dose: 400-600 mcg/day (2-3 inhalations/day)
"High" dose: >600 mcg/day (>3 inhalation/day)

Oral: Adults: Crohn's disease: 9 mg once daily in the morning; safety and efficacy have not been established for therapy duration >8 weeks; recurring episodes may be treated with a repeat 8-week course of treatment

Note: Treatment may be tapered to 6 mg once daily for 2 weeks prior to complete cessation. Patients receiving CYP3A4 inhibitors should be monitored closely for signs and symptoms of hypercorticism; dosage reduction may be required.

Supplied:
Capsule, enteric coated (Entocort™ EC): 3 mg.
Powder for oral inhalation (Pulmicort Turbuhaler®): 200 mcg/inhalation (104 g) [delivers ~160 mcg/inhalation; 200 metered doses] .

Additional dosage strengths available in Canada: 100 mcg/inhalation, 400 mcg/inhalation.
Suspension, nasal spray (Rhinocort® Aqua®): 32 mcg/inhalation (8.6 g) [120 metered doses].
Suspension for oral inhalation (Pulmicort Respules®): 0.25 mg/2 mL (30s), 0.5 mg/2 mL (30s).

cortisone acetate (Cortone):

Use - Management of adrenocortical insufficiency

Dosing:
If possible, administer glucocorticoids before 9 AM to minimize adrenocortical suppression; dosing depends upon the condition being treated and the response of the patient; Note: Supplemental doses may be warranted during times of stress in the course of withdrawing therapy
Children:
Anti-inflammatory or immunosuppressive: Oral: 2.5-10 mg/kg/day or 20-300 mg/m2 /day in divided doses every 6-8 hours
Physiologic replacement: Oral: 0.5-0.75 mg/kg/day or 20-25 mg/m2 /day in divided doses every 8 hours

Adults:
Anti-inflammatory or immunosuppressive: Oral: 25-300 mg/day in divided doses every 12-24 hours.
Physiologic replacement: Oral: 25-35 mg/day.

Supplied
Tablet, as acetate: 25 mg

dexamethasone (Decadron):

Dosing (Adults): Anti-inflammatory: 0.75 to 9 mg/day in divided doses every 6 to 12 hours.
Intra-articular, intralesional, or soft tissue (as sodium phosphate): 0.4-6 mg/day.

Spinal cord compression: 10 to 100mg (Usually 10mg) IV stat, followed by 4 to 24 mg IV every 6 hours. Use larger doses (eg up to 100mg) in patients with profound neurologic injury and lower doses in patients with mild or equivocal signs.

Antiemetic: Prophylaxis: Oral, IV: 10-20 mg 15-30 minutes before treatment. Mildly emetogenic therapy: Oral, I.M., I.V.: 4 mg q4-6h. Delayed nausea/vomiting: Oral: 4-10 mg 1-2 times/day x 2-4 days.
Dexamethasone suppression test (depression indicator) (unlabeled use): Oral: 1 mg at 11 PM, draw blood at 8 AM the following day for plasma cortisol determination.
Cushing's syndrome, diagnostic: Oral: 1 mg at 11 PM, draw blood at 8 AM; greater accuracy for Cushing's syndrome may be achieved by the following:
Dexamethasone 0.5 mg by mouth every 6 hours for 48 hours (with 24-hour urine collection for 17-hydroxycorticosteroid excretion).

Multiple sclerosis (acute exacerbation): Oral: 30 mg/day for 1 week, followed by 4-12 mg/day for 1 month.
Treatment of shock: Addisonian crisis/shock (ie, adrenal insufficiency/responsive to steroid therapy): I.V. (given as sodium phosphate): 4-10 mg x 1, which may be repeated if necessary.
Unresponsive shock (ie, unresponsive to steroid therapy): I.V. (given as sodium phosphate): 1-6 mg/kg as a single I.V. dose or up to 40 mg initially followed by repeat doses every 2-6 hours while shock persists.
Physiological replacement: Oral, I.M., I.V. (should be given as sodium phosphate): 0.03-0.15 mg/kg/day or 0.6-0.75 mg/m2/day in divided doses every 6-12 hours.

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Administration
Oral: Administer with meals to decrease GI upset.

I.M.: Acetate injection is not for I.V. use.

I.V.: Administer as a 5-10 minute bolus; rapid injection is associated with a high incidence of perianal discomfort.

fludrocortisone (Florinef):

INDICATIONS: Florinef Acetate is indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

Dosing (Adults):
Addison's Disease: In Addison's disease, the combination of Florinef Acetate (Fludrocortisone Acetate Tablets USP) with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects. The usual dose is 0.1 mg of Florinef Acetate daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Florinef Acetate is preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses).

Salt-Losing Adrenogenital Syndrome: The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of Florinef Acetate daily.

Supplied: 0.1 mg tablet:

hydrocortisone (Cortef, Solu-Cortef):

Use - Management of adrenocortical insufficiency; relief of inflammation of corticosteroid-responsive dermatoses (low and medium potency topical corticosteroid); adjunctive treatment of ulcerative colitis.

Mechanism of Action - Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability

Dosing:
Dose should be based on severity of disease and patient response
Acute adrenal insufficiency: I.M., I.V.:
Infants and young Children: Succinate: 1-2 mg/kg/dose bolus, then 25-150 mg/day in divided doses every 6-8 hours.
Older Children: Succinate: 1-2 mg/kg bolus then 150-250 mg/day in divided doses every 6-8 hours.
Adults: Succinate: 100 mg I.V. bolus, then 300 mg/day in divided doses every 8 hours or as a continuous infusion for 48 hours; once patient is stable change to oral, 50 mg every 8 hours for 6 doses, then taper to 30-50 mg/day in divided doses

Chronic adrenal corticoid insufficiency:
Adults: Oral: 20-30 mg/day

Anti-inflammatory or immunosuppressive:
Infants and Children:
Oral: 2.5-10 mg/kg/day or 75-300 mg/m 2 /day every 6-8 hours.
I.M., I.V.: Succinate: 1-5 mg/kg/day or 30-150 mg/m 2 /day divided every 12-24 hours.

Adolescents and Adults: Oral, I.M., I.V.: Succinate: 15-240 mg every 12 hours.

Congenital adrenal hyperplasia: Oral: Initial: 10-20 mg/m 2 /day in 3 divided doses; a variety of dosing schedules have been used. Note: Inconsistencies have occurred with liquid formulations; tablets may provide more reliable levels. Doses must be individualized by monitoring growth, bone age, and hormonal levels. Mineralocorticoid and sodium supplementation may be required based upon electrolyte regulation and plasma renin activity.

Physiologic replacement:
Children:
Oral: 0.5-0.75 mg/kg/day or 20-25 mg/m 2 /day every 8 hours
I.M.: Succinate: 0.25-0.35 mg/kg/day or 12-15 mg/m 2 /day once daily

Shock: I.M., I.V.: Succinate:
Children: Initial: 50 mg/kg, then repeated in 4 hours and/or every 24 hours as needed
Adolescents and Adults: 500 mg to 2 g every 2-6 hours

Status asthmaticus:
Children and Adults: I.V.: Succinate: 1-2 mg/kg/dose every 6 hours for 24 hours, then maintenance of 0.5-1 mg/kg every 6 hours

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Adults:
Rheumatic diseases:
Intralesional, intra-articular, soft tissue injection: Acetate:
Large joints: 25 mg (up to 37.5 mg)
Small joints: 10-25 mg
Tendon sheaths: 5-12.5 mg
Soft tissue infiltration: 25-50 mg (up to 75 mg)
Bursae: 25-37.5 mg
Ganglia: 12.5-25 mg

Stress dosing (surgery) in patients known to be adrenally-suppressed or on chronic systemic steroids: I.V.:
Minor stress (ie, inguinal herniorrhaphy): 25 mg/day for 1 day.
Moderate stress (ie, joint replacement, cholecystectomy): 50-75 mg/day (25 mg every 8-12 hours) for 1-2 days.
Major stress (pancreatoduodenectomy, esophagogastrectomy, cardiac surgery): 100-150 mg/day (50 mg every 8-12 hours) for 2-3 days.

Dermatosis: Children >2 years and Adults: Topical: Apply to affected area 2-4 times/day (Buteprate: Apply once or twice daily). Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Ulcerative colitis:
Adults: Rectal: 10-100 mg 1-2 times/day for 2-3 weeks

Administration
Oral: Administer with food or milk to decrease GI upset.
Parenteral: Hydrocortisone sodium succinate may be administered by I.M. or I.V. routes.
I.V. bolus: Dilute to 50 mg/mL and administer over 30 seconds to several minutes (depending on the dose) .
I.V. intermittent infusion: Dilute to 1 mg/mL and administer over 20-30 minutes.
Topical: Apply a thin film to clean, dry skin and rub in gently.

Supplied:
Aerosol, rectal, as acetate (Cortifoam®): 10% (15 g) [90 mg/applicator]
Cream, rectal, as acetate (Nupercainal® Hydrocortisone Cream): 1% (30 g)
Cream, rectal, as base:
Cortizone®-10: 1% (30g) [contains aloe]
Preparation H® Hydrocortisone: 1% (27 g)

Cream, topical, as acetate: 0.5% (9 g, 30 g, 60 g) [available with aloe]; 1% (30 g, 454 g)
Cream, topical, as base: 0.5% (30 g); 1% (1.5 g, 30 g, 114 g, 454 g); 2.5% (20 g, 30 g, 454 g)
Anusol-HC®: 2.5% (30 g) [contains benzyl alcohol]
Cortaid® Intensve Therapy: 1% (60 g)
CCortaid® Maximum Strength: 1% (15 g, 30 g, 40 g, 60 g)
Cortaid® Sensitive Skin: 0.5% (15 g) [contains aloe vera gel]
Cortizone®-10 Maximum Strength: 1% (15 g, 30 g, 60 g) [contains aloe]
Cortizone®-10 Plus Maximum Strength: 1% (30 g, 60 g)
Hytone®: 2.5% (30 g, 60 g)
IvySoothe™: 1% (30 g) [contains aloe]
ProctoCream® HC: 2.5% (30 g) [contains benzyl alcohol]
Proctosol-HC®, Proctozone-HC™: 2.5% (30 g)
Cream, topical, as butyrate (ocoid®, Locoid Lipocream®): 0.1% (15 g, 45 g)
Cream, topical, as probutate (Pandel®): 0.1% (15 g, 45 g, 80 g)
Cream, topical, as valerate (Westcort®): 0.2% (15 g, 45 g, 60 g)

Gel, topical, as base:
Cortagel® Maximum Strength: 1% (15 g, 30 g) [contains aloe vera gel] [DSC]

Injection, powder for reconstitution, as sodium succinate (Solu-Cortef®): 100 mg, 250 mg, 500 mg, 1 g [diluent contains benzyl alcohol; strength expressed as base]

Lotion, topical, as base: 1% (120 mL); 2.5% (60 mL)
Hytone®: 2.5% (60 mL)
LactiCare-HC®: 1% (120 mL); 2.5% (60 mL, 120 mL) [DSC]

Ointment, topical, as acetate: 1% (30 g) [strength expressed as base; available with aloe]
Anusol® HC-1: 1% (21 g) [strength expressed as base]
Cortaid® Maximum Strength: 1% (15 g, 30 g) [strength expressed as base]
Ointment, topical, as base: 0.5% (30 g); 1% (30 g, 454 g); 2.5% (20 g, 30 g, 454 g)
Cortizone®-10 Maximum Strength: 1% (30 g, 60 g)
Hytone®: 2.5% (30 g)
Ointment, topical, as butyrate (Locoid®): 0.1% (15 g, 45 g)
Ointment, topical, as valerate (Westcort®): 0.2% (15 g, 45 g, 60 g)

Solution, topical spray, as base:
Cortaid® Intensive Therapy: 1% (60 mL) [contains alcohol]
Cortizone® 10 Quick Shot: 1% (44 mL) [contains benzyl alcohol]
Dermtex® HC: 1% (52 mL) [contains menthol 1%]

Suppository, rectal, as acetate: 25 mg (12s, 24s, 100s)
Anucort™ HC: 25 mg (12s, 24s, 100s)
Anusol-HC®, Proctosol-HC®: 25 mg (12s, 24s)
Encort™: 30 mg (12s)

Suspension,, rectal, as base: 100 mg/60 mL (7s)
Colocort®: 100 mg/60 mL (1s, 7s)

Tablet
Cortef®: 5 mg, 10 mg, 20 mg

methylprednisolone (Solu-medrol):

INDICATIONS: Primarily as an anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases including those of hematologic, allergic, inflammatory, neoplastic, and autoimmune origin. Prevention and treatment of graft-versus-host disease following allogeneic bone marrow transplantation.

Mechanism of Action - In a tissue-specific manner, corticosteroids regulate gene expression subsequent to binding specific intracellular receptors and translocation into the nucleus. Corticosteroids exert a wide array of physiologic effects including modulation of carbohydrate, protein, and lipid metabolism and maintenance of fluid and electrolyte homeostasis. Moreover cardiovascular, immunologic, musculoskeletal, endocrine, and neurologic physiology are influenced by corticosteroids. Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability.

DOSING:
Dosing should be based on the lesser of ideal body weight or actual body weight
Only sodium succinate may be given I.V.; methylprednisolone sodium succinate is highly soluble and has a rapid effect by I.M. and I.V. routes. Methylprednisolone acetate has a low solubility and has a sustained I.M. effect.

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Children:
Anti-inflammatory or immunosuppressive: Oral, I.M., I.V. (sodium succinate): 0.5-1.7 mg/kg/day or 5-25 mg/m 2 /day in divided doses every 6-12 hours; "Pulse" therapy: 15-30 mg/kg/dose over >/= 30 minutes given once daily for 3 days

Status asthmaticus: I.V. (sodium succinate): Loading dose: 2 mg/kg/dose, then 0.5-1 mg/kg/dose every 6 hours for up to 5 days

Acute spinal cord injury: I.V. (sodium succinate): 30 mg/kg over 15 minutes, followed in 45 minutes by a continuous infusion of 5.4 mg/kg/hour for 23 hours

Lupus nephritis: I.V. (sodium succinate): 30 mg/kg over >/= 30 minutes every other day for 6 doses
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Adults: Only sodium succinate may be given I.V.; methylprednisolone sodium succinate is highly soluble and has a rapid effect by I.M. and I.V. routes. Methylprednisolone acetate has a low solubility and has a sustained I.M. effect.

Acute spinal cord injury: I.V. (sodium succinate): 30 mg/kg over 15 minutes, followed in 45 minutes by a continuous infusion of 5.4 mg/kg/hour for 23 hours

Anti-inflammatory or immunosuppressive:
Oral: 2-60 mg/day in 1-4 divided doses to start, followed by gradual reduction in dosage to the lowest possible level consistent with maintaining an adequate clinical response.

I.M. (sodium succinate): 10-80 mg/day once daily
I.M. (acetate): 10-80 mg every 1-2 weeks

I.V. (sodium succinate): 10-40 mg over a period of several minutes and repeated I.V. or I.M. at intervals depending on clinical response; when high dosages are needed, give 30 mg/kg over a period >/= 30 minutes and may be repeated every 4-6 hours for 48 hours.

Status asthmaticus: I.V. (sodium succinate): Loading dose: 2 mg/kg/dose, then 0.5-1 mg/kg/dose every 6 hours for up to 5 days

High-dose therapy for acute spinal cord injury: I.V. bolus: 30 mg/kg over 15 minutes, followed 45 minutes later by an infusion of 5.4 mg/kg/hour for 23 hours

Lupus nephritis: High-dose "pulse" therapy: I.V. (sodium succinate): 1 g/day for 3 days

Aplastic anemia: I.V. (sodium succinate): 1 mg/kg/day or 40 mg/day (whichever dose is higher), for 4 days. After 4 days, change to oral and continue until day 10 or until symptoms of serum sickness resolve, then rapidly reduce over approximately 2 weeks.

Pneumocystis pneumonia in AIDs patients: I.V.: 40-60 mg every 6 hours for 7-10 days

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Intra-articular (acetate): Administer every 1-5 weeks.
Large joints: 20-80 mg
Small joints: 4-10 mg
Intralesional (acetate): 20-60 mg every 1-5 weeks

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Administration
Oral: Administer after meals or with food or milk

Parenteral: Methylprednisolone sodium succinate may be administered I.M. or I.V.; I.V. administration may be IVP over one to several minutes or IVPB or continuous I.V. infusion. Acetate salt should not be given I.V.

I.V.: Succinate:
Low dose: </= 1.8 mg/kg or </= 125 mg/dose: I.V. push over 3-15 minutes
Moderate dose: >/= 2 mg/kg or 250 mg/dose: I.V. over 15-30 minutes
High dose: 15 mg/kg or >/= 500 mg/dose: I.V. over >/= 30 minutes
Doses >15 mg/kg or >/= 1 g: Administer over 1 hour

Do not administer high-dose I.V. push; hypotension, cardiac arrhythmia, and sudden death have been reported in patients given high-dose methylprednisolone I.V. push over <20 minutes; intermittent infusion over 15-60 minutes; maximum concentration: I.V. push 125 mg/mL

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SUPPLIED
Injection, powder for reconstitution, as sodium succinate: 125 mg [strength expressed as base]
Solu-Medrol®: 40 mg, 125 mg, 500 mg, 1 g, 2 g [packaged with diluent; diluent contains benzyl alcohol; strength expressed as base]
Solu-Medrol®: 500 mg, 1 g

Injection, suspension, as acetate (Depo-Medrol®): 20 mg/mL (5 mL); 40 mg/mL (5 mL); 80 mg/mL (5 mL) [contains benzyl alcohol; strength expressed as base]

Injection, suspension, as acetate [single-dose vial] (Depo-Medrol®): 40 mg/mL (1 mL, 10 mL); 80 mg/mL (1 mL)

Tablet: 4 mg
Medrol®: 2 mg, 4 mg, 8 mg, 16 mg, 32 mg
Tablet, dose-pack: 4 mg (21s)
Medrol® Dosepack™: 4 mg (21s)

prednisone

DOSING:
Oral: Dose depends upon condition being treated and response of patient; dosage for infants and children should be based on severity of the disease and response of the patient rather than on strict adherence to dosage indicated by age, weight, or body surface area. Consider alternate day therapy for long-term therapy. Discontinuation of long-term therapy requires gradual withdrawal by tapering the dose.
Children:
Anti-inflammatory or immunosuppressive dose: 0.05-2 mg/kg/day divided 1-4 times/day

Acute asthma: 1-2 mg/kg/day in divided doses 1-2 times/day for 3-5 days

AAlternatively (for 3- to 5-day "burst"):
<1 year: 10 mg every 12 hours
1-4 years: 20 mg every 12 hours
5-13 years: 30 mg every 12 hours
>13 years: 40 mg every 12 hours

AAsthma long-term therapy (alternative dosing by age):
<1 year: 10 mg every other day
1-4 years: 20 mg every other day
5-13 years: 30 mg every other day
>13 years: 40 mg every other day

Nephrotic syndrome:
Initial (first 3 episodes): 2 mg/kg/day or 60 mg/m2 /day (maximum: 80 mg/day) in divided doses 3-4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1-1.5 mg/kg/dose or 40 mg/m2 /dose given every other day for 4 weeks

MMaintenance dose (long-term maintenance dose for frequent relapses): 0.5-1 mg/kg/dose given every other day for 3-6 months

Children and Adults:
Physiologic replacement: 4-5 mg/m2 /day
Children >/= 5 years and Adults: Asthma:

Moderate persistent: Inhaled corticosteroid (medium dose) or inhaled corticosteroid (low-medium dose) with a long-acting bronchodilator

SSevere persistent: Inhaled corticosteroid (high dose) and corticosteroid tablets or syrup long term: 2 mg/kg/day, generally not to exceed 60 mg/day

Adults:
Immunosuppression/chemotherapy adjunct: Range: 5-60 mg/day in divided doses 1-4 times/day

Allergic reaction (contact dermatitis):
Day 1: 30 mg divided as 10 mg before breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime
Day 2: 5 mg at breakfast, 5 mg at lunch, 5 mg at dinner, 10 mg at bedtime
Day 3: 5 mg 4 times/day (with meals and at bedtime)
Day 4: 5 mg 3 times/day (breakfast, lunch, bedtime)
Day 5: 5 mg 2 times/day (breakfast, bedtime)
Day 6: 5 mg before breakfast

Pneumocystis carinii pneumonia (PCP):
40 mg twice daily for 5 days followed by
40 mg once daily for 5 days followed by
20 mg once daily for 11 days or until antimicrobial regimen is completed

Thyrotoxicosis: Oral: 60 mg/day

Chemotherapy (refer to individual protocols): Oral: Range: 20 mg/day to 100 mg/m 2 /day

Rheumatoid arthritis: Oral: Use lowest possible daily dose (often </= 7.5 mg/day)

Idiopathic thrombocytopenia purpura (ITP): Oral: 60 mg daily for 4-6 weeks, gradually tapered over several weeks

SSystemic lupus erythematosus (SLE): Oral:
Acute: 1-2 mg/kg/day in 2-3 divided doses
Maintenance: Reduce to lowest possible dose, usually <1 mg/kg/day as single dose (morning)

Elderly: Use the lowest effective dose

PACKAGE INSERT DATA
The initial dosage of DELTASONE Tablets may vary from 5 mg to 60 mg of prednisone per day depending on the specific disease entity being treated. 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, DELTASONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. 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 DELTASONE 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.

Multiple Sclerosis: In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.)

ADT® (Alternate Day Therapy): ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion.

Disclaimer

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David F. McAuley, Pharm.D., R.Ph. GlobalRPh Inc.

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