Nasal inhalation: Management of seasonal and perennial allergic rhinitis in patients 6 years of age

Oral inhalation: Control of bronchial asthma and related bronchospastic conditions

Oral topical: Adjunctive treatment and temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma

Systemic: Adrenocortical insufficiency, rheumatic disorders, allergic states, respiratory diseases, systemic lupus erythematosus (SLE), and other diseases requiring anti-inflammatory or immunosuppressive effects

Topical: Inflammatory dermatoses responsive to steroids

Use with caution in patients with hypothyroidism, cirrhosis, nonspecific ulcerative colitis and patients at increased risk for peptic ulcer disease. Corticosteroids should be used with caution in patients with diabetes, hypertension, osteoporosis, glaucoma, cataracts, or tuberculosis. Use caution in hepatic impairment. Do not use occlusive dressings on weeping or exudative lesions and general caution with occlusive dressings should be observed; discontinue if skin irritation or contact dermatitis should occur; do not use in patients with decreased skin circulation; avoid the use of high potency steroids on the face.

Because of the risk of adverse effects, systemic corticosteroids should be used cautiously in the elderly, in the smallest possible dose, and for the shortest possible time. Azmacort® (metered dose inhaler) comes with its own spacer device attached and may be easier to use in older patients.

Controlled clinical studies have shown that orally-inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. (In studies of orally-inhaled corticosteroids, the mean reduction in growth velocity was approximately 1 centimeter per year [range 0.3-1.8 cm per year] and appears to be related to dose and duration of exposure.) The growth of pediatric patients receiving inhaled corticosteroids, should be monitored routinely (eg, via stadiometry). To minimize the systemic effects of orally-inhaled and intranasal corticosteroids, each patient should be titrated to the lowest effective dose.

May suppress the immune system, patients may be more susceptible to infection. Use with caution in patients with systemic infections or ocular herpes simplex. Avoid exposure to chickenpox and measles.

Oral topical: Discontinue if local irritation or sensitization should develop. If significant regeneration or repair of oral tissues has not occurred in seven days, re-evaluation of the etiology of the oral lesion is advised.

Systemic: Frequency not defined:

Cardiovascular: CHF, hypertension

Central nervous system: Convulsions, fever, headache, intracranial pressure increased, vertigo

Dermatologic: Bruising, facial erythema, petechiae, photosensitivity, rash, thin/fragile skin, wound healing impaired

Endocrine & metabolic: Adrenocortical/pituitary unresponsiveness (particularly during stress), carbohydrate tolerance decreased, cushingoid state, diabetes mellitus (manifestations of latent disease), fluid retention, growth suppression (children), hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, potassium loss, sodium retention

Gastrointestinal: Abdominal distention, diarrhea, dyspepsia, nausea, oral Monilia (oral inhaler), pancreatitis, peptic ulcer, ulcerative esophagitis, weight gain

Local: Skin atrophy (at the injection site)

Neuromuscular & skeletal: Femoral/humeral head aseptic necrosis, muscle mass decreased, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, vertebral compression fractures

Ocular: Cataracts, intraocular pressure increased, exophthalmos, glaucoma

Respiratory: Cough increased (nasal spray), epistaxis (nasal inhaler/spray), pharyngitis (nasal spray/oral inhaler), sinusitis (oral inhaler), voice alteration (oral inhaler)

Miscellaneous: Anaphylaxis, diaphoresis increased, suppression to skin tests

Topical: Frequency not defined:

Dermatologic: Itching, allergic contact dermatitis, dryness, folliculitis, skin infection (secondary), itching, hypertrichosis, acneiform eruptions, hypopigmentation, skin maceration, skin atrophy, striae, miliaria, perioral dermatitis, atrophy of oral mucosa

Local: Burning, irritation

Decreased effect: Barbiturates, phenytoin, rifampin increase metabolism of triamcinolone; vaccine and toxoid effects may be reduced

Increased effect: Salmeterol: The addition of salmeterol has been demonstrated to improve response to inhaled corticosteroids (as compared to increasing steroid dosage).

Increased toxicity: Salicylates may increase risk of GI ulceration

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: Triamcinolone interferes with calcium absorption.

Herb/Nutraceutical: Avoid cat's claw, echinacea (have immunostimulant properties).

Injection, suspension: Shake well prior to use

Diacetate suspension: May dilute prior to use using NS or equal parts of NS and procaine 1%. Diluted suspension stable ~1 week. Avoid diluents containing parabens or preservatives (may cause flocculation). Suspensions for intralesional use may be diluted to 1:1 or 1:10 concentration.

Hexacetonide suspension: Avoid diluents containing parabens or preservatives (may cause flocculation). Diluted suspension stable ~1 week. Suspension for intralesional use, may be diluted with D5NS, D10NS or SWFI to a 1:1, 1:2, or 1:4 concentration. Solutions for intra-articular use, may be diluted with lidocaine 1% or 2%.

Topical spray: Avoid excessive heat

Duration: Oral: 8-12 hours

Absorption: Topical: Systemic

Time to peak: I.M.: 8-10 hours

Half-life elimination: Biologic: 18-36 hours

Injection:

Acetonide:

Intra-articular, intrabursal, tendon sheaths: Adults: Initial: Smaller joints: 2.5-5 mg, larger joints: 5-15 mg

Intradermal: Adults: Initial: 1 mg

I.M.: Range: 2.5-60 mg/day

Children 6-12 years: Initial: 40 mg

Children >12 years and Adults: Initial: 60 mg

Diacetate: Adults:

Intra-articular, Intrasynovial: Range: 5-40 mg; duration of effect varies from 1 week to 2 months, although more frequent dosing may be needed in acutely-inflamed joints

Average dose: Knee: 25 mg, finger: 2-5 mg

Intralesional, sublesional: Range: 5-48 mg, dependent upon size of lesion

Maximum: 12.5 mg/injection site, 25 mg/lesion, 75 mg/week

Usual treatment course: 2-3 injections at 1- to 2-week intervals

I.M.: Initial range: 3-48 mg/day; average dose: 40 mg/week

Hexacetonide: Adults:

Intralesional, sublesional: Up to 0.5 mg/square inch of affected skin

Intra-articular: Range: 2-20 mg

Triamcinolone Dosing

Intranasal: Perennial allergic rhinitis, seasonal allergic rhinitis:

Nasal spray:

Children 6-11 years: 110 mcg/day as 1 spray in each nostril once daily.

Children 12 years and Adults: 220 mcg/day as 2 sprays in each nostril once daily

Nasal inhaler:

Children 6-11 years: Initial: 220 mcg/day as 2 sprays in each nostril once daily

Children 12 years and Adults: Initial: 220 mcg/day as 2 sprays in each nostril once daily; may increase dose to 440 mcg/day (given once daily or divided and given 2 or 4 times/day)

Oral: Adults:

Acute rheumatic carditis: Initial: 20-60 mg/day; reduce dose during maintenance therapy

Acute seasonal or perennial allergic rhinitis: 8-12 mg/day

Adrenocortical insufficiency: Range 4-12 mg/day

Bronchial asthma: 8-16 mg/day

Dermatological disorders, contact/atopic dermatitis: Initial: 8-16 mg/day

Ophthalmic disorders: 12-40 mg/day

Rheumatic disorders: Range: 8-16 mg/day

SLE: Initial: 20-32 mg/day, some patients may need initial doses 48 mg; reduce dose during maintenance therapy

Oral inhalation: Asthma:

Children 6-12 years: 100-200 mcg 3-4 times/day or 200-400 mcg twice daily; maximum dose: 1200 mg/day

Children >12 years and Adults: 200 mcg 3-4 times/day or 400 mcg twice daily; maximum dose: 1600 mcg/day

Oral topical: Oral inflammatory lesions/ulcers: Press a small dab (about ¹/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film; do not rub in.

Topical:

Cream, Ointment: Apply thin film to affected areas 2-4 times/day

Spray: Apply to affected area 3-4 times/day

Injection: Avoid injecting into a previously infected joint; do not inject into unstable joints

I.M.: Inject deep in large muscle mass, avoid deltoid.

SubQ: Avoid subcutaneous administration.

Nasal spray, inhalation: Shake well prior to use. Gently blow nose to clear nostrils.

Oral inhalation: Shake well prior to use. Rinse mouth and throat after using inhaler to prevent candidiasis. Use spacer device provided with Azmacort®.

Oral topical: Apply small dab to lesion until a thin film develops; do not rub in. Apply at bedtime or after meals if applications are needed throughout the day.

Tablet: Once-daily doses should be given in the morning.

Topical: Apply a thin film sparingly and avoid topical application on the face. Do not use on open skin or wounds. Do not occlude area unless directed.

Aerosol: Shake gently before use. Use at regular intervals, no more frequently than directed. Not for use during acute asthmatic attack. Follow directions that accompany product. Rinse mouth and throat after use to prevent candidiasis. Do not use intranasal product if you have a nasal infection, nasal injury, or recent nasal surgery. If using two products, consult prescriber in which order to use the two products. Report unusual cough or spasm; persistent nasal bleeding, burning, or irritation; or worsening of condition.

Inhalation: Sit when using. Take deep breaths for 3-5 minutes, and clear nasal passages before administration (use decongestant as needed). Hold breath for 5-10 seconds after use, and wait 1-3 minutes between inhalations. Follow package insert instructions for use. Do not exceed maximum dosage. If also using inhaled bronchodilator, use before triamcinolone. Rinse mouth and throat after use to reduce aftertaste and prevent candidiasis.

Topical: For external use only. Not for eyes or mucous membranes or open wounds. Apply in very thin layer to occlusive dressing. Apply dressing to area being treated. Avoid prolonged or excessive use around sensitive tissues, genital, or rectal areas. Inform prescriber if condition worsens (swelling, redness, irritation, pain, open sores) or fails to improve.

Effects of inhaled/intranasal steroids on growth have been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with orally-inhaled and intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for "catch up" growth following discontinuation of treatment with inhaled corticosteroids has not been adequately studied.

Neuromuscular Effects: ICU-acquired paresis was recently studied in 5 ICUs (3 medical and 2 surgical ICUs) at 4 French hospitals. All ICU patients without pre-existing neuromuscular disease admitted from March 1999 through June 2000 were evaluated (De Jonghe B, 2002). Each patient had to be mechanically ventilated for 7 days and was screened daily for awakening. The first day the patient was considered awake was Study Day 1. Patients with severe muscle weakness on Study Day 7 were considered to have ICU-acquired paresis. Among the 95 patients who were evaluable, about 25% developed ICU-acquired paresis. Independent predictors included female gender, the number of days with 2 organ dysfunction, and administration of corticosteroids. Further studies may be required to verify and characterize the association between the development of ICU-acquired paresis and use of corticosteroids. Concurrent use of a corticosteroid and muscle relaxant appear to increase the risk of certain ICU myopathies; avoid or administer the corticosteroid at the lowest dose possible.

Adrenal Insufficiency: Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. When discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that the steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia. Patients on long-term steroid supplementation will require higher corticosteroid doses when subject to stress (ie, trauma, surgery, severe infection). Guidelines for glucocorticoid replacement during various surgical procedures have been published (Salem M, 1994, Coursin DB, 2002).

Septic Shock: A recent randomized, double-blind, placebo controlled trial assessed whether low dose corticosteroid administration could improve 28-day survival in patients with septic shock and relative adrenal insufficiency. Relative adrenal insufficiency was defined as an inappropriate response to corticotropin administration (increase of serum cortisol of 9 mcg/dL from baseline). Cortisol levels were drawn immediately before corticotropin administration and 30 to 60 minutes afterwards. Three hundred adult septic shock patients requiring mechanical ventilation and vasopressor support were randomized to either hydrocortisone (50 mg IVP every 6 hours) and fludrocortisone (50 mcg tablet daily via nasogastric tube) or matching placebos for 7 days. In patients who did not appropriately respond to corticotropin (nonresponders), there were significantly fewer deaths in the active treatment group. Vasopressor therapy was withdrawn more frequently in this subset of the active treatment group. Adverse events were similar in both groups. Patients who lack adrenal reserve and thus have relative adrenal insufficiency during the stress of septic shock may benefit from physiologic steroid replacement. However, there was a trend for increased mortality in patients who responded to the corticotropin test (increase serum cortisol >9 mcg/dL from baseline). These patients may not benefit from physiologic steroid replacement. Further study is required to better characterize the patient populations who may benefit.

Aerosol for nasal inhalation, as acetonide [CFC free] (Nasacort® [HFA]): 55 mcg/inhalation (9.3 g) [100 doses]

Aerosol for nasal inhalation, as acetonide [spray]:

Nasacort® AQ: 55 mcg/inhalation (16.5 g) [120 doses]

Tri-Nasal®: 50 mcg/inhalation (15 mL) [120 doses]

Aerosol for oral inhalation, as acetonide (Azmacort®): 100 mcg per actuation (20 g) [240 actuations]

Aerosol, topical, as acetonide (Kenalog®): 0.2 mg/2-second spray (63 g)

Cream, as acetonide: 0.025% (15 g, 80 g); 0.1% (15 g, 80 g, 454 g, 2270 g); 0.5% (15 g)

Aristocort® A: 0.025% (15 g, 60 g); 0.1% (15 g, 60 g); 0.5% (15 g) [contains benzyl alcohol]

Kenalog®: 0.1% (15 g, 60 g, 80 g); 0.5% (20 g)

Triderm®: 0.1% (30 g, 85 g)

Injection, suspension, as acetonide:

Kenalog-10®: 10 mg/mL (5 mL) [contains benzyl alcohol; not for I.V. or I.M. use]

Kenalog-40®: 40 mg/mL (1 mL, 5 mL, 10 mL) [contains benzyl alcohol; not for I.V. or intradermal use]

Injection, suspension, as diacetate:

Aristocort®: 25 mg/mL (5 mL) [contains benzyl alcohol; not for I.V. use]

Aristocort® Forte: 40 mg/mL (1 mL, 5mL) [contains benzyl alcohol; not for I.V. use]

Injection, suspension, as hexacetonide (Aristospan®): 5 mg/mL (5 mL); 20 mg/mL (1 mL, 5 mL) [contains benzyl alcohol; not for I.V. use]

Lotion, as acetonide (Kenalog®): 0.025% (60 mL); 0.1% (60 mL)

Ointment, topical, as acetonide: 0.025% (80 g); 0.1% (15 g, 80 g, 454 g)

Aristocort® A, Kenalog®: 0.1% (15 g, 60 g)

Paste, oral, topical, as acetonide (Kenalog® in Orabase®): 0.1% (5 g)

Tablet (Aristocort®): 4 mg [contains lactose and sodium benzoate]

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