Yes

Corticosteroid, Adrenal; Corticosteroid, Oral Inhaler; Corticosteroid, Nasal; Corticosteroid, Parenteral; Corticosteroid, Topical

Inhalation: Control of bronchial asthma and related bronchospastic conditions.

Intranasal: Management of seasonal and perennial allergic rhinitis in patients greater than or equal to 12 years of age

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

Topical: Inflammatory dermatoses responsive to steroids

C

Clinical effects on the fetus: No data on crossing the placenta or effect on fetus

Breast-feeding/lactation: No data on crossing into breast milk or clinical effects on the infant

Known hypersensitivity to triamcinolone; systemic fungal infections; serious infections (except septic shock or tuberculous meningitis); primary treatment of status asthmaticus

Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; several months may be required for recovery from this syndrome; during this period, aerosol steroids do not provide the increased systemic steroid requirement needed to treat patients having trauma, surgery or infections; avoid using higher than recommended dose

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 inhaled and intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Growth velocity provides a means of comparing the rate of growth among children of the same age.

In studies involving inhaled corticosteroids, the average reduction in growth velocity was approximately 1 cm (about 1/3 of an inch) per year. It appears that the reduction is related to dose and how long the child takes the drug.

FDA's Pulmonary and Allergy Drugs and Metabolic and Endocrine Drugs advisory committees discussed this issue at a July 1998 meeting. They recommended that the agency develop class-wide labeling to inform healthcare providers so they would understand this potential side effect and monitor growth routinely in pediatric patients who are treated with inhaled corticosteroids, intranasal corticosteroids or both.

Long-term effects of this reduction in growth velocity on final adult height are unknown. Likewise, it also has not yet been determined whether patients' growth will "catch up" if treatment in discontinued. Drug manufacturers will continue to monitor these drugs to learn more about long-term effects. Children are prescribed inhaled corticosteroids to treat asthma. Intranasal corticosteroids are generally used to prevent and treat allergy-related nasal symptoms.

Patients are advised not to stop using their inhaled or intranasal corticosteroids without first speaking to their healthcare providers about the benefits of these drugs compared to their risks.

>10%:

Central nervous system: Insomnia, nervousness

Gastrointestinal: Increased appetite, indigestion

1% to 10%:

Ocular: Cataracts

Endocrine & metabolic: Diabetes mellitus, hirsutism

Neuromuscular & skeletal: Arthralgia

Respiratory: Epistaxis

<1%: Fatigue, seizures, mood swings, headache, delirium, hallucinations, euphoria, itching, hypertrichosis, skin atrophy, hyperpigmentation, hypopigmentation, acne, bruising, amenorrhea, sodium and water retention, Cushing's syndrome, hyperglycemia, bone growth suppression, oral candidiasis, dry throat, xerostomia, peptic ulcer, abdominal distention, ulcerative esophagitis, pancreatitis, burning, osteoporosis, muscle wasting, hoarseness, wheezing, cough, hypersensitivity reactions

When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur, in those cases discontinuation and withdrawal of the corticosteroid should be done judiciously

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

Increased toxicity: Salicylates may increase risk of GI ulceration

Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system; suppresses adrenal function at high doses

Duration of action: Oral: 8-12 hours

Absorption: Topical: Systemic absorption may occur

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

Half-life, biologic: 18-36 hours

In general, single I.M. dose of 4-7 times oral dose will control patient from 4-7 days up to 3-4 weeks

Oral inhalation: 1-2 inhalations 3-4 times/day, not to exceed 12 inhalations/day

I.M. (acetonide or hexacetonide): 0.03-0.2 mg/kg at 1- to 7-day intervals

Intra-articular, intrabursal, or tendon-sheath injection: 2.5-15 mg, repeated as needed

Children >12 years and Adults:

Intranasal: 2 sprays in each nostril once daily; may increase after 4-7 days up to 4 sprays once daily or 1 spray 4 times/day in each nostril

Topical: Apply a thin film 2-3 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

Oral: 4-48 mg/day

Oral inhalation: 2 inhalations 3-4 times/day, not to exceed 16 inhalations/day

I.M.: Systemic: Children >12 years and Adults:

Acetonide: 60 mg (usual dose); additional 20-100 mg doses (usual: 40-80 mg) may be given when signs and symptoms recur, best at 6-week intervals to minimize HPA suppression

Diacetate: Using 40 mg/mL suspension: 40 mg once weekly

I.M.: Site-specific injection: Children >12 years and Adults:

Acetonide:

Intra-articular, intrasynovial, or soft tissue: Using 10 mg/mL or 40 mg/mL: Large joints: 15-40 mg; small joints: 2.5-10 mg; amount depends on location, size of joints, and degree of inflammation; repeat when signs and symptoms recur

Intra-lesional or sublesional: Using 10 mg/mL: 1 mg per injection site, may be repeated 1 or more times weekly depending upon patient's response; may use multiple injections if they are >1 cm apart (maximum: 30 mg at any one time)

Tendon sheath: 2.5-10 mg

Diacetate:

Intra-articular, intra-synovial, or soft tissue: Using 25 mg/mL or 40 mg/mL: 2-40 mg; amount depends on location, size of joint or area, and degree of inflammation; may be repeated at 1- to 8-week intervals; large joints often require 25 mg, while smaller joints may require 2-5 mg

Intralesional or sublesional: Using 25 mg/mL: 5-40 mg; amount depends on size, location, and type of lesion; in general, no more than 12.5 mg per injection site or 25 mg per lesion should be used

Hexacetonide:

Intra-articular: Large joints: 10-20 mg; small joints: 2-6 mg

Intralesional or sublesional: Up to 0.5 mg per square inch of affected area

May be administered with food to decrease GI distress

Nervousness and insomnia are common; may cause drowsiness, delirium, euphoria, hallucinations, or mood swings

Barbiturates may increase the metabolism of triamcinolone

No information available to require special precautions

No effects or complications reported

Take exactly as directed; do not increase dose or discontinue abruptly without consulting prescriber. Take oral medication with or after meals. Limit intake of caffeine or stimulants. Prescriber may recommend increased dietary vitamins, minerals, or iron. Diabetics should monitor glucose levels closely (antidiabetic medication may need to be adjusted). Inform prescriber if you are experiencing greater than normal levels of stress (medication may need adjustment). Some forms of this medication may cause GI upset (oral medication may be taken with meals to reduce GI upset; small frequent meals and frequent mouth care may reduce GI upset). You may be more susceptible to infection (avoid crowds and persons with contagious or infective conditions). Report promptly excessive nervousness or sleep disturbances; any signs of infection (sore throat, unhealed injuries); excessive growth of body hair or loss of skin color; changes in vision; excessive or sudden weight gain (>3 lb/week); swelling of face or extremities; difficulty breathing; muscle weakness; change in color of stools (black or tarry) or persistent abdominal pain; or worsening of condition or failure to improve. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Aerosol: 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. Inform prescriber if condition worsens or does not improve.

Nasal spray: Shake gently before use. Use at regular intervals, no more frequently than directed. Report unusual cough or spasm; persistent nasal bleeding, burning, or irritation; or worsening of condition.

Once daily doses should be given in the morning; evaluate clinical response and mental status; may mask signs and symptoms of infection; inject I.M. dose deep in large muscle mass, avoid deltoid; avoid S.C. dose; a thin film is effective topically and avoid topical application on the face; do not occlude area unless directed

Aerosol:

Oral inhalation: 100 mcg/metered spray (20 g)

Topical, as acetonide: 0.2 mg/2 second spray (23 g, 63 g)

Cream, as acetonide: 0.025% (15 g, 30 g, 60 g, 80 g, 120 g, 240 g); 0.1% (15 g, 20 g, 30 g, 60 g, 80 g, 90 g, 120 g, 240 g); 0.5% (15 g, 20 g, 30 g, 120 g, 240 g)

Injection, as acetonide: 3 mg/mL (5 mL); 10 mg/mL (5 mL); 40 mg/mL (1 mL, 5 mL, 10 mL)

Injection, as diacetate: 25 mg/mL (5 mL); 40 mg/mL (1 mL, 5 mL)

Injection, as hexacetonide: 5 mg/mL (5 mL); 20 mg/mL (1 mL, 5 mL)

Lotion, as acetonide: 0.025% (60 mL); 0.1% (15 mL, 60 mL)

Ointment, topical, as acetonide: 0.025% (15 g, 28 g, 30 g, 57 g, 80 g, 113 g, 240 g); 0.1% (15 g, 28 g, 57 g, 60 g, 80 g, 113 g, 240 g, 454 g); 0.5% (15 g, 28 g, 57 g, 113 g, 240 g)

Spray, intranasal acetonide: (Tri-Nasal®) 50 mcg per actuation (15 mL/120 actuations [0.5 mg/mL]); 55 mcg per actuation (100 sprays/canister) (15 mg canister)

Syrup: 4 mg/5 mL (120 mL)

Tablet: 1 mg, 2 mg, 4 mg, 8 mg

Expert Panel Report 2, "Guidelines for the Diagnosis and Management of Asthma," Clinical Practice Guidelines, National Institutes of Health, National Heart, Lung, and Blood Institute, NIH Publication No. 94-4051, April, 1997.

Expert Panel Report, National Asthma Education Program, National Heart, Lung, and Blood Institute, "Guidelines For the Diagnosis and Management of Asthma," J Allergy Clin Immunol, 1991, 88(3 pt 2):425-534.