Professional Information

Triamcinolone

Pronouncation: (TRYE-am-SIN-oh-lone)
Class: Corticosteroid, Glucocorticoid, Intranasal steroid Triamcinolone Acetonide

Trade Names:
Azmacort
- Aerosol 75 mcg/actuation (inhaler contains 60 mg)

Trade Names:
Kenalog
- Cream 0.1%
- Aerosol spray 0.147 mg/g

Trade Names:
Kenalog-10
- Injection, suspension 10 mg/mL

Trade Names:
Kenalog-40
- Injection, suspension 40 mg/mL

Trade Names:
Nasacort AQ
- Spray 55 mcg/actuation

Trade Names:
Oralone
- Dental paste 0.1%

Trade Names:
Triamcinolone
- Cream 0.025%
- Cream 0.5%
- Lotion 0.025%
- Lotion 0.1%
- Ointment 0.025%
- Ointment 0.1%
- Ointment 0.5%

Trade Names:
Triderm
- Cream 0.1%
- Ointment 0.1%

Trade Names:
Triesence
- Injection, suspension, intravitreal 40 mg/mL

Trade Names:
Zytopic
- Cream 0.1%

Aristospan (Canada)
Oracort (Canada)
Triamcinolone Hexacetonide

Trade Names:
Aristospan Intra-articular
- Injection, suspension 20 mg/mL

Trade Names:
Aristospan Intralesional
- Injection, suspension 5 mg/mL

Pharmacology

Anti-inflammatory effect by depressing formation, release, and activity of endogenous mediators of inflammation, including prostaglandins, kinins, histamine, liposomal enzymes, and complement system. Also modifies the body's immune response.

Pharmacokinetics

Absorption

Following single intravitreal administration, the peak aqueous humor concentrations range from 2,151 to 7,202 ng/mL.

Distribution

Based on IV data, Vd is approximately 103.4 L; binding to plasma proteins is approximately 68%.

Metabolism

Metabolized primarily in the liver. Metabolites are substantially less active than the parent compound.

Elimination

Based on IV data, mean half-life is 88 min and Cl is 45.2 L/h. After intranasal administration, mean half-life was 5.4 h. Urinary and fecal excretion accounted for 40% and 60%, respectively. Some of the topical corticosteroids and their metabolites are also excreted in the bile.

Following single intravitreal administration, the mean elimination t _½ is approximately 19 days in nonvitrectomized eyes and about 3 days in patients who have undergone vitrectomy.

Indications and Usage

IM ( Kenalog-40 )

Control of severe or incapacitating allergic states (eg, asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions); treatment of dermatologic disease (eg, bullous dermatitis herpetiformis, exfoliative dermatitis, Stevens-Johnson syndrome, mycosis fungoides, pemphigus); replacement therapy for endocrine disorders (eg, primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis); control of GI diseases (eg, regional enteritis, ulcerative colitis); treatment of hematologic disorders (eg, acquired hemolytic anemia, Diamond-Blackfan anemia, selected cases of secondary thrombocytopenia, pure red cell aplasia); palliative management of neoplastic diseases (eg, leukemia, lymphoma); exacerbations of nervous system disorders (eg, multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury); management of ophthalmic diseases (eg, sympathetic ophthalmia, temporal arteritis, uveitis); management of renal disease (induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or lupus erythematosus); treatment of respiratory disease (eg, berylliosis, fulminating or disseminated pulmonary tuberculosis, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis); adjunctive therapy in rheumatic disorders (eg, short-term administration in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis) and treatment of dermatomyositis, polymyositis, and SLE; treatment of tuberculosis meningitis; treatment of trichinosis with neurologic or myocardial involvement.

Intra-articular ( Aristospan 20 mg/mL, Kenalog-10 , Kenalog-40 )

Adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, and synovitis of osteoarthritis.

Intralesional ( Aristospan 5 mg/mL, Kenalog-10 )

Management of alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus, and psoriatic plaques; necrobiosis lipoidica diabeticorum; may be useful in cystic tumors of aponeurosis or tendon.

Topical application

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Oral inhalation

Maintenance treatment of asthma as prophylactic therapy; use in asthma patients requiring systemic corticosteroid administration.

Intranasal

Relief of seasonal and perennial allergic rhinitis symptoms.

Intraviteral ( Triesence )

Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids; visualization during vitrectomy.

Dental

Adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

Contraindications

Systemic fungal infections; IM use in idiopathic thrombocytopenic purpura; administration of live virus vaccines; oral inhalation as primary treatment for status asthmaticus or other acute episodes of asthma; hypersensitivity to any component of the product.

Dosage and Administration

Individualize dose based on disease being treated and response of the patient.

Triamcinolone Acetonide
Adults and Children

Intra-articular 2.5 to 5 mg for smaller joints and 5 to 15 mg for larger joints, depending on disease being treated. Intralesional Dose per injection varies depending on the specific disease entity and lesion being treated. Multiple sites separated by at least 1 cm may be injected, keeping in mind that the greater the total volume used, the more drug that becomes available for systemic absorption and systemic effects. Injections may be repeated weekly or at less frequent intervals if needed.

Adults

IM Recommended initial dose is 60 mg, injected deeply into gluteal muscle. Dosage is adjusted from less than 20 to 80 mg, depending upon patient response and duration of relief.

Children

IM Initial dose ranges from 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m ² BSA).

Adults and Children

Intraviteral

Ophthalmic diseases other than visualization

Initial dose is 4 mg with subsequent dosage as needed over the course of treatment.

Visualization

Recommended dose for visualization during vitrectomy is 1 to 4 mg administered intravitreally.

Adults

Oral Inhalation

Azmacort

2 inhalations (150 mcg) 3 to 4 times daily or 4 inhalations (300 mcg) twice daily (max, 16 inhalations [1,200 mcg] daily). Higher initial doses (12 to 16 inhalations [900 to 1,200 mcg] daily) may be considered for more severe asthma.

Children 6 to 12 yr of age

Oral Inhalation

Azmacort

Recommended dose is 1 to 2 inhalations (75 to 150 mcg) 3 to 4 times a day or 2 to 4 inhalations (150 to 300 mcg) twice daily (max, 12 inhalations [900 mcg] daily).

Adults and Children 12 yr of age and older

Intranasal

Nasacort AQ

Recommended starting dose is 220 mcg/day as 2 sprays in each nostril once daily.

Children 6 to 12 yr of age

Intranasal

Nasacort AQ

Recommended starting dose is 110 mcg/day as 1 spray in each nostril once daily (max, 220 mcg/day as 2 sprays in each nostril once daily).

Adults and Children

Topical

Cream/Ointment (0.025%)

Apply thin film to affected area 2 to 4 times daily, depending on severity of the condition; rub in gently.

Cream/Ointment (0.1%, 0.5%)

Apply thin film to affected area 2 or 3 times daily; rub in gently. Occlusive dressing may be used for management of psoriasis or recalcitrant conditions.

Dental

Press a small dab (about ¼ inch) to the lesion until a thin film develops. May be necessary to apply 2 to 3 times a day after meals, depending on severity of symptoms.

Kenalog Spray

3 or 4 applications daily are generally adequate. Occlusive dressing may be used for management of psoriasis or recalcitrant conditions.

Lotion

Apply thin film to affected area 2 to 4 times daily. Occlusive dressing may be used for management of psoriasis or recalcitrant conditions.

Hay Fever or Pollen Asthma Adults and Children

IM A single 40 to 100 mg injection may provide remission of symptoms lasting throughout the pollen season.

Acute Exacerbations of Multiple Sclerosis Adults and Children

IM 160 mg daily for 1 wk followed by 64 mg every other day for 1 mo.

Triamcinolone Hexacetonide
Adults

Intra-articular Aristospan 20 mg/mL: Average dose of 2 to 20 mg, depending on the size of the joint, degree of inflammation, and amount of fluid present. In general, small joints, 2 to 6 mg; large joints, 10 to 20 mg.

Children

Intra-articular Aristospan 20 mg/mL: Initial dose is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses.

Adults

Intralesional or sublesional Aristospan 5 mg/mL: 2 to 48 mcg/day depending on disease entity being treated. Larger doses may be justified in certain overwhelming, acute, life-threatening conditions. Frequency determined by clinical response.

Children

Intralesional or sublesional Aristospan 5 mg/mL: Initial dose is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses.

General Advice

Triesence
Do not administer IV.
Each vial and injection needle should only be used for the treatment of a single eye.

Storage/Stability

Aristospan 5 and 20 mg/mL, Kenalog-10 injection, Kenalog-40 injection

Store at 68° to 77°F. Protect from light; avoid freezing.

Azmacort inhalation

Store at 68° to 77°F. Shake well before using.

Kenalog spray

Store at 68° to 77°F. Avoid excessive heat.

Kenolog lotion, Zytopic cream

Store at room temperature (68° to 77°F). Avoid freezing.

Nasacort AQ , Nasacort HFA

Store at 68° to 77°F.

Oralone dental paste

Keep tightly closed. Store at 68° to 77°F.

Triamcinolone cream/lotion/ointment

Store at 59° to 86°F. Avoid freezing.

Triesence

Store at 39° to 77°F. Do not freeze. Protect from light.

Drug Interactions

Aminoglutethimide

May lead to loss of corticosteroid-induced adrenal suppression.

Amphotericin B, potassium-sparing diuretics

Risk of hypokalemia may be increased.

Anticholinesterases

May antagonize anticholinesterase effects in myasthenia gravis.

Antidiabetic agents

Because triamcinolone may increase blood sugar levels, dosage adjustments of antidiabetic agents may be needed.

Cholestyramine

May reduce triamcinolone levels by decreasing GI absorption and increasing Cl.

Cyclosporine

Cyclosporine and triamcinolone activity may be increased. Seizures have been reported.

CYP3A4 inducers (eg, barbiturates, carbamazepine, hydantoins [eg, phenytoin], rifampin)

May decrease efficacy of systemically administered triamcinolone.

CYP3A4 inhibitors (eg, azole antifungal agents [eg, ketoconazole], macrolide antibiotics [eg, clarithromycin])

May elevate triamcinolone plasma levels, increasing the pharmacologic effects and adverse reactions.

Digitalis

Risk of arrhythmia due to hypokalemia may be increased.

Estrogens, hormonal contraceptives

Triamcinolone plasma levels may be elevated, increasing therapeutic effects and adverse reactions.

Isoniazid

Serum levels may be reduced by triamcinolone, decreasing the efficacy.

NSAIDs, salicylates (eg, aspirin)

Risk of GI adverse reactions is increased.

Salicylates

Systemic administration may reduce serum levels and efficacy of salicylates.

Skin tests, vaccines

Response to skin tests and vaccines may be suppressed or diminished. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of triamcinolone.

Toxoids and live or inactivated vaccines

Because of inhibition of antibody response, patients on prolonged triamcinolone therapy may exhibit a diminished response to toxoids and live or inactivated vaccines. Replication of some organisms contained in live attenuated vaccines may be potentiated.

Troleandomycin

May increase triamcinolone effects.

Warfarin

Variable effects on warfarin; monitor anticoagulant parameters.

Laboratory Test Interactions

Uptake of thyroidߙI ¹³¹ may be decreased; false-negative results with nitroblue-tetrazolium test may occur; skin test reactions may be suppressed.

Adverse Reactions

Cardiovascular

Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, CHF, fat embolism, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent MI, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

CNS

Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema, insomnia, malaise, meningitis, neuritis, paraparesis/paraplegia, paresthesia, sensory disturbances, vertigo.

Dermatologic

Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper- or hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymosis, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria (IM); allergic contact dermatitis, burning, dryness, folliculitis, hypertrichosis, hypopigmentation, irritation, itching, maceration of the skin, miliaria, perioral dermatitis, secondary infection, skin atrophy, striae (topical).

EENT

Blindness associated with periocular injections, dry mouth (oral inhalational); epistaxis (intranasal); exophthalmos, glaucoma, increased IOP, otitis media, pharyngitis (intranasal/oral inhalational); posterior subcapsular cataracts, rhinitis (intranasal).

Electrolytes

Hypokalemic alkalosis, potassium loss, sodium retention.

Endocrine

Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increase in insulin and oral hypoglycemic requirements, moon face, secondary adrenocortical and pituitary unresponsiveness, suppression of growth in children.

GI

Abdominal distention, abdominal pain, diarrhea (oral inhalational); hiccups, nausea, oral moniliasis (oral inhalational); pancreatitis, peptic ulcer with perforation and hemorrhage, toothache (oral inhalational); ulcerative esophagitis, vomiting (intranasal/oral inhalational).

Genitourinary

Alteration in motility and number of spermatozoa, cystitis (oral inhalational); menstrual irregularities, UTI, vaginal moniliasis (oral inhalational).

Hepatic

Elevated serum liver enzymes, hepatomegaly.

Metabolic-Nutritional

Negative nitrogen balance, weight gain.

Musculoskeletal

Aseptic necrosis of femoral and humeral heads, back pain, bursitis (oral inhalational); charcot-like arthropathy, loss of muscle mass, muscle weakness, myalgia (oral inhalational); osteoporosis, pathologic fracture of long bones, postinjection flare (intra-articular); steroid myopathy, tendon rupture, tenosynovitis (oral inhalational); vertebral compression fractures.

Respiratory

Asthma, chest congestion (oral inhalational); cough, sinusitis (intranasal/oral inhalational); voice alteration (oral inhalational).

Miscellaneous

Anaphylactoid reactions, anaphylaxis, angioedema, decreased resistance to infection, flu syndrome, photosensitivity (oral inhalational).

Precautions

Monitor

Following intraocular injection, monitor for elevation in IOP and endophthalmitis. Monitor bone density in patients receiving long-term therapy.

Pregnancy

Category C ; Category D ( Triesence ).

Lactation

Undetermined.

Children

Children may be more susceptible to adverse reactions from topical use. Monitor growth and development of infants and children on prolonged therapy. Intranasal/oral inhalation form not recommended in children younger than 6 yr of age. Data for safety and efficacy is available for treatment of nephrotic syndrome in children older than 2 yr of age and for aggressive lymphomas and leukemia for children older than 1 mo of age.

Elderly

Elderly patients may require lower doses.

Hypersensitivity

Reactions, including anaphylaxis, may occur.

Renal Function

Use drug with caution.

Special Risk Patients

Use corticosteroids with caution in patients with active or quiescent tuberculosis infection; untreated systemic fungal, bacterial, parasitic, or viral infections; or ocular herpes simplex.

Acute asthma

Oral inhalation is not indicated for rapid relief of bronchospasm.

Adrenal suppression

Prolonged therapy may lead to hypothalamic-pituitary-adrenal (HPA) axis suppression.

Allergy

Transfer of patients from systemic steroids therapy to inhalation therapy may unmask allergic conditions previously suppressed by systemic steroid therapy (eg, rhinitis).

Behavioral disturbances

Existing emotional instability or psychotic tendencies may be aggravated. CNS effects ranging from euphoria, insomnia, mood swings, personality changes, and severe depression may occur.

Benzyl alcohol

Present in the parenteral products and has been associated with fatal gasping syndrome in premature infants.

Bronchospasm

Bronchospasm may occur with an immediate increase in wheezing following dosing, requiring immediate treatment with fast-acting inhaled bronchodilator.

Cataracts

May occur, particularly posterior subcapsular cataracts.

CV effects

May cause BP elevation, salt and water retention, and increased potassium and calcium excretion. Use with caution in patients with hypertension, CHF, renal function impairment, or recent MI.

GI

Use with caution in patients with active or latent peptic ulcer, diverticulitis, fresh intestinal anastomosis, and nonspecific ulcerative colitis.

Hepatitis

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

Immunosuppression

Do not administer live virus vaccines while patient is on therapy.

Increased IOP

Elevated IOP may occur in 20% to 60% of patients receiving triamcinolone injection and may persist for up to 6 mo following injection.

Infections

Risks related to infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections, may be increased. Signs of infection may be masked, resistance to new infections may be reduced, and host-defense mechanisms to prevent dissemination of infection may be decreased.

Inhalant only

Transfer from oral corticosteroids to inhaled corticosteroids has resulted in death caused by adrenal insufficiency related to lower systemic availability. A number of months are required for recovery of HPA axis suppression. Patients maintained prednisone 20 mg/day or more may be at higher risk. During periods of stress or severe asthma attack, instruct patients who have been withdrawn from systemic corticosteroids to resume oral steroids immediately.

Kaposi sarcoma

Has been reported in patients receiving corticosteroids for chronic conditions.

Latent disease

May be activated or exacerbated, including intercurrent infections (eg, tuberculosis).

Musculoskeletal

Bone formation may be decreased while bone resorption may be increased. Acute myopathy has been reported with high-dose corticosteroids.

Ocular effects

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

Peptic ulcer

Drug may contribute to peptic ulceration, especially in large doses.

Repository injections

Do not inject subcutaneously. Avoid injection into deltoid muscle and repeated IM injection into same site.

Stress

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

Viral infections

Chickenpox and measles may be more serious and sometimes fatal in patients receiving corticosteroids.

Withdrawal

Abrupt discontinuation may result in adrenal insufficiency.

Overdosage

Symptoms

Acne, central obesity, ecchymoses, electrolyte and fluid imbalance (excessive or long-term use), hirsutism, hyperglycemia, hyperlipidemia, hypertension, moon face, myopathy, osteoporosis, peptic ulcer, sexual dysfunction, striae.

Patient Information

Advise patient to read the patient information leaflet before starting therapy and again with each refill.
Advise patient to continue taking other medications for same condition as prescribed by health care provider.
Advise patient that dose may be changed periodically, depending on how well symptoms are controlled.
Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually begins to occur within 1 or 2 days, but full benefit may take 1 to 2 wk, depending on the condition being treated and the dose and route of administration of medication being used.
Caution patient not to increase dose but to inform health care provider if symptoms do not seem to be improving or are worsening.
Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed, and to inform health care provider of significant changes in readings.
Advise patient to immediately notify health care provider if any of the following occurs: black, tarry stools; fever; muscle weakness; sore throat; swelling of feet or ankles; vomiting of blood; or other signs of infection.
Advise patient to avoid exposure to chickenpox and measles and to seek medical advice immediately if exposed.
If patient is being converted from oral to inhaled or intranasal corticosteroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete.

Oral Inhalation
Review proper administration technique. Have patient demonstrate technique to ensure effective use of the metered-dose inhaler and attached spacer.
Warn patient that drug is an asthma controller and is not to be used to treat an acute asthma attack. Rescue medication (bronchodilator) must be used to obtain rapid relief of asthma symptoms.
Instruct patient not to stop using the medication once symptoms have been controlled. Continued daily use is necessary to control symptoms.
Advise patient to discard the aerosol canister when the labeled number of doses has been used.
Instruct patient to carry medical identification (eg, card, bracelet) if experiencing acute severe asthma attacks requiring rapid systemic treatment.
Advise patient to report the following symptoms to health care provider: cough, dry mouth, facial swelling, rash, sore throat or mouth, worsening asthma symptoms (increasing need for bronchodilator).

Intranasal
Review proper administration technique. Have patient demonstrate technique to ensure effective use of the nasal spray.
Instruct patient not to stop the medication once symptoms have been controlled. Continued daily use is necessary to control symptoms.
Instruct patient to use with caution if sores develop or injuries occur in nasal passages. Drug may prevent or slow proper healing.
Advise patient to report the following symptoms to health care provider: nasal irritation, nosebleed, sneezing.
Advise patient using pump spray to discard bottle when labeled number of sprays have been used even if bottle is not completely empty.

IM
Advise patient to carry medical identification (eg, card, bracelet) indicating use of corticosteroids, the condition(s) being treated, and possible need for supplemental systemic corticosteroids during periods of stress or severe asthma attack.
Caution patient not to suddenly stop taking this medication after more than 1 mo of use. Advise patient that if medication needs to be discontinued after prolonged therapy (eg, more than 1 mo), it will be slowly withdrawn to prevent adrenal insufficiency.
Review signs and symptoms of adrenal insufficiency (eg, abdominal, joint, or muscle pain; depression; dizziness; fatigue; hypotension; nausea). Instruct patient to immediately seek medical care if symptoms suggestive of adrenal insufficiency develop.

Dental Paste
Teach patient proper technique for applying the paste: press small dab (about ¼ inch) on the lesion until thin film develops. Caution patient not to rub the paste into the lesion.
Advise patient to apply at bedtime if being used once daily and after meals if being used more than once daily.
Advise patient to stop using and inform health care provider if any of the following local reactions occur: burning, irritation, itching, new blistering or peeling, new sores.