Triamcinolone (injection)

Triamcinolone (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Triamcinolone (injection) is an adrenal glucocorticoid, immune suppressant that is FDA approved for the treatment of allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block, neoplastic diseases, acute exacerbations of multiple sclerosis; cerebral edema, ophthalmic diseases, renal diseases, respiratory diseases, rheumatic disorders, and adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis, or osteoarthritis. Common adverse reactions include hypertension, atrophic condition of skin, finding of impaired skin healing, cushing's syndrome, decreased body growth, disorder of gastrointestinal tract, loss of appetite, osteoporosis, depression, euphoria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adrenal insufficiency

Allergic rhinitis, seasonal or perennial

• Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.

• Dosing Information

• The recommended dose of triamcinolone acetonide for the treatment of hay fever or pollen asthma in patients who are not responding to conventional therapy is a single intramuscular injection of 40 mg to 100 mg, administered deeply into the gluteal muscle. Remission of symptoms following one dose may last throughout the pollen season. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• For the treatment of seasonal and perennial allergic rhinitis symptoms, the recommended initial dose of triamcinolone acetonide nasal inhaler for adults and adolescents 12 years and older is 220 mcg once daily, which is administered as 2 sprays in each nostril once daily. After symptoms are controlled, a dose of 110 mcg per day (1 spray in each nostril) is often effective for controlling symptoms. If adequate symptom relief is not attained by 3 weeks, discontinue triamcinolone acetonide nasal inhaler.

Alopecia areata

• Dosing Information

• The average dose of triamcinolone diacetate for ALOPECIA AREATA and totalis is 25 to 30 milligrams once or twice weekly with a maximum dose of 75 milligrams per week (Prod Info Aristocort A(R), 2000).
• A series of fanlike injections one-half to one inch apart may be given for large lesions such as psoriasis and alopecia areata (Prod Info Aristocort A(R), 2000).

• Intralesional injections of triamcinolone diacetate have usually been 3 to 48 milligrams in divided amounts appropriate for the affected area . Generally, the usual maximum dose is 12.5 milligrams per injection site and 25 milligrams per any one lesion. Large areas require multiple injections and smaller doses per injection site. Two to three injections every one to two weeks usually are adequate (Prod Info Aristocort(R), 2000).
• A series of fanlike injections one-half to one inch apart may be given for large lesions such as psoriasis and alopecia areata (Prod Info Aristocort A(R), 2000).

Arthritis

Asthma

• Dosing Information

• The triamcinolone acetonide oral inhalation aerosol (Azmacort(R)) was removed from the market effective December 31, 2009 due to the international environmental protection agreement, which calls for the elimination from the market of certain chlorofluorocarbon (CFC)-containing medical products.
• Triamcinolone acetonide aerosol (Azmacort(R)) releases 200 mcg triamcinolone acetonide per actuation, and delivers approximately 75 mcg to the patient. Usual daily dosage in adults is 2 inhalations (75 mcg/inhalation) three to four times daily or 4 inhalations twice daily, not to exceed the maximum of 16 inhalations (1200 mcg) per day. In patients with more severe asthma, higher initial doses (12 to 16 inhalations daily) may be considered. Titrating to the lowest, most effective dose is recommended. The inhaler should be used on a regular schedule, not on an "as needed" basis. Patients using inhaled bronchodilators should use the bronchodilator several minutes before the triamcinolone inhaler to enhance penetration of triamcinolone into the bronchial tree and to reduce potential toxicity from the fluorocarbon propellants.
• In steroid-dependent patients, triamcinolone acetonide aerosol should be used concurrently with usual maintenance doses of systemic steroids. After approximately 1 week, the systemic steroid can be gradually withdrawn by reducing the daily or alternate-daily dose. The next dose reduction is made after an interval of 1 to 2 weeks depending upon patient response. In general, decrements in dosage should not exceed 2.5 mg of prednisone or its equivalent and slow rate of withdrawal is imperative. Some patients may experience systemic corticosteroid withdrawal symptoms eg, joint and/or muscular pain, lassitude and depression even with continued maintenance or improvement of pulmonary function. In this case, patients should continue with the inhaler and should be monitored for objective signs of adrenal insufficiency. If adrenal insufficiency is suspected, the systemic corticosteroid dose should be increased temporarily, followed by slower withdrawal [20].
• The recommended dose for asthma maintenance in steroid-independent adult patients is 2 inhalations (75 mcg/inhalation) three to four times daily or 4 inhalations twice daily, not to exceed the maximum of 16 inhalations (1200 mcg) per day[20].
• The recommended dose of triamcinolone acetonide injectable suspension for the treatment of asthma that does not respond to adequate trials of conventional treatment, when oral therapy is not feasible, is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Carditis (Acute), rheumatic

Collagen disease

• Dosing Information

• The recommended intramuscular dose of triamcinolone acetonide injectable suspension for the treatment of collagen diseases when oral therapy is not feasible is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Disorder of endocrine system

• 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), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

• Dosing Information

• The recommended intramuscular dose of triamcinolone acetonide injectable suspension for the treatment of endocrine disorders when oral therapy is not feasible is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Disorder of eye

• Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the systemic treatment of ophthalmic disorders is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• The recommended dose of triamcinolone acetonide injectable suspension for local treatment of ophthalmic disorders is a single intravitreal injection of 4 mg/0.05 mL, administered under controlled aseptic conditions.

Disorder of gastrointestinal tract

• Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the treatment of acute ulcerative colitis and regional enteritis, when oral therapy is not feasible, is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Disorder of hematopoietic structure

• Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Disorder of respiratory system

• Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the treatment of disorders of the respiratory system, when oral therapy is not feasible, is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Disorder of skin

• Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

• Dosing Information

• The recommended intralesional dose of triamcinolone acetonide injectable suspension for the treatment of dermatologic diseases is dependant upon the injection site and lesion size, given once weekly or less frequently as needed. Multiple sites of injection, separated by one centimeter, may be administered. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• The recommended intramuscular dose of triamcinolone acetonide injectable suspension for the treatment of dermatologic diseases when oral therapy is not feasible is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• The recommended topical dose of triamcinolone acetonide cream, lotion, ointment, or aerosol for the treatment of corticosteroid responsive dermatoses is application to affected areas 2 to 4 times a day. The cream, lotion, and ointment should be rubbed in gently after application. Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. If spraying the topical aerosol about the face, eyes should be covered and inhaling the spray should be avoided.

• Subcutaneous administration of 13 milligrams triamcinolone diacetate at 3 week intervals has been effective in the treatment of psoriasis.

Drug allergy

Exacerbation of multiple sclerosis (Acute)

Ganglion and synovial cyst

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the treatment of cystic tumors of an aponeurosis or tendon is a single local injection of 2.5 to 15 mg. Maintenance doses can be adjusted to a total dose 20 mg or more as needed. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Inflammatory disorder of musculoskeletal system

• Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

• Dosing Information

• Usual dose: Intra-articular or soft tissue administration as a single local injection of 2.5 to 15 mg; maintenance doses can be adjusted from 20 to 40 mg as needed; dosage must be individualized based on disease state and patient response.

• Usual dose: Single IM injection of 60 mg, administered deeply into the gluteal muscle; maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief; dosage requirements must be individualized based on disease state and patient response.

Leukemia

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the palliative management of leukemias is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Malignant lymphoma

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the palliative management of lymphoma, is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Multiple sclerosis

• Dosing Information

• The recommended intramuscular dose of triamcinolone acetonide injectable suspension in the treatment of acute exacerbations of multiple sclerosis is 160 mg injected deeply into gluteal muscle once daily for 7 days, followed by 64 mg injected deeply into gluteal muscle once every other day for one month.

Neoplastic disease

• Neoplastic diseases: For the palliative management of leukemias and lymphomas.

Nephrotic syndrome, idiopathic or lupus erythematosus-induced

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension to induce diureses or decrease proteinuria in nephrotic syndrome or lupus nephritis is a single intramuscular injection of 60 mg, administered deeply into the gluteal muscle. Maintenance doses can be adjusted from 2.5 to 100 mg as needed, with frequency of doses dependent upon patient response and duration of relief. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Stomatitis

• Dosing Information

• The recommended dose of triamcinolone dental paste for adjunctive treatment and temporary relief of symptoms associated with oral inflammatory or ulcerative lesions resulting from trauma is a small amount (about 1/4 inch) applied to oral mucous membranes 2 to 3 times daily after meals, and at bedtime. For optimal results, apply only enough to form a thin film over the lesion, and do not rub in. If significant repair or regeneration has not occurred in 7 days, further investigation is advisable.

Systemic lupus erythematosus

Transfusion reaction due to serum protein reaction

Trichinosis, with neurologic or myocardial involvement

Tuberculosis of meninges; Adjunct

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (injection) in adult patients.

Non–Guideline-Supported Use

• There is limited information regarding Off-Label Non–Guideline-Supported Use of Triamcinolone (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Adrenal insufficiency

Allergic rhinitis, seasonal or perennial

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range of triamcinolone acetonide is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

• For adolescents 12 years and older, the initial recommended dosage for the treatment of seasonal and perennial allergic rhinitis symptoms is 220 mcg once daily, which is administered as 2 sprays in each nostril once daily. After symptoms are controlled, a dose of 110 mcg per day (1 spray in each nostril) is often effective for controlling symptoms. If adequate symptom relief is not attained by 3 weeks, discontinue triamcinolone acetonide nasal inhaler.

• For children 6 to 12 years old, the initial recommended dosage for the treatment of seasonal and perennial allergic rhinitis symptoms is 110 mcg once daily, which is administered as 1 spray in each nostril. Once control of symptoms is achieved, the lowest effective dose should be used. The maximum recommended daily dose is 220 mcg/day (2 sprays in each nostril once daily). If adequate symptom relief is not attained by 3 weeks, discontinue triamcinolone acetonide nasal inhaler.

• For children 2 to 5 years old, the initial recommended dosage for the treatment of seasonal and perennial allergic rhinitis symptoms is 110 mcg once daily, which is administered as 1 spray in each nostril. If adequate symptom relief is not attained by 3 weeks, discontinue triamcinolone acetonide nasal inhaler.

Alopecia areata

Arthritis

Asthma

• Dosing Information

• The triamcinolone acetonide oral inhalation aerosol (Azmacort(R)) was removed from the market effective December 31, 2009 due to the international environmental protection agreement, which calls for the elimination from the market of certain CFC (chlorofluorocarbon) containing medical products.
• Recommended dose of triamcinolone acetonide aerosol for asthma in children is 1 to 2 inhalations (75 mcg/inhalation) three to four times daily or 2 to 4 inhalations twice daily, not to exceed a maximal dose of 12 inhalations (900 mcg) in children 6 to 12 years old Titrating to the lowest, most effective dose is recommended. Rinsing the mouth with water is recommended after each dose Data is insufficient to recommend safety and efficacy in children under the age of 6 years. The inhaler should be used on a regular schedule, not on an "as needed" basis.
• In steroid-dependent patients, triamcinolone acetonide aerosol should be used concurrently with usual maintenance doses of systemic steroids. After approximately 1 week, the systemic steroid can be gradually withdrawn by reducing the daily or alternate-daily dose. The next dose reduction is made after an interval of 1 to 2 weeks depending upon patient response. In general, decrements in dosage should not exceed 2.5 mg of prednisone or its equivalent and slow rate of withdrawal is imperative. Some patients may experience systemic corticosteroid withdrawal symptoms eg, joint and/or muscular pain, lassitude and depression even with continued maintenance or improvement of pulmonary function. In this case, patients should continue with the inhaler and should be monitored for objective signs of adrenal insufficiency. If adrenal insufficiency is suspected, the systemic corticosteroid dose should be increased temporarily, followed by slower withdrawal.
• The recommended dose for asthma maintenance in steroid-independent pediatric patients is 1 to 2 inhalations (75 mcg/inhalation) three to four times daily or 2 to 4 inhalations twice daily, not to exceed a maximal dose of 12 inhalations (900 mcg) in children 6 to 12 years old.
• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Carditis (Acute), rheumatic

Disorder of endocrine system

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Disorder of eye

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

• The recommended dose of triamcinolone acetonide injectable suspension for local treatment of ophthalmic disorders is a single intravitreal injection of 4 mg/0.05 mL, administered under controlled aseptic conditions.

Disorder of gastrointestinal tract

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Disorder of hematopoietic structure

Disorder of respiratory system

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Disorder of skin

• Dosing Information

• The recommended intralesional dose of triamcinolone acetonide injectable suspension for the treatment of dermatologic diseases is dependant upon the injection site and lesion size, given once weekly or less frequently as needed. Multiple sites of injection, separated by one centimeter, may be administered. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

• The recommended topical dose of triamcinolone acetonide cream, lotion, ointment, or aerosol for the treatment of corticosteroid responsive dermatoses is application to affected areas 2 to 4 times a day. The cream, lotion, and ointment should be rubbed in gently after application. Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. If spraying the topical aerosol about the face, eyes should be covered and inhaling the spray should be avoided.
• Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult patients because of a larger skin surface area to body weight ratio. Administration of topical corticosteroids should be limited in children to the smallest amount that will be clinically effective. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Drug allergy

Exacerbation of multiple sclerosis (Acute)

Ganglion and synovial cyst

• Dosing Information

• The recommended dose of triamcinolone acetonide injectable suspension for the treatment of cystic tumors of an aponeurosis or tendon is a single local injection of 2.5 to 15 mg. Maintenance doses can be adjusted to a total dose 20 mg or more as needed. Dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

Inflammatory disorder

Inflammatory disorder of musculoskeletal system

• Dosing Information

• Usual dose: Intra-articular or soft tissue administration as a single local injection of 2.5 to 15 mg; maintenance doses can be adjusted from 20 to 40 mg as needed; dosage requirements must be individualized based on disease state and patient response.
• Initial dose range, systemic administration of triamcinolone acetonide injectable suspension: 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle; dosage requirements must be individualized based on disease state, severity of symptoms, and patient response.

Leukemia

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Malignant lymphoma

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Neoplastic disease

Nephrotic syndrome, idiopathic or lupus erythematosus-induced

• Dosing Information

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. The initial dose range for systemic administration of triamcinolone acetonide injectable suspension is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses, injected deeply into gluteal muscle. Dosage requirements are variable and must be individualized on the basis of the disease under treatment, severity of symptoms, and the response of the patient.

Systemic lupus erythematosus

Transfusion reaction due to serum protein reaction

Trichinosis, with neurologic or myocardial involvement

Tuberculosis of meninges; Adjunct

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

• There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (injection) in pediatric patients.

Non–Guideline-Supported Use

Tight foreskin

Contraindications

• Kenalog-40 Injection is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: General).

• Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Warnings

Serious Neurologic Adverse Reactions with Epidural Administration

• Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: Neurologic). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

General

• Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: Pediatric Use).

• Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

• Because Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is a suspension, it should not be administered intravenously.

• Unless a deep intramuscular injection is given, local atrophy is likely to occur. (For recommendations on injection techniques, see DOSAGE AND ADMINISTRATION.) Due to the significantly higher incidence of local atrophy when the material is injected into the deltoid area, this injection site should be avoided in favor of the gluteal area.

• Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Kenalog-40 Injection is a long-acting preparation, and is not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with Kenalog-40 Injection and for a year afterwards.

• Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including Kenalog-40 Injection, should not be used for the treatment of traumatic brain injury.

Cardio-Renal

• Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when they are used in large doses. Dietary salt restriction and potassium supplementation may be necessary (see PRECAUTIONS). All corticosteroids increase calcium excretion.

• Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine

• Corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

• Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage.

Infections

General

• Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents. These infections may be mild to severe. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Corticosteroids may also mask some signs of current infection.

Fungal Infections

• Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B injection and potassium-depleting agents).

Special Pathogens

• Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, or Toxoplasma.

• It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

• Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

• Corticosteroids should not be used in cerebral malaria.

Tuberculosis

• The use of corticosteroids in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculosis regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Vaccination

• Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted. Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, eg, for Addison’s disease.

Viral Infections

• Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents should be considered.

Neurologic

• Epidural and intrathecal administration of this product is not recommended. Reports of serious medical events, including death, have been associated with epidural and intrathecal routes of corticosteroid administration (see ADVERSE REACTIONS: Gastrointestinal and Neurologic/Psychiatric).

Ophthalmic

• Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of oral corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should not be used in active ocular herpes simplex.

• Adequate studies to demonstrate the safety of Kenalog Injection use by intraturbinal, subconjunctival, sub-Tenons, retrobulbar, and intraocular (intravitreal) injections have not been performed. Endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances including vision loss have been reported with intravitreal administration. Administration of Kenalog Injection intraocularly or into the nasal turbinates is not recommended.

• Intraocular injection of corticosteroid formulations containing benzyl alcohol, such as Kenalog Injection, is not recommended because of potential toxicity from the benzyl alcohol.

Precautions

General

• This product, like many other steroid formulations, is sensitive to heat. Therefore, it should not be autoclaved when it is desirable to sterilize the exterior of the vial.

• The lowest possible dose of corticosteroid should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual.

• Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

• Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement.

Cardio-Renal

• As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency.

Endocrine

• Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

Gastrointestinal

• Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

• Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent.

• There is an enhanced effect of corticosteroids in patients with cirrhosis.

Intra-Articular and Soft Tissue Administration

• Intra-articularly injected corticosteroids may be systemically absorbed.

• Appropriate examination of any joint fluid present is necessary to exclude a septic process.

• A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this complication occurs and the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.

• Injection of a steroid into an infected site is to be avoided. Local injection of a steroid into a previously infected joint is not usually recommended.

• Corticosteroid injection into unstable joints is generally not recommended.

• Intra-articular injection may result in damage to joint tissues (see ADVERSE REACTIONS: Musculoskeletal).

Musculoskeletal

• Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (ie, decreasing absorption and increasing excretion) and inhibition of osteoblast function. This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (ie, postmenopausal women) before initiating corticosteroid therapy.

Neuro-Psychiatric

• Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

• An acute myopathy has been observed with the use of high doses of corticosteroids, most often occurring in patients with disorders of neuromuscular transmission (eg, myasthenia gravis), or in patients receiving concomitant therapy with neuromuscular blocking drugs (eg, pancuronium). This acute myopathy is generalized, may involve ocular and respiratory muscles, and may result in quadriparesis. Elevation of creatinine kinase may occur. Clinical improvement or recovery after stopping corticosteroids may require weeks to years.

• Psychiatric derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Ophthalmic

• Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

Adverse Reactions

Clinical Trials Experience

• (listed alphabetically under each subsection)

• The following adverse reactions may be associated with corticosteroid therapy:

• Allergic reactions: Anaphylaxis including death, angioedema.

• Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

• Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

• Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

• Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

• Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration [see WARNINGS: Neurologic]), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

• Metabolic: Negative nitrogen balance due to protein catabolism.

• Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post injection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.

• Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids (see WARNINGS: Serious Neurologic Adverse Reactions with Epidural Administration and WARNINGS: Neurologic).

• Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.

• Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

Postmarketing Experience

• There is limited information regarding Postmarketing Experience of Triamcinolone (injection) in the drug label.

Drug Interactions

• Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression.

• Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

• Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance.

• Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.

• Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

• Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

• Antitubercular drugs: Serum concentrations of isoniazid may be decreased.

• Cholestyramine: Cholestyramine may increase the clearance of corticosteroids.

• Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

• Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

• Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

• Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased.

• Ketoconazole: Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.

• Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids.

• Skin tests: Corticosteroids may suppress reactions to skin tests.

• Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: Infections: Vaccination).

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Teratogenic Effects: Pregnancy Category C

• Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

• There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Triamcinolone (injection) in women who are pregnant.

Labor and Delivery

• There is no FDA guidance on use of Triamcinolone (injection) during labor and delivery.

Nursing Mothers

• Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when corticosteroids are administered to a nursing woman.

Pediatric Use

• This product contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

• The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). Other indications for pediatric use of corticosteroids, eg, severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

• The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (ie, cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

Geriatic Use

• No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

• There is no FDA guidance on the use of Triamcinolone (injection) with respect to specific gender populations.

Race

• There is no FDA guidance on the use of Triamcinolone (injection) with respect to specific racial populations.

Renal Impairment

• There is no FDA guidance on the use of Triamcinolone (injection) in patients with renal impairment.

Hepatic Impairment

• There is no FDA guidance on the use of Triamcinolone (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

• There is no FDA guidance on the use of Triamcinolone (injection) in women of reproductive potentials and males.

Immunocompromised Patients

• There is no FDA guidance one the use of Triamcinolone (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

General

• NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).

• The initial dose of Kenalog-40 Injection may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see Dosage section below). However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

• 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. 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 the corticosteroid 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.

Dosage

SYSTEMIC

• The suggested initial dose is 60 mg, injected deeply into the gluteal muscle. Atrophy of subcutaneous fat may occur if the injection is not properly given. Dosage is usually adjusted within the range of 40 mg to 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on doses as low as 20 mg or less.

• Hay fever or pollen asthma: Patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single injection of 40 mg to 100 mg.

• In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of triamcinolone for a week followed by 64 mg every other day for one month are recommended (see PRECAUTIONS: Neuro-Psychiatric).

• In pediatric patients, the initial dose of triamcinolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m2bsa/day).

• For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

• These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

LOCAL

• Intra-articular administration: A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms.

• Initial dose: 2.5 mg to 5 mg for smaller joints and from 5 mg to 15 mg for larger joints, depending on the specific disease entity being treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient. Single injections into several joints, up to a total of 80 mg, have been given.

Administration

GENERAL

• STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, Kenalog-40 Injection should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

SYSTEMIC

• For systemic therapy, injection should be made deeply into the gluteal muscle (see WARNINGS). For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.

LOCAL

• For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid.

• With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

• In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

Monitoring

• Intraocular pressure may become elevated in some individuals. If steroid therapy is continued for more than 6 weeks, intraocular pressure should be monitored.

• Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

• The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

IV Compatibility

• There is limited information regarding IV Compatibility of Triamcinolone (injection) in the drug label.

Overdosage

• Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

Pharmacology

Mechanism of Action

• Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.

• Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Synthetic analogs such as triamcinolone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

Structure

• Kenalog®-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION.

• Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

• The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:

• MW 434.50

• Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.

Pharmacodynamics

• There is limited information regarding Pharmacodynamics of Triamcinolone (injection) in the drug label.

Pharmacokinetics

• Kenalog-40 Injection has an extended duration of effect which may be sustained over a period of several weeks. Studies indicate that following a single intramuscular dose of 60 mg to 100 mg of triamcinolone acetonide, adrenal suppression occurs within 24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days. This finding correlates closely with the extended duration of therapeutic action achieved with the drug.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis.

• Steroids may increase or decrease motility and number of spermatozoa in some patients.

Clinical Studies

• There is limited information regarding Clinical Studies of Triamcinolone (injection) in the drug label.

How Supplied

• Kenalog®-40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.

Storage

• Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate.

Images

Drug Images

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Patient Counseling Information

Information for Patients

• Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids, and to seek medical advice at once should they develop fever or other signs of infection.

• Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Precautions with Alcohol

• Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources.

• This product contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Brand Names

Aristocort

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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