Triamcinolone

Serious side effects have been reported with triamcinolone. See the “Triamcinolone Precautions” section.

Common side effects of topical triamcinolone include the following:

• Drying of the skin
• Acne
• Itching or burning of the skin
• Change in skin color

Common side effects of injectable triamcinolone include the following:

• Stomach upset
• Depression
• Emotional instability
• Headache
• Weight gain
• Fluid retention

This is not a complete list of triamcinolone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Aminoglutethimide (Cytadren)
• Amphotericin B (Fungizone, Abelcet, AmBisome, Amphotec)
• Antibiotics
• Anticholinesterase agents such as donepezil (Aricept), rivastigmine (Exelon), and galantamine (Ryzadyne)
• Anticoagulants such as warfarin (Coumadin)
• Antidiabetic agents
• Isoniazid
• Cholestyramine
• Cyclosporine (Neoral, Sandimmune)
• Digoxin (Lanoxin)
• Estrogens, including oral contraceptives
• Phenytoin (Dilantin)
• Carbamazepine (Tegretol)
• Rifampin (Rifadin)
• Ketoconazole (Nizoral)
• Non-steroidal anti-inflammatory agents such as aspirin, ibuprofen (Motrin), naproxen (Aleve), and celecoxib (Celebrex)

This is not a complete list of triamcinolone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with topical triamcinolone including the following:

• Burning, drying and itching of the skin
• Convulsions
• Depression
• Increased blood pressure
• Muscle weakness
• Nervousness
• Psychosis
• Sleepiness
• Changes in menstrual cycle
• Swelling in lower extremities
• Water retention
• Worsening of diabetes or ulcers

Serious side effects have been reported with injectable triamcinolone including the following:

• Stomach upset
• Muscle weakness or atrophy
• Adrenal insufficiency
• Increased blood pressure
• Water and salt retention
• Increased susceptibility to infection

Glaucoma, cataracts, optic nerve damage, and ocular infections have been reported with the ophthalmic injections of triamcinolone.

Triamcinolone can cause dizziness. Do not drive or operate heavy machinery until you know how triamcinolone affects you.

Do not take triamcinolone if you are allergic to triamcinolone or to any of its ingredients.

Before taking triamcinolone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to triamcinolone or to any of its ingredients
• have diabetes
• have glaucoma
• have cataracts
• have or have had a circulation disorder
• have or have had an immune system disorder
• are pregnant or plan to become pregnant
• are breastfeeding or plan to begin breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Synthetic glucocorticoid; virtually no mineralocorticoid activity.c j

Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.b

Usually inadequate alone for adrenocortical insufficiency because essentially devoid of mineralocorticoid activity.b c j

Adrenocortical Insufficiency

Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.b

Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.b j

If triamcinolone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.b j

Adrenogenital Syndrome

Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.b

In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.b A glucocorticoid, usually alone, is continued for long-term therapy after early childhood.b j

In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred;b avoid long-acting glucocorticoids because of tendency toward overdosage and growth retardation.b

Hypercalcemia

Treatment of hypercalcemia associated with malignancy.b j

Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.b

Treatment of hypercalcemia associated with sarcoidosis†.b m

Treatment of hypercalcemia associated with vitamin D intoxication†.b

Not effective for hypercalcemia caused by hyperparathyroidism†.b

Thyroiditis

Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.b d j Anti-inflammatory actions relieve fever, acute thyroid pain, and swelling.b

Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.b

May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).b

Rheumatic Disorders and Collagen Diseases

Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, acute and subacute bursitis, Reiter syndrome†m , rheumatic fever† [especially with carditis]m ) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, polyarteritis nodosa†m , vasculitis†m ) refractory to more conservative measures.b c d e g h j

Relieves inflammation and suppresses symptoms but not disease progression.b

Rarely indicated as maintenance therapy.b

May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.b However, glucocorticoid withdrawal is extremely difficult in these patients; relapse and recurrence usually occur with drug discontinuance.b

Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae;b inflammation tends to recur and sometimes is more intense after drug cessation.b

Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.b

Controls acute manifestations of rheumatic carditisb m more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and is no better than salicylates for long-term treatment.b

Adjunctively for severe systemic complications of Wegener's granulomatosis†, but cytotoxic therapy is the treatment of choice.b

Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with polyarteritis nodosa†, relapsing polychondritis†, polymyalgia rheumatica†, or mixed connective tissue disease syndrome†.b High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.b

In osteoarthritis†, intra-articular injections may be beneficial but should be limited in number as joint damage may occur.b d e

Dermatologic Diseases

Treatment of pemphigus and pemphigoid†m , bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema†m , cutaneous sarcoidosis†m , mycosis fungoides, lichen planus, severe psoriasis, and severe seborrheic dermatitis.b d e h j

Rarely indicated for psoriasis.b d j If used, exacerbation may occur when the drug is withdrawn or dosage is decreased.b j

Usually reserved for acute exacerbations unresponsive to conservative therapy.b

Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid†, and high or massive doses may be required.b

For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.d j

Chronic skin disorders seldom an indication for systemic glucocorticoids.b

Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders including keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, granuloma annulare, or lichen simplex chronicus (neurodermatitis)e unresponsive to topical therapy.b e h

Rarely indicated systemically for alopecia (areata, totalis, or universalis).b May stimulate hair growth, but hair loss returns when the drug is discontinued.b

Allergic Conditions

For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including serum sickness, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.b d j

Systemic therapy usually reserved for acute conditions and severe exacerbations.b

For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).b

Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.b

Ocular Disorders

To suppress a variety of allergic and nonpyogenic ocular inflammations.b

To reduce scarring in ocular injuries†.b

For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia).b d j

Acute optic neuritis optimally treated with initial high-dose IV therapy (e.g., methylprednisolone) followed by chronic oral therapy. Can slow progression to clinically definite multiple sclerosis.

Less severe allergic and inflammatory allergic conditions of the eye are treated with topical (to the eye) corticosteroids.i

Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.b

Asthma

Used by oral inhalation for the long-term prevention of bronchospasm in patients with asthma.102 104 105

Used orally for severe bronchial asthma intractable to conventional treatment.j

Used orally for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred).j Speeds resolution of airflow obstruction and reduces rate of relapse.j

Because onset of effects is delayed, do not use alone for emergency treatment.

Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.i

In hospital management of an acute asthma exacerbation, systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.b

For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral corticosteroids for maintenance because inhaled corticosteroids have fewer systemic effects.

Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthma (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).102 104

A long-acting β2-agonist (e.g., formoterol, salmeterol) added to low- to medium-dose inhaled corticosteroids is the preferred therapy in patients with moderate persistent asthma (i.e., patients with daily asthmatic symptoms); 102 104 alternatively, may increase (e.g., double) maintenance dosage of inhaled corticosteroid within medium-dosage range in such patients.102 104

Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.c

Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.

Do not use oral inhalation for the treatment of nonasthmatic bronchitis or for relief of acute bronchospasm.105

COPD

For severe exacerbations of COPD†, a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.

Effects in stable COPD are much less dramatic than in asthma, and role of glucocorticoids in the management of stable COPD is limited to very specific indications.

Inhaled corticosteroids are not appropriate in the treatment of acute exacerbations of COPD.

Sarcoidosis

Management of symptomatic sarcoidosis.b d j

Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.b

Advanced Pulmonary and Extrapulmonary Tuberculosis

Systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary tuberculosis.

Adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities) in advanced pulmonary tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary disease (e.g., meningitis, pericarditis).

Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival in moderate to severe tuberculous meningitis.

Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion) in acute tuberculous pericarditis.

Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.b

Loeffler’s Syndrome

Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.j

Berylliosis

Symptomatic relief of acute manifestations of berylliosis.j

Aspiration Pneumonitis

Symptomatic relief of acute manifestations of aspiration pneumonitis.j

Hematologic Disorders

Management of acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.d j

High or even massive glucocorticoid dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.b

Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.

Glucocorticoids may not affect or prevent renal complications in Henoch-Schoenlein purpura.b

Insufficient evidence of effectiveness of glucocorticoids in aplastic anemia in children, but widely used.b

Pericarditis

To reduce the pain, fever, and inflammation of pericarditis†, including that associated with MI.b m

Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for post-MI pericarditis because of greater evidence establishing benefit.

Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.

Glucocorticoids may cause thinning of developing scar and myocardial rupture.g Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development. (See Cardiovascular Effects under Cautions.)

Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)

GI Diseases

Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis, and Crohn's disease†m .b d j

Do not use if a probability of impending perforation, abscess, or other pyogenic infection.b

Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis) since does not prevent relapses and may produce severe adverse reactions with long-term administration.b

Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.b

Neoplastic Diseases

Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).d j

Treatment of breast cancer†m ; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.b

Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer†.m

Low Back Pain

Has been used epidurally† (alone or combined with a local anesthetic and/or an opiate analgesic) for symptomatic relief of low back pain†.

Although use remains controversial and convincing evidence of efficacy is lacking, most experts consider such therapy an option for short-term relief of acute, subacute, or chronic radicular pain in patients with low back pain and radiculopathy associated with disk disease or herniation or spinal stenosis when more conservative therapies (e.g., rest, analgesics, physical therapy) fail and as a means of potentially avoiding surgery. (See Nervous System Effects under Cautions.)

Limited evidence suggests that therapeutic facet joint† and intradiscal glucocorticoid injections† are minimally effective or ineffective in the treatment of low back pain, although facet joint injections may be useful in some patients with facet arthropathy. Inclusion of a glucocorticoid in trigger point injections does not appear to be beneficial.

Sacroiliac joint injections performed using fluoroscopic guidance may provide temporary pain relief in some patients when the principal source of spinal pain is the sacroiliac joint.

Oral glucocorticoids† have been used; however, they do not appear to be effective and evidence supporting such use is lacking.

Multiple Sclerosis

Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosis.j

Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.

Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.

Myasthenia Gravis

Management of myasthenia gravis†, usually when there is an inadequate response to anticholinesterase therapy.m

Organ Transplants

In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs†.b m

Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.b

Trichinosis

Treatment of trichinosis with neurologic or myocardial involvement.j

Nephrotic Syndrome and Lupus Nephritis

Treatment of idiopathic nephrotic syndrome without uremia.d

Can induce diuresis and remission of proteinuria in nephrotic syndromed secondary to primary renal disease, especially when there is minimal renal histologic change.b

Treatment of lupus nephritis.d

Carpal Tunnel Syndrome

Local injection of glucocorticoids into the tissue near the carpal tunnel has been used in a limited number of patients to relieve symptoms (e.g., pain, edema, sensory deficit) of carpal tunnel syndrome†.

Contraindications

• Known hypersensitivity to triamcinolone or any ingredient in the formulation.a g h j

• Oral or parenteral administration in presence of systemic fungal infections.d e j (See Increased Susceptibility to Infection under Cautions.)

• Concurrent administration of live virus vaccines in patients receiving immunosuppressive dosages of glucocorticoids (oral or parenteral formulations).g h (See Immunosuppression under Cautions.)

• IM administration for conditions prone to bleeding (e.g., ITP).d g h

• Oral inhalation for primary treatment of severe acute asthmatic attacks or status asthmaticus when intensive measures are required.a

• Epidural administration in patients with local or systemic infection; individuals with bleeding disorders or receiving concurrent anticoagulant therapy (e.g., warfarin, heparin, antiplatelet agents); patients with known hypersensitivity to local anesthetic agents, contrast agents, or glucocorticoids; and patients who experienced complications with prior glucocorticoid injections.

Warnings/Precautions

Warnings

May precipitate mental disturbances ranging from euphoria, insomnia, mood swings, depression and anxiety, and personality changes to frank psychoses.d e g h j Use may aggravate emotional instability or psychotic tendencies.d e g h j

Use with caution in patients with seizure disorders and patients with myasthenia gravis receiving anticholinesterase therapy.b d

Aseptic meningitis, arachnoiditis, exacerbation of pain, spinal cord trauma, subdural injection, intracranial air injection, increased intracranial pressure, nerve injury, seizures, bladder or bowel dysfunction, paraparesis or paralysis, sensory disturbances, and brain damage reported following epidural and/or intrathecal glucocorticoid injection. Unclear whether these effects involved improper needle placement or were related to administration of the drug and/or preservatives.

Serious, potentially permanent, and sometimes fatal adverse neurologic events (e.g., spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke, seizures, nerve injury, brain edema) reported rarely, often within minutes to 48 hours following epidural glucocorticoid injection given either with or without fluoroscopic guidance.1000 1001 1002 1003

FDA states efficacy and safety of epidural glucocorticoid administration not established; not FDA-labeled for this use.1000 1001 (See Advice to Patients.)

When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause decreased secretion of endogenous corticosteroids by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).b

The degree and duration of adrenocortical insufficiency is highly variable among patients and depends on the dose, frequency and time of administration, and duration of glucocorticoid therapy.b

Acute adrenal insufficiency (even death) may occur if the drugs are withdrawn abruptly or if patients are transferred from systemic glucocorticoid therapy to local (e.g., inhalation) therapy.b a

Withdraw triamcinolone very gradually following long-term therapy with pharmacologic dosages.b (See Discontinuance of Therapy under Dosage and Administration.)

Adrenal suppression may persist up to 12 months in patients who receive large dosages for prolonged periods.a b With recommended dosages administered by oral inhalation, suppression of the HPA axis has occurred within 6–12 weeks in some patients.

Until recovery occurs, signs and symptoms of adrenal insufficiency may develop if subjected to stress (e.g., surgery, trauma, infection) and replacement therapy may be required.b Since mineralocorticoid secretion may be impaired, sodium chloride and/or a mineralocorticoid should also be administered.b

If the disease flares up during withdrawal, dosage may need to be increased and followed by a more gradual withdrawal.b

Increased susceptibility to infections secondary to glucocorticoid-induced immunosuppression. Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.a d e g h j (See Increased Susceptibility to Infection under Warnings.)

Administration of live virus vaccines, including smallpox, is contraindicated in patients receiving immunosuppressive dosages of glucocorticoids.d e g j h If inactivated or killed vaccines are administered to such patients, the expected antibody response may not be obtained.g May undertake immunization procedures in patients receiving glucocorticoids as replacement therapy (e.g., Addison’s disease).g h (See Specific Drugs and Laboratory Tests under Interactions.)

Glucocorticoids, especially in large doses, increase susceptibility to and mask symptoms of infection.g

Infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections in any organ system, may be associated with glucocorticoids alone or in combination with other immunosuppressive agents.

Infections may be mild, but they can be severe or fatal, and localized infections may disseminate.

Do not use, except in life-threatening situations, in patients with viral infections or bacterial infections not controlled by anti-infectives.b

Some infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome, particularly in children.a

Children and any adult who are not likely to have been exposed to varicella or measles should avoid exposure to these infections while receiving glucocorticoids.a g

If exposure to varicella or measles occurs in susceptible patients, treat appropriately (e.g., VZIG, IG, acyclovir).a

Fatal outcome (e.g., in those developing hemorrhagic varicella) may not always be avoided even if appropriate therapy is initiated aggressively.

Immunosuppression may result in activation of latent infection or exacerbation of intercurrent infections (e.g., those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia, Ameba).

Use with great care in patients with known or suspected Strongyloides (threadworm) infection. Immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

May exacerbate fungal infections and should not be used in the presence of such infections unless needed to control drug reactions.g

Some clinicians recommend avoidance of glucocorticoid inhalation therapy when risk of activating bronchopulmonary mycoses appears high, as in patients with bronchiectasis or inadequate immunologic responses.b

Not effective and can have detrimental effects in the management of cerebral malaria.b

Can reactivate tuberculosis.j Include chemoprophylaxis in patients with a history of active tuberculosis undergoing prolonged glucocorticoid therapy.b j Observe closely for evidence of reactivation.d Restrict use in active tuberculosis to those with fulminating or disseminated tuberculosis in which glucocorticoids are used in conjunction with appropriate chemoprophylaxis.d j

Can reactivate latent amebiasis.g Exclude possible amebiasis in any patient who has been in the tropics or who has unexplained diarrhea prior to initiating therapy.g

Rarely, epidural abscess reported following epidural glucocorticoid injection; infectious complications (e.g., bacterial meningitis) also reported.

Muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones are manifestations of protein catabolism that may occur during prolonged therapy with glucocorticoids.b d These adverse effects may be especially serious in geriatric or debilitated patients.b A high-protein diet may help to prevent adverse effects associated with protein catabolism.b

An acute, generalized myopathy can occur with the use of high doses of glucocorticoids, particularly in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) or in patients receiving concomitant therapy with neuromuscular blocking agents (e.g., pancuronium).g d e

Possible tendon rupture, particularly of the Achilles tendon.

Osteoporosis and related fractures are one of the most serious adverse effects of long-term glucocorticoid therapy.

To minimize the risk of glucocorticoid-induced bone loss, the smallest possible effective dosage and duration should be used. Topical and inhaled preparations should be used whenever possible.

Before initiating glucocorticoid therapy in postmenopausal women, consider that they are especially prone to osteoporosis.b

Withdraw glucocorticoids if osteoporosis develops, unless their use is life-saving.b

Glucocorticoid-induced bone loss can be both prevented and treated. Obtain baseline measurement of bone mass density (BMD) at the lumbar spine and/or hip when initiating long-term (e.g., >6 months) glucocorticoid therapy and initiate appropriate preventive therapy. Longitudinal measurements may be repeated as often as every 6 months to detect possible bone loss. Less frequent (e.g., annually) follow-up probably is sufficient in patients who are receiving therapy to prevent bone loss.

Skeletal wasting is most rapid during the initial 6 months of therapy; trabecular bone is affected to a greater degree than is cortical bone.

Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects.

Calcitonin may be considered as second-line therapy for patients who refuse or do not tolerate bisphosphonate therapy or in whom the drugs are contraindicated.

Sodium retention with resultant edema, potassium loss, and elevation of BP may occur but is less common with triamcinolone than with average or large doses of cortisone or hydrocortisone.j Risk is increased with high-dose synthetic glucocorticoids for prolonged periods.b j Edema and CHF (in susceptible patients) may occur.b

Dietary salt restriction and potassium supplementation may be necessary.b d e g h j

Increased calcium excretion and possible hypocalcemia.c j

Prolonged use may result in posterior subcapsular and nuclear cataracts (particularly in children), exophthalmos, and/or increased IOP which may result in glaucoma or may occasionally damage the optic nerve.b j

Increased risk of ocular hypertension or open-angle glaucoma observed in patients receiving the maximum dosage of oral inhalation for 3 or more months.

May enhance the establishment of secondary fungal and viral infections of the eye.j

Do not use in patients with active ocular herpes simplex infections for fear of corneal perforation.b g h

Transient blindness, amblyopia, acute retinal necrosis syndrome, intraocular hemorrhage, and cortical blindness have occurred following epidural glucocorticoid injection.1001 1002 1003

Administration over a prolonged period may produce various endocrine disorders including hypercorticism (cushingoid state) and amenorrhea or other menstrual difficulties.a b e

May decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus, especially in patients predisposed to diabetes mellitus.b If glucocorticoid therapy is required in patients with diabetes mellitus, changes in insulin or oral antidiabetic agent dosage or diet may be necessary.b

Administer by epidural injection with caution in patients with diabetes mellitus.

Exaggerated glucocorticoid response in patients with hypothyroidism.b e

Possible association between use of glucocorticoids and left ventricular free-wall rupture; use with extreme caution in patients with recent MI.b g

Use with caution in patients with CHF or hypertension.e g

Administer by epidural injection with caution in patients with CHF.

Bronchospasm,a and/or wheezing may occur with oral inhalation therapy.a

If bronchospasm occurs, treat immediately with a short-acting bronchodilator, and discontinue treatment with triamcinolone acetonide and institute alternative therapy.a

Unknown long-term, systemic, and local effects of the drug in humans, particularly developmental or immunologic processes in the mouth, pharynx, trachea, and lung.a

Sensitivity Reactions

Some commercially available injections of triamcinolone contain benzyl alcohol as a preservative.d e g h Administration of injections preserved with benzyl alcohol has been associated with toxicity in neonates (gasping syndrome).b g

Anaphylactic or anaphylactoid reactions have occurred with parenteral corticosteroids.e d e Take appropriate precautionary measures prior to administration, especially in patients with a history of allergy to any drug.e

General Precautions

Prior to initiation of long-term glucocorticoid therapy, perform baseline ECGs, BP, chest and spinal radiographs, glucose tolerance tests, and evaluations of HPA-axis function in all patients.b d

Perform upper GI radiographs in patients predisposed to GI disorders, including those with known or suspected peptic ulcer disease or appreciable dyspepsia.b d

During long-term therapy, perform periodic height, weight, chest and spinal radiographs, hematopoietic, electrolyte, glucose tolerance, and ocular and BP evaluations.

Because systemic absorption possible with orally inhaled corticosteroids, carefully observe patients for systemic effects.a

Increased or decreased motility and number of sperm in some men.b h

Corticosteroids should be used with caution in patients with diverticulitis, nonspecific ulcerative colitis (if there is a probability of impending perforation, abscess, or other pyogenic infection), or those with recent intestinal anastomoses.d g j

Use with caution in patients with active or latent peptic ulcer.d g Manifestations of peritoneal irritation following GI perforation may be minimal or absent in patients receiving corticosteroids.b g Suggest concurrent administration of antacids between meals to prevent peptic ulcer formation in patients receiving high dosages of corticosteroids.b

Cortisone reported rarely to increase blood coagulability and to precipitate intravascular thrombosis, thromboembolism, and thrombophlebitis; use corticosteroids with caution in patients with thromboembolic disorders.b d e

Specific Populations

Category C.a g h

Fluoroscopy (recommended for ensuring proper needle placement for epidural injections) is contraindicated in pregnant women.

Distributed into milk.g h Caution if used in nursing women.g h

Insufficient experience with triamcinolone acetonide IM injection or inhalation aerosol in children <6 years of age; use not recommended.a d

With long-term use, may delay growth and maturation in children and adolescents.b h j Monitor carefully the growth and development of pediatric patients receiving prolonged corticosteroid therapy.b Titrate dosage to the lowest effective level.b h Weigh potential growth effects of prolonged therapy against the clinical benefits and availability of treatment alternatives.h

Glucocorticoid-induced osteoporosis and associated fractures are common in children and adolescents receiving long-term systemic therapy. In addition, may prevent achievement of peak bone mass during adolescence by inhibiting bone formation. Methods for monitoring bone mineralization (e.g., dual-energy x-ray absorptiometry [DXA]) in children and adolescents are similar to those in adults.

Ensure children and adolescents consistently ingest, either through diet or supplementation, adequate calcium and vitamin D.

Do not use preparations containing benzyl alcohol in newborn infants.g h

Triamcinolone acetonide: Insufficient experience with oral inhalation in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.a (See Special Populations under Dosage and Administration.)

Triamcinolone hexacetonide: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.g h

With prolonged therapy, muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones may occur.b May be especially serious in geriatric or debilitated patients.b (See Musculoskeletal Effects under Cautions.)

Before initiating glucocorticoid therapy in postmenopausal women, consider that such women are especially prone to osteoporosis.b Use with caution in patients with osteoporosis.b (See Musculoskeletal Effects under Cautions.)

Exaggerated glucocorticoid response in patients with cirrhosis.b j

Use with caution in patients with renal insufficiency, acute glomerulonephritis, or chronic nephritis.d g j

Common Adverse Effects

With oral inhalation, sinusitis, pharyngitis, headache, flu syndrome, back pain.a

Associated with long-term therapy: bone loss, cataracts, indigestion, muscle weakness, back pain, bruising, oral candidiasis.k l

Storage

Oral

15–30°C.j

Oral Inhalation

20–25°C.105 Contents of oral inhaler are under pressure; do not puncture, use or store aerosol container near heat or an open flame, expose to temperatures >49°C, or place into a fire or incinerator for disposal.a c

Parenteral

Triamcinolone acetonide: 20–25°C; avoid freezing.d e Protect triamcinolone acetonide injectable suspension (Kenalog-10) from light.e

Triamcinolone hexacetonide: room temperature; do not freeze.g h Following dilution, discard after 7 days.g h

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

May dilute with a local anesthetic (e.g., 1 or 2% lidocaine hydrochloride) prior to intra-articular or intralesional injection.c g h May dilute with sterile water for injection, 0.9% sodium chloride injection, or 5 or 10% dextrose in 0.9% sodium chloride injection prior to intralesional injection.c h

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

NDC 52565-056-15

Rx only

Teligent Pharma, Inc. 

Triamcinolone ACETONIDE CREAM USP, 0.1%

WARNING: Keep out of reach of children.

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

NET WT 15 grams