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Triamcinolone (Systemic)

Pronunciation

Pronunciation

(trye am SIN oh lone)

Index Terms

  • Triamcinolone Acetonide
  • Triamcinolone Acetonide, Parenteral
  • Triamcinolone Hexacetonide

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Kit, Injection, as acetonide:

Arze-Ject-A: 40 mg/mL (3 x 1 mL) [contains benzyl alcohol, polysorbate 80]

Pro-C-Dure 5: 40 mg/mL (2 x 1 mL) [contains benzyl alcohol, polysorbate 80]

Pro-C-Dure 6: 40 mg/mL (3 x 1 mL) [contains benzyl alcohol, polysorbate 80]

Suspension, Injection, as acetonide:

Kenalog: 10 mg/mL (5 mL); 40 mg/mL (1 mL, 5 mL, 10 mL) [contains benzyl alcohol, polysorbate 80]

Suspension, Injection, as hexacetonide:

Aristospan Intra-Articular: 20 mg/mL (1 mL [DSC], 5 mL [DSC]) [contains benzyl alcohol]

Aristospan Intralesional: 5 mg/mL (5 mL [DSC]) [contains benzyl alcohol]

Brand Names: U.S.

  • Aristospan Intra-Articular [DSC]
  • Aristospan Intralesional [DSC]
  • Arze-Ject-A
  • Kenalog
  • Pro-C-Dure 5
  • Pro-C-Dure 6

Pharmacologic Category

  • Corticosteroid, Systemic

Pharmacology

A long acting corticosteroid with minimal sodium-retaining potential. Decreases inflammation by suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability; suppresses the immune system by reducing activity and volume of the lymphatic system; suppresses adrenal function at high doses

Distribution

Vd: IV (acetonide): 99.5 L

Metabolism

Hepatic (Asare 2007)

Excretion

Urine (75% primarily); bile and feces (25%) (Asare 2007)

Onset of Action

IM (acetonide): Adrenal suppression: 24 to 48 hours

Duration of Action

IM (acetonide): Adrenal suppression: 30 to 40 days

Half-Life Elimination

Plasma: 300 minutes (Asare 2007)

Use: Labeled Indications

Intra-articular or soft tissue administration: As adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis (RA), or synovitis of osteoarthritis.

Intralesional administration (triamcinolone hexacetonide and triamcinolone acetonide [Kenalog-10 only]): Alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum; cystic tumors of an aponeurosis or tendon (ganglia).

Intramuscular administration (triamcinolone acetonide [Kenalog-40] only):

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, or transfusion reactions.

Dermatologic diseases: Atopic dermatitis, bullous dermatitis herpetiformis, contact dermatitis, exfoliative erythroderma, mycosis fungoides, pemphigus, or severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice), congenital adrenal hyperplasia, hypercalcemia associated with cancer, or nonsuppurative thyroiditis.

GI diseases: To tide the patient over a critical period of disease in Crohn disease or ulcerative colitis.

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

Neoplastic diseases: Palliative management of leukemias and lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).

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

Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that is caused by lupus erythematosus.

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

Rheumatic disorders: As adjunctive therapy for short-term administration in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; RA, including juvenile RA; treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Miscellaneous: Trichinosis with neurologic or myocardial involvement; tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Contraindications

Hypersensitivity to triamcinolone or any component of the formulation; idiopathic thrombocytopenic purpura (IM administration only).

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually.

Dermatoses (steroid-responsive):

Acetonide (Kenalog-10): 1 mg Intralesional: Initial dose varies depending on the specific disease and lesion being treated; may be repeated at weekly or less frequent intervals; multiple sites may be injected if they are 1 cm or more apart

Hexacetonide (Aristospan 5 mg/mL): Intralesional, sublesional: Up to 0.5 mg/square inch of affected skin; range: 2 to 48 mg/day

Inflammatory/allergic conditions/other steroid-responsive systemic conditions: Acetonide (Kenalog-40): IM: Initial: 60 mg; adjust dose to a range of 40 to 80 mg. For patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy, a single injection of 40 mg to 100 mg per season may be given.

Multiple sclerosis (acute exacerbation):

Note: Treatment guidelines recommend the use of high dose IV or oral methylprednisolone for acute exacerbations of multiple sclerosis (AAN [Scott 2011]; NICE 2014).

Acetonide (Kenalog-40): IM: 160 mg daily for 1 week, followed by 64 mg every other day for 1 month.

Rheumatic conditions:

Intra-articular (or similar injection as designated):

Acetonide: Intra-articular, intrabursal, tendon sheaths: Initial: Smaller joints: 2.5 to 5 mg, larger joints: 5 to 15 mg; may require up to 10 mg for small joints and up to 40 mg for large joints; maximum dose/treatment (several joints at one time): 80 mg

Hexacetonide (Aristospan 20 mg/mL): Intra-articular: Average dose: 2 to 20 mg; smaller joints (interphalangeal, metacarpophalangeal): 2 to 6 mg; large joints (knee, hip, shoulder): 10 to 20 mg. Frequency of injection into a single joint is every 3 to 4 weeks as necessary; to avoid possible joint destruction use as infrequently as possible.

IM: Acetonide (Kenalog-40): Initial: 60 mg; range: 2.5 to 100 mg/day

Pericarditis (off-label use): Intrapericardial (off-label route): 300 mg/m2 as a single dose (Maisch 2002) or 50 mg every 6 hours for 2 to 3 days (ESC [Maisch 2004]); may use in conjunction with oral colchicine therapy. Administration may be painful and appropriate analgesic premedication (eg, morphine) should be administered (Frasiolas 2010; Maisch 2002). Additional data may be necessary to further define the role of triamcinolone in this condition.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Adjust dose depending upon condition being treated and response of patient. The lowest possible dose should be used to control the condition; when dose reduction is possible, the dose should be reduced gradually.

Dermatoses (steroid-responsive):

Acetonide (Kenalog-10): Intralesional: Children and Adolescents: Initial dose varies depending on the specific disease and lesion being treated; may be repeated at weekly or less frequent intervals; multiple sites may be injected if they are 1 cm or more apart

Hexacetonide (Aristospan 5 mg/mL): Intralesional, sublesional: Up to 0.5 mg/square inch of affected skin; initial range: 2 to 48 mg; frequency of dose is determined by clinical response

Inflammatory/allergic conditions/other steroid-responsive systemic conditions: Children and Adolescents:

Manufacturer's labeling: Acetonide (Kenolog-40): IM: Initial: 0.11 to 1.6 mg/kg/day (or 3.2 to 48 mg/m2/day) in 3 to 4 divided doses

Alternative dosing: Limited data available: Acetonide: Children 6 to 12 years: IM: 0.03 to 0.2 mg/kg/dose every 1 to 7 days (Kliegman, 2011)

Rheumatic conditions: Children and Adolescents: Intra-articular:

Manufacturer's labeling:

Acetonide: Initial: Smaller joints: 2.5 to 5 mg, larger joints: 5 to 15 mg; Up to 80 mg (total) has been given for single injections into several joints.

Hexacetonide (Aristospan 20 mg/mL): Average dose: 2 to 20 mg; small joints (interphalangeal, metacarpophalangeal): 2 to 6 mg; large joints (knee, hip, shoulder): 10 to 20 mg. Frequency of injection into a single joint is every 3 to 4 weeks as necessary; to avoid possible joint destruction use as infrequently as possible

Alternative dosing: Limited data available: Hexacetonide: Large joints (typically knees, ankles): 1 to 1.5 mg/kg/dose; maximum dose: 40 mg; doses greater than 1.5 mg/kg have not been associated with additional clinical benefit; similar dosing for the acetonide salt can be used; however, data show that the response is greater and lasts longer with hexacetonide (Bloom, 2011; Hashkes, 2005; Zulian, 2003; Zulian 2004)

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Reconstitution

Hexacetonide injectable suspension: Avoid diluents containing parabens, phenol, or other preservatives (may cause flocculation). Suspension for intralesional use may be diluted with lidocaine 1% or 2% (or similar local anesthetic), D5NS, D10NS, NS, or SWFI to a 1:1, 1:2, or 1:4 concentration. Solutions for intra-articular use, may be diluted with lidocaine 1% or 2% (or similar local anesthetic).

Intrapericardial (off-label route) administration: Triacinolone hexacetonide dose should be diluted in at least 100 mL of warm (37°C) NS (Frasiolas 2010).

Administration

Shake well before use to ensure suspension is uniform. Inspect visually to ensure no clumping; administer immediately after withdrawal so settling does not occur in the syringe. Do not administer any product IV or via the epidural or intrathecal route.

Acetonide:

Kenalog-10 injection: For intra-articular or intralesional administration only. When administered intralesionally, inject directly into the lesion (ie, intradermally or subcutaneously). One mL syringes with a 23- to 25-gauge needle are preferable for intralesional injections.

Kenalog-40 injection: For intra-articular, soft tissue or IM administration. When administered IM, inject deep into the gluteal muscle using a minimum needle length of 11/2 inches for adults. Obese patients may require a longer needle. Alternate sites for subsequent injections. Avoid IM injections into deltoid area.

Intrapericardial (off-label route): Triamcinolone hexacetonide: Instillation of triamcinolone suspension (diluted in 100 mL of warm [37°C] NS) may be administered as a slow injection over a 7F pigtail catheter introduced after periocardiocentesis; may be painful and appropriate analgesic premedication (eg, morphine) should be administered (Frasiolas 2010; Maisch 2002).

Hexacetonide: Dilute with a compatible solution prior to administration.

Aristospan (5 mg/mL): For intralesional or sublesional administration only; use a ≥23-gauge needle

Aristospan (20 mg/mL): For intra-articular and soft tissue administration only; use a ≥23-gauge needle

Dietary Considerations

Ensure adequate intake of calcium and vitamins (or consider supplementation) in patients on medium-to-high doses of systemic corticosteroids.

Storage

Acetonide injectable suspension: Store at 20°C to 25°C (68°F to 77°F); avoid freezing. Protect from light.

Hexacetonide injectable suspension: Store at 20°C to 25°C (68°F to 77°F); avoid freezing. Protect from light. Diluted suspension stable up to 1 week.

Drug Interactions

Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Monitor therapy

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Amphotericin B: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Androgens: Corticosteroids (Systemic) may enhance the fluid-retaining effect of Androgens. Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Antihepaciviral Combination Products: May increase the serum concentration of Triamcinolone (Systemic). Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Management: No dose adjustment is needed for single 40 mg aprepitant doses. For other regimens, reduce oral dexamethasone or methylprednisolone doses by 50%, and IV methylprednisolone doses by 25%. Antiemetic regimens containing dexamethasone reflect this adjustment. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Calcitriol (Systemic): Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol (Systemic). Monitor therapy

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Corticosteroids (Systemic). Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Desirudin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Desirudin. More specifically, corticosteroids may increase hemorrhagic risk during desirudin treatment. Management: Discontinue treatment with systemic corticosteroids prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification

DilTIAZem: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Monitor therapy

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Consider therapy modification

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Monitor therapy

Indium 111 Capromab Pendetide: Corticosteroids (Systemic) may diminish the diagnostic effect of Indium 111 Capromab Pendetide. Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loop Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Loop Diuretics. Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Avoid combination

MiFEPRIStone: May diminish the therapeutic effect of Corticosteroids (Systemic). MiFEPRIStone may increase the serum concentration of Corticosteroids (Systemic). Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses or conditions (e.g., for immunosuppression following transplantation). Corticosteroid effects may be reduced by mifepristone treatment. Avoid combination

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Consider therapy modification

Nicorandil: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Nicorandil. Gastrointestinal perforation has been reported in association with this combination. Monitor therapy

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Monitor therapy

NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Quinolone Antibiotics: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Quinolone Antibiotics. Specifically, the risk of tendonitis and tendon rupture may be increased. Monitor therapy

Ritonavir: May enhance the adverse/toxic effect of Triamcinolone (Systemic). Specifically, risks of developing iatrogenic Cushing syndrome and secondary adrenal insufficiency may be increased. Ritonavir may increase the serum concentration of Triamcinolone (Systemic). Monitor therapy

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Corticosteroids (Orally Inhaled) may enhance the hypokalemic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Avoid combination

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. More specifically, Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations, thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Monitor therapy

Adverse Reactions

Frequency not defined; reactions reported with corticosteroid therapy in general:

Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac enlargement, CHF, circulatory collapse, edema, hypertension, hypertrophic cardiomyopathy (premature infants), myocardial rupture (following recent MI), syncope, tachycardia, thromboembolism, vasculitis

Central nervous system: Arachnoiditis (intrathecal), depression, emotional instability, euphoria, headache, insomnia, intracranial pressure increased, malaise, meningitis (intrathecal), mood changes, neuritis, neuropathy, personality change, pseudotumor cerebri (with discontinuation), seizure, spinal cord infarction, stroke, vertigo

Dermatologic: Abscess (sterile), acne, allergic dermatitis, angioedema, atrophy (cutaneous/subcutaneous), bruising, dry skin, erythema, hair thinning, hirsutism, hyper-/hypopigmentation, hypertrichosis, impaired wound healing, lupus erythematosus-like lesions, petechiae, purpura, rash, skin test suppression, striae, thin skin

Endocrine & metabolic: Carbohydrate intolerance, Cushingoid state, diabetes mellitus, fluid retention, glucose intolerance, growth suppression (children), hypokalemia, hypokalemic alkalosis, menstrual irregularities, negative nitrogen balance, sodium retention, sperm motility altered

Gastrointestinal: Abdominal distention, appetite increased, GI hemorrhage, GI perforation, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis, weight gain

Hepatic: Hepatomegaly, liver function tests increased

Local: Thrombophlebitis

Neuromuscular & skeletal: Aseptic necrosis of femoral and humeral heads, calcinosis, Charcot-like arthropathy, fractures, joint tissue damage, muscle mass loss, myopathy, osteoporosis, parasthesia, paraplegia, quadriplegia, tendon rupture, vertebral compression fractures, weakness

Ocular: Cataracts, cortical blindness, exophthalmos, glaucoma, ocular pressure increased, papilledema

Renal: Glycosuria

Respiratory: Pulmonary edema

Miscellaneous: Abnormal fat deposits, anaphylactoid reaction, anaphylaxis, diaphoresis, hiccups, infection, moon face

Warnings/Precautions

Concerns related to adverse effects:

• Adrenal suppression: May cause hypercorticism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids; aerosol steroids do not provide the systemic steroid needed to treat patients having trauma, surgery, or infections.

• Anaphylactoid reactions: Rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.

• Dermal changes: Atrophy at the injection site has been reported. Avoid IM deltoid injection; subcutaneous atrophy may occur.

• Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, cause activation of latent infections, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided; corticosteroids should not be used to treat ocular herpes simplex, cerebral malaria, fungal infections, or viral hepatitis. Close observation is required in patients with latent tuberculosis and/or TB reactivity; restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination, and fatalities have occurred.

• Kaposi sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered (Goedert 2002).

• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders or when given concomitantly with neuromuscular blocking agents; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.

• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including severe depression, euphoria, insomnia, mood swings, and personality changes to frank psychotic manifestations. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

• Septic arthritis: May occur as a complication to intra-articular or soft tissue administration; institute appropriate antimicrobial therapy as required.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with HF and/or hypertension; use has been associated with fluid retention, electrolyte disturbances, and hypertension. Use with caution following acute MI; corticosteroids have been associated with myocardial rupture.

• Diabetes: Use corticosteroids with caution in patients with diabetes mellitus; may alter glucose production/regulation leading to hyperglycemia.

• Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, ulcerative colitis, abscess or other pyogenic infection) due to perforation risk.

• Head injury: Increased mortality was observed in patients receiving high-dose IV methylprednisolone; high-dose corticosteroids should not be used for the management of head injury.

• Hepatic impairment: Use with caution in patients with hepatic impairment, including cirrhosis; long-term use has been associated with fluid retention.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation of symptoms has occurred, especially during initial treatment with corticosteroids.

• Ocular disease: Use with caution in patients with cataracts and/or glaucoma; increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with prolonged use. Use with caution in patients with a history of ocular herpes simplex; corneal perforation has occurred; do not use in active ocular herpes simplex. Not recommended for the treatment of optic neuritis; may increase frequency of new episodes. Consider routine eye exams in chronic users.

• Osteoporosis: Use with caution in patients with osteoporosis; high doses and/or long-term use of corticosteroids have been associated with increased bone loss and osteoporotic fractures.

• Renal impairment: Use with caution in patients with renal impairment; fluid retention may occur.

• Seizure disorders: Use corticosteroids with caution in patients with a history of seizure disorder; seizures have been reported with adrenal crisis.

• Thyroid disease: Changes in thyroid status may necessitate dosage adjustments; metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Use with caution in the elderly with the smallest possible effective dose for the shortest duration.

• Pediatric: May affect growth velocity; growth should be routinely monitored in pediatric patients.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate administration: Administer products only via recommended route (depending on product used). Do not administer any triamcinolone product via the intrathecal route; serious adverse events, including fatalities, have been reported following intrathecal administration of corticosteroids.

• Discontinuation of therapy: Withdraw therapy with gradual tapering of dose.

• Epidural injection: Corticosteroids are not approved for epidural injection. Serious neurologic events (eg, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, stroke), some resulting in death, have been reported with epidural injection of corticosteroids, with and without use of fluoroscopy.

• Stress: Patients may require higher doses when subject to stress (ie, trauma, surgery, severe infection).

Monitoring Parameters

Blood pressure, blood glucose, electrolytes; weight; intraocular pressure (use >6 weeks); bone mineral density; growth and development in children; HPA axis suppression

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed with corticosteroids in animal reproduction studies. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts (Park-Wyllie, 2000; Pradat, 2003). Systemic corticosteroids may also influence fetal growth (decreased birth weight); however, information is conflicting (Lunghi, 2010). Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. When systemic corticosteroids are needed in pregnancy, it is generally recommended to use the lowest effective dose for the shortest duration of time, avoiding high doses during the first trimester (Leachman 2006; Lunghi 2010; Makol 2011; Østensen 2009).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, insomnia, agitation, sweating a lot, or hair thinning. Have patient report immediately to prescriber signs of infection, signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), signs of Cushing's disease (weight gain in upper back or stomach; moon face; severe headache; or slow healing), signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), severe loss of strength and energy, irritability, tremors, tachycardia, confusion, sweating a lot, arrhythmia, dizziness, shortness of breath, excessive weight gain, swelling of arms or legs, thrush, severe bone pain, severe joint pain, vision changes, mood changes, behavioral changes, depression, seziures, burning or numbness feeling, injection site irritation or edema, or signs of skin changes (pimples, stretch marks, slow healing, or hair growth) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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