Aristocort Tablet (Triamcinolone)

ARISTOCORT® Tablets

Stiefel/Glades

Triamcinolone

Corticosteroid

Indications And Clinical Uses: Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone are the drugs of choice although synthetic analogs may be used in conjunction with mineralocorticoids where applicable; mineralocorticoid supplementation is of particular importance when treating this condition in infants); nonsuppurative thyroiditis; hypercalcemia associated with cancer.

Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis; rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; and acute gouty arthritis, synovitis of osteoarthritis, epicondylitis.

Collagen Diseases: for use during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus and acute rheumatic carditis.

Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, and severe psoriasis. Severe seborrheic dermatitis.

Allergic States: control of seasonal or perennial allergic rhinitis, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions and urticaria when they are severe or incapacitating, and intractable to adequate trials of conventional treatment.

Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its associated anatomic parts such as allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, and sympathetic ophthalmia.

Respiratory Diseases: symptomatic sarcoidosis, Leffler’s syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when concurrently accompanied by appropriate antituberculous chemotherapy, aspiration pneumonitis.

Hematologic Disorders: idiopathic and secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), and congenital (erythroid) hypoplastic anemia.

Neoplastic Diseases: palliative management of leukemias and lymphomas in adults and acute leukemia of childhood.

Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome (nonuremic, the idiopathic type, or that which is due to lupus erythematosus) and, in conjunction with diuretic agents, to induce a diuresis in refractory congestive heart failure and in cirrhosis of the liver with refractory ascites.

Gastrointestinal Diseases: to tide the patient over a critical period of the disease in ulcerative colitis, regional enteritis. Nervous System: exacerbations of multiple sclerosis.

Miscellaneous: Tuberculous meningitis with subarachnoid block or impending block when concurrently accompanied by appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

Contra-Indications: Acute psychosis; ocular herpes simplex, fungal or viral infections for which adequate anti-infective therapy is lacking; untreated acute or chronic infection, including tuberculosis.

Precautions: When patients who are receiving corticosteroid therapy are subjected to unusual stress (trauma, surgery or severe illness), increased dosage of rapidly acting corticosteroids is indicated before, during and after the stressful situation.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during corticosteroid therapy, it should be promptly controlled by suitable antimicrobial therapy.

Pregnancy: Weigh the potential hazards of corticosteroid therapy to the embryo or fetus carefully against possible benefits when using the drug during pregnancy. The observation of fetal abnormalities in experimental animals indicates a potential hazard during the first trimester. If corticosteroids were given during pregnancy, watch the newborn infant closely for signs of hypoadrenalism and institute appropriate therapy if such signs are present.

Do not vaccinate patients receiving corticosteroids against smallpox. Avoid other immunization procedures because of the possible hazards of neurological complication and lack of antibody response.

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. The employment of triamcinolone may be a lifesaving measure to control the acute toxicity associated with overwhelming tuberculous infection. Its use must be accompanied by appropriate, specific antituberculous therapy. Triamcinolone should not be used to alleviate joint pain arising from infectious states such as gonococcal or tuberculous arthritis.

If corticosteroids are considered for use in the following conditions, weigh the risks carefully against possible benefits: myasthenia gravis, metastatic carcinoma, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, hypertension, Cushing’s syndrome, renal insufficiency, chronic nephritis, thromboembolic tendencies, thrombophlebitis, osteoporosis, diabetes mellitus and psychotic tendencies.

Systemic steroid administration for prolonged periods may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerve or may enhance the establishment of secondary ocular infection due to fungi and viruses.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased potassium excretion. 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. Edema may occur in the presence of renal disease with a fixed or decreased glomerular filtration rate. All corticosteroids increase calcium excretion.

Triamcinolone should be administered only with full knowledge of characteristic activity of, and varied responses to, adrenocortical hormones. Use corticosteroids under close clinical supervision.

Unlike other corticosteroids, triamcinolone and its derivatives do not stimulate the appetite. During prolonged therapy, a liberal protein intake is essential, and administration of anabolic steroids may be useful for counteracting the tendency to gradual weight loss, sometimes associated with negative nitrogen balance and wasting or weakness of skeletal muscles.

There is an enhanced corticosteroid effect in patients with hyperthyroidism and in those with cirrhosis of the liver. Corticosteroids should be used only with caution in patients with acute glomerulonephritis, convulsive disorders and congestive heart failure.

Exercise caution when using ASA in conjunction with corticosteroids in hypoprothrombinemia.

When bacterial infections are present, corticosteroid therapy is not recommended but may be employed with caution and only in conjunction with appropriate antibiotic or chemotherapeutic medication. Corticosteroids may mask signs of infection and enhance dissemination of the infecting organism. Hence, all patients receiving corticosteroids should be watched for evidence of intercurrent infection. Should infection occur, initiate vigorous, appropriate anti-infective therapy. If possible, avoid abrupt cessation of steroids because of the danger of superimposing adrenocortical insufficiency on the infectious process.

Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by corticosteroids.

Use corticosteroids cautiously in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection.

Glucocorticoids may aggravate diabetes, so that higher dosages of insulin or oral hypoglycemic agents may become necessary; or, steroid therapy may precipitate the manifestations of latent diabetes mellitus.

The use of steroids in myasthenia gravis may aggravate myasthenic symptoms and should, therefore, be given with proper precautions.

In peptic ulcer, recurrence may be asymptomatic until perforation or hemorrhage occurs. Long-term adrenocorticoid therapy may evoke hyperacidity or peptic ulcer; therefore, as a prophylactic measure, an ulcer regimen and the administration of an antacid are highly recommended. Take x-rays in peptic ulcer patients complaining of gastric distress or when therapy is prolonged. Whether or not changes are observed, an ulcer regimen is recommended.

With corticosteroids, consider the possibility of other severe reactions, including anaphylactoid reactions. Take precautionary measures prior to administration, especially with patients having a history of drug allergy.

Reductions or discontinuation of dosage should be gradual. Continued supervision of the patient after termination of steroid therapy is essential, since there may be a sudden reappearance of severe manifestations of the disease for which the patient was treated. Relative adrenocortical insufficiency may persist for months after cessation of therapy; therefore, in any stress situation reinstitute hormone therapy. Since mineralocorticoid secretion may be impaired in such cases, administer salt and/or a mineralocorticoid concurrently.

Growth and development of children should be carefully followed due to the possibility of growth suppression after prolonged therapy.

Menstrual irregularities may occur, and this possibility should be mentioned to female patients past menarche.

Use the lowest possible corticosteroid dose to control the condition being treated. A gradual dosage reduction should be made when possible.

Advise patients to inform subsequent physicians of the prior use of corticosteroids.

Adverse Reactions: Watch patients receiving triamcinolone closely for the following adverse effects which may be associated with any corticosteroid therapy:

Fluid and Electrolyte Disturbances: sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, cardiac arrhythmias or ECG changes due to potassium deficiency, hypokalemic alkalosis, hypertension.

Musculoskeletal: muscle weakness, fatigue, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, delayed healing of fractures, aspectic necrosis of femoral and humeral heads, pathologic fractures of long bones, spontaneous fractures.

Gastrointestinal: peptic ulcer with possible subsequent perforation and hemorrhage, pancreatitis, abdominal distention, ulcerative esophagitis.

Dermatologic: impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpura, striae, hirsutism, acneiform eruptions, lupus erythematosus like lesions, suppressed reactions to skin tests.

Neurological: convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache, neuritis or paresthesias, aggravation of preexisting psychiatric conditions.

Endocrine: menstrual irregularities; development of the Cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g. trauma, surgery or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos.

Metabolic: hyperglycemia, glycosuria, negative nitrogen balance due to protein catabolism.

Others: necrotizing angiitis, thrombophlebitis, thromboembolism, aggravation or masking of infections, insomnia, syncopal episodes, anaphylactoid reactions.

Dosage And Administration: The physician should individualize the dosage for the patient and the disease under treatment. In adults and children over 34 kg with the common diseases amenable to steroid therapy, the usual initial dose ranges from 8 to 20 mg per day divided into 3 or 4 doses. When a satisfactory response is obtained, the initial dose should be reduced gradually by decrements of 2 mg over 2 to 3 days until the smallest dose is obtained which will adequately maintain the patient. 4 mg of triamcinolone is approximately equivalent to: cortisone 25 mg, prednisolone or prednisone 5 mg, methylprednisolone 4 mg, hydrocortisone 20 mg, dexamethasone 0.75 mg, paramethasone 2 mg.

SuppliedSupplied: 2 mg: Each oblong pink, scored tablet, engraved “LL” and “A2”, contains: triamcinolone 2 mg. Nonmedicinal ingredients: calcium phosphate dibasic, docusate sodium, dye D&C Red 30 Lake (talc), dye D&C Yellow 10 Al Lake, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch. Tartrazine-free. Bottles of 100.

4 mg: Each oblong white, scored tablet, engraved “LL” and “A4”, contains: triamcinolone 4 mg. Nonmedicinal ingredients: calcium phosphate dibasic, docusate sodium with sodium benzoate, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and starch. Tartrazine-free. Bottles of 100.

ARISTOCORT® Tablets Stiefel/Glades Triamcinolone Corticosteroid

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