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Aristocort

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Aristocort

Indications
Dosage
How Supplied

INDICATIONS

Where oral therapy is not feasible, Aristocort® Forte (triamcinolone diacetate injectable suspension), 40 mg/mL, is indicated for intramuscular use as follows:

Allergic States

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.

Dermatologic Diseases

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

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.

Gastrointestinal Disease

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

Hematologic Disorders

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

Miscellaneous

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

Neoplastic Diseases

For palliative management of leukemias and lymphomas.

Nervous System

Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, or craniotomy.

Ophthalmic Diseases

Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Renal Diseases

To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to 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 (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.

For Intra-Articular or Soft Tissue Administration

The intra-articular or soft tissue administration of Aristocort® Forte is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

For Intralesional Administration

The intralesional administration of Aristocort® Forte is indicated for 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.

It may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

DOSAGE AND ADMINISTRATION

NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS: Pediatric Use)

Because of possible physical incompatibilities, Aristocort® Forte Sterile Aqueous Suspension should not be diluted or mixed with other solutions.

General

The initial intramuscular dosage of triamcinolone diacetate injectable suspension may vary from 3 to 48 mg per day depending on the specific disease entity being treated. 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.

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: Neurologic/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 three or four divided doses (3.2 to 48 mg/m² bsa/day).

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

Betamethasone, 0.75 Methylprednisolone, 4
Cortisone, 25 Paramethasone, 2
Dexamethasone, 0.75 Prednisolone, 5
Hydrocortisone, 20 Triamcinolone, 4

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.

Specific

Aristocort® Forte Parenteral is triamcinolone diacetate injectable suspension (40 mg/mL) suspended in a suitable vehicle. The full-strength suspension may be employed. Topical ethyl chloride spray may be used locally prior to injection.

Since this product has been designed for ease of administration, a small bore needle (not smaller than 23 gauge) may be used.

Intramuscular

Although Aristocort® Forte Parenteral may be administered intramuscularly for initial therapy, most physicians prefer to adjust the dose orally until adequate control is attained. Intramuscular administration provides a sustained or depot action which can be used to supplement or replace initial oral therapy. With intramuscular therapy, greater supervision of the amount of steroid used is made possible in the patient who is inconsistent in following an oral dosage schedule. In maintenance therapy, the patient-to-patient response is not uniform and, therefore, the dose must be individualized for optimal control.

The average dose is 40 mg (1 mL) administered intramuscularly once a week for conditions in which anti-inflammatory action is desired.

In general, a single parenteral dose 4 to 7 times the oral daily dose may be expected to control the patient from 4 to 7 days up to 3 to 4 weeks. Dosage should be adjusted to the point where adequate but not necessarily complete relief of symptoms is obtained.

Intra-Articular and Intrasynovial

The usual dose varies from 5 to 40 mg. The average for the knee, for example, is 25 mg. The duration of effect varies from one week to 2 months. However, acutely inflamed joints may require more frequent injections.

A lesser initial dosage range of triamcinolone diacetate injectable suspension may produce the desired effect when the drug is administered to provide a localized concentration. The site of the injection and the volume of the injection should be carefully considered when triamcinolone diacetate is administered for this purpose.

A specific dose depends largely on the size of the joint.

Strict surgical asepsis is mandatory. The physician should be familiar with anatomical relationships as described in standard textbooks. Aristocort® Forte Parenteral may be used in any accessible joint except the intervertebrals. In general, intrasynovial therapy is suggested under the following circumstances:

  1. When systemic steroid therapy is contraindicated because of side effects such as peptic ulcer.
  2. When it is desirable to secure relief in one or two specific joints.
  3. When good systemic maintenance fails to control flare-ups in a few joints, and it is desirable to secure relief without increasing oral therapy.

Such treatment should not be considered to constitute a cure, for although this method will ameliorate the joint symptoms, it does not preclude the need for the conventional measures usually employed.

It is suggested that infiltration of the soft tissue by local anesthetic precede intra-articular injection. A 24gauge or larger needle on a dry syringe may be inserted into the joint and excess fluid aspirated. For the first few hours following injection, there may be local discomfort in the joint but this is usually followed rapidly by effective relief of pain and improvement in local function.

HOW SUPPLIED

Aristocort® Forte (triamcinolone diacetate injectable suspension), 40 mg/mL, parenteral, Not For Intravenous Use, supplied as follows:

NDC 0781-3037-71 40 mg/mL (1 mL Fill in a 2 mL Vial), boxes of 1
NDC 0781-3037-75 40 mg/mL (5 mL Fill in a 10 mL Vial), boxes of 1

Protect from light.

DO NOT FREEZE

SHAKE WELL

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Irreversible clumping occurs when product is frozen.

Manufactured in Canada by : Sandoz Canada Inc. for Sandoz Inc., Princeton, NJ 08540

Last reviewed on RxList: 7/18/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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