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Aristospan Injection 20

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Aristospan Injection 20 mg

Indications
Dosage
How Supplied

INDICATIONS

The intra-articular or soft tissue administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 20 mg/mL 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.

DOSAGE AND ADMINISTRATION

NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS)

General

The initial dosage of Aristospan (triamcinolone hexacetonide injectable suspension, USP) may vary from 2 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 If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.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 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/m²bsa/day).

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

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

Directions for Use

Strict aseptic administration technique is mandatory.

Topical ethylchloride spray may be used locally before injection.

The syringe should be gently agitated to achieve uniform suspension before use. Since this product has been designed for ease of administration, a small bore needle (not smaller than 23 gauge) may be used.

Dilution

Aristospan suspension may be mixed with 1% or 2% Lidocaine Hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided since these compounds may cause flocculation of the steroid. These dilutions will retain full potency for one week, but care should be exercised to avoid contamination of the vial's contents and the dilutions should be discarded after 7 days.

Intra-articular

Average dose - 2 to 20 mg (0.1 mL to 1 mL)

The dose depends on the size of the joint to be injected, the degree of inflammation, and the amount of fluid present. In general, large joints (such as knee, hip, shoulder) require 10 to 20 mg. For small joints (such as interphalangeal, metacarpophalangeal), 2 to 6 mg, may be employed. When the amount of synovial fluid is increased, aspiration may be performed before administering Aristospan. Subsequent dosage and frequency of injection can best be judged by clinical response.

The usual frequency of injection into a single joint is every three or four weeks, and injection more frequently than that is generally not advisable. To avoid possible joint destruction from repeated use of intra-articular corticosteroids, injection should be as infrequent as possible, consistent with adequate patient care. Attention should be paid to avoiding deposition of drug along the needle path which might produce atrophy.

HOW SUPPLIED

Aristospan® (triamcinolone hexacetonide injectable suspension, USP), 20 mg/mL is available as follows:

NDC 0781-3085-71 1 mL fill in a 2 mL vial

NDC 0781-3085-75 5 mL fill in a 10 mL vial

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from light.

DO NOT FREEZE.

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

Last reviewed on RxList: 6/22/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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