Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1741
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Aristospan (Injection, Suspension)
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NOTE: CONTAINS BENZYL ALCOHOL<br/>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 dosagewhich 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 If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.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/mbsa/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: 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.<br/>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.<br/>Dilution: Aristospan suspension may also 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. Aristospan suspension 5 mg/mL may also be diluted, if desired, with Dextrose and Sodium Chloride Injection USP, (5% and 10% Dextrose), Sodium Chloride Injection USP, or Sterile Water for Injection USP. The optimum dilution, i.e., 1:1, 1:2, 1:4, should be determined by the nature of the lesion, its size, the depth of injection, the volume needed, and location of the lesion. In general, more superficial injections should be performed with greater dilution. Certain conditions, such as keloids, require a less dilute suspension such as 5 mg/mL, with variation in dose and dilution as dictated by the condition of the individual patient. Subsequent dosage, dilution, and frequency of injections are best judged by the clinical response.<br/>Intralesional or Sublesional: Average dose���Up to 0.5 mg per square inch of affected skin injected intralesionally or sublesionally. The frequency of subsequent injections is best determined by the clinical response. If desired, the vial may be diluted as indicated under Directions for Use. A lesser initial dosage range of Aristospan 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 Aristospan is administered for this purpose.
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| dailymed-instance:descripti... |
A sterile suspension containing 5 mg/mL of micronized triamcinolone hexacetonide in the following inactive ingredients: Polysorbate 80 NF 0.20% w/vSorbitol Solution USP 50.00% w/vWater for Injection qs ad 100.00% VHydrochloric Acid and Sodium Hydroxide, if required, to adjust pH to 4.0-8.0Preservative:Benzyl Alcohol 0.90% w/v Chemically triamcinolone hexacetonide USP is 9��-Fluoro-11��,16��, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate). The molecular weight is 532.65. The structural formula is: The hexacetonide ester of the glucocorticoid triamcinolone is relatively insoluble (0.0002% at 25��C in water).
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| dailymed-instance:clinicalP... |
Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems. When injected intralesionally or sublesionally, triamcinolone hexacetonide can be expected to be absorbed slowly from the injection site.
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| dailymed-instance:contraind... |
Aristospan is contraindicated in patients who are hypersensitive to any components of this product. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
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| dailymed-instance:supply |
Aristospan' (triamcinolone hexacetonide injectable suspension, USP), 5 mg/mL is available as follows: NDC 0781-3084-75 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.
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| dailymed-instance:overdosag... |
Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
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| dailymed-instance:genericMe... |
triamcinolone hexacetonide
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| dailymed-instance:fullName |
Aristospan (Injection, Suspension)
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| dailymed-instance:indicatio... |
The intralesional administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL 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. Aristospan may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).
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| dailymed-instance:name |
Aristospan
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