ARISTOSPAN- triamcinolone hexacetonide injection, suspension
Sandoz Inc
NOT FOR USE IN NEWBORNS
FOR INTRALESIONAL ADMINISTRATION
NOT FOR INTRAVENOUS USE
DESCRIPTION
A sterile suspension containing mg/mL of micronized triamcinolone hexacetonide in the following inactive ingredients:
Polysorbate 80
0.20% w/v
Sorbitol Solution USP
50.00% w/v
Water for Injection qs ad
100.00% V
Hydrochloric Acid and Sodium Hydroxide, if required, to adjust pH to
4.0-8.0
Preservative:
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 hexacetonide ester of the glucocorticoid triamcinolone is relatively insoluble (0.0002% at 25?C in water).
CLINICAL PHARMACOLOGY
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.
INDICATIONS AND USAGE
The intralesional administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 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).
CONTRAINDICATIONS
Aristospan is contraindicated in patients who are hypersensitive to any components of this product.
Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
WARNINGS
Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke
General
This product contains benzyl alcohol. Benzyl alcohol has been associated with fatal ?Gasping Syndrome? in premature infants and infants of low birth weight.
Pregnancy
Teratogenic Effects
Pregnancy Category C
DOSAGE AND ADMINISTRATION
NOTE: CONTAINS BENZYL ALCOHOL
General
The initial dosage of Aristospan (triamcinolone hexacetonide injectable suspension, USP) may vary from 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.
HOW SUPPLIED
Aristospan? (triamcinolone hexacetonide injectable suspension, USP), mg/mL is available as follows:
NDC 0781-3084-75 mL fill in 10 mL vial
Store at 20?-25?C (68?-77?F) [see USP Controlled Room Temperature]. Protect from light.
