Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Ltd., The Courtyard Barns, Choke Lane, Maidenhead, Berkshire, SL6 6PT, United Kingdom
Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids
ATC code: H02AB08
The mode of action of glucocorticoids is not fully known, but local injections are thought to have an anti-inflammatory effect.
TRIAMCINOLONE HEXACETONIDE is a synthetic glucocorticoid with pronounced anti-inflammatory activity. The product is a microcrystalline water suspension with a depot effect.
The anti-inflammatory potency of triamcinolone on a milligram by milligram comparison is approximately five times that of hydrocortisone. Triaminolone has practically no mineralocorticoid effect, so no sodium retention occurs.
The efficacy and safety of triamcinolone hexacetonide in children and adolescents are based on the well-researched effects of glucocorticoids, which are the same in children and adults. Published studies and current therapeutic guidelines for treatment of Juvenile Idiopathic Arthritis (JIA) indicate efficacy and safety in children and adolescents for the treatment of JIA.
The hexacetonide ester is almost insoluble in water, so dissolution is slow and the effect in the tissue of the injection site lasts for a long time, from a few weeks to several months. Generally, the onset of effect after TRIAMCINOLONE HEXACETONIDE administration occurs after 24 hours and normally lasts for 4 to 6 weeks.
Triamcinolone hexacetonide is hydrolysed by human serum in vitro (43% hydrolysed after 24 hours), but following intra-articular injection, the substance does not disperse in situ.
Triamcinolone hexacetonide is a potent teratogen in many animals. For example cleft palate has been reported in mice, rats, rabbits, and hamsters. CNS anomalies and cranial malformations have been observed in monkeys following gestational exposure. To date, however, no signs of teratogenicity of corticosteroids have been observed in humans.
The environmental risk assessment has been performed according to European standards. From these results it is assumed that the medicinal product is unlikely to represent a risk for the environment following the recommended use in patients.
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