Elvanse 50 mg

Capsule, hard.

Elvanse 50 mg capsule: white opaque body and blue opaque cap, printed ‘S489′ and ’50 mg’ in black ink.

Each capsule measures approximately 16 mm long and 6 mm wide.

Lisdexamfetamine dimesylate showed significant improvement in child achievement in academic performance, as measured by the Health-Related Quality of life instrument, Parent Report Form of the Child Health and Illness Profile-Child Edition (CHIP-CE:PRF) Achievement Domain.

Lisdexamfetamine dimesylate had no effect on embryofoetal development or survival when administered orally to pregnant rats at doses up to 40 mg/kg/day, and rabbits at doses up to 120 mg/kg/day.

Acute administration of high doses of amfetamine (d- or d,l-) has been shown to produce long lasting neurotoxic effects in rodents, including irreversible nerve fibre damage. However, in definitive juvenile toxicity studies with lisdexamfetamine dimesylate in rats and dogs, adverse central nervous system changes were not apparent. The significance of these findings to humans is unknown.

Amfetamine (d- to l-enantiomer ratio of 3:1) did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amfetamine (d– or d,l-) at doses similar to those used clinically can result in long-term neurochemical and behavioural alterations.

Reported behavioural effects include learning and memory deficits, altered locomotor activity, and changes in sexual function. Similar studies have not been conducted for lisdexamfetamine dimesylate.

However, an assessment of fertility following cessation of treatment with lisdexamfetamine dimesylate was included in a juvenile rat toxicity study, with no adverse effects on fertility observed.

Elvanse 50mg Hard Capsule