CAMCOLIT Film-coated tablet Ref.[27663] Active ingredients: Lithium

Distribution

It crosses the placenta and is excreted in breast milk.

The pharmacokinetics of lithium are extremely well documented. A single oral dose of CAMCOLIT 400 gives a peak plasma level approximately 3-4 hours later, with the level at 24 hours being approximately 40% of peak levels.

Elimination

Lithium is excreted almost exclusively in the urine by the kidneys.

The half-life of lithium varies considerably between formulations, but generally is considered to be about 12 to 24 hours following a single dose.

Special populations

Elderly

Half-lives of up to 36 hours have been reported for elderly patients and 40 to 50 hours for patients with renal impairment. Steady-state concentrations may not be attained until 4 to 7 days after starting treatment.

Lithium is teratogenic in rats and mice. In rats, lithium caused a reduction in fetal weights, numbers of live fetuses, delayed development of the skeleton and kidney toxicity in newborns at maternally toxic doses. In male rats, lithium caused morphological and histological changes in sperm tube epithelium and spermatids at doses comparable to human dosing, and reduced testicular weights and sperm production at doses more than 20 times higher than the human administered dose. The safety margin for these effects cannot be estimated due to an absence of exposure data.