PRIADEL Prolonged-release tablet Ref.[27675] Active ingredients: Lithium

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Essential Pharma Limited, Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara, CBD 1070, Malta

5.1. Pharmacodynamic properties

Mood-stabilizing agent
ATC code: N05AN01 (antipsychotics)

Lithium is an alkali metal available for medical use as lithium carbonate or lithium citrate. The exact mechanism of action of lithium in the treatment of bipolar disorders is not known. However, lithium modifies the production and turnover of certain neurotransmitters, particularly serotonin, and it may also block dopamine receptors.

It modifies concentrations of some electrolytes, particularly calcium and magnesium, and it may reduce thyroid activity.

5.2. Pharmacokinetic properties

Lithium is rapidly absorbed from the gastrointestinal tract. Steady-state lithium levels may not be obtained until 4-6 days.

Time to peak serum level for controlled release Priadel tablets is about 2 hours and approximately 90% bioavailability would be expected.

Lithium has a low volume of distribution (0.7 to 0.9 L/kg). It is not bound to plasma proteins. Lithium crosses the placenta and is excreted in breast milk.

Lithium is not metabolized in the liver.

Lithium is excreted primarily by the kidneys (>95% of the dose). Elimination half-life ranges from 18 to 36 hours. Lithium can be eliminated by haemodialysis.

Elimination half-life may be increased in elderly patients due to age related decrease in renal function and also in patients with renal impairment (see section 4.2 & section 4.4).

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

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