Flash VIG-news : MANIPREX® (lithium carbonate): temporary halt to marketing that may be problematic for the treatment of certain patients

date: 12/03/2018

The company Kela Pharma has indicated that, due to production issues, its Maniprex® 250 mg coated tablets and Maniprex® 500 mg film-coated tablets will be unavailable for an indefinite period once current stocks have been exhausted. The stock of Maniprex® 500 mg has already been exhausted, and Kela Pharma predicts, based on normal circumstances, that the stock of Maniprex® 250 mg will be exhausted by June 2018.

In practice
An alternative speciality, CAMCOLIT® 400 mg (scored tablets) is available on the Belgian market. A magistral formula is also a possible alternative.

Lithium has a narrow therapeutic window. The FAMHP has therefore placed lithium carbonate on the 'NO SWITCH' list in the context of INN prescriptions (Prescription under an International Non-proprietary Name).This means that it is not recommended to switch from one speciality to another during the treatment. If a switch nevertheless needs to take place during the course of the treatment, this must be done under the strict supervision of the doctor.

 The dosage must be adapted according to the clinical condition and based on the plasma lithium level, which must be brought to the therapeutic level of between 0.5 mEq and 1.2 mEq (or mmol) per litre.

Last updated on 16/03/2018