Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
LITHIUM CARBONATE
Norgine Limited
400 mg Milligram
Film Coated Tablet
1978-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CAMCOLIT 400 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg Lithium Carbonate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet The tablets are engraved “CAMCOLIT-S” around one face and having a breakline on the reverse. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment and prophylaxis of mania, bipolar affective disorders illness and recurrent depression, and the treatment of aggressive or self mutilating behaviour. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. CAMCOLIT 400mg film coated tablets are usually administered according to a twice daily regimen. 4.2.1 DOSAGE Lithium carbonate has a narrow therapeutic window. The dose required for treatment must be titrated and adjusted on the basis of regular monitoring of the serum concentration of lithium (See Section 4.4.1). Lithium therapy should not be initiated unless adequate facilities for routine monitoring of plasma concentrations are available. Toxic symptoms are usually associated with lithium concentrations exceeding 1.5 mmol/l. Levels of more than 1.5 mmol/l must be avoided. WITHDRAWAL If lithium is to be discontinued, particularly in cases of high doses, the dose should be reduced gradually. _ACUTE MANIA:_ _ADULTS: _Treatment should be initiated in hospital where regular monitoring of plasma lithium levels can be conducted. The dosage of Camcolit should be adjusted to produce a plasma lithium level between 0.6 and 1.0 mmol/l 12 hours after the last dose. The required plasma lithium level may be achieved in one of two ways Citiți documentul complet