Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
LITHIUM CARBONATE
Essential Pharma Ltd
N05AN01
LITHIUM CARBONATE
400 mg Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
lithium
Not Marketed
1978-04-01
5 060334 120053 Belgenin tamamını okuyun
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 White film coated tablet The tablets are engraved “CAMCOLIT-S” around one face and having a scoreline 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. When lithium levels have stabilised, a once daily regimen may be preferred. 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. On initiation of treatment, plasma therapy concentrations should be measured weekly until stabilisation is achieved, then weekly for one month and at monthly intervals thereafter. Additional measurements should be made if signs of lithium toxicity occur, on dosage alteration, development of significant intercurrent disease, signs of manic depressions or depressive relapse and if significant change in sodium or fluid intake occurs. More frequent monitoring is required if patients are receiving any drug treatment that affects renal clearance of lithium e.g. diuretics and NSAID (See section 4.4 and section 4.5). As bioavailability may vary between formulations, should a change of preparations be made, blood levels should be monitored weekly until r Belgenin tamamını okuyun