LITHICARB

What it is

LITHICARB is a medicine containing lithium carbonate 250 mg per tablet. The tablets are white to off-white, oval-shaped, film-coated tablets with a breakline on one side.

Approved indications —

Mania, as treatment and prophylaxis — Manic depressive (bipolar) illness, as treatment and prophylaxis — Recurrent endogenous (unipolar) depressive illness, as prophylaxis and probably as treatment, especially if there is a family history of manic depressive illness and response to lithium — Schizo-affective illness and chronic schizophrenia in some cases — Character or personality disorders in young people with clear evidence of cyclothymia

Dosing overview

In acute mania, doses of up to 1.75 g daily may be given in divided doses, with a target of 500 to 1000 mg on Day 1, 1250 to 1750 mg on Day 2, and 1500 to 2000 mg on Day 3 to achieve blood levels of 0.8 to 1.6 mmol/L. When remission is achieved in 7 to 14 days, dosage is reduced to a maintenance dose sufficient to maintain blood level within the therapeutic range, usually 500 mg to 1 g per day, taken in one or two doses. LITHICARB should be taken with food, as it causes less nausea than on an empty stomach.

Key safety warnings

Lithium is a known inhibitor of cardiac sodium channels and can unmask Brugada syndrome; for this reason lithium should be avoided in patients with Brugada syndrome. Lithium toxicity is closely related to serum lithium concentrations and can occur at doses close to therapeutic concentrations. Vomiting, diarrhoea, intercurrent infection, fluid deprivation and drugs likely to upset electrolyte balance, such as diuretics, may all reduce lithium excretion and precipitate intoxication, requiring reduction in dosage. Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus with polyuria and polydipsia; such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity, though this condition is usually reversible when lithium is discontinued. Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic lithium therapy, though some structural changes have also been reported in manic-depressives never exposed to lithium, and the relationship between renal function, morphologic changes and lithium therapy has not been established. Treatment with lithium can cause hypercalcaemia that may or may not be accompanied by hyperparathyroidism; it is recommended to monitor blood calcium levels before onset of treatment and periodically thereafter during treatment, and if necessary, parathyroid hormone level. An encephalopathic syndrome, characterised by weakness, lethargy, fever, tremulousness, confusion, extrapyramidal symptoms and leucocytosis has occurred in a few patients treated with lithium and neuroleptics; in some instances, the syndrome was followed by irreversible brain damage, and patients receiving combined therapy should be monitored closely for early evidence of neurological toxicity.

Contraindications

LITHICARB is contraindicated in patients with significant cardiovascular or renal disease; frank hypothyroidism; conditions associated with hyponatraemia such as Addison's disease, dehydrated or severely debilitated patients, and patients on low sodium diets; and patients with a previous history of hypersensitivity to lithium or any of the excipients contained in the tablets. Diuretics should not be used during lithium therapy without appropriate dosage adjustment.

Regulatory history

LITHICARB was first approved on 21 July 1994. The standard LITHICARB lithium carbonate 250 mg tablet was listed on the ARTG on 21 July 1994. Extended-release variants (LITHICARB SR 400 mg) were registered on 14 August 1995.