Manufactured forMiles PharmaceuticalsDivision of Miles Laboratories, Inc.West Haven, Connecticut 06516 USAby Pfizer Inc., New York, N.Y.10017LAB-0140-2.0
Lithium carbonate is indicated in the treatment of manic episodes of manic-depressive illness.
Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility.When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients.
If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals.
In such instances, hospitalization is a necessity.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.
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.
Morphologic changes have also been seen in manic-depressive patients never exposed to lithium.
The relationship between renal functional and morphologic changes and their association with lithium therapy have not been established.When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24 hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance).
During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.Lithium therapy has been reported in some cases to be associated with morphologic changes in the kidneys.
The relationship between such changes and renal function has not been established.An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol.
A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear.
The possibility of similar adverse interactions with other antipsychotic medication exists.Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION).Outpatients and their families should be warned that the patient must discontinue lithium carbonate therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur.Lithium carbonate may impair mental and/or physical abilities.
Caution patients about activities requiring alertness (e.g., operating vehicles or machinery).Lithium may prolong the effects of neuromuscular blocking agents.Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.