Lithium Hydroxide Monohydrate Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.
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 bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has 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 toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (See DOSAGE AND ADMINISTRATION).
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Lithium Oral Solution, USP is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive Illness, Manic, in the older DSM-II terminology.
Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.
Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgement, 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.
There is currently no drug history available for this drug.
Lithium Oral Solution, USP is a palatable oral dosage form of lithium ion, with a raspberry flavor. It is prepared in solution from lithium hydroxide and citric acid in a ratio approximately di-lithium citrate.
Each 5 mL of Lithium Oral Solution, USP contains 8 mEq of lithium ion (Li+), equivalent to the amount of lithium in 300 mg of lithium carbonate and alcohol 0.3% v/v. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer.
Lithium Citrate is a white, granular or crystalline powder which is soluble in water and slightly soluble in alcohol. Its molecular formula is C6H5Li3O7•4H2O. Its chemical name is 1,2,3-Propanetricarboxylic acid, 2-hydroxy-trilithium salt tetrahydrate and its molecular weight is 282.0. Lithium acts as an antimanic.
Inactive Ingredients: artificial raspberry flavor; citric acid anhydrous, glycerin, methylparaben, propylene glycol, propylparaben, purified water, and sorbitol solution. It may also contain hydrochloric acid, and sodium hydroxide.