Lithium Carbonate Er (lithium carbonate)

Dosage of lithium carbonate is expressed in terms of the salt, while dosage of lithium citrate is expressed in terms of lithium.

Lithium is administered orally in divided doses (e.g., 2 or 3 times daily). Lithium carbonate is commercially available as conventional tablets, extended-release tablets, and capsules. Lithium citrate is commercially available only as an oral solution. Extended-release preparations of lithium should be swallowed intact and should not be chewed, crushed, or split in half. Lithium citrate oral solution may be used in patients unable to swallow capsules or tablets; 5 mL of a commercially available solution contains about 8 mEq of lithium and is approximately equivalent to 300 mg of lithium carbonate as conventional tablets or capsules.

Individualize the dosage according to serum lithium concentrations, patient tolerance, and clinical response. The manufacturers state that serum lithium concentrations should be determined 3 days (drawn 12 hours after the previous oral dose and just prior to the next dose) after therapy initiation during the acute phase of therapy with the conventional tablets, capsules or liquid and then regularly until the serum concentration and clinical condition of the patient have been stabilized. When extended-release preparations are used, serum lithium concentrations generally should be monitored twice weekly (drawn immediately prior to the next dose (i.e., 8-12 hours after previous dose)) during initiation of the acute phase of therapy and until the serum concentration and clinical condition of the patient have been stabilized. Thereafter, serum concentrations should be monitored at least every 2 months in most patients. Additional monitoring of serum lithium concentrations is recommended after any change in dosage, change in concomitant medications (e.g., diuretics, nonsteroidal anti-inflammatory agents (NSAIAs), renin-angiotensin system antagonists, metronidazole), marked increase or decrease in routine physical activity, or in the event of a concomitant disease.

Total reliance must not be placed on serum lithium concentrations alone; accurate patient evaluation requires both careful clinical and laboratory evaluation.

Adverse effects such as nausea and general discomfort may develop during the first few days of initial therapy. Fine hand tremor, polyuria, or thirst may also occur during the acute phase, and can persist throughout treatment. Continuation of lithium, administering doses with food, or temporary reduction or cessation in dosage may help to mitigate these adverse effects.

When transitioning a patient from the immediate-release capsules to the extended-release tablets, the same total daily dose should be given and divided into twice daily dosages. When the prior dosage is not available in the exact dosage equivalent of the extended-release product, initiate the extended-release regimen at the closest dosage equivalent below the original daily dosage. If the daily dosage is split into unequal divided doses, administer the larger dose in the evening. Once patients have transitioned to the extended-release tablets, monitor serum levels at 1-2 week intervals and adjust dosage as necessary until serum concentrations and clinical condition are stable.

Lithium carbonate conventional tablets and capsules should be stored in tight, child-resistant containers protected from moisture at 20-25degreesC (with excursions permitted to 15-30degreesC). Lithium carbonate extended-release tablets should be stored between 15-30degreesC.

Lithium citrate oral solution should be stored in tight, child-resistant containers at 20-25degreesC (with excursions permitted to 15-30degreesC).

No dosing information is available for this tab.

No dosing information is available for this tab.

Lithium is not metabolized.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Prior hypersensitivity to any inactive ingredient in lithium carbonate or lithium citrate products.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Common adverse effects in adults receiving lithium include fine hand tremor, polyuria, mild thirst, nausea, and general discomfort during lithium initiation.

Common adverse effects in pediatric patients 7-17 years of age receiving lithium therapy include nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbances, decreased appetite, and blurry vision.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy of lithium monotherapy (as conventional tablets, capsules, or lithium citrate oral solution) for the treatment of acute manic or mixed episodes and maintenance monotherapy of bipolar I disorder have been established in pediatric patients 7 to 17 years of age. Safety and efficacy were established based on an acute-phase study of 8 weeks' duration followed by a 28-week randomized withdrawal study.

Safety and efficacy of lithium therapy (as conventional tablets, capsules, or lithium citrate oral solution) in children <7 years of age with bipolar I disorder have not been established.

Safety and efficacy of lithium carbonate as extended-release tablets have not been established in pediatric patients <12 years of age.

There is potential for fetal harm when lithium is used during pregnancy. Reports from international birth registries suggest an increased risk of cardiovascular malformation, particularly Ebstein's anomaly, with first trimester exposure to lithium. Additional case-control and cohort studies indicate risk of cardiovascular malformations is likely small; however, current data are insufficient to establish a drug-associated risk. There are additional concerns for maternal and/or neonatal lithium toxicity during late pregnancy and during the postpartum period. Animal developmental and toxicity studies indicate an increased risk of fetal mortality, decreased fetal weight, increased fetal skeletal malformations, and cleft palate with oral doses of lithium that produce lithium concentrations similar to the human therapeutic range. Inform pregnant females of the potential fetal risk with lithium therapy.

Consider fetal echocardiography between 16 to 20 weeks' gestation in females with first trimester lithium exposure because of the fetal risk of cardiac malformations.

The renal excretion of lithium increases during pregnancy; therefore, if the decision is made to continue lithium, the dosage generally needs to be increased, serum concentrations monitored, and the dosage of lithium adjusted as needed. The lithium dosage should be reduced 2 to 3 days prior to delivery to reduce the risk of maternal and/or neonatal toxicity. Lithium may then be resumed during the postpartum period at preconception dosages in medically stable patients as long as lithium levels are closely monitored.

Lithium toxicity has been reported in neonates exposed to lithium during late pregnancy. Floppy baby syndrome, along with neurologic, cardiac, and hepatic abnormalities similar to that observed in adults with lithium toxicity, has been reported. Symptoms of floppy baby syndrome include hypotonia, respiratory distress syndrome, cyanosis, lethargy, feeding difficulties, depressed neonatal reflexes, neonatal depression, apnea, and bradycardia. Neonates should be monitored and supportive care provided until lithium is excreted and symptoms of toxicity disappear, which may take up to 14 days.

Lithium carbonate is excreted into breast milk at levels measured at 0.12 to 0.7 mEq/L or 40-45% of maternal plasma concentrations. Infants exposed to lithium through breast-feeding may have plasma concentrations that are 30-40% of maternal plasma levels. Signs and symptoms of lithium toxicity, which include hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some breast-fed infants and neonates. Increased prolactin levels have also been detected in some breast-feeding females; however, the effect on milk production is not known.

Breast-feeding is not recommended when the mother is receiving lithium therapy; however, if the mother chooses to breast-feed, the infant should be closely monitored for signs of lithium toxicity. Breast-feeding should be discontinued if the infant develops lithium toxicity.

Regular monitoring of lithium levels and thyroid function should be considered in breast-fed infants exposed to lithium.

Although the manufacturer does not provide specific dosage recommendations in geriatric patients, due to the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and other medication therapy in this population, patients in this age group should receive initial dosages of lithium on the lower end of the usual range. Geriatric patients often respond to a reduce dosage, and may exhibit signs of toxicity at serum concentrations tolerated by other patients.

Lithium is substantially excreted by the kidneys and the risk of severe adverse reactions may be increased in patients with impaired renal function. Because geriatric patients may have decreased renal function, renal function should be monitored and dosage adjusted accordingly.

Clinical studies of lithium carbonate as extended-release tablets did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger patients. While clinical experience with lithium generally has not revealed age-related differences in response, care should be taken in dosage selection. Because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and other medication therapy in geriatric patients, patients should receive initial dosages on the lower end of the usual range. Lithium is substantially excreted by the kidneys and risk of severe adverse reactions may be increased in patients with impaired renal function. Because geriatric patients may have decreased renal function, renal function should be monitored and dosage adjusted accordingly.