Lithium carbonate

Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older • Maintenance treatment in patients 7 years and older Lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar I disorder: • Treatment of acute manic and mixed episodes in patients 7 years and older. • Maintenance treatment in patients 7 years and older

The mechanism of action of lithium as a mood stabilizing agent is unknown.

• Recommended starting dosage for adults and pediatric patients over 30 kg: • Tablets or Capsules: 300 mg, three times daily • Recommended starting dosage for pediatric patients 20 to 30 kg: • Tablets or Capsules: 300 mg twice daily • Obtain serum lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. • Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L. • Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1 mEq/L. • Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status.

Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule. Known hypersensitivity to any inactive ingredient in the drug product.

Boxed warning (lithium toxicity): Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy. • Lithium-Induced Polyuria: May develop during initiation of treatment. Increases risk of lithium toxicity. Educate patient to avoid dehydration. Monitor for lithium toxicity and metabolic acidosis. Discontinue lithium or treat with amiloride as a therapeutic agent. • Hyponatremia: Symptoms are more severe with faster-onset hyponatremia. Dehydration from protracted sweating, diarrhea, or elevated temperatures from infection increases risk of hyponatremia and lithium toxicity.

The following adverse reactions are described in greater detail in other sections: • Acute Lithium Toxicity • Lithium-Induced Polyuria • Hyponatremia • Lithium-Induced Chronic Kidney Disease • Encephalopathic Syndrome • Serotonin Syndrome • Hypothyroidism or Hyperthyroidism • Hypercalcemia and Hyperparathyroidism • Unmasking of Brugada Syndrome • Pseudotumor Cerebri Common Adverse Reactions: • Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment. • Pediatric Patients (7-17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision

• Diuretics, NSAID, renin-angiotensin system antagonists, or metronidazole may increase lithium serum concentrations. Recommend frequent monitoring of serum lithium concentration and adjust dosage when necessary. • Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. • Antipsychotics: There have been reports of neurologic adverse reactions in patients treated with lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome.

Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). PROTECT FROM MOISTURE.