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Lithium Carbonate

LITHIUM CARBONATE

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Lithium Carbonate is a mood-stabilizing agent used for the treatment of bipolar I disorder, including acute manic and mixed episodes, and maintenance treatment. It has a narrow therapeutic index and requires careful monitoring of serum lithium concentrations to avoid toxicity. The drug is contraindicated in patients with known hypersensitivity to any inactive ingredient and has several important safety warnings, including the risk of lithium toxicity, serotonin syndrome, and hypothyroidism. Dosing recommendations vary based on age, weight, and renal function, and special considerations are needed for use in pregnancy, pediatric, and geriatric populations.

Key Clinical Findings and Indications

  • Treatment of acute manic and mixed episodes in patients 7 years and older
  • Maintenance treatment in patients 7 years and older
  • Mood-stabilizing agent for bipolar I disorder

Important Safety Information

Warning

Lithium toxicity is closely related to serum lithium concentrations and can occur at doses close to therapeutic concentrations

Contraindications

  • Known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products

Adverse Reactions

  • Fine hand tremor
  • Polyuria
  • Mild thirst
  • Nausea
  • General discomfort during initial treatment
  • Serotonin syndrome
  • Hypothyroidism
  • Hypercalcemia
  • Hyperparathyroidism

Dosing Recommendations

General Guidance

Dose adjustments are necessary for patients with renal impairment, and serum lithium concentrations should be monitored regularly

Acute manic or mixed episodes

Adult Dose

300 mg, three times daily, or Oral Solution: 8mEq lithium (5 mL) three times daily

Pediatric Dose

Pediatric patients over 30 kg: 300 mg, three times daily, or Oral Solution: 8mEq (5 mL) three times daily; Pediatric patients 20 to 30 kg: 300 mg twice daily, or Oral Solution: 8 mEq (5 mL) twice daily

Maintenance treatment

Adult Dose

Titrate to serum lithium concentrations 0.8 to 1 mEq/L

Pediatric Dose

Titrate to serum lithium concentrations 0.8 to 1 mEq/L

Special Population Considerations

Pregnancy

  • Lithium may cause harm when administered to a pregnant woman
  • Monitor serum lithium concentrations and adjust the dosage as needed
  • Decrease or discontinue lithium therapy two to three days before the expected delivery date to reduce the risk of maternal and/or neonatal toxicity

Nursing Mothers

Pediatric Use

  • The safety and effectiveness of lithium for monotherapy treatment of acute manic or mixed episodes of bipolar I disorder and maintenance monotherapy of bipolar I disorder in pediatric patients ages 7 to 17 years of age have been established
  • The safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder

Geriatric Use

  • Clinical studies of lithium carbonate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
  • Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range
  • Care should be taken in dose selection, and it may be useful to monitor renal function

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