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Lithium

LITHIUM

Manufacturer: REMEDYREPACK INC.

Score: 141.0

Quick Summary

Lithium is a mood-stabilizing agent used for the treatment of bipolar I disorder. It is indicated for the treatment of acute manic and mixed episodes, as well as maintenance treatment. The drug has a narrow therapeutic index, and its use requires careful monitoring of serum lithium concentrations. Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient and has several important safety considerations, including the risk of lithium toxicity, serotonin syndrome, and hypothyroidism. The recommended starting dosage for adults and pediatric patients over 30 kg is 8 mEq of lithium (5 mL) three times daily, with adjustments based on serum lithium concentrations and clinical response. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring and dose adjustments as needed.

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 citrate products

Adverse Reactions

  • Fine hand tremor
  • Polyuria
  • Mild thirst
  • Nausea
  • General discomfort during initial treatment
  • 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

Dosing Recommendations

General Guidance

Dose adjustments should be made based on serum lithium concentrations and clinical response, with careful monitoring and adjustments as needed.

Acute manic or mixed episodes

Adult Dose

8 mEq of lithium (5 mL) three times daily

Pediatric Dose

8 mEq (5 mL) twice daily for patients 20-30 kg

Maintenance treatment

Adult Dose

8 mEq of lithium (5 mL) two to three times daily

Pediatric Dose

8 mEq (5 mL) twice daily for patients 20-30 kg

Special Population Considerations

Pregnancy

  • Lithium may cause harm when administered to a pregnant woman
  • Monitor serum lithium concentrations and adjust the dosage as needed during pregnancy
  • 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, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other treatment

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