Lithium Carbonate Ww 300 00143 1300 01 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
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 [see Clinical Studies ( 14 )] Maintenance treatment in patients 7 years and older [see Clinical Studies ( 14 )]
What should I know before taking it?
Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products [see Adverse Reactions ( 6)].
What important warnings are listed?
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 [see Dosage and Administration ( 2.3), Warnings and Precautions ( 5.1)] .
How is this medication usually taken?
Each 300 mg tablet for oral administration contains: lithium carbonate USP and is a white to off-white, biconvex tablet, scored on one side with product identification "54 452" debossed on the other side.
What side effects are listed?
The following adverse reactions are described in greater detail in other sections: Acute Lithium Toxicity [see Warnings and Precautions ( 5.1)] Lithium-Induced Polyuria [see Warnings and Precautions ( 5.2)] Hyponatremia [see Warnings and Precautions ( 5.3)] Lithium-Induced Chronic Kidney Disease [see Warnings and Precautions ( 5.4)] Encephalopathic Syndrome [see Warnings and Precautions ( 5.5)] Serotonin Syndrome [see Warnings and Precautions ( 5.6)] Hypothyroidism or Hyperthyroidism [see Warnings and Precautions ( 5.7)] Hypercalcemia and Hyperparathyroidism [see Warnings and Precautions ( 5.8)] Unmasking of Brugada Syndrome [see Warnings and Precautions ( 5.9)] Pseudotumor Cerebri [see.
What interactions are listed?
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. ( 2.3, 7.1) Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. ( 5.6, 7.1) 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. ( 5.5, 7.1)
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c84cce95-cfcb-4426-aac6-d2f48f946ada
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.