Finished product reference
Lithium Carbonate
Tablet, Extended Release · Oral · 400 mg
- List code
- 768
WARNING Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION ).
Indications
INDICATIONS Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Acute Mania Optimal patient response can usually be established with 1,800 mg/day in the following dosages: 1 Can also be administered on 600 mg TID recommended dosing interval. ACUTE MANIA Morning Afternoon Nighttime Lithium Carbonate 3 tablets 3 tablets Extended-Release Tablets 1 (900 mg) (900 mg) Such doses will normally produce an effective serum lithium concentration ranging between 1.0 and 1.5 mEq/L. Dosage must be individualized according to serum concentrations and clinical response. Regular monitoring of the patient's clinical state and of serum lithium concentrations is necessary.
Warnings and precautions
WARNINGS Lithium Toxicity The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic range (0.8 to 1.2 mEq/L). Some patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations that are considered within the therapeutic range (see BOXED WARNING and DOSAGE AND ADMINISTRATION ). Lithium may take up to 24 hours to distribute into brain tissue, so occurrence of acute toxicity symptoms may be delayed.
Pregnancy
Usage in Pregnancy See WARNINGS .
Storage and supply
HOW SUPPLIED Lithium Carbonate Extended-Release Tablets USP, 300 mg are available for oral administration as round, beige film coated tablet. Debossed EP 148 on one side and plain on the reverse side.
Source: Lithium Carbonate (Lithium Carbonate) — US FDA prescribing information, 2025-09-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
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Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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