*Safety and effectiveness 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 have been established in a clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase. *Safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar I disorder. *Common adverse reactions in pediatric patients 7 to 17 years included nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision. *Information on dosing, PK parameters and clinical trials. *Off-patent Written Request.
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