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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  10/04/2018
 
Trade Name:  Lithium
 
Generic Name or Proper Name (*):  lithium
 
Indications Studied:  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
 
Label Changes Summary:  *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.
 
Product Labeling:  [INVALID]  Opens a new window
 
BPCA(B):  B
 
Sponsor:  West-Ward Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Mood-stabilizing agent
 
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