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hikma pharmaceuticals usa inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: 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)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations] . published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreas

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - 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)] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet  [see adverse reactions (6)] . risk summary lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see cl

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 150 mg - 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)]. 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)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pre

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 150 mg - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see adverse reactions (6)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations]. published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skele

United States - English - NLM (National Library of Medicine)

cardinal health 107, llc - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - lithium is a mood-stabilizing agent indicated as monotherapy for the treatment of bipolar i disorder: 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)]. risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations]. published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreas

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - 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)] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule or lithium citrate products [see adverse reactions ( 6)].   risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations]. published animal developmental and toxicity studies in mice and rats report an increased incidence of fetal mortality, decreased fetal weight, increased fetal skeletal abnormalities, and cleft palate (mouse fetuses only) with oral doses of lithium that produced serum concentrations similar to the human therapeutic range. other published animal studies report adverse effects on embryonic implantation in rats after lithium administration. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated population(s) is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations: dose adjustments during pregnancy and the postpartum period: if the decision is made to continue lithium treatment during pregnancy, serum lithium concentrations should be monitored and the dosage adjusted during pregnancy. two to three days prior to delivery, lithium dosage should be decreased or discontinued to reduce the risk of maternal and/or neonatal toxicity. lithium may be restarted in the post-partum period at preconception doses in medically stable patients as long as serum lithium levels are closely monitored [see dosage and administration ( 2.4), warnings and precautions ( 5.1)]. fetal/neonatal adverse reactions:  lithium toxicity may occur in neonates who were exposed to lithium in late pregnancy. a floppy baby syndrome including neurological, cardiac, and hepatic abnormalities that are similar to those seen with lithium toxicity in adults have been observed. symptoms include hypotonia, respiratory distress syndrome, cyanosis, lethargy, feeding difficulties, depressed neonatal reflexes, neonatal depression, apnea, and bradycardia. monitor neonates and provide supportive care until lithium is excreted and toxic signs disappear, which may take up to 14 days. consider fetal echocardiography between 16 and 20 weeks gestation in a woman with first trimester lithium exposure because of the potential increased risk of cardiac malformations. risk summary: limited published data reports the presence of lithium carbonate in human milk with breast milk levels measured at 0.12 to 0.7 meq or 40 to 45% of maternal plasma levels. infants exposed to lithium during breastfeeding may have plasma levels that are 30 to 40% of maternal plasma levels. signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ecg changes have been reported in some breastfed neonates and infants. increased prolactin levels have been measured in lactating women, but the effects on milk production are not known. breastfeeding is not recommended with maternal lithium use; however, if a woman chooses to breastfeed, the infant should be closely monitored for signs of lithium toxicity. discontinue breastfeeding if a breastfed infant develops lithium toxicity. clinical considerations: consider regular monitoring of lithium levels and thyroid function in a breastfed infant. 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 in an acute-phase clinical trial of 8 weeks in duration followed by a 28-week randomized withdrawal phase [see dosage and administration (2.1), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14)] . the safety and effectiveness of lithium has not been established in pediatric patients less than 7 years of age with bipolar i disorder. 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. other reported clinical experience has not identified differences in response between the elderly and younger patients. in general, 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. lithium is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. as lithium is eliminated primarily through the kidney, lithium renal clearance is decreased in patients with abnormal renal function, and the risk of lithium intoxication increases considerably in this setting. lithium should not be used in severe renal insufficiency (creatinine clearance less than 30 ml/min evaluated by cockcroft-gault), especially if the condition requires adherence to a low-sodium diet [see dosage and administration ( 2.5)] . start patients with mild to moderately impaired renal function (creatinine clearance 30 to 89 ml/min evaluated by cockcroft-gault) with lower doses of lithium and titrate slowly while frequently monitoring serum lithium concentrations and for signs of lithium toxicity [see dosage and administration ( 2.5)]. 

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 150 mg - 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)] lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule or lithium citrate products [see adverse reactions ( 6)].   risk summary: lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein’s anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish

United States - English - NLM (National Library of Medicine)

precision dose inc. - lithium citrate (unii: 5z6e9k79yv) (lithium cation - unii:8h8z5uer66) - lithium cation 8 meq in 5 ml - lithium is a mood-stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for bipolar i disorder. 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), description (11)] . risk summary lithium may cause harm when administered to a pregnant woman. early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for ebstein's anomaly, with first trimester use of lithium. subsequent case-control and cohort studies indicate that the increased risk for cardiac malformations is likely to be small; however, the data are insufficient to establish a drug-associated risk. there are concerns for maternal and/or neonatal lithium toxicity during late pregnancy and the postpartum period [see clinical considerations] . published animal developmental and toxicity studies in mice and rats report

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 300 mg - lithium is indicated in the treatment of manic episodes of bipolar disorder. bipolar disorder, manic (dsm-iii) is equivalent to manic depressive illness, manic, in the older dsm-ii terminology. lithium is 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. lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. if the psychiatri

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hikma pharmaceuticals usa inc. - lithium carbonate (unii: 2bmd2gna4v) (lithium cation - unii:8h8z5uer66) - lithium carbonate 450 mg - lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of manic-depressive illness. maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. 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 carbonate extended-release tablets may produce a normalization of symptomatology within 1 to 3 weeks.