LITHANE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LITHANE (LITHANE).

How it works

Lithium is thought to modulate neurotransmitter release and second messenger systems, including inhibition of inositol monophosphatase and alterations in G-protein signaling, though exact mechanism in bipolar disorder is unclear.

What the body does with it

Metabolism	Lithium is not metabolized; excreted renally; reabsorption in the proximal tubule influenced by sodium balance.
Excretion	Renal: >95% unchanged; tubular reabsorption parallels sodium; negligible biliary/fecal.
Half-life	18-24 hours (single dose); 24-36 hours after chronic dosing; prolonged in elderly or renal impairment.
Protein binding	None (0% bound; lithium is ionic).
Volume of Distribution	0.7-1.0 L/kg; distributes throughout total body water, initial central compartment 0.2-0.3 L/kg.
Bioavailability	Oral: 95-100% immediate-release; food delays but does not reduce extent. No IV form.
Onset of Action	Oral: 1-3 hours for acute mania (therapeutic serum levels within 5-7 days).
Duration of Action	Maintenance: 24-hour dosing interval; continuous steady-state required for mood stabilization.

Classification & Brands

Dosing & administration

300-600 mg orally 3 times daily; usual therapeutic serum lithium level 0.6-1.2 mEq/L. Extended-release formulations given 2-3 times daily.

Dosage form	TABLET
Renal impairment	CrCl 30-59 mL/min: reduce dose by 50%; CrCl 15-29 mL/min: reduce dose by 75%; CrCl <15 mL/min: contraindicated or use with extreme caution.
Liver impairment	No specific Child-Pugh based adjustments; monitor lithium levels and renal function as hepatic impairment may affect fluid/electrolyte balance.
Pediatric use	Children ≥12 years: initial 15-20 mg/kg/day in 2-3 divided doses, adjust to serum levels. Children <12 years: safety not established.
Geriatric use	Start at lower doses (e.g., 150-300 mg once or twice daily); titrate slowly to achieve serum levels 0.4-0.8 mEq/L due to reduced renal clearance and increased toxicity risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LITHANE (LITHANE).

Breastfeeding	Lithium is excreted into breast milk with M/P ratio ~0.3-0.6. Infant levels are 10-50% of maternal serum. Risk of infant toxicity (hypotonia, lethargy, hypothyroidism). Contraindicated in breastfeeding due to potential adverse effects. Alternative feeding recommended.
Teratogenic Risk	First trimester: Increased risk of Ebstein's anomaly and other cardiac defects (estimated risk 0.05-0.1% vs 0.01% general). Second/third trimester: Risks include fetal goiter, hypothyroidism, nephrogenic diabetes insipidus, preterm birth, and perinatal complications. Lithium levels in cord blood similar to maternal serum. Avoid unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Lithium toxicity: narrow therapeutic index; monitor serum lithium levels, renal function, and thyroid function; risk of encephalopathy with neuroleptics.

Side Effect Profile

Serious Effects

Absolute Contraindications

Severe renal failure, uncontrolled hypothyroidism, acute myocardial infarction, Brugada syndrome, severe dehydration, pregnancy (first trimester) unless benefit outweighs risk.

Clinical Precautions

Precautions

Renal impairment, thyroid dysfunction, cardiac conduction abnormalities, dehydration, sodium depletion, CNS effects (tremor, ataxia), drug interactions (NSAIDs, diuretics, ACE inhibitors), pregnancy risk (Ebstein's anomaly).

Clinical Tips & Counseling

Drug interactions

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LITHANE

Clinical safety rating: caution

Comprehensive clinical and safety monograph for LITHANE (LITHANE).

How it works

What the body does with it

Metabolism	Lithium is not metabolized; excreted renally; reabsorption in the proximal tubule influenced by sodium balance.
Excretion	Renal: >95% unchanged; tubular reabsorption parallels sodium; negligible biliary/fecal.
Half-life	18-24 hours (single dose); 24-36 hours after chronic dosing; prolonged in elderly or renal impairment.
Protein binding	None (0% bound; lithium is ionic).
Volume of Distribution	0.7-1.0 L/kg; distributes throughout total body water, initial central compartment 0.2-0.3 L/kg.
Bioavailability	Oral: 95-100% immediate-release; food delays but does not reduce extent. No IV form.
Onset of Action	Oral: 1-3 hours for acute mania (therapeutic serum levels within 5-7 days).
Duration of Action	Maintenance: 24-hour dosing interval; continuous steady-state required for mood stabilization.

Classification & Brands

Dosing & administration

300-600 mg orally 3 times daily; usual therapeutic serum lithium level 0.6-1.2 mEq/L. Extended-release formulations given 2-3 times daily.

Dosage form	TABLET
Renal impairment	CrCl 30-59 mL/min: reduce dose by 50%; CrCl 15-29 mL/min: reduce dose by 75%; CrCl <15 mL/min: contraindicated or use with extreme caution.
Liver impairment	No specific Child-Pugh based adjustments; monitor lithium levels and renal function as hepatic impairment may affect fluid/electrolyte balance.
Pediatric use	Children ≥12 years: initial 15-20 mg/kg/day in 2-3 divided doses, adjust to serum levels. Children <12 years: safety not established.
Geriatric use	Start at lower doses (e.g., 150-300 mg once or twice daily); titrate slowly to achieve serum levels 0.4-0.8 mEq/L due to reduced renal clearance and increased toxicity risk.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for LITHANE (LITHANE).

Breastfeeding	Lithium is excreted into breast milk with M/P ratio ~0.3-0.6. Infant levels are 10-50% of maternal serum. Risk of infant toxicity (hypotonia, lethargy, hypothyroidism). Contraindicated in breastfeeding due to potential adverse effects. Alternative feeding recommended.
Teratogenic Risk	First trimester: Increased risk of Ebstein's anomaly and other cardiac defects (estimated risk 0.05-0.1% vs 0.01% general). Second/third trimester: Risks include fetal goiter, hypothyroidism, nephrogenic diabetes insipidus, preterm birth, and perinatal complications. Lithium levels in cord blood similar to maternal serum. Avoid unless benefit outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Lithium toxicity: narrow therapeutic index; monitor serum lithium levels, renal function, and thyroid function; risk of encephalopathy with neuroleptics.

Side Effect Profile

Serious Effects

Absolute Contraindications

Severe renal failure, uncontrolled hypothyroidism, acute myocardial infarction, Brugada syndrome, severe dehydration, pregnancy (first trimester) unless benefit outweighs risk.