{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "lithium carbonate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Lithium Carbonate and Lithium Oral Solution Dose Conversion Lithium Carbonate Tablets or Capsules Lithium Oral Solution 150 mg 4 mEq (2.5 mL) 300 mg 8 mEq (5 mL) 600 mg 16 mEq (10 mL) 2.3 Serum Lithium Monitoring Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 12 hours after the previous dose).",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "No child dose in this label. That usually means untested in children, not unsuitable - use a paediatric source.",
        "source": "Read and found silent: the US FDA label for lithium carbonate (Lithium Carbonate), retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": false
      }
    ],
    "renal": [
      {
        "text": "Mild to Moderate Renal Impairment (CLer 30 to 89 mL/min): Start with dosages less than those for patients with normal renal function, titrate slowly with frequent monitoring ( 2.5 ).",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "Severe Renal Impairment (CLer<30mL/min): Avoid use of lithium ( 2.5 ). 2.1 Pre-treatment Screening Before initiating treatment with lithium, renal function, vital signs, serum electrolytes, and thyroid function should be evaluated.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "Restart treatment at the preconception dose when the patient is medically stable after delivery with careful monitoring of serum lithium concentrations [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] .",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for lithium carbonate (Lithium Carbonate), retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary: Lithium may cause harm when administered to a pregnant woman.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "Early voluntary reports to international birth registries suggested an increase in cardiovascular malformations, especially for Ebstein’s anomaly, with first trimester use of lithium.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "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.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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. 8.2 Lactation 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.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "Signs and symptoms of lithium toxicity such as hypertonia, hypothermia, cyanosis, and ECG changes have been reported in some breastfed neonates and infants.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      },
      {
        "text": "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.",
        "source": "US FDA label for lithium carbonate (Lithium Carbonate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/lithium-carbonate.json",
        "verbatim": true
      }
    ]
  }
}