Lithium Carbonate

LITHIUM CARBONATE — lithium carbonate capsule
Camber Pharmaceuticals, Inc.

BOXED WARNING

WARNING: LITHIUM TOXICITY
Lithium toxicity is closely related to serum lithium concentrations, and can occur at doses close to therapeutic concentrations. Facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Dosage and Administration ( 2.6), Warnings and Precautions ( 5.1)].

1 INDICATIONS & USAGE

Lithium is a mood-stabilizing agent indicated for the treatment of manic episodes and as maintenance treatment for Bipolar I Disorder.

2 DOSAGE & ADMINISTRATION

2.1 Pre-treatment Screening


Before initiating treatment with lithium, renal function, vital signs, serum electrolytes, and thyroid function should be evaluated. Concurrent medications should be assessed, and if the patient is a woman of childbearing potential, pregnancy status and potential should be considered.

2.2 Starting Dosage


Consider medical conditions and drug interactions that would affect lithium dosage and administration [see Warnings and Precautions ( 5.1), Drug Interactions ( 7.1)]. In the absence of medical conditions and concomitant medications that would suggest starting at a lower dose, the recommended starting dose in adults is:
• Capsules: 300 mg three times daily Obtain serum lithium concentration assay after 4 days, drawn 12 hours after the last oral dose. Adjust daily dosage based on serum lithium concentration and clinical response. Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration. These adverse reactions may subside with continued treatment, concomitant administration with food, temporary reduction or cessation of dosage.

2.3 Dosage for Acute Treatment of Manic Episodes in Bipolar I Disorder

Titrate to serum lithium concentrations between 0.8 and 1.2 mEq/L, which may be achieved in adults with:
• Capsules: 600 mg, two to three times daily Obtain serum lithium concentrations regularly until the serum concentration and clinical condition of the patient has stabilized [see Dosage and Administration ( 2.6)]. Adjust daily dosage based on serum lithium concentration and clinical response.

2.4 Dosage for Maintenance Treatment of Bipolar I Disorder

Titrate to serum lithium concentrations between 0.8 and 1 mEq/L, which may be achieved in adults with:
• Capsules: 300 mg to 600 mg, two to three times daily
Monitor the patient’s clinical state and serum lithium concentrations regularly [see Dosage and Administration ( 2.6)]. Adjust daily dosage based on serum lithium concentration and clinical response.

2.5 Dosage Recommendations in Pediatric Patients 12 to 17 Years of Age

Dosage recommendations for lithium in patients 12 years and older are similar to that of adults [see Use in Specific Populations ( 8.4)] .

2.6 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). Total reliance must not be placed on serum concentrations alone. Accurate patient evaluation requires both clinical and laboratory analysis.
In addition to regular monitoring of serum lithium concentrations for patients on maintenance treatment, serum lithium concentrations should be monitored after any change in dosage, concurrent medication (e.g., diuretics, non-steroidal anti-inflammatory drugs, renin-angiotensin system antagonists, or metronidazole), marked increase or decrease in routinely performed strenuous physical activity (such as an exercise program) and in the event of a concomitant disease [See Boxed Warning, Warnings and Precautions ( 5.1), Drug Interactions ( 7.1)] . Patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations that are within what is considered the therapeutic range. Geriatric patients often respond to reduced dosage, and may exhibit signs of toxicity at serum concentrations ordinarily tolerated by other patients [see Use in Specific Populations ( 8.5)] .

2.7 Dosage Adjustments during Pregnancy and the Postpartum Period

If the decision is made to continue lithium treatment during pregnancy, monitor serum lithium concentrations and adjust the dosage as needed in a pregnant woman because renal lithium clearance increases during pregnancy. Avoid sodium restriction or diuretic administration. To decrease the risk of postpartum lithium intoxication, decrease or discontinue lithium therapy two to three days before the expected delivery date to reduce neonatal concentrations and reduce the risk of maternal lithium intoxication due to the change in vascular volume which occurs during delivery. At delivery, vascular volume rapidly decreases and the renal clearance of lithium may decrease to pre-pregnancy concentrations. 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)] .

2.8 Dosage Adjustments for Patients with Renal Impairment

Start patients with mild to moderately impaired renal function (creatinine clearance 30 to 89 mL/min evaluated by Cockcroft-Gault) with dosages less than those for patients with normal renal function [see Dosage and Administration ( 2.2)]. Titrate slowly while frequently monitoring serum lithium concentrations and monitoring for signs of lithium toxicity. Lithium is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min evaluated by Cockcroft-Gault) [see Use in Specific Populations ( 8.6)] .

3 DOSAGE FORMS & STRENGTHS

Each 150 mg capsule for oral administration contains: lithium carbonate 150 mg and is a white/white size ‘4’ hard gelatin capsules, imprinted with ’97’ on body and ‘H’ on cap, containing white to off-white powder.
Each 300 mg capsule for oral administration contains: lithium carbonate 300 mg and is a pink/pink size ‘1’ hard gelatin capsules, imprinted with ’98’ on body and ‘H’ on cap, containing white to off-white powder.
Each 600 mg capsule for oral administration contains: lithium carbonate 600 mg and is a pink/white size ‘0EL’ hard gelatin capsules, imprinted with ‘ 141’ on body and ‘H’ on cap, containing white to off-white powder.

4 CONTRAINDICATIONS

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), Description ( 11)].

5 WARNINGS AND PRECAUTIONS

5.1 Acute Lithium Toxicity


The toxic concentrations for lithium (≥1.5 mEq/L) are close to the therapeutic range (0.8 to 1.2mEq/L). Some patients abnormally sensitive to lithium may exhibit toxic signs at serum concentrations that are considered within the therapeutic range [see Boxed Warning, Dosage and Administration ( 2.6)] . Lithium may take up to 24 hours to distribute into brain tissue, so occurrence of acute toxicity symptoms may be delayed.
Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium concentrations below 2.0 mEq/L. At higher concentrations, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium concentrations above 3.0 mEq/L may produce a complex clinical picture involving multiple organs and organ systems, coma, and eventually death. Serum lithium concentrations should not be permitted to exceed 2.0 mEq/L.
Neurological signs of lithium toxicity range from mild neurological adverse reactions such as fine tremor, lightheadedness, and weakness; to moderate manifestations like apathy, drowsiness, hyperreflexia, muscle twitching, and slurred speech; and severe manifestations such as clonus, confusion, seizure, coma and death. Cardiac manifestations involve electrocardiographic changes, such as prolonged QT interval, ST and T-wave changes and myocarditis. Renal manifestations include urine concentrating defect, nephrogenic diabetes insipidus, and renal failure. Respiratory manifestations include dyspnea, aspiration pneumonia, and respiratory failure. Gastrointestinal manifestations include nausea, vomiting, and bloating. No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of lithium, before restarting treatment at a lower dose 24 to 48 hours later [See Overdosage ( 10)] .
The risk of acute toxicity is increased with a recent onset of concurrent illness or with the concomitant administration of drugs which increase lithium serum concentrations by pharmacokinetic interactions [see Drug Interactions ( 7)] . Additional risk factors for acute lithium toxicity include acute ingestion, age-related decline in renal function, volume depletion and/or changes in electrolyte concentrations, especially sodium and potassium. Dose requirements during the acute manic phase are higher to maintain therapeutic serum concentrations and decrease when manic symptoms subside. The risk of lithium toxicity is very high in patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and for patients receiving prescribed medications that may affect kidney function, such as angiotensin converting enzyme inhibitors (ACE inhibitors), diuretics (loops and thiazides) and NSAIDs. For these patients, consider starting with lower doses and titrating slowly while frequently monitoring serum lithium concentrations and signs of lithium toxicity.
To reduce the risk of acute lithium toxicity during treatment initiation, facilities for prompt and accurate serum lithium determinations should be available before initiating treatment [see Boxed Warning, Dosage and Administration ( 2.6)] . Advise patients and caregivers to watch for signs of early toxicity and to discontinue lithium and immediately inform their health care provider if they occur.

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