Drugplain

lithium carbonate 150 mg/1

lithium carbonate · CAPSULE · Camber Pharmaceuticals, Inc.

No Recall History
Plain English

Lithium Carbonate is a prescription medication taken by mouth as a capsule to treat bipolar disorder, helping to reduce mood swings and stabilize moods. Your doctor will determine the right dose for you based on your individual needs and blood test results.

Key Facts

Brand Name
lithium carbonate
Generic Name
lithium carbonate
NDC Code (Product)
31722-544
Manufacturer
Camber Pharmaceuticals, Inc.
Strength
150 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA090702
Marketing Start
12/15/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

toxicity to various agents1,196 reports
drug ineffective1,101 reports
tremor1,063 reports
drug interaction979 reports
nausea798 reports
weight increased793 reports
insomnia699 reports
depression687 reports
fatigue673 reports
vomiting656 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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 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 ( 1 ) • Maintenance treatment in patients 7 years and older ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Recommended starting dosage for adults and pediatric patients over 30 kg ( 2.2 ): • Capsules: 300 mg, three times daily • Recommended starting dosage for pediatric patients 20 to 30 kg ( 2.2 ): • Capsules: 300 mg twice daily • Obtain serum lithium concentration assay after 3 days, drawn 12 hours after the last oral dose and regularly until patient is stabilized. • Acute Manic or Mixed Episodes (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1.2 mEq/L ( 2.2 ). • Maintenance Treatment for Bipolar I Disorder (patients 7 years and older): Titrate to serum lithium concentrations 0.8 to 1 mEq/L ( 2.2 ). • Pre-treatment Screening: Evaluate renal function, vital signs, electrolytes, thyroid function, concurrent medications, and pregnancy status ( 2.1 ). • 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 ). • 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 thyr…

Contraindications

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 )]. Known hypersensitivity to any inactive ingredient in the drug product ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Diuretics, NSAID, renin-angiotensin system antagonists, or metronidazole may increase lithium serum concentrations. Recommend frequent monitoring of serum lithium concentration and adjust dosage when necessary. ( 2.3 , 7.1 ) • Serotonergic Agents: Increased risk of serotonin syndrome when co-administered with lithium. ( 5.6 , 7.1 ) • Antipsychotics: There have been reports of neurologic adverse reactions in patients treated with lithium and an antipsychotic, ranging from extrapyramidal symptoms to neuroleptic malignant syndrome. ( 5.5 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Lithium Table 4: Clinically Important Drug Interactions with Lithium Diuretics Clinical Impact: Diuretic-induced sodium loss may reduce lithium clearance and increase serum lithium concentrations . Intervention: More frequent monitoring of serum electrolyte and lithium concentrations. Reduce lithium dosage based on serum lithium concentration and clinical response [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 )]. Non-Steroidal Anti-inflammatory Drugs (NSAID) Clinical Impact: NSAID decrease renal blood flow, resulting in decreased renal cleara…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: • Acute Lithium Toxicity [see Warnings and Precautions ( 5.1 )] • Lithium-Induced Polyuria [see Warnings and Precautions ( 5.2 )] • Hyponatremia [see Warnings and Precautions ( 5.3 )] • Lithium-Induced Chronic Kidney Disease [see Warnings and Precautions ( 5.4 )] • Encephalopathic Syndrome [see Warnings and Precautions ( 5.5 )] • Serotonin Syndrome [see Warnings and Precautions ( 5.6 )] • Hypothyroidism or Hyperthyroidism [see Warnings and Precautions ( 5.7 )] • Hypercalcemia and Hyperparathyroidism [see Warnings and Precautions ( 5.8 )] • Unmasking of Brugada Syndrome [see Warnings and Precautions ( 5.9 )] • Pseudotumor Cerebri [see Warnings and Precautions ( 5.10 )] Common Adverse Reactions: • Adult Patients: fine hand tremor, polyuria, mild thirst, nausea, general discomfort during initial treatment ( 6 ) • Pediatric Patients (7 to 17 years): nausea/vomiting, polyuria, thyroid abnormalities, tremor, thirst/polydipsia, dizziness, rash/dermatitis, ataxia/gait disturbance, decreased appetite, and blurry vision ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limite…

Frequently Asked Questions

What is lithium carbonate used for?

Lithium Carbonate is a prescription medication taken by mouth as a capsule to treat bipolar disorder, helping to reduce mood swings and stabilize moods. Your doctor will determine the right dose for you based on your individual needs and blood test results.

Is lithium carbonate a controlled substance?

lithium carbonate is not classified as a controlled substance by the DEA.

What is the generic name for lithium carbonate?

The generic name for lithium carbonate is lithium carbonate. There are 9 other brand versions of lithium carbonate.

What is the NDC code for lithium carbonate 150 mg/1?

The NDC (National Drug Code) for lithium carbonate 150 mg/1 is 31722-544, listed by Camber Pharmaceuticals, Inc..

Product NDC

31722-544

Package NDC

31722-544-01

Other Lithium Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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