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 [see Adverse Reactions ( 6 )].
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 ( 2.3 ), Warnings and Precautions ( 5.1 )].
Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see Adverse Reactions ( 6 )].
Each 150 mg capsule for oral administration contains: lithium carbonate, USP 150 mg and is a two piece light gray hard gelatin capsules (size ‘4’) imprinted with ‘150’ on the body and ‘G220’ on the cap. Each 300 mg capsule for oral administration contains: lithium carbonate, USP 300 mg and is a two piece pink hard gelatin capsules (size ‘2’) imprinted with ‘300’ on the body and ‘G221’ on the cap. Each 600 mg capsule for oral administration contains: lithium carbonate, USP 600 mg and is a two piece hard gelatin capsules (size ‘0’ elongated) pink colored cap and light gray colored body imprinted with ‘600’ on the body and ‘G222’ on the cap.
The toxic concentrations for lithium (≥ 1.5 mEq/L) are close to the therapeutic concentrations [see Warnings and Precautions ( 5.1 )]. At lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage. Treatment: For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org. No specific antidote for lithium poisoning is known. Mild symptoms of lithium toxicity can usually be treated by reduction in dose or cessation of the drug. In severe cases of lithium poisoning, the goal of treatment is elimination of this ion from the patient. Administration of gastric lavage should be performed, but use of activated charcoal is not recommended as it does not significantly absorb lithium ions. Hemodialysis is the treatment of choice as it is an effective and rapid means of removing lithium in patients with severe toxicity. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in lithium excretion. Appropriate supportive care for the patient should be undertaken. Patients with impaired consciousness should have their airway protected and it is critical to correct any volume depletion or electrolyte imbalance. Patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance. Serum lithium concentrations should be closely monitored as there may be a rebound in serum lithium concentrations as a result of delayed diffusion from the body tissues. Likewise, during the late recovery phase, lithium should be re-administered with caution taking into account the possible release of significant lithium stores in body tissues.
Lithium Carbonate Capsules, USP 150 mg supplied as light gray hard gelatin capsules imprinted with ‘150’ on the body and ‘G220’ on the cap, filled with white to off-white granules. 300 mg supplied as pink hard gelatin capsules imprinted with ‘300’ on the body and ‘G221’ on the cap, filled with white to off-white granules. Blistecards of 30 NDC 0615-8480-39 600 mg supplied as hard gelatin capsules, pink cap imprinted with ‘G222’ and light gray body imprinted with ‘600’, filled with white to off-white granules. Storage and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.
| Class | Version | Type | Effective |
|---|---|---|---|
| LITHIUM CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b3053bb1-353b-4a0b-bca5-28fe7228957c | Product name | 2 | 20250124 |
| 8ce6e144-236f-b7be-f690-f06e0c8c6bd3 | Product name | 2 | 20170725 |
| f09af6ee-c6dd-d0ce-77ad-93508bcdaced | Product name | 4 | 20161205 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0615-8480-39 | Lithium Carbonate | 30 in 1 BLISTER PACK | CAPSULE | 30 | 1 |
| Name | UNII | Kind |
|---|---|---|
| LITHIUM CARBONATE | 2BMD2GNA4V | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SHELLAC | 46N107B71O | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POTASSIUM HYDROXIDE | WZH3C48M4T | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
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 ( 2.3 ), Warnings and Precautions ( 5.1 )].
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)]
Each 150 mg capsule for oral administration contains: lithium carbonate, USP 150 mg and is a two piece light gray hard gelatin capsules (size ‘4’) imprinted with ‘150’ on the body and ‘G220’ on the cap. Each 300 mg capsule for oral administration contains: lithium carbonate, USP 300 mg and is a two piece pink hard gelatin capsules (size ‘2’) imprinted with ‘300’ on the body and ‘G221’ on the cap. Each 600 mg capsule for oral administration contains: lithium carbonate, USP 600 mg and is a two piece hard gelatin capsules (size ‘0’ elongated) pink colored cap and light gray colored body imprinted with ‘600’ on the body and ‘G222’ on the cap.
Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate capsule [see Adverse Reactions ( 6 )].
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 )]
The toxic concentrations for lithium (≥ 1.5 mEq/L) are close to the therapeutic concentrations [see Warnings and Precautions ( 5.1 )]. At lithium concentrations greater than 3 mEq/L, patients may progress to seizures, coma, and irreversible brain damage. Treatment: For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org. No specific antidote for lithium poisoning is known. Mild symptoms of lithium toxicity can usually be treated by reduction in dose or cessation of the drug. In severe cases of lithium poisoning, the goal of treatment is elimination of this ion from the patient. Administration of gastric lavage should be performed, but use of activated charcoal is not recommended as it does not significantly absorb lithium ions. Hemodialysis is the treatment of choice as it is an effective and rapid means of removing lithium in patients with severe toxicity. As an alternative option, urea, mannitol and aminophylline can induce a significant increase in lithium excretion. Appropriate supportive care for the patient should be undertaken. Patients with impaired consciousness should have their airway protected and it is critical to correct any volume depletion or electrolyte imbalance. Patients should be monitored to prevent hypernatremia while receiving normal saline and careful regulation of kidney function is of utmost importance. Serum lithium concentrations should be closely monitored as there may be a rebound in serum lithium concentrations as a result of delayed diffusion from the body tissues. Likewise, during the late recovery phase, lithium should be re-administered with caution taking into account the possible release of significant lithium stores in body tissues.
Each capsule for oral administration contains lithium carbonate, USP 150 mg, 300 mg or 600 mg and the following inactive ingredients: colloidal silicon dioxide, gelatin, sodium lauryl sulfate, talc, titanium dioxide, FD&C Blue No. 1, FD&C Red No. 40, D&C Yellow No. 10, and the imprinting ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer. Lithium Carbonate, USP is a white, crystalline powder with molecular formula Li 2 CO 3 and molecular weight 73.89.
The safety and efficacy of lithium as a treatment for acute manic or mixed episodes of bipolar I disorder in pediatric patients (ages 7 to ≤18 years) was demonstrated in an 8-week, randomized, placebo-controlled, parallel group study (NCT01166425). In this study, 81 patients with a Young Mania Rating Scale (YMRS) score of 20 or more were randomized to receive lithium or placebo in a 2:1 ratio. Patients weighing more than 30 kg started lithium at 300 mg three times daily (900 mg/day) and could increase their dose by 300 mg every 3 days. Patients weighing 20 to 30 kg started lithium at 300 mg twice daily (600 mg/day) and could increase their dose by 300 mg weekly. No patients weighing less than 20 kg were enrolled. Lithium (mean serum level 0.98 ± 0.47 mEq/L) was statistically significantly superior to placebo in decreasing acute mania or mixed states as measured by the YMRS (see Table 5). In a 28-week randomized withdrawal analysis, 31 pediatric patients stabilized on lithium were assigned to either continue lithium or switch to placebo. The group receiving lithium demonstrated superiority to those receiving placebo in all-cause discontinuation (see Table 5). Table 5: Primary Efficacy Results Analysis Treatment Group Change From Baseline at Week 8 in YMRS Summary Score N Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Difference 1 (95% CI) Acute Efficacy Lithium: 53 29.5 (5.6) -12.9 (3.1) -5.5 (-10.5, -0.5) Placebo: 28 30 (6) -7.3 (3.1) Analysis Treatment Group 2 All-cause Discontinuation N Number of Discontinued Subjects Hazard Ratio 3 (95% CI) Randomized Withdrawal Lithium: 17 7 (41.2%) 0.28 (0.10, 0.78) Placebo: 14 11 (78.6%) SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval. 1 Difference (drug minus placebo) in least-squares mean change from baseline. 2 Patients analyzed by received treatment. 3 Lithium to placebo.
Lithium Carbonate Capsules, USP 150 mg supplied as light gray hard gelatin capsules imprinted with ‘150’ on the body and ‘G220’ on the cap, filled with white to off-white granules. 300 mg supplied as pink hard gelatin capsules imprinted with ‘300’ on the body and ‘G221’ on the cap, filled with white to off-white granules. Blistecards of 30 NDC 0615-8480-39 600 mg supplied as hard gelatin capsules, pink cap imprinted with ‘G222’ and light gray body imprinted with ‘600’, filled with white to off-white granules. Storage and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, child-resistant container as defined in the USP/NF.
Advise the patient to read FDA-approved patient labeling (Medication Guide). Dosage and Administration: Advise patients that lithium is a mood stabilizer, and should only be taken as directed. Emphasize the importance of compliance with the prescribed treatment and to not adjust the dose of lithium without first consulting their healthcare provider. Inform patients that they will need to have regular blood draws to determine if their dose of lithium is appropriate. Instruct patients not to double the dose if a dose is missed, due to the complexity of individualized dosing and potential for lithium toxicity [see Dosage and Administration ( 2 ), Warnings and Precautions ( 5.1 )]. Lithium Toxicity: Inform patients on adverse reactions related to lithium toxicity that require medical attention. Advise patients to discontinue lithium treatment and contact their healthcare provider if clinical signs of lithium toxicity such as diarrhea, vomiting, tremor, lack of muscle coordination, drowsiness, abnormal heart rhythm or muscular weakness occur [see Warnings and Precautions ( 5.1 )] . Lithium-Induced Polyuria: Counsel patients on the adverse reactions related to lithium-induced polyuria, when to seek medical attention, and the importance of maintaining normal diet with salt and staying hydrated [see Warnings and Precautions ( 5.2 )] . Hyponatremia: Counsel patients on the adverse reactions of hyponatremia, when to seek medical attention, the importance of maintaining a normal diet including adequate salt intake and staying hydrated [see Warnings and Precautions ( 5.3 )] . Salt supplements and additional fluids may be required if excessive losses occur. Serotonin Syndrome: Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of lithium with other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, tramadol, tryptophan, buspirone, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions ( 5.6 ) and Drug Interactions ( 7 )] . Drug Interactions: Advise patients that many drugs can interact with lithium and to inform their doctor and pharmacist if they are taking any over the counter medication, including herbal medication, or are started on a new prescription [see Drug Interactions ( 7 )] . Somnolence: Tell patients that lithium may cause somnolence particularly when initiating treatment and to be cautious about operating vehicles or hazardous machinery, until they are reasonably certain that lithium treatment does not affect them adversely [see Adverse Reactions ( 6 )] . Pregnancy: Advise pregnant women of the potential risk to a fetus and/or neonate [see Use in Specific Populations ( 8.1 )] . Lactation: Advise women that breastfeeding is not recommended during treatment with lithium [see Use in Specific Populations ( 8.2 )] . Medication Guide available at www.glenmarkpharma-us.com/medguides Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com November 2022
Lithium ( LITH-ee-əm ) Carbonate capsules, USP What is the most important information I should know about lithium carbonate capsules? Lithium carbonate capsules can cause serious side effects, including: too much lithium in your blood (lithium toxicity). Lithium toxicity that can cause death may happen even if the lithium level in your blood is close to the right level for you. Your healthcare provider will need to monitor your blood levels of lithium to find the best dose for you. Take your lithium carbonate capsules exactly as your healthcare provider tells you to take it. Stop taking lithium carbonate capsules and call your healthcare provider right away if you have any symptoms of lithium toxicity including: Other symptoms may include: What are lithium carbonate capsules? Lithium carbonate capsules are prescription medicines called mood-stabilizing agents used alone (monotherapy) for: the acute (short-term) treatment of people 7 years of age and older with manic and mixed episodes that happen with bipolar I disorder. maintenance treatment of bipolar I disorder in people 7 years of age and older. It is not known if lithium carbonate capsules are safe and effective in children under 7 years of age with bipolar I disorder. Who should not take lithium carbonate capsules? Do not take lithium carbonate capsules if you are allergic to lithium or any of the ingredients in lithium carbonate capsules. See the end of this Medication Guide for a complete list of ingredients in lithium carbonate capsules. What should I tell my healthcare provider before taking lithium carbonate capsules? Before taking lithium carbonate capsules, tell your healthcare provider if you: have kidney problems have heart problems have breathing problems have thyroid problems are pregnant or plan to become pregnant. Lithium carbonate may harm your unborn baby. are breastfeeding or plan to breastfeed. Lithium carbonate can pass into your breastmilk and may harm your baby. You should not breastfeed during treatment with lithium carbonate capsules. Talk to your healthcare provider about the best way to feed your baby if you take lithium carbonate capsules. Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Using lithium carbonate capsules with certain other medicines may affect each other causing possible side effects. Lithium carbonate capsules may affect the way other medicines work, and other medicines may affect how lithium carbonate capsules works. Especially tell your healthcare provider if you take: Your healthcare provider can tell you if it is safe to take lithium carbonate capsules with your other medicines. Do not start or stop any medicines while taking lithium carbonate capsules without talking to your healthcare provider first. Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. How should I take lithium carbonate capsules? Take your lithium carbonate capsules exactly as prescribed by your healthcare provider. Your healthcare provider will do certain blood tests before starting and during treatment with lithium carbonate capsules. Your healthcare provider may change your dose if needed. Do not change your dose on your own. Do not double your dose if a dose is missed. Talk with your healthcare provider if you miss a dose. Do not stop taking lithium carbonate capsules suddenly without talking to your healthcare provider. Your healthcare provider may change your lithium carbonate capsules dose to make sure you are taking the dose that is right for you. If you take too much lithium carbonate capsules, call your healthcare provider or poison control center, or go to the nearest hospital emergency room right away. In case of poisoning, call your poison control center at 1-800-222-1222. What should I avoid while taking lithium carbonate capsules? Do not drive, operate heavy machinery, or do other dangerous activities when you start taking lithium carbonate capsules, when your dose is changed, or until you know how lithium carbonate capsules affects you. Lithium carbonate capsules can make you sleepy. Talk to your healthcare provider about these activities. Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your healthcare provider instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough. Do not change the amount of salt in your diet. Changing the amount of salt in your diet could change the amount of lithium carbonate in your blood. What are the possible side effects of lithium carbonate capsules? See “What is the most important information I should know about lithium carbonate capsules? Lithium carbonate capsules may cause serious side effects, including: kidney problems. People who take lithium carbonate capsules may have to urinate often (polyuria) and have other kidney problems that may affect how their kidneys work. These problems can happen within a few weeks of starting to take lithium carbonate capsules or after taking lithium carbonate capsules for a long time. low levels of sodium (salt) in your blood (hyponatremia). Lithium carbonate capsules can cause you to lose sodium. Talk to your healthcare provider about your diet and how much fluid you are drinking when starting lithium carbonate capsules. If you have been sweating more than usual or have had diarrhea, you may need extra salt and more fluids. Talk to your healthcare provider if this happens. neurological problems. People who take lithium carbonate capsules with certain other medicines called antipsychotics may have symptoms such as weakness, tiredness, fever, tremors, and confusion. Talk to your healthcare provider if this happens. Ask if you are not sure about the medicines you take. serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take lithium carbonate capsules while you take certain medicines called serotonergic and MAOIs. Symptoms of serotonin syndrome include: thyroid problems. high calcium levels in your blood (hypercalcemia) and changes in your parathyroid gland (hyperparathyroidism) that may not go away when you stop taking lithium carbonate capsules. heart problems. People who take lithium carbonate capsules may find out they also have a heart problem called Brugada Syndrome. People who have unexplained fainting or who have a family history of sudden unexplained death before 45 years of age may have Brugada Syndrome and not know it. If you faint or feel abnormal heartbeats, talk to your healthcare provider right away. increased pressure in the brain and swelling in the eye (pseudotumor cerebri) that can cause vision problems or blindness. If you have severe headaches behind your eyes, ringing in the ears, blurred vision, double vision, or brief periods of blindness, talk to your health care provider right away. The most common sideeffects of lithium carbonate capsules include: Adults with manic or mixed episodes of bipolar I disorder: hand trembling excessive urination increased thirst nausea general discomfort when you start treatment Children 7 to 17 years of age with manic or mixed episodes of bipolar I disorder: excessive urination thyroid problems hand trembling excessive thirst dizziness rash difficulty walking decreased appetite blurred vision nausea vomiting These are not all the possible side effects of lithium carbonate capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store lithium carbonate capsules? Store lithium carbonate capsules at room temperature, between 68°F to 77°F (20°C to 25°C). Keep capsules dry and keep in a tightly closed container. Keep lithium carbonate capsules, and all medicines out of the reach of children. General information abo...