PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Lithium Carbonate

GENERIC: Lithium Carbonate

DOSAGE: CAPSULE, GELATIN COATED

ADMINSTRATION: ORAL

NDC: 70518-1434-0

NDC: 70518-1434-1

NDC: 70518-1434-2

COLOR: white

SHAPE: CAPSULE

SCORE: No score

SIZE: 12 mm

IMPRINT: 54;213

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

LITHIUM CARBONATE 150mg in 1

INACTIVE INGREDIENT(S):

TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
AMMONIA
ALCOHOL
FERROSOFERRIC OXIDE
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC

MM1

MM2

MM3

DESCRIPTION SECTION

11 DESCRIPTION

Eachtablet for oral administration contains lithium carbonate USP, 300 mg and the following inactive ingredients: calcium stearate, microcrystalline cellulose, povidone, purified water, sodium lauryl sulfate, and sodium starch glycolate.

Eachcapsule for oral administration contains lithium carbonate USP, 150 mg, 300 mg or 600 mg and the following inactive ingredient: talc. The capsule shells contain black monogramming ink, FD&C Red No. 40 (300 mg and 600 mg only), gelatin and titanium dioxide. The black monogramming ink contains ammonium hydroxide, ethanol, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze.

Each 5 mL ofsolution for oral administration contains lithium ion (Li+), 8 mEq (equivalent to amount of lithium in 300 mg of lithium carbonate), alcohol 0.3% v/v and the following other inactive ingredients: citric acid, purified water, raspberry blend, sodium benzoate and sorbitol solution.

Lithium Oral Solution is a palatable oral dosage form of lithium ion. It is prepared in solution from lithium hydroxide and citric acid in a ratio approximately di-lithium citrate.

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.

The empirical formula for Lithium Citrate is C 6H 5Li 3O 7; molecular weight 209.93. Lithium acts as an antimanic.

Lithium Carbonate USP is a granular, white powder with molecular formula Li 2CO 3 and molecular weight 73.89.

INDICATIONS & USAGE SECTION

Highlight: 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)

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)]

DOSAGE FORMS & STRENGTHS SECTION

Highlight: * Capsules: 150 mg of lithium carbonate ( 3)

3 DOSAGE FORMS AND STRENGTHS

Each 150 mg capsule for oral administration contains: lithium carbonate USP and is an opaque, white capsule, imprinted with product identification “54 213” on both the cap and the body and containing a white powder.

CONTRAINDICATIONS SECTION

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

4 CONTRAINDICATIONS

Lithium is contraindicated in patients with known hypersensitivity to any inactive ingredient in the lithium carbonate tablet or capsule or lithium citrate products [see Adverse Reactions ( 6)].

BOXED WARNING SECTION

WARNING: LITHIUM TOXICITY

See full prescribing information for complete boxed warning.

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 therapy (2.3,5.1).

CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

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

Difference (drug minus placebo) in least-squares mean change from baseline. † Patients analyzed by received treatment. ‡ Lithium to placebo.
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 * (95% CI)
Acute Efficacy	Lithium:	53	29.5 (5.6)	-12.9 (3.1)	-5.5 (-10.5, -0.5)
Placebo:	28	30.0 (6.0)	-7.3 (3.1)
Analysis	Treatment Group †	All-cause Discontinuation
N	Number of Discontinued Subjects	Hazard Ratio ‡ (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.

OVERDOSAGE SECTION

10 OVERDOSAGE

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.

INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

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.

SerotoninSyndrome:

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)] .

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SPL MEDGUIDE SECTION

Medication Guide

MEDICATION GUIDE Lithium (LITH-ee-əm) oral solution Lithium Carbonate tablets Lithium Carbonate capsules
What is the most important information I should know about Lithium and Lithium Carbonate? Lithium and Lithium Carbonate 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 or Lithium Carbonate exactly as your healthcare provider tells you to take it.Stop taking Lithium and Lithium Carbonate and call your healthcare provider right away if you have any symptoms of lithium toxicity including:
abnormal heartbeat	vomiting	diarrhea	drowsiness
weak muscles	blurred vision	clumsiness	ringing in your ears
muscle twitching
Other symptoms may include:
lightheadedness	confusion
bloating	mood changes
slurred speech	breathing problems
seizure	coma
What is Lithium and Lithium Carbonate? Lithium and Lithium Carbonate 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 and Lithium Carbonate are safe and effective in children under 7 years of age with bipolar I disorder.
Who should not take Lithium or Lithium Carbonate? Do not take Lithium or Lithium Carbonate if you are allergic to Lithium or any of the ingredients in Lithium Carbonate or Lithium Citrate. See the end of this Medication Guide for a complete list of ingredients in Lithium and Lithium Carbonate.
What should I tell my healthcare provider before taking Lithium or Lithium Carbonate? Before taking Lithium or Lithium Carbonate, 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 and Lithium Carbonate may harm your unborn baby.
are breastfeeding or plan to breastfeed. Lithium and Lithium Carbonate can pass into your breastmilk and may harm your baby. You should not breastfeed during treatment with Lithium or Lithium Carbonate. Talk to your healthcare provider about the best way to feed your baby if you take Lithium or Lithium Carbonate.
Tell your healthcare provider about all the medicines you take,including prescription, over-the-counter medicines, vitamins, and herbal supplements. Using Lithium and Lithium Carbonate with certain other medicines may affect each other causing possible side effects. Lithium and Lithium Carbonate may affect the way other medicines work, and other medicines may affect how Lithium and Lithium Carbonate works. Especially tell your healthcare provider if you take:
MAOIs	selective serotonin reuptake inhibitors (SSRIs)
serotonin norepinephrine reuptake inhibitors (SNRIs)	medicines used to treat migraine headaches called triptans
tricyclic antidepressants	fentanyl
antipsychotic medicines	tramadol
tryptophan	buspirone
St. John’s Wort
Your healthcare provider can tell you if it is safe to take Lithium or Lithium Carbonate with your other medicines.Do not start or stop any medicines while taking Lithium or Lithium Carbonate 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 and Lithium Carbonate?
Take your Lithium and Lithium Carbonate exactly as prescribed by your healthcare provider.
Your healthcare provider will do certain blood tests before starting and during treatment with Lithium and Lithium Carbonate.
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 or Lithium Carbonate suddenly without talking to your healthcare provider.
Your healthcare provider may change your Lithium or Lithium Carbonate dose to make sure you are taking the dose that is right for you.
If you take too much Lithium or Lithium Carbonate, 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 or Lithium Carbonate?
*Do not drive, operate heavy machinery, or do other dangerous activities when you start taking Lithium or Lithium Carbonate, when your dose is changed, or until you know how Lithium or Lithium Carbonate affects you. Lithium or Lithium Carbonate 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 or Lithium Carbonate in your blood.
What are the possible side effects of Lithium and Lithium Carbonate? See “What is the most important information I should know about Lithium and Lithium Carbonate?” Lithium and Lithium Carbonate may cause serious side effects, including:
*kidney problems.People who take Lithium or Lithium Carbonate 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 or Lithium Carbonate or after taking Lithium or Lithium Carbonate for a long time.
*low levels of sodium (salt) in your blood (hyponatremia).Lithium and Lithium Carbonate can cause you to lose sodium. Talk to your healthcare provider about your diet and how much fluid you are drinking when starting Lithium or Lithium Carbonate. 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 or Lithium Carbonate 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 or Lithium Carbonate while you take certain medicines called serotonergic and MAOIs. Symptoms of serotonin syndrome include:
agitation	seeing things that are not there	confusion
coma	rapid pulse	high or low blood pressure
dizziness	sweating	flushing
fever	tremors	stiff muscles
muscle twitching	become unstable	seizures
nausea	vomiting	diarrhea
*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 or Lithium Carbonate.
*heart problems. People who take Lithium or Lithium Carbonate 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 side effects of Lithium and Lithium Carbonate, 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 and Lithium Carbonate. 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 and Lithium Carbonate? Store Lithium and Lithium Carbonate at room temperature, between 68°F to 77°F (20°C to 25°C). Keep capsules and tablets dry and keep in a tightly closed container. Keep Lithium, Lithium Carbonate, and all medicines out of the reach of children.
General information about the safe and effective use of Lithium and Lithium Carbonate. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lithium or Lithium Carbonate for a condition for which it was not prescribed. Do not give Lithium or Lithium Carbonate to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Lithium or Lithium Carbonate that is written for healthcare professionals. For more information about Lithium and Lithium Carbonate, please call West- Ward Pharmaceuticals Corp. at 1-800-962-8364.
What are the ingredients in Lithium and Lithium Carbonate? Active ingredient: lithium carbonate, USP (tablets and capsules) and lithium citrate (oral solution). Inactive ingredients: Tablets: calcium stearate, microcrystalline cellulose, povidone, purified water, sodium lauryl sulfate, and sodium starch glycolate. Capsules: talc. The capsule shells contain black monogramming ink, FD&C Red No. 40 (300 mg and 600 mg only), gelatin and titanium dioxide. The black monogramming ink contains ammonium hydroxide, ethanol, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Oral solution: alcohol 0.3%, citric acid, purified water, raspberry blend, sodium benzoate and sorbitol solution.

This Medication Guide has been approved by the U.S. Food and Drug Administration.	Revised 10 2020

10008909/10

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HOW SUPPLIED SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

Lithium Carbonate Capsules USP

150 mg supplied as opaque white capsules imprinted with product identification “54 213” on both caps and bodies and containing a white powder.

NDC: 70518-1434-00

NDC: 70518-1434-01

NDC: 70518-1434-02