The mechanism of action of lithium as a mood stabilizing agent is unknown.
After oral administration, lithium is reported to be completely absorbed in the upper gastrointestinal tract. Peak serum concentrations (T
max ) occur 0.25 to 3 hours after oral administration of immediate release preparations and 2 to 6 hours after sustained-release preparations.
The distribution space of lithium approximates that of total body water, and the plasma protein binding is negligible. After equilibrium, the apparent volume of distribution is 0.7 to 1 L/kg. Lithium is not metabolized.
Lithium is primarily excreted in urine, proportionally to its serum concentration. Lithium is filtered by the glomerulus, and 80% is reabsorbed by passive diffusion in the proximal tubule. The elimination half-life of lithium is approximately 18 to 36 hours. Lithium excretion in feces is insignificant.
There have been no long-term studies performed in animals to evaluate the carcinogenic potential of lithium.
There have been no adequate studies conducted to evaluate the mutagenic and genotoxic potential of lithium.
Impairment of Fertility
There have been no adequate studies performed in animals at current standards to evaluate the effect of lithium treatment on fertility. However, published studies in male mice and rats administered repeated daily dosing of lithium carbonate report adverse effects on male reproductive organs, decreased spermatogenesis and decreased testosterone levels. The clinical significance of these findings is not clear.
Lithium Carbonate Capsules, USP
Lithium Carbonate Capsules USP, 150 mg are white/white size ‘4’ hard gelatin capsules, imprinted with ’97’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 31722-544-30)
Bottles of 100 Capsules (NDC 31722-544-01)
Bottles of 500 Capsules (NDC 31722-544-05)
Bottles of 1000 Capsules (NDC 31722-544-10)
Lithium Carbonate Capsules USP, 300 mg are pink/pink size ‘1’ hard gelatin capsules, imprinted with ’98’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 31722-545-30)
Bottles of 100 Capsules (NDC 31722-545-01)
Bottles of 500 Capsules (NDC 31722-545-05)
Bottles of 1000 Capsules (NDC 31722-545-10)
Bottles of 5000 Capsules (NDC 31752- 545-50)
Blister Pack of 3×10′ s (NDC 31722-545-03)
Lithium Carbonate Capsules USP, 600 mg are pink/white size ‘0EL’ hard gelatin capsules, imprinted with ‘141’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 31722-546-30)
Bottles of 100 Capsules (NDC 31722-546-01)
Bottles of 500 Capsules (NDC 31722-546-05)
Bottles of 1000 Capsules (NDC 31722-546-10)
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight 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)].
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)].
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)].
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.
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)].
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)].
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)].
Advise pregnant women of the potential risk to a fetus and/or neonate [see Use in Specific Populations (8.1)].
Advise women that breastfeeding is not recommended during treatment with lithium [see Use in Specific Populations (8.2)].
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Hetero Labs Limited
Jeedimetla, Hyderabad — 500 055,
Lithium Carbonate (LITH ee um KAR-bo-nate)
What is the most important information I should know about lithium carbonate capsules?
Lithium Carbonate can cause serious side effects, including too much lithium in your blood (lithium toxicity).
Lithium toxicity can 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 exactly as your healthcare provider tells you to take it. Stop taking 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 • ear ringing
What is lithium carbonate capsules?
Lithium Carbonate is prescription medicines called mood-stabilizing agents used to treat manic episodes and as a long term treatment of bipolar disorder.
Lithium Carbonate is not for people with severe kidney problems.
It is not known if lithium carbonate is safe and effective in children.
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 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. Talk to your healthcare provider about the best way to feed your baby if you take lithium carbonate.
Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements.
Using lithium carbonate with certain other medicines may affect each other causing possible side effects. Lithium Carbonate may affect the way other medicines work, and other medicines may affect how lithium carbonate works.
Your healthcare provider can tell you if it is safe to take lithium carbonate with your other medicines. Do not start or stop any medicines while taking 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 carbonate capsules?
• Take your lithium carbonate exactly as prescribed by your healthcare provider. 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 suddenly without talking to your healthcare provider.
• Your healthcare provider may change your lithium carbonate dose to make sure you are taking the dose that is right for you.
• Your healthcare provider will do certain blood tests before and while you take lithium carbonate.
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, when your dose is changed, or until you know how lithium carbonate affects you. 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 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 may cause serious side effects, including:
• kidney problems. People who take 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 carbonate or after taking lithium carbonate for a long time.
• low levels of sodium (salt) in your blood (hyponatremia). 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 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 carbonate with certain other medicines called neuroleptics 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 while you take certain medicines called serotonergic and MAOIs. Symptoms of serotonin syndrome include:
o agitation o seeing things that are not there o confusion
o coma o rapid pulse o high or low blood pressure
o dizziness o sweating o flushing
o fever o tremors o stiff muscles
o muscle twitching o become unstable o seizures
o nausea o vomiting o 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 carbonate.
• heart problems. People who take 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 carbonate include hand trembling, increased thirst, nausea, and general discomfort when you start taking your medicine.
These are not all the possible side effects of lithium carbonate. For more information, ask your healthcare provider or pharmacist.
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 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, and all medicines out of the reach of children.
General information about the safe and effective use of Lithium Carbonate. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lithium carbonate for a condition for which it was not prescribed. Do not give lithium carbonate to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about lithium carbonate. If you would like more information about lithium carbonate, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about lithium carbonate that is written for healthcare professionals.
What are the ingredients in lithium carbonate capsules?
Active ingredient: lithium carbonate, USP
Inactive ingredients: gelatin, sodium lauryl sulfate, talc, titanium dioxide and the imprinting ink contains black iron oxide E172 dye, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
Hetero Labs Limited
Jeedimetla, Hyderabad — 500 055, India
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