lithium carbonate ER 450 mg tablet,extended release

Generic name:
Lithium controlled-release - oral

Pronunciation
(LITH-ee-um)

Brand name(s)
Eskalith CR , Lithobid

It is very important to have the right amount of lithium in your body. Too much lithium may lead to unwanted effects such as nausea, diarrhea, shaking of the hands, dizziness, twitching, seizures, trouble speaking, confusion, or increase in the amount of urine. Tell your doctor right away if these effects occur.

There is only a small difference between the correct amount of lithium and too much lithium. It is important that your doctor monitor you closely during treatment. Keep all medical and lab appointments while you are taking lithium.

This medication is used to treat manic-depressive disorder (bipolar disorder). It works to stabilize the mood and reduce extremes in behavior by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Some of the benefits of continued use of this medication include decreasing how often manic episodes occur and decreasing the symptoms of manic episodes such as exaggerated feelings of well-being, feelings that others wish to harm you, irritability, anxiousness, rapid/loud speech, and aggressive/hostile behaviors.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to reduce the risk of a certain type of headache (cluster headache).

There are different brands of this medication available. They may not have the same effects. Do not change brands without asking your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2-3 times daily. Take lithium with or immediately after meals to lessen stomach upset. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Drink 8 to 12 glasses (8 ounces or 240 milliliters each) of water or other fluid each day, and eat a healthy diet with normal amounts of salt (sodium) as directed by your doctor or dietician while taking this medication. Large changes in the amount of salt in your diet may change your lithium blood levels. Do not change the amount of salt in your diet unless your doctor tells you to do so.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. The dosage is based on your medical condition, lithium blood levels, and response to treatment. This medication works best if the amount of the drug in your body is kept at a constant level. Take this drug at evenly spaced intervals.

This medication must be taken exactly as prescribed. Keep taking lithium even if you feel well. Do not stop taking this drug without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Consult your doctor or pharmacist for more details.

Tell your doctor if your condition does not get better or if it gets worse. It may take 1 to 3 weeks to notice improvement in your condition.

See also Warning section.

Drowsiness, dizziness, tiredness, increased thirst, increased frequency of urination, weight gain, and mildly shaking hands (fine tremor) may occur. These should go away as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• diarrhea
• vomiting
• unsteady walk
• confusion
• trouble speaking
• blurred vision
• severe hand trembling (coarse tremor)
• vision changes (such as growing blind spot, vision loss)
• joint swelling/pain
• pain/discoloration of finger/toes
• cold hands/feet

Get medical help right away if you have any very serious side effects, including:

• severe dizziness
• fainting
• slow/fast/irregular heartbeat
• shortness of breath
• seizures

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms:

• fast heartbeat
• hallucinations
• loss of coordination
• severe dizziness
• severe nausea/vomiting/diarrhea
• twitching muscles
• unexplained fever
• unusual agitation/restlessness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking lithium, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart disease
• kidney disease
• urinary problems (such as difficulty urinating)
• underactive thyroid (hypothyroidism)
• seizures
• Parkinson's disease
• leukemia
• severe dehydration
• any infection with high fever
• a certain skin disorder (psoriasis)

Lithium treatment may rarely reveal an existing condition that affects the heart rhythm (Brugada syndrome). Brugada syndrome is an inherited, life-threatening heart problem that some people may have without knowing it. It can cause a serious (possibly fatal) abnormal heartbeat and other symptoms (such as severe dizziness, fainting, shortness of breath) that need medical attention right away. Brugada syndrome may cause death suddenly. Before starting lithium treatment, tell your doctor if you have any of the following risk factors:

• Brugada syndrome
• unexplained fainting
• family history of certain heart problems (Brugada syndrome, sudden unexplained death before 45 years old)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If heavy sweating or severe diarrhea occurs, check with your doctor right away how to best keep taking lithium. Take care in hot weather or during activities that cause you to sweat heavily such as during hot baths, saunas, or exercise.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using lithium. Lithium may harm an unborn baby. However, since untreated mental/mood problems (such as bipolar disorder) can harm a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. Instead, ask your doctor if a different medication would be right for you. If you are planning pregnancy, become pregnant, or think you may be pregnant, talk to your doctor right away about the risks and benefits of this medication.

Lithium passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of lithium from your body, which may affect how lithium works. Examples include ACE inhibitors (such as captopril, enalapril), ARBs (such as losartan, valsartan), NSAIDs (such as celecoxib, ibuprofen), "water pills" (diuretics such as hydrochlorothiazide, furosemide), other drugs for mental/mood conditions (such as chlorpromazine, haloperidol, thiothixene), among others. Your doctor may need to adjust your dose of lithium if you are on these medications.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Some examples are street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (such as SSRIs like fluoxetine/paroxetine, SNRIs like duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Eat a normal diet with an average amount of sodium. Consult your doctor or dietician for more details.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: diarrhea, vomiting, ringing in the ears, blurred vision, trouble walking, unusual drowsiness, seizures, shaking, loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as kidney/thyroid function, lithium and calcium blood levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is within 6 hours of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.