LithiumCarbonateEr

IMPORTANT: 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.

LITHIUM CONTROLLED-RELEASE – ORAL

(LITH-ee-um)

COMMON BRAND NAME(S): Eskalith CR, Lithobid

WARNING: 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, slurred speech, confusion, or increase in the amount of urine. Tell your doctor immediately if these effects occur.

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

USES: 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.

OTHER USES: 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 medication may also be used to prevent a certain type of headache (cluster headache).

HOW TO USE: 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. Therefore, take this drug at evenly spaced intervals.

This medication must be taken exactly as prescribed. It is important to continue 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 improve or if it worsens. It may take 1 to 3 weeks to notice improvement in your condition.

SIDE EFFECTS: 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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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, fever, unsteady walk, confusion, slurred speech, 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.

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: 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.

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

PRECAUTIONS: 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 (severe loss of body water), any infection with high fever, a certain skin disorder (psoriasis).

Lithium treatment may infrequently 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 cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

If heavy sweating or severe diarrhea occurs, check with your doctor immediately how to best continue 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).

This drug is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

Lithium passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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.

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

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: diarrhea, vomiting, ringing in the ears, blurred vision, trouble walking, unusual drowsiness, seizures, shaking, loss of consciousness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as kidney function, thyroid function, lithium and calcium blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember unless your next scheduled dose is within 6 hours. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: 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.

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.