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|Lithium Controlled-Release and Extended-Release Tablets

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Lithium Controlled-Release and Extended-Release Tablets

Generic Name: Lithium Controlled-Release and Extended-Release Tablets (LITH-ee-um)
Brand Name: Examples include Eskalith CR and Lithobid

Symptoms of toxicity may sometimes occur even with normal doses of Lithium Controlled-Release and Extended-Release Tablets. Do not exceed the recommended dose. Your doctor should monitor your blood lithium levels routinely to help prevent lithium toxicity. Contact your doctor immediately if you experience symptoms of toxicity such as nausea, diarrhea, vomiting, blurred vision, ringing in the ears, drowsiness, giddiness, muscle weakness, tremor, twitching, seizures, loss of consciousness, loss of coordination, or increased urination.

Lithium Controlled-Release and Extended-Release Tablets is used for:

Treating manic episodes in patients with bipolar disorder. It is also used to reduce the frequency and decrease the severity of manic episodes in patients with bipolar disorder. It may also be used for other conditions as determined by your doctor.

Lithium Controlled-Release and Extended-Release Tablets is an antimanic agent. Exactly how Lithium Controlled-Release and Extended-Release Tablets works is unknown, but it may work by altering the balance of certain chemicals in the brain.

Do NOT use Lithium Controlled-Release and Extended-Release Tablets if:

you are allergic to any ingredient in Lithium Controlled-Release and Extended-Release Tablets
you have moderate to severe kidney, heart, or blood vessel problems
you have low blood sodium levels
you are severely dehydrated, ill, or weakened
you are taking an angiotensin-converting enzyme (ACE) inhibitor (eg, enalapril) or a diuretic (eg, furosemide, hydrochlorothiazide)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lithium Controlled-Release and Extended-Release Tablets:

Some medical conditions may interact with Lithium Controlled-Release and Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have diarrhea, vomiting, excessive sweating, dehydration, fever, infection, or illness, or you are in a weakened state
if you have kidney, heart, blood vessel, or thyroid problems
if you have brain or nerve problems (eg, organic brain syndrome)
if you are on a low-salt diet

Some MEDICINES MAY INTERACT with Lithium Controlled-Release and Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Acetazolamide, urea, urinary alkalinizers (eg, sodium bicarbonate), or xanthines (eg, theophylline) because effectiveness of Lithium Controlled-Release and Extended-Release Tablets may be decreased
ACE inhibitors (eg, enalapril), angiotensin II receptor antagonists (eg, losartan), calcium channel blockers (eg, verapamil), carbamazepine, diuretics (eg, furosemide, hydrochlorothiazide), hydantoins (eg, phenytoin), methyldopa, metronidazole, nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin, celecoxib), or selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine) because risk of toxicity of Lithium Controlled-Release and Extended-Release Tablets may be increased
Butyrophenones (eg, haloperidol) or other medicines for mental or mood problems because the risk of serious side effects, such as confusion, involuntary muscle movements, fever, and brain damage, may be increased
Iodide preparations (eg, potassium iodide) because risk of low thyroid levels may be increased
Nondepolarizing neuromuscular blockers (eg, vecuronium) or succinylcholine because actions and side effects may be increased by Lithium Controlled-Release and Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lithium Controlled-Release and Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lithium Controlled-Release and Extended-Release Tablets:

Use Lithium Controlled-Release and Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Lithium Controlled-Release and Extended-Release Tablets after meals or with food or milk to decrease stomach upset.
Swallow Lithium Controlled-Release and Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Drinking extra fluids (10 to 12 full [8 oz/240 mL] glasses of water or other liquid per day) while you are taking Lithium Controlled-Release and Extended-Release Tablets is recommended.
Do not change your diet, including the amount of salt in your diet, unless instructed by your doctor.
If you miss a dose of Lithium Controlled-Release and Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lithium Controlled-Release and Extended-Release Tablets.

Important safety information:

Lithium Controlled-Release and Extended-Release Tablets may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lithium Controlled-Release and Extended-Release Tablets. Using Lithium Controlled-Release and Extended-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
Do not exceed the recommended dose of Lithium Controlled-Release and Extended-Release Tablets.
It may take 1 to 3 weeks for Lithium Controlled-Release and Extended-Release Tablets to work. Do not stop using Lithium Controlled-Release and Extended-Release Tablets without checking with your doctor.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Lithium Controlled-Release and Extended-Release Tablets.
Fever, infection, vomiting, diarrhea, or excessive sweating may affect the levels of Lithium Controlled-Release and Extended-Release Tablets in your blood. If you experience any of these conditions, contact your doctor. Talk to your doctor about how to replace the salt lost through sweating during exercise.
Do not change the amount of salt in your diet unless instructed by your doctor. Check with your doctor before restricting your salt intake. Tell your doctor if you are on a low-salt diet.
LAB TESTS, including blood lithium levels and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Lithium Controlled-Release and Extended-Release Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Use of Lithium Controlled-Release and Extended-Release Tablets is not recommended in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
PREGNANCY and BREAST-FEEDING: Lithium Controlled-Release and Extended-Release Tablets may cause harm to the fetus. If you think you may be pregnant, discuss with your doctor the benefits and risks of using Lithium Controlled-Release and Extended-Release Tablets during pregnancy. Lithium Controlled-Release and Extended-Release Tablets is excreted in breast milk. Do not breast-feed while you are taking Lithium Controlled-Release and Extended-Release Tablets.

Possible side effects of Lithium Controlled-Release and Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild hand tremor; mild thirst; temporary, mild nausea and general discomfort at the beginning of treatment.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; confusion; diarrhea; drowsiness; excessive weight gain; fainting; giddiness; inability to control the bladder or bowels; increased thirst; increased or decreased urination; involuntary twitching or muscle movements; loss of consciousness; loss of coordination; muscle weakness; persistent headache; persistent or severe nausea; ringing in the ears; seizures; slow or irregular heartbeat; slurred speech; swelling of the ankles or wrists; unsteadiness; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include blurred vision; diarrhea; drowsiness; giddiness; increased urination; loss of consciousness; loss of coordination; muscle weakness; nausea; ringing in the ears; seizures; tremor; twitching; vomiting.

Proper storage of Lithium Controlled-Release and Extended-Release Tablets:

Store Lithium Controlled-Release and Extended-Release Tablets at 77 degrees F (25 degrees C) in a tightly closed container. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, light, and moisture. Keep Lithium Controlled-Release and Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Lithium Controlled-Release and Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Lithium Controlled-Release and Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lithium Controlled-Release and Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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