Eskalith CR

Before taking lithium,

• tell your doctor and pharmacist if you are allergic to lithium or any other medications.
• tell your doctor if you are taking diuretics ('water pills'). Your doctor may tell you not to take lithium if you are taking this medication or will monitor you carefully for side effects.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); aminophylline; angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); angiotensin II receptor antagonists such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis); and valsartan (Diovan); antacids such as sodium bicarbonate; caffeine (found in certain medications to treat drowsiness and headaches); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan); carbamazepine (Tegretol); medications for mental illness such as haloperidol (Haldol); methyldopa (Aldomet); metronidazole (Flagyl); nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib (Celebrex), indomethacin (Indocin), and piroxicam (Feldene); potassium iodide; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); and theophylline (Theolair, Theochron). Your doctor may have to change the doses of your medication or monitor you more carefully for side effects.
• tell your doctor if you have or have ever had heart or kidney disease. Also tell your doctor if you have or develop severe diarrhea, excessive sweating, or fever during your treatment. Your doctor may tell you not to take lithium or may monitor you more carefully for side effects.
• tell your doctor if you have or have ever had organic brain syndrome (any physical condition that affects the way your brain works) or thyroid disease or if you have ever fainted without an explanation. Also tell your doctor if you or anyone in your family have or have ever had Brugada syndrome (a disorder that can cause a potentially fatal irregular heart rhythm) or if anyone in your family has died suddenly with no explanation before the age of 45 years.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking lithium, call your doctor. Lithium may harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lithium.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

It is important to follow a proper diet, including the right amounts of fluid and salt during your treatment. Your doctor will give you specific directions about the diet that is right for you. Follow these directions carefully.

Talk to your doctor about drinking drinks that contain caffeine, such as tea, coffee, cola, or chocolate milk.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Applies to lithium: oral capsule, oral solution, oral syrup, oral tablet, oral tablet extended release

Along with its needed effects, lithium (the active ingredient contained in Eskalith-CR) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lithium:

• Confusion, poor memory, or lack of awareness
• fainting
• fast or slow heartbeat
• frequent urination
• increased thirst
• irregular pulse
• stiffness of the arms or legs
• troubled breathing (especially during hard work or exercise)
• unusual tiredness or weakness
• weight gain

• Blue color and pain in the fingers and toes
• coldness of the arms and legs
• dizziness
• eye pain
• headache
• noise in the ears
• vision problems

• Dry, rough skin
• fast, irregular, pounding, or racing heartbeat or pulse
• hair loss
• hoarseness
• lightheadedness
• mental depression
• sensitivity to cold
• shortness of breath
• swelling of the feet or lower legs
• swelling of the neck
• unusual excitement

Get emergency help immediately if any of the following symptoms of overdose occur while taking lithium:

• Blurred vision
• clumsiness or unsteadiness
• convulsions (seizures)
• diarrhea
• drowsiness
• increase in the amount of urine
• lack of coordination
• loss of appetite
• muscle weakness
• nausea or vomiting
• ringing in the ears
• slurred speech
• trembling (severe)

Some side effects of lithium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acne or skin rash
• bloated feeling or pressure in the stomach
• muscle twitching (slight)

Acute Control:
-Usual dose: 1800 mg/day
-Extended release formulations: 900 mg orally in the morning and at nighttime
-Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime

Long-term Control:
-Maintenance dose: 900 to 1200 mg/day
-Extended release formulations: 600 mg orally in the morning and at nighttime
-Regular release formulations: 300 mg orally 3 to 4 times a day

Comments:
-Dosing must be individualized according to serum levels and the response to treatment.
-Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).

Uses:
-Treatment of manic episodes of bipolar disorder
-Maintenance treatment for individuals with bipolar disorder

12 years and older:
Acute Control:
-Usual dose: 1800 mg/day
-Extended release formulations: 900 mg orally in the morning and at nighttime
-Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime

Long-term Control:
-Maintenance dose: 900 to 1200 mg/day
-Extended release formulations: 600 mg orally in the morning and at nighttime
-Regular release formulations: 300 mg orally 3 to 4 times a day

Comments:
-Dosing must be individualized according to serum levels and the response to treatment.
-Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).
-Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of the episodes.

Uses:
-Treatment of manic episodes of bipolar disorder
-Maintenance treatment for individuals with bipolar disorder

12 years and older:
Acute Control:
-Usual dose: 1800 mg/day
-Extended release formulations: 900 mg orally in the morning and at nighttime
-Regular release formulations: 600 mg orally 3 times a day, in the morning, afternoon, and nighttime

Long-term Control:
-Maintenance dose: 900 to 1200 mg/day
-Extended release formulations: 600 mg orally in the morning and at nighttime
-Regular release formulations: 300 mg orally 3 to 4 times a day

Comments:
-Dosing must be individualized according to serum levels and the response to treatment.
-Alternative extended release formulation doses are 600 mg 3 times a day (acute control) and 300 mg 3 to 4 times a day (long-term control).
-Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of the episodes.

Uses:
-Treatment of manic episodes of bipolar disorder
-Maintenance treatment for individuals with bipolar disorder

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction:
-Immediate release formulations: Contraindicated
-Extended release formulations: Begin with lower doses and titrate slowly; closely monitor serum concentrations and signs/symptoms of lithium toxicity.

Any progressive/sudden change in renal function (even within the normal range): Reevaluate treatment

Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction:
-Immediate release formulations: Contraindicated
-Extended release formulations: Begin with lower doses and titrate slowly; closely monitor serum concentrations and signs/symptoms of lithium toxicity.

Any progressive/sudden change in renal function (even within the normal range): Reevaluate treatment