Eskalith

• Lithium is used for treating manic episodes due to bipolar disorder (manic-depressive illness).
• It also is combined with antidepressants to treat depression.

• Nonsteroidal anti-inflammatory drugs (NSAIDs), (for example, ibuprofen [Motrin, Advil], naproxen [Naprosyn, Aleve], indomethacin [Indocin], nabumetone [Relafen], diclofenac [Voltaren, Cataflam, Arthrotec], ketorolac [Toradol]), reduce the kidney's ability to eliminate lithium and lead to elevated levels of lithium in the blood andside effects from lithium. Blood concentrations of lithium may need to be measured for 4 to 7 days after an NSAID is either added or stopped during lithium therapy. Aspirin and sulindac (Clinoril) do not appear to affect lithium concentrations in the blood.
• Diuretics (water pills) should be used cautiously in patients receiving lithium. Diuretics that act at the distal renal tubule, (for example, hydrochlorothiazide [Hydrodiuril], spironolactone [Aldactone], triamterene [Dyrenium; Dyazide, Maxzide]), can increase blood concentrations of lithium. Diuretics that act at the proximal tubule, (for example, acetazolamide [Diamox]), are more likely to reduce blood concentrations of lithium. Diuretics such as furosemide (Lasix) and bumetanide (Bumex) may have no affect on lithium concentrations in blood.
• ACE inhibitors, (for example, enalapril [Vasotec], lisinopril [Zestril, Prinivil], benazepril [Lotensin], quinapril [Accupril], moexipril [Univasc], captopril [Capoten], ramipril [Altace]), may increase the risk of developing lithium toxicity by increasing the amount of lithium that is reabsorbed into the body in the tubules of the kidney and thereby reducing the excretion of lithium.
• When carbamazepine (Tegretol) and lithium are used together, some patients may experience side effects, including dizziness, lethargy, and tremor. Central nervous system side effects also may occur when lithium is used with antidepressants, (for example, fluoxetine [Prozac] sertraline [Zoloft], and paroxetine [Paxil], fluvoxamine [Luvox], amitriptyline [Elavil], imipramine [Tofranil], desipramine [Norpramin]). Combining lithium with monoamine oxidase inhibitor (MAOI) class of antidepressants (for example, isocarboxazid [Marplan], phenelzine [Nardil], tranylcypromine [Parnate], selegiline [Eldepryl], and procarbazine [Matulane]) or other drugs that inhibit monoamine oxidase (for example, linezolid [Zyvox]) may lead to serious reactions.
• Medications which cause the urine to become alkaline (the opposite of acidic) can increase the amount of lithium that is lost into the urine. This results in lower blood concentrations of lithium and reduces the effects of lithium. Such drugs include potassium acetate, potassium citrate (Urocit-K), sodium bicarbonate, and sodium citrate (Bicitra, Cytra-2, Liqui-Citra, Oracit, Shohl's).
• Caffeine appears to reduce serum lithium concentrations, and side effects of lithium have increased in frequency when caffeine is consumed.
• Both diltiazem (Cardizem-CD, Tiazac, Dilacor-XR) and verapamil (Calan-SR, Isoptin-SR, Verelan, Covera-HS) have been reported to have variable effects on lithium levels in blood. In some patients there may be decreased lithium blood levels and in others lithium toxicity.
• Methyldopa (Aldomet) may increase the likelihood of lithium toxicity.
• Various reactions have resulted when lithium is administered with phenothiazines, (for example, chlorpromazine [Thorazine], thioridazine [Mellaril], trifluoperazine [Stelazine] or with haloperidol [Haldol]). Such reactions have included delirium, seizures, encephalopathy, high fever or certain neurologic reactions that affect movement of muscles, called extrapyramidal symptoms.
• Lithium can cause goiter or hypothyroidism. The use of lithium with potassium iodide can increase the likelihood of this adverse reaction.
• The use of the beta blocker, propranolol (Inderal), with lithium can lead to a slow heart rate and dizziness. Other beta blockers, (for example, metoprolol [Lopressor], atenolol [Tenormin]) also may interact with lithium and be associated with a slow heart rate.

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Lithium, which comes as a tablet, capsule, extended-release tablet, and an oral liquid, should be taken at about the same times each day. Dosage varies, but most people require 900 to 2,400 milligrams (mg) of lithium daily.

The extended-release tablets are typically taken two to three times daily. The capsules, tablets, and liquid are usually taken three to four times daily.

Don’t split, chew, or crush the extended-release tablets. Swallow them whole. Use a special dose-measuring spoon or cup, not a regular tablespoon, when measuring the liquid form of lithium.

Use this medicine exactly as directed; do not take more or less of it.

Lithium Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately. You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Lithium

If you miss a dose of lithium, take it as soon as you remember.

However, if it’s almost time for your next dose, skip the missed dose and continue on your regular schedule. Don’t double up on doses to make up for a missed one.

>10%

Leukocytosis (most patients)

Polyuria/polydypsia (30-50%)

Dry mouth (20-50%)

Hand tremor (45% initially, 10% after 1 year of treatment)

Confusion (40%)

Decreased memory (40%)

Headache (40%)

Muscle weakness (30% initially, 1% after 1 year of treatment)

Electrocardiographic (ECG) changes (20-30%)

Nausea, vomiting, diarrhea (10-30% initially, 1-10% after 1-2 years of treatment)

Hyperreflexia (15%)

Muscle twitch (15%)

Vertigo (15%)

1-10%

Extrapyramidal symptoms, goiter (5%)

Hypothyroidism (1-4%)

Acne (1%)

Hair thinning (1%)

Frequency Not Defined

Coma

Lethargy

Seizures

Renal toxicity

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Many drugs can interact with lithium. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• carbamazepine;

• a diuretic or "water pill";

• fluoxetine (Prozac);

• metronidazole;

• potassium iodide thyroid medication;

• heart or blood pressure medication--benazepril, candesartan, captopril, diltiazem, enalapril, lisinopril, losartan, olmesartan, telmisartan, valsartan, verapamil, and others; or

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs can interact with lithium. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Shortness of breath.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Feeling confused.
• Hallucinations (seeing or hearing things that are not there).
• Memory problems or loss.
• Very upset stomach or throwing up.
• Loose stools (diarrhea).
• Too much sweat or fluid loss.
• Feeling very tired or weak.
• Restlessness.
• Trouble walking.
• Extra muscle action.
• Swelling in the feet or hands.
• A change in weight without trying.
• Slurred speech.
• Change in eyesight.
• Ringing in ears.
• Not able to control bladder.
• Not able to control bowels.
• Feeling sleepy.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Eskalith (lithium capsules and tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Eskalith. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION).

Immediate-release capsules are usually given t.i.d. or q.i.d. Doses of controlled-release tablets are usually given b.i.d. (approximately 12-hour intervals). When initiating therapy with immediate-release or controlled-release lithium, dosage must be individualized according to serum levels and clinical response.

When switching a patient from immediate-release capsules to Eskalith CR Controlled-Release Tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily, e.g., Eskalith CR 450 mg b.i.d. When the previous dosage of immediate-release lithium is not a multiple of 450 mg, e.g., 1,500 mg, initiate Eskalith CR at the multiple of 450 mg nearest to, but below, the original daily dose, i.e., 1,350 mg. When the 2 doses are unequal, give the larger dose in the evening. In the above example, with a total daily dose of 1,350 mg, generally 450 mg of Eskalith CR should be given in the morning and 900 mg of Eskalith CR in the evening. If desired, the total daily dose of 1,350 mg can be given in 3 equal 450-mg doses of Eskalith CR. These patients should be monitored at 1- to 2-week intervals, and dosage adjusted if necessary, until stable and satisfactory serum levels and clinical state are achieved.

When patients require closer titration than that available with doses of Eskalith CR in increments of 450 mg, immediate-release capsules should be used.

Acute Mania

Optimal patient response to Eskalith can usually be established and maintained with 1,800 mg per day in divided doses. Such doses will normally produce the desired serum lithium level ranging between 1.0 and 1.5 mEq/L.

Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient’s clinical state and serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control

The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 900 mg to 1,200 mg per day in divided doses will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients unusually sensitive to lithium may exhibit toxic signs at serum levels below 1.0 mEq/L.

N.B.: Blood samples for serum lithium determinations should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i.e., 8 to 12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by younger patients.

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) 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)

Excretion of this drug into breastmilk is highly variable. There have been reports of breastfed infants who have shown signs/symptoms associated with lithium toxicity (e.g., hypertonia, hypothermia, cyanosis, and ECG changes); this may occur more frequently in infants with elimination impairments (e.g., dehydration) or in newborn/premature infants.

Use is contraindicated (AU, UK) Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (US) Excreted into human milk: Yes Comments: -Bottle feeding is recommended due to the risk of lithium toxicity. -If breastfeeding is continued, monitoring of infant serum lithium, serum creatinine, blood urea nitrogen, and thyroid stimulating hormone levels are recommended.