ESKALITH contains lithium carbonate, a white, light alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer.

ESKALITH Capsules: Each capsule, with opaque gray cap and opaque yellow body, is imprinted with the product name ESKALITH and SB and contains lithium carbonate, 300 mg. Inactive ingredients consist of benzyl alcohol, cetylpyridinium chloride, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, titanium dioxide, and trace amounts of other inactive ingredients.

ESKALITH CR Controlled-Release Tablets: Each round, yellow, biconvex tablet, debossed with SKF and J10 on one side and scored on the other side, contains lithium carbonate, 450 mg. Inactive ingredients consist of alginic acid, gelatin, iron oxide, magnesium stearate, and sodium starch glycolate.

ESKALITH CR Tablets 450 mg are designed to release a portion of the dose initially and the remainder gradually; the release pattern of the controlled release tablets reduces the variability in lithium blood levels seen with the immediate release dosage forms.

Last updated on RxList: 8/20/2007

ESKALITH (lithium carbonate) is indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness and possibly hostility. When given to a patient experiencing a manic episode, ESKALITH may produce a normalization of symptomatology within 1 to 3 weeks.

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.

ESKALITH Capsules 300 mg are gray and yellow capsules imprinted with "ESKALITH" and "SB" on one side of each half of the capsule, in bottles of 100 (NDC 0007-4007-20).

ESKALITH CR Tablets 450 mg are round, yellow, biconvex, controlled-release tablets, debossed with "SKF" and "J10" on one side and scored on the other side, in bottles of 100 (NDC 0007-4010-20).

STORAGE CONDITIONS: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured by: Cardinal Health., Winchester, KY 40391 for GlaxoSmithKline., Research Triangle Park, NC 27709. September 2003
FDA rev date: 03/11/2004

Last updated on RxList: 8/20/2007

The occurrence and severity of adverse reactions are generally directly related to serum lithium concentrations as well as to individual patient sensitivity to lithium, and generally occur more frequently and with greater severity at higher concentrations.

Adverse reactions may be encountered at serum lithium levels below 1.5 mEq/L. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq/L, and moderate to severe reactions may be seen at levels of 2.0 mEq/L and above.

Fine hand tremor, polyuria, and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration.

These side effects usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, cessation of lithium therapy may be required.

Diarrhea, vomiting, drowsiness, muscular weakness, and lack of coordination may be early signs of lithium intoxication, and can occur at lithium levels below 2.0 mEq/L. At higher levels, ataxia, giddiness, tinnitus, blurred vision, and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/L may produce a complex clinical picture, involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/L during the acute treatment phase.

The following reactions have been reported and appear to be related to serum lithium levels, including levels within the therapeutic range:

Neuromuscular/Central Nervous System: Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreo-athetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes, myasthenia gravis (rarely).

Cardiovascular: Cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia (which may result in syncope).

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion.

Genitourinary: Glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst and polydipsia.

Dermatologic: Drying and thinning of hair, alopecia, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with or without rash, cutaneous ulcers, angioedema.

Autonomic: Blurred vision, dry mouth, impotence/sexual dysfunction.

Thyroid Abnormalities: Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4. I131 uptake may be elevated. (See PRECAUTIONS.) Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes: Diffuse slowing, widening of the frequency spectrum, potentiation and disorganization of background rhythm.

EKG Changes: Reversible flattening, isoelectricity or inversion of T-waves. Miscellaneous: Fatigue, lethargy, transient scotomata, exophthalmos, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypercalcemia, hyperparathyroidism, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism, and hypothyroidism which persist after lithium discontinuation have been received.

A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment with lithium. The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known. Recovery followed discontinuance.

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields, and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs.

Caution should be used when lithium and diuretics are used concomitantly because diuretic-induced sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. Patients receiving such combined therapy should have serum lithium levels monitored closely and the lithium dosage adjusted if necessary.

Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other nonsteroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg b.i.d. with celecoxib 200 mg b.i.d. as compared to subjects receiving lithium alone.

Concurrent use of metronidazole with lithium may provoke lithium toxicity due to reduced renal clearance. Patients receiving such combined therapy should be monitored closely.

There is evidence that angiotensin-converting enzyme inhibitors, such as enalapril and captopril, and angiotension II receptor antagonists, such as losartan, may substantially increase steady-state plasma lithium levels, sometimes resulting in lithium toxicity. When such combinations are used, lithium dosage may need to be decreased, and plasma lithium levels should be measured more often.

Concurrent use of calcium channel blocking agents with lithium may increase the risk of neurotoxicity in the form of ataxia, tremors, nausea, vomiting, diarrhea, and/or tinnitus. Caution is recommended.

The concomitant administration of lithium with selective serotonin reuptake inhibitors should be undertaken with caution as this combination has been reported to result in symptoms such as diarrhea, confusion, tremor, dizziness, and agitation.

The following drugs can lower serum lithium concentrations by increasing urinary lithium excretion: acetazolamide, urea, xanthine preparations, and alkalinizing agents such as sodium bicarbonate.

The following have also been shown to interact with lithium: methyldopa, phenytoin, and carbamazepine.

Last updated on RxList: 8/20/2007

Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephron atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in manic-depressive patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy have not been established.

When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e.g., urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e.g., serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus a neuroleptic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of lithium and neuroleptics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (See DOSAGE AND ADMINISTRATION).

Outpatients and their families should be warned that the patient must discontinue lithium carbonate therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur.

Lithium carbonate may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.

Usage in Pregnancy: Adverse effects on implantation in rats, embryo viability in mice and metabolism in vitro of rat testes and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice.

In humans, lithium carbonate may cause fetal harm when administered to a pregnant woman. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein's anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Usage in Nursing Mothers: Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Usage in Pediatric Patients: Since information regarding the safety and effectiveness of lithium carbonate in children under 12 years of age is not available, its use in such patients is not recommended.

There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of lithium carbonate.

Usage in the Elderly: Elderly patients often require lower lithium dosages to achieve therapeutic serum levels. They may also exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.

General: The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (See DOSAGE AND ADMINISTRATION).

The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2,500 to 3,000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered under careful medical supervision and lithium intake reduced or suspended until the condition is resolved.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any; where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used.

Last updated on RxList: 8/20/2007

The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early toxic symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS.

Treatment: No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient. Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance, and 3) regulation of kidney function. Urea, mannitol and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays and preservation of adequate respiration are essential.

No information provided.

Last updated on RxList: 8/20/2007

ACTIONS

Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown.

Last updated on RxList: 8/20/2007

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 8/20/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

LITHIUM - ORAL

(LITH-ee-um)

COMMON BRAND NAME(S): Eskalith

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 drug may also be used to help treat or prevent episodes of depression.

HOW TO USE: Take this medication by mouth, usually 3-4 daily or as directed by your doctor. Take lithium with or immediately after meals to lessen stomach upset. Drink 8 to 12 glasses (8 ounces or 240 milliliters each) of water or other fluid each day, and maintain 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. 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. Continue taking lithium even if your symptoms are improved. Do not stop taking this drug suddenly without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped.

Tell your doctor if your condition persists or worsens. It may take 1 to 3 weeks to notice improvement in your condition.

SIDE EFFECTS: See also Warning section.

Drowsiness, 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 immediately if any of these unlikely but serious side effects occur: diarrhea, vomiting, fever, dizziness, unsteady walk, confusion, slurred speech, blurred vision, severe hand trembling (coarse tremor).

Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, vision changes (e.g., growing blind spot, vision loss), seizures, slow/fast/irregular heartbeat, joint swelling/pain, pain/discoloration of finger/toes, cold hands/feet.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, kidney disease, urinary problems (e.g., 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).

This drug may make you dizzy or drowsy or cause blurred vision. Use caution while driving, using machinery, or doing any activity that requires alertness or clear vision. 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 surgeon that you are using this medication.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the muscles, nervous system, thyroid, and kidneys.

This drug is not recommended for use during pregnancy because of possible harm to an unborn baby (e.g., heart problems, other birth defects). 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: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because a very serious interaction may occur: sibutramine.

If you are currently using this medication listed above, tell your doctor or pharmacist before starting lithium.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: acetazolamide, ACE inhibitors (e.g., captopril, enalapril, lisinopril), angiotensin receptor blockers (ARBs such as losartan, valsartan), bulk-producing laxatives (psyllium), calcium channel blockers (e.g. verapamil, diltiazem, nifedipine), other drugs for mental/mood conditions (e.g., chlorpromazine, haloperidol, thiothixene), methyldopa, metronidazole, nonsteroidal anti-inflammatory drugs (NSAIDs such as celecoxib, ibuprofen, indomethacin, naproxen, piroxicam), anti-seizure drugs (e.g., carbamazepine, phenytoin), SSRI antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine), theophylline, tricyclic antidepressants (e.g., amitriptyline), "water pills" (diuretics such as hydrochlorothiazide, furosemide).

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

Avoid products that contain sodium (such as sodium bicarbonate, an ingredient in some types of antacids).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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 (e.g., kidney function, thyroid function, lithium blood levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Not all brands of this medication are identical. Do not change brands without checking with your doctor or pharmacist first.

MISSED DOSE: If you miss a dose, take it as soon as you remember unless your next scheduled dose is within 4 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 moisture and light. Different forms of this medication have different storage temperatures. Consult your pharmacist or the product labeling for more information. Do not freeze liquid forms. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.