Lithium Carbonate Full Prescribing Information

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Brand Name: Eskalith; Eskalith-Cr; Lithane; Lithobid; Lithonate; Lithotabs
Generic Name: Lithium Carbonate

Lithium is an antipsychotic, antimanic medication used in treatment of manic episodes associated with bipolar disorder. Uses, dosage, side effects of Lithium.

Outside U.S., Brand Names also known as: Calith; Camcolit; Carbolit; Carbolith; Ceglution; Ceglution 300; Duralith; Hypnorex; Hynorex Retard; Hyponrex; Lentolith; Licab; Licarb; Licarbium; Lidin; Lilipin; Lilitin; Limas; Liskonum; Lithan; Litheum; Litheum 300; Lithicarb; Lithionate; Lithizine; Lithocarb; Lithocap; Lithosun SR; Lithuril; Litilent; Manialit; Maniprex; Phanate; Phasal; Plenur; Priadel; Priadel Retard; Quilonium-R; Quilonorm Retardtabletten; Quilonum Retard; Teralithe; Theralite; Theralite 300

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Eskalith patient information (in plain English)

Description

Lithium is an antipsychotic, antimanic medication used for those with Affective Disorder, Bipolar; Bipolar Disorder; Depression; Mania. (Lithium medications may also go by the brand names: Eskalith, Eskalith-Cr, Lithane, Lithium, Lithobid, Lithonate, Lithotabs.)

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Pharmacology

Lithium is an element of the alkali-metal group. 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.

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Indications and Usage

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, lithium carbonate may produce a normalization of symptomatology within 1 to 3 weeks.

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Contraindications

Patients with severe cardiovascular or renal disease and those with evidence of severe debilitation or dehydration, sodium depletion, brain damage. Conditions requiring low sodium intake.

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Warnings

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels.

Lithium (Eskalith, Eskalith-Cr, Lithane, Lithium, Lithobid, Lithonate, Lithotabs ) 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).

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

Usage in Pregnancy & Nursing

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 Ebsteins 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.

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 Children:: 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 at this time.

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 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.

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Precautions

The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside.

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.

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 (2500-3000 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.

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Drug Interactions

Indomethacin and piroxicam have been reported to increase significantly, steady state plasma lithium levels. In some cases, lithium toxicity has resulted from such interactions. There is also some evidence that other nonsteroidal anti-inflammatory agents may have a similar effect. When such combinations are used, increased plasma lithium level monitoring is recommended. 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, 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 following drugs can lower serum lithium concentrations by increasing urinary lithium excretion acetazolamide, urea, xanthine preparations and alkalinizing agents such as sodium bicarbonate.

AVOID LARGE AMOUNTS OF caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. Avoid excessive sweating caused by hot weather, hot baths, saunas, or exercising.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes medicines that contain ibuprofen or naproxen; diuretics; carbamazepine; fluoxetine; fluvoxamine; paroxetine; sertraline; astemizole; terfenadine; risperidone; nonsteroidal anti-inflammatory drugs (NSAIDs); and medicine for behavioral, emotional, or mood changes; high blood pressure; and asthma. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

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

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 of without rash, cutaneous ulcers, angioedema

Autonomic: blurred vision, dry mouth, impotence/sexual dysfunction

Miscellaneous: fatigue, lethargy, transient scotomata, 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.

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Overdose

Signs and Symptoms

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

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

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.

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Dosage

Several days to weeks may pass before you feel the full benefit of this medicine. Do not stop taking this medicine with checking with your doctor. Keep all laboratory appointments while taking this medicine.

Check with your doctor before restricting your salt intake. After exercising, or if you have a fever, eat salty foods to replace sodium lost through sweating.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
  • Take this medicine everyday at evenly spaced intervals.
  • If you miss a dose of this medicine, 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.
  • Take this medicine with food or milk. Drinking extra fluids (8 to 12 glasses of water or other liquid) while you are taking this medicine is recommended.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

Immediate release capsules and tablets 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 or tablets to the lithium carbonate controlled release tablets, give the same total daily dose when possible. Most patients on maintenance therapy are stabilized on 900 mg daily (e.g., 450 mg lithium carbonate controlled release b.i.d). When the previous dosage of immediate release lithium is not a multiple of 450 mg, for example, 1500 mg, initiate lithium carbonate controlled release dosage at the multiple of 450 mg nearest to, but below, the original daily dose (i.e., 1350 mg). When the two doses are unequal, give the larger dose in the evening. In the above example, with a total daily dosage of 1350 mg, generally 450 mg lithium carbonate controlled release should be given in the morning and 900 mg lithium carbonate controlled release in the evening. If desired, the total daily dosage of 1350 mg can be given in three equal 450 mg lithium carbonate controlled release doses. 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 lithium carbonate controlled release doses in increments of 450 mg, immediate release capsules should be used.

Acute Mania: Optimal patient response to lithium carbonate can usually be established and maintained with 1800 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 1200 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., 8-12 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.

Children: 0.5 to 1.5 g/m(2) in divided doses for the acute phase; the maintenance dose should be adjusted to maintain lithium serum concentrations of 0.5 to 1.2 mmol/L. Dose in children should not exceed adult dose.

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How Supplied

Eskalith Capsules: Each capsule contains lithium carbonate, 300 mg.

Eskalith Controlled Release Tablets: Each scored tablet contains lithium carbonate, 450 mg.

Lithobid Tablets: 300 mg lithium carbonate

Lithium carbonate controlled release 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.

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Last updated: 03/2003

Eskalith patient information (in plain English)


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

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