LITHIUM CARBONATE- lithium carbonate capsule

Stati Uniti - Ingliż - NLM (National Library of Medicine)

Ixtrih issa

Ingredjent attiv:
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)
Disponibbli minn:
Hikma Pharmaceutical
INN (Isem Internazzjonali):
LITHIUM CARBONATE
Kompożizzjoni:
LITHIUM CARBONATE 300 mg
Rotta amministrattiva:
ORAL
Tip ta 'preskrizzjoni:
PRESCRIPTION DRUG
Indikazzjonijiet terapewtiċi:
Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. 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 may produce a normalization of symptomatology within 1 to 3 weeks. Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatri
Sommarju tal-prodott:
Lithium Carbonate Capsules USP, 150 mg are supplied as No. 4 White/White Opaque Hard Gelatin Capsules Printed “West-ward 3188” in Black Ink and are available in: Bottles of 30 capsules              Bottles of 100 capsules            Bottles of 500 capsules   Lithium Carbonate Capsules USP, 300 mg are supplied as No. 1 Grey/Yellow Opaque Hard Gelatin Capsules Printed "West-ward 3189" in Black Ink and are available in: Bottles of 100 capsules Bottles of 1000 capsules          Lithium Carbonate Capsules USP, 600 mg are supplied as No. 0 White/Flesh Opaque Capsules Printed “West-ward 3190” in Black Ink and are available in: Bottles of 100 capsules                         Unit Dose Boxes of 100 capsules          Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: Hikma Pharmaceuticals P.O.Box 182400, Amman 11118-Jordan Distributed By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised June 2008
L-istatus ta 'awtorizzazzjoni:
Abbreviated New Drug Application
Numru ta 'awtorizzazzjoni:
59115-135-01, 59115-135-10

LITHIUM CARBONATE- lithium carbonate capsule

Hikma Pharmaceutical

----------

LITHIUM CARBONATE

CAPSULES, USP

Rev. 6/08

Rx Only

WARNING

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).

DESCRIPTION

Each capsule for oral administration contains 150 mg, 300 mg or 600 mg of lithium carbonate. In

addition, each capsule contains the following inactive ingredient:

150 mg: Talc.

300 mg: Talc.

600 mg: Colloidal Silicon Dioxide, Stearic Acid and Talc.

Capsule shell for the 150 mg potency contains: Gelatin and Titanium Dioxide.

Capsule shell for the 300 mg potency contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40,

FD&C Yellow #6, Gelatin and Titanium Dioxide.

Capsule shell for the 600 mg potency contains: Titanium Dioxide, Gelatin and FD&C Red #40.

The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl

Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol, and Synthetic Black Iron Oxide.

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.

Lithium Carbonate is a white, light, alkaline powder with molecular formula Li

CO and molecular

weight 73.89.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic

(DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.

Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar

Disorder.

Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those

episodes which may occur.

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 may produce a normalization of symptomatology

within 1 to 3 weeks.

CONTRAINDICATIONS

Lithium should generally not be given to patients with significant renal or cardiovascular disease,

severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, 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.

WARNINGS

Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of

lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in-vitro of

rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian

species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of

lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other

anomalies, especially Ebstein's anomaly. If the patient becomes pregnant while taking lithium, she

should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least

the first trimester unless it is determined that this would seriously endanger the mother.

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 bipolar patients

never exposed to lithium. The relationship between renal functional and morphologic changes and their

association with lithium therapy has 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.

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

levels (see DOSAGE AND ADMINISTRATION).

PRECAUTIONS

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 (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.

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.

Information for the Patients:

Outpatients and their families should be warned that the patient must discontinue lithium 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 impair mental and/or physical abilities. Caution patients about activities requiring alertness

(e.g., operating vehicles or machinery).

Drug Interactions:

Combined use of haloperidol and lithium. An encephalopathic syndrome (characterized by weakness,

lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum

enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated

with lithium plus haloperidol. A causal relationship between these events and the concomitant

administration of lithium and haloperidol has not been established; however, patients receiving such

combined therapy should be monitored closely for early evidence of neurological toxicity and treatment

discontinued promptly if such signs appear.

The possibility of similar adverse interactions with other antipsychotic medication exists.

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking

agents should be given with caution to patients receiving lithium.

Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors

are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase

serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage

may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDS): 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 nonsteriodal 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 BID with celecoxib 200 mg BID as compared

to subjects receiving lithium alone.

Pregnancy, Teratogenic Effects: Pregnancy Category D.

See WARNINGS section.

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.

Pediatric Use:

Since information regarding the safety and effectiveness of lithium 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.

ADVERSE REACTIONS

Lithium Toxicity:

The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater

than 1.5 mEq/L carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit

toxic signs at serum levels below 1.5 mEq/L.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of

lithium toxicity, and can occur at lithium levels below 2 mEq/L. At higher levels, giddiness, ataxia,

blurred vision, tinnitus, and a large output of dilute urine may be seen. Serum lithium levels above 3

mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum

lithium levels should not be permitted to exceed 2 mEq/L during the acute treatment phase.

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 are an inconvenience rather than a disabling condition, and usually subside with

continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage

is indicated.

The following adverse reactions have been reported and do not appear to be directly related to serum

lithium levels.

Neuromuscular: Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole

limbs), ataxia, choreo-athetotic movements, hyperactive deep tendon reflexes.

Central Nervous System: Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo,

incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor,

coma, acute dystonia, downbeat nystagmus.

Cardiovascular: Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node

dysfunction with severe bradycardia (which may result in syncope).

Neurological: 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.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea.

Genitourinary: Albuminuria, oliguria, polyuria, glycosuria.

Dermatologic: Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis,

alopecia and exacerbation of psoriasis.

Autonomic Nervous System: Blurred vision, dry mouth.

Thyroid Abnormalities: Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by

lower T and T . Iodine 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, dehydration, weight loss, tendency to sleep.

Miscellaneous reactions unrelated to dosage are: Transient electroencephalographic and

electrocardiographic changes, leukocytosis, headache, diffuse non-toxic goiter with or without

hypothyroidism, transient hyperglycemia, generalized pruritis with or without rash, cutaneous ulcers,

albuminuria, worsening of organic brain syndromes, excessive weight gain, edematous swelling of

ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste.

A single report has 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 of lithium. The mechanism

through which these symptoms (resembling Raynaud's Syndrome) developed is not known. Recovery

followed discontinuance.

OVERDOSAGE

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 functioning. 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.

DOSAGE AND ADMINISTRATION

Acute Mania - Optimal patient response to Lithium Carbonate usually can be established and maintained

with 600 mg t.i.d. Such doses will normally produce an effective serum lithium level ranging between 1

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 300 mg of Lithium Carbonate t.i.d. or q.i.d. will maintain this level.

Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be

monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L.

Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels

ordinarily tolerated by other patients.

N.B.: Blood samples for serum lithium determination should be drawn immediately prior to the next

N.B.: Blood samples for serum lithium determination 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.

HOW SUPPLIED

Lithium Carbonate Capsules USP, 150 mg are supplied as No. 4 White/White Opaque Hard Gelatin

Capsules Printed “West-ward 3188” in Black Ink and are available in:

Bottles of 30 capsules

Bottles of 100 capsules

Bottles of 500 capsules

Lithium Carbonate Capsules USP, 300 mg are supplied as No. 1 Grey/Yellow Opaque Hard Gelatin

Capsules Printed "West-ward 3189" in Black Ink and are available in:

Bottles of 100 capsules

Bottles of 1000 capsules

Lithium Carbonate Capsules USP, 600 mg are supplied as No. 0 White/Flesh Opaque Capsules Printed

“West-ward 3190” in Black Ink and are available in:

Bottles of 100 capsules

Unit Dose Boxes of 100 capsules

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured By:

Hikma Pharmaceuticals

P.O.Box 182400, Amman 11118-Jordan

Distributed By:

West-ward Pharmaceutical Corp.

Eatontown, NJ 07724

Revised June 2008

PRINCIPAL DISPLAY PANEL

Lithium Carbonate Capsules, USP 300 mg

LITHIUM CARBONATE

lithium carbonate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:59 115-135

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LITHIUM CARBO NATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8 H8 Z5UER6 6 )

LITHIUM CARBONATE

30 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

TALC (UNII: 7SEV7J4R1U)

GELATIN (UNII: 2G8 6 QN327L)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

BUTYL ALCO HO L (UNII: 8 PJ6 1P6 TS3)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

FD&C BLUE NO . 2 (UNII: L0 6 K8 R7DQK)

Product Characteristics

Color

GRAY, YELLOW

S core

no sco re

S hap e

CAPSULE

S iz e

20 mm

Flavor

Imprint Code

WW;318 9

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 115-135-0 1

10 0 in 1 BOTTLE, PLASTIC

2

NDC:59 115-135-10

10 0 0 in 1 BOTTLE, PLASTIC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 243

0 6 /27/20 0 2

Hikma Pharmaceutical

Labeler -

Hikma Pharmaceutical (534661645)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Hikma Pharmaceutical

5346 6 16 45

MANUFACTURE

Revised: 1/2010

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