Label: LITHIUM CARBONATE capsule

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).

Each capsule for oral administration contains: Lithium Carbonate USP……… 150 mg, 300 mg and 600 mg.
 
Inactive Ingredients
The capsules contain talc. The hard gelatin shell consists of gelatin, titanium dioxide, sodium lauryl sulphate and FD & C Red 40.
 
The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide E172 dye, potassium hydroxide.

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.

The empirical formula for Lithium Citrate is C6H 5Li3O7; molecular weight 209.92. Lithium acts as an antimanic.

Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89.

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.

Lithium Carbonate Capsule USP 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 Carbonate Capsule USP 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 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.

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

Lithium Toxicity
The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/mL carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/mL.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2.0 mEq/mL. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq/mL may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2.0 mEq/mL 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), unmasking of Brugada Syndrome (See WARNINGS: Unmasking of Brugada Syndromeand PRECAUTIONS: Information for the Patients).
 
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 T3 and T4. Iodine 131 uptake may be elevated. (See PRECAUTIONS). Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes:
Diffuse slowing, widening of 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, leucocytosis, 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.

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 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 of 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.

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 1.0 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 of 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/mL. 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 1.0 to 1.5 mEq/mL. 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 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.

Lithium Carbonate Capsules USP
 
150 mg White/White hard gelatin capsules (size 4)
Lithium Carbonate 150 mg Capsules are White/White size ‘4’ hard gelatin capsules, imprinted with ‘97’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 65977-5044-0)
Bottles of 100 Capsules (NDC 65977-5044-1)
Bottles of 500 Capsules (NDC 65977-5044-2)
Bottles of 1000 Capsules (NDC 65977-5044-3)
 
300 mg Pink/Pink hard gelatin capsules (size 1)
Lithium Carbonate 300 mg Capsules are Pink/Pink size ‘1’ hard gelatin capsules, imprinted with ‘98’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 65977-5045-0)
Bottles of 100 Capsules (NDC 65977-5045-1)
Bottles of 500 Capsules (NDC 65977-5045-2)
Bottles of 1000 Capsules (NDC 65977-5045-3)
Bottles of 5000 Capsules (NDC 65977-5045-4)
Blister Pack of 3x10’s (NDC 65977-5045-5)
 
600 mg Pink/White hard gelatin capsules (size ‘0EL’)
Lithium Carbonate 600 mg Capsules are Pink/White size ‘0EL’ hard gelatin capsules, imprinted with ‘141’ on body and ‘H’ on cap, containing white to off-white powder. They are supplied in
Bottles of 30 Capsules (NDC 65977-5046-0)
Bottles of 100 Capsules (NDC 65977-5046-1)
Bottles of 500 Capsules (NDC 65977-5046-2)
Bottles of 1000 Capsules (NDC 65977-5046-3)

Store and Dispense:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP/NF.


Revised: December 2011

Lithium Carbonate Capsules USP, 150 mg - 30s Count

 
Lithium Carbonate Capsules USP, 300 mg - 30s Count

 
Lithium Carbonate Capsules USP, 300 mg Foil

Lithium carbonate Capsules USP, 300 mg - Carton

Lithium Carbonate Capsules USP, 600 mg - 30s Count