LITHIUM CARBONATE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)

Available from:

A-S Medication Solutions

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lithium carbonate extended-release tablets are 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 extended-release tablets may produce a normalization of symptomatology within 1 to 3 weeks.

Product summary:

Product: 50090-2754 NDC: 50090-2754-0 1 TABLET, EXTENDED RELEASE in a BLISTER PACK / 30 in a BOX, UNIT-DOSE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, EXTENDED RELEASE
A-S MEDICATION SOLUTIONS
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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
Lithium carbonate extended-release tablets, USP contain lithium
carbonate, USP, a white,
granular, odorless powder with molecular formula Li
CO 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.
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS
Each white to off-white, round, scored tablet, debossed with LC above
the score and
450 below the score on one side of the tablet and M on the other side,
contains lithium
carbonate 450 mg. Inactive ingredients consist of magnesium stearate,
povidone,
sodium alginate, and sodium starch glycolate (potato).
_Meets USP Dissolution Test 3._
Lithium carbonate extended-release tablets 450 mg are designed to
release a portion of
the dose initially and the remainder gradually; the release pattern of
the extended-
release tablets reduces the variability in lithium blood levels seen
with the immediate
release dosage forms.
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 carbonate extended-release tablets are 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 ju