LITHIUM CARBONATE tablet, film coated, 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:

REMEDYREPACK INC.

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lithium carbonate extended-release tablets are indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium carbonate extended-release tablets are 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.

Product summary:

Lithium Carbonate Extended-Release Tablets, USP are available containing 300 mg of lithium carbonate, USP. The 300 mg tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and LC over 300 on the other side. They are available as follows: NDC: 70518-0904-00 PACKAGING: 30 in 1 BLISTER PACK Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED
RELEASE
REMEDYREPACK INC.
----------
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.
Each peach, film-coated, extended-release tablet contains 300 mg of
lithium carbonate.
This slowly dissolving film-coated tablet is designed to give lower
serum lithium peak
concentrations than obtained with conventional oral lithium dosage
forms. Inactive
ingredients consist of calcium stearate, hypromellose, polydextrose,
povidone,
polyethylene glycol, red iron oxide, sodium chloride, sodium lauryl
sulfate, sorbitol,
titanium dioxide, triacetin, and yellow iron oxide.
_Meets USP Dissolution Test 4._
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 Bipolar Disorder. Bipolar Disorder, Manic (DSM-IV) is
equivalent to Manic
Depressive illness, Manic, in the older DSM-II terminology. Lithium
carbonate extended-
release tablets are 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