LITHOBID- 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:

ANI Pharmaceuticals, Inc.

INN (International Name):

LITHIUM CARBONATE

Composition:

LITHIUM CARBONATE 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LITHOBID® (lithium carbonate) is 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. LITHOBID® 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.

Product summary:

LITHOBID® (Lithium Carbonate USP) Extended-Release Tablets, 300 mg, peach-colored imprinted “LITHOBID 300” NDC 62559-280-01 Bottle of 100

Authorization status:

New Drug Application

Summary of Product characteristics

LITHOBID- LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED RELEASE
ANI PHARMACEUTICALS, INC.
----------
LITHOBID (LITHIUM CARBONATE USP)
EXTENDED-RELEASE TABLETS 300 MG
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
LITHOBID tablets contain lithium carbonate, a white odorless alkaline
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-colored, 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, carnauba wax,
cellulose compounds,
FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C
Yellow No. 6
Aluminum Lake, povidone, propylene glycol, sodium chloride, sodium
lauryl sulfate,
sodium starch glycolate, sorbitol, and titanium dioxide. Product meets
USP Drug Release
Test 1.
ACTIONS
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
LITHOBID (lithium carbonate) is 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. LITHOBID 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.
Typica