LITHIUM CARBONATE tablet, film coated, extended release

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

A-S Medication Solutions

INN (International ime):

LITHIUM CARBONATE

Sastav:

LITHIUM CARBONATE 300 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Product: 50090-1470 NDC: 50090-1470-0 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED
RELEASE
A-S MEDICATION SOLUTIONS
----------
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS
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
Lithium Carbonate Extended-Release Tablets, USP contain lithium
carbonate, USP a white
crystalline 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 light pink to pink colored circular, biconvex, coated,
extended-release tablet
contains 300 mg of lithium carbonate, USP. 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 sodium chloride,
povidone, sorbitol, sodium starch glycolate, sodium lauryl sulfate,
calcium stearate,
hypromellose, titanium dioxide, polyethylene glycol and iron oxide
red.
Product meets USP Dissolution 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
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