LITHIUM CARBONATE tablet, film coated, extended release

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

A-S Medication Solutions

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Product: 50090-6052 NDC: 50090-6052-0 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED
RELEASE
A-S MEDICATION SOLUTIONS
----------
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