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:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Adı):

LITHIUM CARBONATE

Kompozisyon:

LITHIUM CARBONATE 300 mg

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:

Lithium Carbonate Extended Release Tablets, USP 300 mg beige-colored, biconvex, film-coated tablets (Identified 54 107) 0615-5593-39 Blisterpacks of 30 0615-5593-31 Blisterpacks of 31 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in tight, child-resistant container as defined in USP/NF. 10002523/04 O ctober 2007 © RLI, 2007

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, FILM COATED, EXTENDED
RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
LITHIUM CARBONATEEXTENDED RELEASE TABLETS USP, 300 MG
RX ONLY
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, 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 beige-colored, extended release tablet contains 300 mg of lithium
carbonate. This slowly
dissolving, film-coated tablet for oral administration is designed to
give lower serum lithium peak
concentrations than obtained with conventional oral lithium dosage
forms. Inactive ingredients consist of
calcium stearate, Opadry II (Flesh), povidone, sodium chloride, sodium
lauryl sulfate, and sorbitol.
Opadry II (Flesh) contains hypromellose, iron oxide red, iron oxide
yellow, polyethylene glycol,
polydextrose, titanium dioxide, and triacetin.
The tablets meet the requirements of USP Dissolution Test 5 in the USP
monograph for Lithium
Carbonate Extended Release Tablets USP, 300 mg.
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
maintenan