LITHIUM CARBONATE tablet, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Hikma Pharmaceuticals USA Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. Lithium carbonate 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.

Produktsammanfattning:

Lithium Carbonate Extended-release Tablets, USP 300 mg tablets are supplied as beige coated, round biconvex tablets with “54 107” debossed on one side and plain on the other side. NDC 0054-0021-25: Bottle of 100 Tablets NDC 0054-0021-29: Bottle of 500 Tablets 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. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000334/01 Revised October 2022

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LITHIUM CARBONATE- LITHIUM CARBONATE TABLET, EXTENDED RELEASE
HIKMA PHARMACEUTICALS USA INC.
----------
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP
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
Lithium Carbonate Extended-release Tablets, USP contain lithium
carbonate, USP, a
white granular 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.
Lithium Carbonate Extended-release Tablets, USP are available for oral
administration
containing 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. Each tablet contains the
following inactive
ingredients: calcium stearate, Opadry II (Beige), povidone, sodium
chloride, sodium
lauryl sulfate and sorbitol. Opadry II (Beige) contains: hypromellose,
polydextrose,
polyethylene glycol, red iron oxide, titanium dioxide, triacetin and
yellow iron oxide.
The tablets meet the requirements of USP Dissolution Test 5 in the USP
monograph for
Lithium Carbonate Extended-release Tablets USP, 300 mg.
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 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. Lithium carbonate is also indicated as a
maintenance
treatment for individuals with a diagnosis o