LITHIUM CARBONATE ER- lithium carbonate tablet

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Bryant Ranch Prepack

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Lithium Carbonate Extended-Release Tablets are indicated in the treatment of manic episodes of manic-depressive illness. Maintenance therapy prevents or diminishes the intensity of subsequent episodes in those manic-depressive patients with a history of mania. 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 Carbonate Extended-Release Tablets may produce a normalization of symptomatology within 1 to 3 weeks.

Prehľad produktov:

NDC: 63629-7903-1: 30 Tablets in a BOTTLE

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

LITHIUM CARBONATE ER- LITHIUM CARBONATE TABLET
BRYANT RANCH PREPACK
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LITHIUM CARBONATE EXTENDED-RELEASE TABLETS USP, 450 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, crystalline powder with molecular formula Li
CO and molecular weight 73.89
g/mol. 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
Each off-white to pale yellow, circular, beveled edged, biconvex
uncoated tablets with
‘224’ debossed on one side, ‘G’ and a break line debossed on
the other side, contains
lithium carbonate, 450 mg. Inactive ingredients consist of ferric
oxide yellow,
hypromellose, magnesium stearate, microcrystalline cellulose, sodium
alginate, sodium
starch glycolate and talc. Product meets USP Dissolution Test 2.
Lithium Carbonate Extended-Release Tablets USP, 450 mg are designed to
release a
portion of the dose initially and the remainder gradually; the release
pattern of the
controlled release tablets reduces the variability in lithium blood
levels seen with the
immediate release dosage forms.
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 manic-depressive illness. Maintenance therapy prevents or
diminishes the
intensity of subsequent episodes in those manic-depressive patients
with a history of
mania.
Typical symptoms o